{"id":"semaglutide","rwe":[{"pmid":"41906074","year":"2026","title":"GLP-1 and dual GIP/GLP-1 agonists in obese patients with HFpEF: a systematic review and meta-analysis of RCTs.","finding":"","journal":"BMC cardiovascular disorders","studyType":"Clinical Study"},{"pmid":"41906069","year":"2026","title":"Revisional Metabolic and Bariatric Surgery Versus Semaglutide: Which Strategy Has Greater Efficacy for Recurrent Weigh Gain After Primary Bariatric Surgery?","finding":"","journal":"Obesity surgery","studyType":"Clinical Study"},{"pmid":"41903539","year":"2026","title":"Advancing precision health discovery in a genetically diverse health system.","finding":"","journal":"Cell","studyType":"Clinical Study"},{"pmid":"41902614","year":"2026","title":"Real-World Weight-Loss Outcomes in Weight-Reduced Patients Treated With Tirzepatide.","finding":"","journal":"Obesity (Silver Spring, Md.)","studyType":"Clinical Study"},{"pmid":"41902362","year":"2026","title":"Effectiveness of a Psychiatrist-Led Clinic for Metabolic Health in Severe Mental Illness: A Retrospective Chart Review Study.","finding":"","journal":"Acta psychiatrica Scandinavica","studyType":"Clinical Study"}],"_fda":{"id":"dfe441cd-c20f-452b-a8a5-3a6017b6b006","set_id":"27f15fac-7d98-4114-a2ec-92494a91da98","openfda":{"nui":["N0000178480","M0160181","N0000020058"],"unii":["53AXN4NNHX"],"route":["ORAL"],"rxcui":["2200644","2200650","2200652","2200654","2200656","2200658","2707547","2707549","2707551","2707553","2707555","2707557","2736944","2736946","2736948"],"spl_id":["dfe441cd-c20f-452b-a8a5-3a6017b6b006"],"brand_name":["OZEMPIC","RYBELSUS"],"spl_set_id":["27f15fac-7d98-4114-a2ec-92494a91da98"],"package_ndc":["0169-1715-30","0169-1715-90","0169-1704-30","0169-1709-30","0169-4303-01","0169-4303-13","0169-4303-90","0169-4303-93","0169-4303-30","0169-4303-99","0169-4307-01","0169-4307-13","0169-4307-30","0169-4314-01","0169-4314-13","0169-4314-30","0169-4815-30","0169-4815-90","0169-4804-30","0169-4809-30"],"product_ndc":["0169-1704","0169-1715","0169-1709","0169-4303","0169-4307","0169-4314","0169-4815","0169-4804","0169-4809"],"generic_name":["ORAL SEMAGLUTIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Glucagon-Like Peptide 1 [CS]"],"substance_name":["SEMAGLUTIDE"],"pharm_class_epc":["GLP-1 Receptor Agonist [EPC]"],"pharm_class_moa":["Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"],"manufacturer_name":["Novo Nordisk"],"application_number":["NDA213051"],"is_original_packager":[true]},"version":"12","pregnancy":["8.1 Pregnancy Risk Summary Available data with semaglutide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations ). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. RYBELSUS or OZEMPIC tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at exposure below the MRHD (rabbit) and ≥10-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species (see Data ). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with an HbA 1c >7 and has been reported to be as high as 20% to 25% in women with an HbA 1c >10. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease Associated Maternal and Fetal Risk : Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth and macrosomia related morbidity. Data Animal Data : In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure. In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.06-, 0.6- and 4.4-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures. In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.9-, 9.9- and 29-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50. Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly (≥9X human exposure). In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.3-, 6.4- and 14-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at ≥0.075 mg/kg twice weekly (≥6X human exposure). Salcaprozate sodium (SNAC), an absorption enhancer in RYBELSUS and OZEMPIC tablets, crosses the placenta and reaches fetal tissues in rats. In a pre- and postnatal development study in pregnant Sprague Dawley rats, SNAC was administered orally at 1,000 mg/kg/day (exposure levels were not measured) on Gestation Day 7 through Lactation Day 20. An increase in gestation length, an increase in the number of stillbirths and a decrease in pup viability were observed."],"overdosage":["10 OVERDOSAGE In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of semaglutide of approximately 1 week."],"description":["11 DESCRIPTION RYBELSUS and OZEMPIC tablets, for oral use, contain semaglutide, a GLP-1 receptor agonist. The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C 187 H 291 N 45 O 59 and the molecular weight is 4113.58 g/mol. Structural formula: Semaglutide is a white to almost white hygroscopic powder. RYBELSUS tablets contain 3 mg, 7 mg or 14 mg of semaglutide and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC). OZEMPIC tablets contain 1.5 mg, 4 mg or 9 mg of semaglutide and the following inactive ingredients: magnesium stearate and SNAC. structural_formula"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RYBELSUS strengths are available as follows: Tablet Strength Description Package Configuration NDC Number 3 mg White to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side Bottle of 30 tablets 0169-4303-30 7 mg White to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side Bottle of 30 tablets 0169-4307-30 14 mg White to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side Bottle of 30 tablets 0169-4314-30 OZEMPIC tablet strengths are available as follows: Tablet Strength Description Package Configuration NDC Number 1.5 mg White to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side Bottle of 30 tablets 0169-1715-30 4 mg White to light yellow, round shaped debossed with “4” on one side and “novo” on the other side Bottle of 30 tablets 0169-1704-30 9 mg White to light yellow, round shaped debossed with “9” on one side and “novo” on the other side Bottle of 30 tablets 0169-1709-30 Storage and Handling Store RYBELSUS and OZEMPIC tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store and dispense in the original bottle. Store tablets in the original bottle until use to protect tablets from moisture. Store product in a dry place away from moisture."],"spl_medguide":["Medication Guide MEDICATION GUIDE RYBELSUS ® (reb-EL-sus) (semaglutide) tablets, for oral use OZEMPIC ® (oh-ZEM-pick) (semaglutide) tablets, for oral use Read this Medication Guide before you start using RYBELSUS or OZEMPIC tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about RYBELSUS and OZEMPIC tablets? RYBELSUS and OZEMPIC tablets may cause serious side effects, including: • Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS and OZEMPIC tablets and other medicines that work like RYBELSUS and OZEMPIC tablets caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS and OZEMPIC tablets will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. • Do not use RYBELSUS or OZEMPIC tablets if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). What are RYBELSUS and OZEMPIC tablets? RYBELSUS and OZEMPIC tablets are prescription medicines used: • along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. • to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus who are at high risk for these events. It is not known if RYBELSUS and OZEMPIC tablets are safe and effective for use in children. Do not use RYBELSUS or OZEMPIC tablets if: • you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). • you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS or OZEMPIC tablets. See the end of this Medication Guide for a complete list of ingredients in RYBELSUS and OZEMPIC tablets. See “What are the possible side effects of RYBELSUS and OZEMPIC tablets?” for symptoms of a serious allergic reaction . Before using RYBELSUS or OZEMPIC tablets, tell your healthcare provider if you have any other medical conditions, including if you: • have or have had problems with your pancreas or kidneys. • have a history of vision problems related to your diabetes. • are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). • are pregnant or plan to become pregnant. It is not known if RYBELSUS and OZEMPIC tablets will harm your unborn baby. You should stop using RYBELSUS or OZEMPIC tablets 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant. • are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS or OZEMPIC tablets. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS and OZEMPIC tablets may affect the way some medicines work, and some medicines may affect the way RYBELSUS and OZEMPIC tablets work. Before using RYBELSUS or OZEMPIC tablets, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take RYBELSUS or OZEMPIC tablets? • Take RYBELSUS or OZEMPIC tablets exactly as your healthcare provider tells you to. • Take 1 RYBELSUS or OZEMPIC tablet by mouth on an empty stomach in the morning with water (no more than 4 ounces). Do not take RYBELSUS or OZEMPIC tablets with any other liquids besides water. • Do not split, crush, chew, or dissolve RYBELSUS or OZEMPIC tablets. Swallow RYBELSUS or OZEMPIC tablets whole. • After 30 minutes, you can eat, drink, or take other oral medicines. • Do not take more than 1 RYBELSUS or OZEMPIC tablet each day. • If you miss a dose of RYBELSUS or OZEMPIC tablets, skip the missed dose and go back to your regular schedule. • If you take too much RYBELSUS or OZEMPIC tablets, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away. Advice is also available online at poisonhelp.org. Your dose of RYBELSUS or OZEMPIC tablets and other diabetes medicines may need to change because of: change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, fever, trauma, infection, surgery or because of other medicines you take. What are the possible side effects of RYBELSUS and OZEMPIC tablets? RYBELSUS and OZEMPIC tablets may cause serious side effects, including: • See “What is the most important information I should know about RYBELSUS and OZEMPIC tablets?” • inflammation of your pancreas (pancreatitis). Stop using RYBELSUS or OZEMPIC tablets and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. • changes in vision. Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS or OZEMPIC tablets. • low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use RYBELSUS or OZEMPIC tablets with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: o dizziness or light-headedness o blurred vision o anxiety, irritability, or mood changes o sweating o slurred speech o hunger o confusion or drowsiness o shakiness o weakness o headache o fast heartbeat o feeling jittery • dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. • severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use RYBELSUS or OZEMPIC tablets. Tell your healthcare provider if you have stomach problems that are severe or will not go away. • serious allergic reactions. Stop using RYBELSUS or OZEMPIC tablets and get medical help right away, if you have any symptoms of a serious allergic reaction including: o swelling of your face, lips, tongue or throat o problems breathing or swallowing o severe rash or itching o fainting or feeling dizzy o very rapid heartbeat • gallbladder problems. Gallbladder problems have happened in some people who take RYBELSUS and OZEMPIC tablets. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include: o pain in your upper stomach (abdomen) o yellowing of skin or eyes (jaundice) o fever o clay-colored stools • food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). RYBELSUS and OZEMPIC tablets may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking RYBELSUS or OZEMPIC tablets before you are scheduled to have surgery or other procedures. The most common side effects of RYBELSUS and OZEMPIC tablets may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting and constipation. Nausea, vomiting and diarrhea are most common when you first start RYBELSUS or OZEMPIC tablets. Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of RYBELSUS and OZEMPIC tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088. How should I store RYBELSUS and OZEMPIC tablets? • Store RYBELSUS or OZEMPIC tablets at room temperature between 68°F and 77°F (20°C to 25°C). • Store in a dry place away from moisture. • Store tablets in the original closed RYBELSUS or OZEMPIC bottle until you are ready to take one. Do not store in any other container. • Keep RYBELSUS, OZEMPIC tablets and all medicines out of the reach of children. General information about the safe and effective use of RYBELSUS and OZEMPIC tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RYBELSUS or OZEMPIC tablets for a condition for which it was not prescribed. Do not give RYBELSUS or OZEMPIC tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RYBELSUS or OZEMPIC tablets that is written for health professionals. What are the ingredients in RYBELSUS and OZEMPIC tablets? Active Ingredient in RYBELSUS and OZEMPIC : semaglutide Inactive Ingredients in RYBELSUS: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium Inactive ingredients in OZEMPIC : magnesium stearate and salcaprozate sodium Marketed by: Novo Nordisk Inc., Plainsboro, NJ 08536 RYBELSUS ® and OZEMPIC ® are registered trademarks of Novo Nordisk A/S. Patent Information: http://www.novonordisk-us.com/products/product-patents.html © 2026 Novo Nordisk For more information, go to www.RYBELSUS.com, www.OZEMPIC.com or call 1-833-GLP-PILL. This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 1/2026"],"boxed_warning":["WARNING: RISK OF THYROID C-CELL TUMORS • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • RYBELSUS and OZEMPIC tablets are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of RYBELSUS or OZEMPIC tablets and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with RYBELSUS or OZEMPIC tablets [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). • RYBELSUS and OZEMPIC tablets are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 )."],"geriatric_use":["8.5 Geriatric Use In the pool of glycemic control trials, 1,229 (30%) patients treated with semaglutide tablets were 65 years of age and over and 199 (5%) patients treated with semaglutide tablets were 75 years of age and over [see Clinical Studies ( 14 )] . In Trial 8, one of the CV outcomes trials, 891 (56%) patients treated with semaglutide tablets were 65 years of age and over and 200 (13%) patients treated with semaglutide tablets were 75 years of age and over. No overall differences in safety or effectiveness for semaglutide tablets have been observed between patients 65 years of age and older and younger adult patients."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of RYBELSUS and OZEMPIC tablets have not been established in pediatric patients."],"effective_time":"20260130","clinical_studies":["14 CLINICAL STUDIES 14.1 Overview of Clinical Studies The effectiveness of OZEMPIC tablets (1.5 mg, 4 mg and 9 mg strengths) [see Dosage and Administration ( 2.2 )] and RYBELSUS (3 mg, 7, mg and 14 mg strengths) [see Dosage and Administration ( 2.3 )] has been established as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus based on adequate and well-controlled studies of RYBELSUS in adult patients with type 2 diabetes mellitus [see Clinical Pharmacology ( 12.3 )] . Below is a display of the efficacy results of the adequate and well-controlled studies of RYBELSUS, referred to below as semaglutide tablets, in adult patients with type 2 diabetes mellitus. Semaglutide tablets have been studied as monotherapy and in combination with metformin, sulfonylureas, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulins, and thiazolidinediones in patients with type 2 diabetes mellitus. The efficacy of semaglutide tablets was compared with placebo, empagliflozin, sitagliptin and liraglutide. Semaglutide tablets have also been studied in patients with type 2 diabetes mellitus with mild and moderate renal impairment. In patients with type 2 diabetes mellitus, semaglutide tablets produced clinically significant reduction from baseline in HbA 1c compared with placebo. The efficacy of semaglutide tablets was not impacted by baseline age, sex, race, ethnicity, BMI, body weight, duration of diabetes and degree of renal impairment. 14.2 Monotherapy Use of Semaglutide Tablets in Patients with Type 2 Diabetes Mellitus In a 26-week double-blind trial (Trial 1, NCT02906930), 703 adult patients with type 2 diabetes mellitus inadequately controlled with diet and exercise were randomized to semaglutide tablets 3 mg, semaglutide tablets 7 mg or semaglutide tablets14 mg orally once daily or placebo. Patients had a mean age of 55 years and 51% were men. The mean duration of type 2 diabetes mellitus was 3.5 years, and the mean BMI was 32 kg/m 2 . Overall, 75% were White, 5% were Black or African American and 17% were Asian; 26% identified as Hispanic or Latino ethnicity. Monotherapy with semaglutide tablets7 mg and semaglutide tablets 14 mg tablets once daily for 26 weeks resulted in a statistically significant reduction in HbA 1c compared with placebo (see Table 4 ). Table 4. Trial 1 Results at Week 26 in a Monotherapy Trial of Semaglutide Tablets in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise Placebo Semaglutide Tablets 7 mg Semaglutide Tablets 14 mg Intent-to-Treat (ITT) Population (N) a 178 175 175 HbA 1c (%) Baseline (mean) 7.9 8 8 Change at Week 26 b -0.3 -1.2 -1.4 Difference from placebo b [95% CI] -0.9 [-1.1; -0.6] c -1.1 [-1.3; -0.9] c Patients (%) achieving HbA 1c <7% 31 69 77 FPG (mg/dL) Baseline (mean) 160 162 158 Change at Week 26 b -3 -28 -33 a The intent-to-treat population includes all randomized patients. At Week 26, the primary HbA 1c endpoint was missing for 5.6%, 8.6% and 8.6% of patients randomized to placebo, semaglutide tablets 7 mg and semaglutide tablets14 mg, respectively. Missing data were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at Week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 15%, 2% and 1% of patients randomized to placebo, semaglutide tablets 7 mg and semaglutide tablets 14 mg, respectively. b Estimated using an ANCOVA model based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value and region. c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity. The mean baseline body weight was 88.6 kg, 89 kg and 88.1 kg in the placebo, semaglutide tablets 7 mg, and semaglutide tablets 14 mg arms, respectively. The mean changes from baseline to week 26 were -1.4 kg, -2.3 kg and -3.7 kg in the placebo, semaglutide tablets7 mg and semaglutide tablets 14 mg arms, respectively. The difference from placebo (95% CI) for semaglutide tablets 7 mg was -0.9 kg (-1.9, 0.1) and for semaglutide tablets 14 mg was -2.3 kg (-3.1, -1.5). 14.3 Combination Therapy Use of Semaglutide Tablets in Patients with Type 2 Diabetes Mellitus Combination with Metformin In a 26-week trial (Trial 2, NCT02863328), 822 adult patients with type 2 mellitus diabetes were randomized to semaglutide tablets 14 mg orally once daily or empagliflozin 25 mg orally once daily, all in combination with metformin. Patients had a mean age of 58 years and 50% were men. The mean duration of type 2 diabetes mellitus was 7.4 years and the mean BMI was 33 kg/m 2 . Overall, 86% were White, 7% were Black or African American and 6% were Asian; 24% identified as Hispanic or Latino ethnicity. Treatment with semaglutide tablets 14 mg once daily for 26 weeks resulted in a statistically significant reduction in HbA 1c compared to empagliflozin 25 mg once daily (see Table 5 ). Table 5. Trial 2 Results at Week 26 in a Trial of Semaglutide Tablets Compared to Empagliflozin in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin Semaglutide Tablets 14 mg Empagliflozin 25 mg Intent-to-Treat (ITT) Population (N) a 411 410 HbA 1c (%) Baseline (mean) 8.1 8.1 Change at Week 26 b -1.3 -0.9 Difference from empagliflozin b [95% CI] -0.4 [-0.6, -0.3] c Patients (%) achieving HbA 1c <7% 67 40 FPG (mg/dL) Baseline (mean) 172 174 Change at Week 26 b -36 -36 a The intent-to-treat population includes all randomized patients. At Week 26, the primary HbA 1c endpoint was missing for 4.6% and 3.7% of patients randomized to semaglutide tablets 14 mg and empagliflozin 25 mg, respectively. Missing data were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at Week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 1.9% and 1.2% of patients randomized to semaglutide tablets 14 mg and empagliflozin 25 mg, respectively. b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value and region. c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity. The mean baseline body weight was 91.9 kg and 91.3 kg in the semaglutide tablets 14 mg and empagliflozin 25 mg arms, respectively. The mean changes from baseline to Week 26 were -3.8 kg and -3.7 kg in the semaglutide tablets 14 mg and empagliflozin 25 mg arms, respectively. The difference from empagliflozin (95% CI) for semaglutide tablets 14 mg was -0.1 kg (-0.7, 0.5). Combination with Metformin or Metformin with Sulfonylurea In a 26-week, double-blind trial (Trial 3, NCT02607865), 1864 adult patients with type 2 mellitus diabetes on metformin alone or metformin with sulfonylurea were randomized to semaglutide tablets 3 mg, semaglutide tablets 7 mg, semaglutide tablets 14 mg orally once daily or sitagliptin 100 mg once daily. Patients had a mean age of 58 years and 53% were men. The mean duration of type 2 diabetes mellitus was 8.6 years, and the mean BMI was 32 kg/m 2 . Overall, 71% were White, 9% were Black or African American and 13% were Asian; 17% identified as Hispanic or Latino ethnicity. Treatment with semaglutide tablets 7 mg and semaglutide tablets 14 mg once daily for 26 weeks resulted in a statistically significant reduction in HbA 1c compared to sitagliptin 100 mg once daily (see Table 6 ). Table 6. Trial 3 Results at Week 26 in a Trial of Semaglutide Tablets Compared to Sitagliptin 100 mg Once Daily in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin or Metformin with Sulfonylurea Semaglutide Tablets 7 mg Semaglutide Tablets 14 mg Sitagliptin 100 mg Intent-to-Treat (ITT) Population (N) a 465 465 467 HbA 1c (%) Baseline (mean) 8.4 8.3 8.3 Change at Week 26 b -1 -1.3 -0.8 Difference from sitagliptin b [95% CI] -0.3 [-0.4; -0.1] c -0.5 [-0.6; -0.4] c Patients (%) achieving HbA 1c <7% 44 56 32 FPG (mg/dL) Baseline (mean) 170 168 172 Change at Week 26 b -21 -31 -15 a The intent-to-treat population includes all randomized patients. At Week 26, the primary HbA 1c endpoint was missing for 5.8%, 6.2% and 4.5% of patients randomized to semaglutide tablets 7 mg, semaglutide tablets 14 mg and sitagliptin 100 mg, respectively. Missing values were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at Week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 2.4%, 1.1% and 2.8% of patients randomized to semaglutide tablets 7 mg, semaglutide tablets 14 mg and sitagliptin 100 mg, respectively. b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value, background medication and region. c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity. The mean baseline body weight was 91.3 kg, 91.2 kg and 90.9 kg in the semaglutide tablets 7 mg, semaglutide tablets 14 mg and sitagliptin 100 mg arms, respectively. The mean changes from baseline to Week 26 were -2.2 kg, -3.1 kg and -0.6 kg in the semaglutide tablets 7 mg, semaglutide tablets 14 mg and sitagliptin 100 mg arms, respectively. The difference from sitagliptin (95% CI) for semaglutide tablets 7 mg was -1.6 kg (-2.0, -1.1) and semaglutide tablets 14 mg was -2.5 kg (-3.0, -2.0). Combination with Metformin or Metformin with SGLT-2 Inhibitors In a 26-week, double-blind, double-dummy trial (Trial 4, NCT02863419), 711 adult patients with type 2 diabetes mellitus on metformin alone or metformin with SGLT-2 inhibitors were randomized to semaglutide tablets 14 mg orally once daily, liraglutide 1.8 mg subcutaneous injection once daily or placebo. Patients had a mean age of 56 years and 52% were men. The mean duration of type 2 diabetes mellitus was 7.6 years and the mean BMI was 33 kg/m 2 . Overall, 73% were White, 4% were Black or African American and 13% were Asian; 6% identified as Hispanic or Latino ethnicity. Treatment with semaglutide tablets 14 mg once daily for 26 weeks resulted in statistically significant reductions in HbA 1c compared to placebo. Treatment with semaglutide tablets 14 mg once daily for 26 weeks resulted in non-inferior reductions in HbA 1c compared to liraglutide 1.8 mg (see Table 7 ). Table 7. Trial 4 Results at Week 26 in a Trial of Semaglutide Tablets Compared to Liraglutide and Placebo in Adult Patients with Type 2 Diabetes Mellitus in Combination with Metformin or Metformin with SGLT-2i Placebo Semaglutide Tablets 14 mg Liraglutide 1.8 mg Intent-to-Treat (ITT) Population (N) a 142 285 284 HbA 1c (%) Baseline (mean) 7.9 8 8 Change at Week 26 b -0.2 -1.2 -1.1 Difference from placebo b [95% CI] -1.1 [-1.2; -0.9] c Difference from liraglutide b [95% CI] -0.1 [-0.3; 0] Patients (%) achieving HbA 1c <7% 14 68 62 FPG (mg/dL) Baseline (mean) 167 167 168 Change at Week 26 b -7 -36 -34 a The intent-to-treat population includes all randomized patients. At Week 26, the primary HbA 1c endpoint was missing for 5.6%, 4.2% and 2.5% of patients randomized to placebo, liraglutide 1.8 mg and semaglutide tablets 14 mg, respectively. Missing values were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at Week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 7.7%, 3.2% and 3.5% of patients randomized to placebo, liraglutide 1.8 mg and semaglutide tablets 14 mg respectively. b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value, background medication and region. c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity. The mean baseline body weight was 93.2 kg, 95.5 kg and 92.9 kg in the placebo, liraglutide 1.8 mg and semaglutide tablets 14 mg arms, respectively. The mean changes from baseline to Week 26 were -0.5 kg, -3.1 kg and -4.4 kg in the placebo, liraglutide 1.8 mg and semaglutide tablets 14 mg arms, respectively. The difference from placebo (95% CI) for semaglutide tablets 14 mg was -3.8 kg (-4.7, -3). The difference from liraglutide 1.8 mg for semaglutide tablets 14 mg was -1.2 (-1.9, -0.6). Combination in patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment with Metformin alone, Sulfonylurea alone, Basal Insulin alone or Metformin in Combination with either Sulfonylurea or Basal Insulin In a 26-week, double-blind trial (Trial 5, NCT02827708), 324 adult patients with moderate renal impairment (eGFR CKD-EPI 30 to 59 mL/min/1.73 m 2 ) were randomized to semaglutide tablets 14 mg orally once daily or placebo once daily. Semaglutide tablets were added to the patient’s stable pre-trial antidiabetic regimen. The insulin dose was reduced by 20% at randomization for patients on basal insulin. Dose reduction of insulin and sulfonylurea was allowed in case of hypoglycemia; up titration of insulin was allowed but not beyond the pre-trial dose. Patients had a mean age of 70 years and 48% were men. The mean duration of type 2 diabetes mellitus was 14 years and the mean BMI was 32 kg/m 2 . Overall, 96% were White, 4% were Black or African American and 0.3% were Asian; 6.5% identified as Hispanic or Latino ethnicity. 39.5% of patients had an eGFR value of 30 to 44 mL/min/1.73 m 2 . Treatment with semaglutide tablets 14 mg once daily for 26 weeks resulted in a statistically significant reduction in HbA 1c from baseline compared to placebo (see Table 8 ). Table 8. Trial 5 Results at Week 26 in a Trial of Semaglutide Tablets Compared to Placebo in Patients with Moderate Renal Impairment Placebo Semaglutide Tablets 14 mg Intent-to-Treat (ITT) Population (N) a 161 163 HbA 1c (%) Baseline (mean) 7.9 8 Change at Week 26 b -0.2 -1 Difference from placebo b [95% CI] -0.8 [-1.0; -0.6] c Patients (%) achieving HbA 1c <7% 23 58 FPG (mg/dL) Baseline (mean) 164 164 Change at Week 26 b -7 -28 a The intent-to-treat population includes all randomized patients including patients on rescue medication. At Week 26, the primary HbA 1c endpoint was missing for 3.7% and 5.5% of patients randomized to placebo and semaglutide tablets 14 mg, respectively. Missing values were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at Week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 10% and 4.3% of patients randomized to placebo and semaglutide tablets 14 mg, respectively. b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value, background medication, renal status and region. c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity. The mean baseline body weight was 90.4 kg and 91.3 kg in the placebo and semaglutide tablets 14 mg arms, respectively. The mean changes from baseline to Week 26 were -0.9 kg and -3.4 kg in the placebo and semaglutide tablets 14 mg arms, respectively. The difference from placebo (95% CI) for semaglutide tablets 14 mg was -2.5 kg (-3.2, -1.8). Combination with Insulin with or without Metformin In a 26-week double blind trial (Trial 6, NCT03021187), 731 adult patients with type 2 diabetes mellitus inadequately controlled on insulin (basal, basal/bolus or premixed) with or without metformin, were randomized to semaglutide tablets 3 mg, 7 mg and 14 mg orally once daily or placebo once daily. All patients reduced their insulin dose by 20% at randomization to reduce the risk of hypoglycemia. Patients were allowed to increase the insulin dose only up to the starting insulin dose prior to randomization. Patients had a mean age of 61 years and 54% were men. The mean duration of type 2 diabetes mellitus was 15 years and the mean BMI was 31 kg/m 2 . Overall, 51% were White, 7% were Black or African American and 36% were Asian; 13% identified as Hispanic or Latino ethnicity. Treatment with semaglutide tablets 7 mg and 14 mg once daily for 26 weeks resulted in a statistically significant reduction in HbA 1c from baseline compared to placebo once daily (see Table 9 ). Table 9. Trial 6 Results at Week 26 in a Trial of Semaglutide Tablets Compared to Placebo in Adult Patients with Type 2 Diabetes Mellitus in Combination with Insulin alone or with Metformin Placebo Semaglutide Tablets 7 mg Semaglutide Tablets 14 mg Intent-to-Treat (ITT) Population (N) a 184 182 181 HbA 1c (%) Baseline (mean) 8.2 8.2 8.2 Change at Week 26 b -0.1 -0.9 -1.3 Difference from placebo b [95% CI] -0.9 [-1.1; -0.7] c -1.2 [-1.4; -1] c Patients (%) achieving HbA 1c <7% 7 43 58 FPG (mg/dL) Baseline (mean) 150 153 150 Change at Week 26 b 5 -20 -24 a The intent-to-treat population includes all randomized patients. At Week 26, the primary HbA 1c endpoint was missing for 4.3%, 4.4% and 4.4% of patients randomized to placebo, semaglutide tablets 7 mg and semaglutide tablets 14 mg, respectively. Missing values were imputed by a pattern mixture model using multiple imputation (MI). Pattern was defined by randomized treatment and treatment status at Week 26. During the trial, additional anti-diabetic medication was initiated as an add on to randomized treatment by 4.9%, 1.1 % and 2.2% of patients randomized to placebo, semaglutide tablets 7 mg and semaglutide tablets 14 mg, respectively. b Estimated using an ANCOVA based on data irrespectively of discontinuation of trial product or initiation of rescue medication adjusted for baseline value, background medication and region. c p<0.001 (unadjusted 2-sided) for superiority, controlled for multiplicity. The mean baseline body weight was 86 kg, 87.1 kg and 84.6 kg in the placebo, semaglutide tablets7 mg and semaglutide tablets 14 mg arms, respectively. The mean changes from baseline to Week 26 were -0.4 kg, -2.4 kg and -3.7 kg in the placebo, semaglutide tablets 7 mg and semaglutide tablets 14 mg arms, respectively. The difference from placebo (95% CI) for semaglutide tablets 7 mg was -2 kg (-3, -1) and for semaglutide tablets 14 mg was -3.3 kg (-4.2, -2.3). 14.4 Cardiovascular Outcomes Trial of Semaglutide Tablets in Adult Patients with Type 2 Diabetes Mellitus and High Risk of Having a Cardiovascular Event Trial 7 (NCT03914326) was a randomized, double-blind, parallel-group, placebo-controlled trial. In this trial, 9,650 patients with type 2 diabetes mellitus and established cardiovascular (CV) disease and/or chronic kidney disease (CKD) (defined as eGFR <60 mL/min/1.73 m 2 ), were randomized to either once daily semaglutide tablets 14 mg or placebo, in addition to standard of care. The primary endpoint, major adverse cardiovascular events (MACE), was the time to first occurrence of a three-part composite outcome which included CV death, non-fatal myocardial infarction (MI) and non-fatal stroke. Patients eligible to enter the trial were: 50 years of age or older and with established CV disease or CKD. In total, 5,468 patients (56.7%) had established CV disease without CKD, 1,241 (13%) had CKD only, and 2,620 (27%) had both CV disease and CKD. Most patients (97%) were treated with one or more glucose lowering medications at baseline: metformin (76%), insulin (51%), SGLT-2 inhibitor (27%), sulfonylurea (29%), and DPP-4 inhibitor (23%). At baseline, CV disease and risk factors were managed with lipid-lowering medications (89%), platelet-aggregation inhibitors including aspirin (77%), angiotensin converting enzyme inhibitors or angiotensin II receptor blockers (79%), and beta blockers (64%). The mean age at baseline was 66.1 years, and 71% of the patients were men. Overall, 69% were White, 3% were Black or African American, and 23% were Asian; 14% identified as Hispanic or Latino ethnicity. The mean duration of diabetes was 15.4 years, the mean BMI was 31.1 kg/m 2 , the mean HbA 1c was 8%, and the mean eGFR was 73.8 mL/min/1.73 m 2 . Concomitant diseases included heart failure (23%), hypertension (91%), previous ischemic stroke (12%), previous MI (40%), and peripheral artery disease (16%). In total, 98.4% patients completed the trial, and the vital status was known at the end of the trial for 99.5%. Semaglutide tablets significantly reduced the occurrence of MACE. The estimated hazard ratio for time to first MACE was 0.86 (95% CI: 0.77, 0.96) over the median follow-up duration of 49.6 months and 49.4 months for patients randomized to RYBELSUS and placebo, respectively. Refer to Table 10 and Figure 1 . The treatment effect for the primary composite endpoint and its components in Trial 7 are shown in Table 10 . Table 10. Trial 7 Treatment Effect for MACE and its Components Placebo N=4,825 Semaglutide Tablets 14 mg N=4,825 Hazard Ratio vs Placebo (95% CI) Primary composite endpoint MACE: Composite of CV death, non-fatal MI, non-fatal stroke (time to first occurrence) 668 (13.8%) 579 (12%) 0.86 (0.77, 0.96) CV death 320 (6.6%) 301 (6.2%) 0.93 (0.8, 1.09) Non-fatal MI 253 (5.2%) 191 (4%) 0.74 (0.61, 0.89) Non-fatal stroke 161 (3.3%) 144 (3%) 0.88 (0.7, 1.11) Note: Data from the in-trial period based on full analysis set defined as all randomized patients. Time from randomization to each endpoint was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor. Subjects without events of interest were censored at the end of their in-trial period. For the primary endpoint the hazard ratio and CI were adjusted for the group sequential design using likelihood ratio ordering. CV death, non-fatal MI and non-fatal stroke are listed descriptively for supportive purpose. CV death includes both CV death and undetermined cause of death. N=number of patients; %: percentage of participants in the full analysis set with at least one event; CI: confidence interval Figure 1: Time to First Occurrence of a MACE in Trial 7 Data from the in-trial period based on full analysis set defined as all randomized patients. Cumulative incidence estimates are based on time from randomization to first EAC-confirmed MACE with non-CV death modeled as competing risk using the Aalen-Johansen estimator. Patients without events of interest were censored at the end of their in-trial observation period. Time from randomization to first MACE was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor. The hazard ratio and confidence interval are adjusted for the group sequential design using the likelihood ratio ordering. HR: Hazard ratio; CI: confidence interval. Cardiovascular Outcomes Trial in Patients with Type 2 Diabetes Mellitus and Cardiovascular Disease Trial 8 (NCT02692716) was a multi-center, multi-national, placebo-controlled, double-blind trial. In this trial, 3,183 adult patients with inadequately controlled type 2 diabetes mellitus and atherosclerotic CV disease were randomized to semaglutide tablets 14 mg orally once daily or placebo for a median observation time of 16 months. The trial compared the risk of a MACE between semaglutide tablets 14 mg and placebo when added to current standard of care treatments for diabetes and cardiovascular CV disease. The primary endpoint, MACE, was the time to first occurrence of a three-part composite outcome which included cardiovascular death, non-fatal MI and non-fatal stroke. Patients eligible to enter the trial were 50 years of age or older and had established, stable, CV, cerebrovascular, peripheral artery disease, CKD or NYHA class II and III heart failure or were 60 years of age or older and had other specified risk factors for CV disease. In total, 1,797 patients (56.5%) had established CV disease without CKD, 354 patients (11.1%) had CKD only, and 544 patients (17.1%) had both CV disease and CKD; 488 patients (15.3%) had CV risk factors without established CV disease or CKD. The mean age at baseline was 66 years and 68% were men. The mean duration of diabetes was 14.9 years and mean BMI was 32 kg/m 2 . Overall, 72% were White, 6% were Black or African American and 20% were Asian; 16% identified as Hispanic or Latino ethnicity. Concomitant diseases of patients in this trial included, but were not limited to, heart failure (12%), history of ischemic stroke (8%) and history of a MI (36%). In total, 99.7% of the patients completed the trial and the vital status was known at the end of the trial for 100%. For the primary analysis, a Cox proportional hazards model was used to test for non-inferiority of semaglutide tablets 14 mg to placebo for time to first MACE using a risk margin of 1.3. Type-1 error was controlled across multiple tests using a hierarchical testing strategy. Non‑inferiority to placebo was established, with a hazard ratio equal to 0.79 (95% CI: 0.57, 1.11) over the median observation time of 16-months. The proportion of patients who experienced at least one MACE was 3.8% (61/1591) for semaglutide tablets14 mg and 4.8% (76/1592) for placebo. figure_1"],"pharmacodynamics":["12.2 Pharmacodynamics The pharmacodynamic evaluations described below were in patients with type 2 diabetes mellitus who received once-weekly subcutaneous injections of placebo or semaglutide injection over 12 weeks (semaglutide injection-treated patients were started on lower dosages and then titrated up to 1 mg once weekly). RYBELSUS and OZEMPIC tablets are not approved for subcutaneous use. Fasting and Postprandial Glucose Semaglutide reduces fasting and postprandial glucose concentrations. In patients with type 2 diabetes mellitus, treatment with semaglutide injection 1 mg resulted in reductions in glucose in terms of absolute change from baseline and relative reduction compared to placebo of 29 mg/dL (22%) for fasting glucose, 74 mg/dL (36%) for 2-hour postprandial glucose and 30 mg/dL (22%) for mean 24-hour glucose concentration. Insulin Secretion Both first- and second-phase insulin secretion are increased in patients with type 2 diabetes mellitus treated with semaglutide compared with placebo. Glucagon Secretion Semaglutide lowers the fasting and postprandial glucagon concentrations. Glucose dependent insulin and glucagon secretion Semaglutide lowers high blood glucose concentrations by stimulating insulin secretion and lowering glucagon secretion in a glucose-dependent manner. During induced hypoglycemia, semaglutide did not alter the counter regulatory responses of increased glucagon compared to placebo and did not impair the decrease of C-peptide in patients with type 2 diabetes mellitus. Gastric emptying Semaglutide causes a delay of early postprandial gastric emptying, thereby reducing the rate at which glucose appears in the circulation postprandially. Cardiac Electrophysiology The effect of subcutaneously administered semaglutide on cardiac repolarization was tested in a thorough QTc trial. At an average exposure level 4-fold higher than that of the maximum recommended dose of semaglutide tablets, semaglutide does not prolong QTc intervals to any clinically relevant extent."],"pharmacokinetics":["12.3 Pharmacokinetics Semaglutide estimated mean steady-state concentration was 6.7 nmol/L and 14.6 nmol/L following once daily oral administration of 7 mg and 14 mg of RYBELSUS, respectively, in patients with type 2 diabetes mellitus. Semaglutide exposures increased in a dose-proportional manner. Steady-state exposure was achieved following 4 to 5 weeks of semaglutide tablets oral administration. Absorption RYBELSUS and OZEMPIC tablets are co-formulated with SNAC which facilitates the absorption of semaglutide after oral administration. The absorption of semaglutide predominantly occurs in the stomach. Semaglutide estimated absolute bioavailability was approximately: • 0.4% to 1% after oral administration of 3 mg, 7 mg and 14 mg of RYBELSUS. • 1% to 2% after oral administration of 1.5 mg, 4 mg and 9 mg of OZEMPIC tablets. Semaglutide maximum concentration was reached approximately 1-hour after oral administration of semaglutide tablets. Effect of Semaglutide Tablet Formulations : There were no clinically significant differences observed in the mean steady state AUC 0-24h,SS and C max,SS between the 3 mg, 7 mg and 14 mg doses of RYBELSUS and the 1.5 mg, 4 mg and 9 mg doses of OZEMPIC tablets, respectively, in a clinical study conducted in healthy subjects. Effect of Volume and Timing of Water Consumption : Single oral doses of semaglutide tablets were administered with 50 mL or 240 mL of water after an 8-hour overnight fast and a continued fast of 4 hours post-dose in healthy subjects. Semaglutide absorption (i.e., area under the curve (AUC) and peak concentrations (C max ) were higher following dosing with 50 mL water compared to that of 240 mL water. For 10 days, healthy subjects received semaglutide tablets once daily doses orally with 50 mL or 120 mL of water under fasting conditions with post-dose fasting period of 15, 30, 60 or 120 minutes. In this study, semaglutide absorption (i.e., AUC and C max ) was higher after a longer post-dose fasting period. There were no clinically significant differences in semaglutide absorption with administration of 50 mL or 120 mL of water. Distribution Semaglutide absolute volume of distribution is approximately 8 L in patients with type 2 diabetes. Semaglutide is >99% bound to plasma albumin. Elimination Semaglutide elimination half-life is approximately one week with an absolute clearance of approximately 0.04 L/hour in patients with type 2 diabetes. Semaglutide is present in the circulation for about five weeks after the last semaglutide tablet dose. Metabolism : The primary route of elimination for semaglutide is metabolism following proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid side chain. Excretion : The primary excretion routes of semaglutide-related material are via the urine and feces. Approximately 3% of the absorbed dose is excreted in the urine as intact semaglutide. Specific Populations No clinically significant differences in semaglutide pharmacokinetics were observed based on age (≥18 years old), sex, race (White, Asian or Black or African American), ethnicity, body weight (40 to 188 kg), upper GI disease (i.e., chronic gastritis and/or gastroesophageal reflux disease), hepatic impairment (i.e., mild, moderate, severe based on the Child-Pugh system) and renal impairment (i.e., mild, moderate, severe, end staged renal disease). Drug Interaction Studies Clinical Studies and Model-Informed Approaches : The delay of gastric emptying with semaglutide may influence the absorption of concomitantly administered oral drugs. Trials were conducted to study the potential effect of semaglutide on the absorption of oral drugs taken with semaglutide administered orally at steady-state exposure. Levothyroxine : Total thyroxine (i.e., adjusted for endogenous levels) AUC was increased by 33% following administration of a single dose of levothyroxine 600 mcg concomitantly administered with semaglutide tablets. Maximum exposure (C max ) was unchanged. Other Drugs : No clinically significant differences in semaglutide pharmacokinetics were observed when used concomitantly with omeprazole. No clinically significant differences in the pharmacokinetics of the following drugs were observed when used concomitantly with semaglutide: lisinopril, S-warfarin, R-warfarin, metformin, digoxin, ethinyl estradiol, levonorgestrel, furosemide or rosuvastatin. In Vitro Studies : Semaglutide has very low potential to inhibit or induce CYP enzymes, and to inhibit drug transporters."],"adverse_reactions":["6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] • Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] • Diabetic Retinopathy Complications [see Warnings and Precautions ( 5.3 )] • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.4 )] • Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] • Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] • Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] • Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence ≥5%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-833-457-7455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OZEMPIC tablets (1.5 mg, 4 mg and 9 mg strengths) [see Dosage and Administration ( 2.2 )] and RYBELSUS (3 mg, 7, mg and 14 mg strengths) [see Dosage and Administration ( 2.2 )] has been established as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus based on adequate and well-controlled studies of RYBELSUS in adult patients with type 2 diabetes mellitus [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14 )] . Below is a display of the safety results of the adequate and well-controlled studies of RYBELSUS (referred to below as semaglutide tablets) in adult patients with type 2 diabetes mellitus. Pool of Placebo-Controlled Trials The data in Table 2 are derived from 2 placebo-controlled trials in adult patients with type 2 diabetes mellitus [see Clinical Studies ( 14 )] . These data reflect exposure of 1,071 patients to semaglutide tablets (3 mg, 7, mg or 14 mg orally once daily) with a mean duration of exposure of 41.8 weeks. The mean age of patients was 58 years, 3.9% were 75 years or older and 52% were male. In these trials, 63% were White, 6% were Black or African American and 27% were Asian; 19% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 mellitus diabetes for an average of 9.4 years and had a mean HbA 1c of 8.1%. At baseline, 20.1% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m 2 ) in 66.2%, mildly impaired (eGFR 60 to 90 mL/min/1.73m 2 ) in 32.4% and moderately impaired (eGFR 30 to 60 mL/min/1.73m 2 ) in 1.4% of patients. Pool of Placebo- and Active-Controlled Trials The occurrence of adverse reactions was also evaluated in a larger pool of adult patients with type 2 diabetes mellitus participating in 9 placebo- and active-controlled trials [see Clinical Studies ( 14 )] . In this pool, 4,116 patients with type 2 diabetes mellitus were treated with semaglutide tablets for a mean duration of 59.8 weeks. The mean age of patients was 58 years, 5% were 75 years or older and 55% were male. In these trials, 65% were White, 6% were Black or African American and 24% were Asian; 15% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes mellitus for an average of 8.8 years and had a mean HbA 1c of 8.2%. At baseline, 16.6% of the population reported retinopathy. Baseline estimated renal function was normal (eGFR ≥90 mL/min/1.73m 2 ) in 65.9%, mildly impaired (eGFR 60 to 90 mL/min/1.73m 2 ) in 28.5% and moderately impaired (eGFR 30 to 60 mL/min/1.73m 2 ) in 5.4% of the patients. Common Adverse Reactions Table 2 shows common adverse reactions, excluding hypoglycemia, associated with the use of semaglutide tablets in adult patients with type 2 diabetes mellitus in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on semaglutide tablets than on placebo and occurred in at least 5% of patients treated with semaglutide tablets. Table 2. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Semaglutide Tablets-Treated Patients with Type 2 Diabetes Mellitus Adverse Reaction Placebo (N=362) % Semaglutide Tablets 7 mg (N=356) % Semaglutide Tablets 14 mg (N=356) % Nausea 6 11 20 Abdominal Pain 4 10 11 Diarrhea 4 9 10 Decreased appetite 1 6 9 Vomiting 3 6 8 Constipation 2 6 5 In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed in Table 2 . In a 4-year CV outcomes trial (Trial 7), 4,825 patients were randomized to semaglutide tablets for a median follow-up of 49.6 months and 4,825 patients were randomized to placebo for a median follow-up of 49.4 months [see Clinical Studies ( 14.4 )] . Safety data collection was limited to serious adverse events (including death), adverse events leading to discontinuation, and adverse events of special interest. Study drug was permanently discontinued due to an adverse event in 15.5% of semaglutide tablets-treated patients and 11.6% of placebo-treated patients. Additional information from this trial is included in subsequent sections below, when relevant. Gastrointestinal Adverse Reactions In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients who received semaglutide tablets than placebo: semaglutide tablets 14 mg once daily (41%), semaglutide tablets 7 mg once daily (32%) and placebo (21%), including severe reactions (semaglutide tablets 14 mg 2.0%, semaglutide tablets 7 mg 0.6%, placebo 0.3%). The majority of reports of nausea, vomiting and/or diarrhea occurred during dose escalation. A greater percentage of patients who received semaglutide tablets 14 mg once daily (8%) and semaglutide tablets 7 mg once daily (4%) discontinued treatment due to gastrointestinal adverse reactions than patients who received placebo (1%). In addition to the reactions in Table 2 , the following gastrointestinal adverse reactions with a frequency of <5% occurred in semaglutide tablets -treated patients (frequencies listed, respectively, as 14 mg once daily, 7 mg once daily and placebo): abdominal distension (3%, 2% and 1%), dyspepsia (0.6%, 3%, 0.6%), eructation (2%, 0.6%, 0%,), flatulence (1%, 2%, 0%), gastroesophageal reflux disease (2%, 2%, 0.3%) and gastritis (2%, 2%, 0.8%). Other Adverse Reactions Pancreatitis : In the pool of placebo- and active-controlled trials with semaglutide tablets, pancreatitis was reported as a serious adverse event in 6 semaglutide tablets -treated patients (0.1 events per 100 patient years) versus 1 in comparator-treated patients (<0.1 events per 100 patient years). Diabetic Retinopathy Complications : In the pool of placebo- and active-controlled trials with semaglutide tablets, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with semaglutide tablets and 3.8% with comparator). Hypoglycemia : Table 3 summarizes the incidence of hypoglycemia by various definitions in the placebo-controlled trials. Table 3. Hypoglycemia Adverse Reactions in Placebo-Controlled Trials in Patients with Type 2 Diabetes Mellitus Placebo Semaglutide Tablets 7 mg Semaglutide Tablets 14 mg Monotherapy (26 weeks) N=178 N=175 N=175 Severe* 0% 1% 0% Plasma glucose <54 mg/dL 1% 0% 0% Add-on to metformin and/or sulfonylurea, basal insulin alone or metformin in combination with basal insulin in patients with moderate renal impairment (26 weeks) N=161 - N=163 Severe* 0% - 0% Plasma glucose <54 mg/dL 3% - 6% Add-on to insulin with or without metformin (52 weeks) N=184 N=181 N=181 Severe* 1% 0% 1% Plasma glucose <54 mg/dL 32% 26% 30% * “Severe” hypoglycemia adverse reactions are episodes requiring the assistance of another person. Hypoglycemia was more frequent when semaglutide tablets were used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Increases in Amylase and Lipase : In placebo-controlled trials, patients exposed to semaglutide tablets 7 mg and 14 mg tablets had a mean increase from baseline in amylase of 10% and 13%, respectively and lipase of 30% and 34%, respectively. These changes were not observed in placebo-treated patients. Cholelithiasis : In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets 7 mg. In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide 14 mg tablets and in 0.9% of placebo-treated patients. In Trial 7, cholecystitis was reported in 1.1% of patients treated with semaglutide14 mg tablets and in 0.7% of placebo-treated patients. Increases in Heart Rate : In placebo-controlled trials, semaglutide tablets 7 mg and 14 mg tablets resulted in a mean increase in heart rate of 1 to 3 beats per minute. There was no change in heart rate in placebo-treated patients. 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient in RYBELSUS and OZEMPIC tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Gastrointestinal : acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction • Hypersensitivity : anaphylaxis, angioedema, rash, urticaria • Hepatobiliary : cholecystitis, cholelithiasis requiring cholecystectomy • Nervous system disorders : dizziness, dysesthesia, dysgeusia, headache • Pulmonary : Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation • Renal : acute kidney injury • Skin and Subcutaneous Tissue : alopecia"],"contraindications":["4 CONTRAINDICATIONS RYBELSUS and OZEMPIC tablets are contraindicated in patients with: • A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . • A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS or OZEMPIC tablets. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with semaglutide tablets [see Warnings and Precautions ( 5.7 )] . • Personal or family history of MTC or in patients with MEN 2 syndrome type 2 ( 4 ) • Prior serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS Other Oral Drugs : RYBELSUS and OZEMPIC tablets delay gastric emptying. Consider increased clinical or laboratory monitoring when co-administered with other oral medications that have a narrow therapeutic index or that require clinical monitoring. ( 7.2 ) 7.1 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin Semaglutide stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving RYBELSUS or OZEMPIC tablets in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. When initiating RYBELSUS or OZEMPIC tablets, consider reducing the dosage of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.1 )] . 7.2 Other Oral Drugs Semaglutide cause a delay of gastric emptying and thereby has the potential to impact the absorption of other oral drugs. Levothyroxine exposure was increased 33% (90% CI: 1.25 to 1.42) when administered with semaglutide tablets in a drug interaction study [see Clinical Pharmacology ( 12.3 )] . When using RYBELSUS or OZEMPIC tablets concomitantly with other oral drugs that have a narrow therapeutic index or that require clinical monitoring, consider increased clinical or laboratory monitoring [see Dosage and Administration ( 2 )] ."],"how_supplied_table":["
Tablet StrengthDescriptionPackage ConfigurationNDC Number
3 mgWhite to light yellow, oval shaped debossed with “3” on one side and “novo” on the other sideBottle of 30 tablets 0169-4303-30
7 mgWhite to light yellow, oval shaped debossed with “7” on one side and “novo” on the other sideBottle of 30 tablets 0169-4307-30
14 mgWhite to light yellow, oval shaped debossed with “14” on one side and “novo” on the other sideBottle of 30 tablets 0169-4314-30
","
Tablet StrengthDescriptionPackage ConfigurationNDC Number
1.5 mgWhite to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other sideBottle of 30 tablets 0169-1715-30
4 mgWhite to light yellow, round shaped debossed with “4” on one side and “novo” on the other sideBottle of 30 tablets 0169-1704-30
9 mgWhite to light yellow, round shaped debossed with “9” on one side and “novo” on the other sideBottle of 30 tablets 0169-1709-30
"],"spl_medguide_table":["Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, RYBELSUS and OZEMPIC tablets and other medicines that work like RYBELSUS and OZEMPIC tablets caused thyroid tumors, including thyroid cancer. It is not known if RYBELSUS and OZEMPIC tablets will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.Do not use RYBELSUS or OZEMPIC tablets if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus.to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus who are at high risk for these events.It is not known if RYBELSUS and OZEMPIC tablets are safe and effective for use in children.you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).you have had a serious allergic reaction to semaglutide or any of the ingredients in RYBELSUS or OZEMPIC tablets. See the end of this Medication Guide for a complete list of ingredients in RYBELSUS and OZEMPIC tablets.See “What are the possible side effects of RYBELSUS and OZEMPIC tablets?” for symptoms of a serious allergic reaction.have or have had problems with your pancreas or kidneys.have a history of vision problems related to your diabetes.are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).are pregnant or plan to become pregnant. It is not known if RYBELSUS and OZEMPIC tablets will harm your unborn baby. You should stop using RYBELSUS or OZEMPIC tablets 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with RYBELSUS or OZEMPIC tablets.Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS and OZEMPIC tablets may affect the way some medicines work, and some medicines may affect the way RYBELSUS and OZEMPIC tablets work.Before using RYBELSUS or OZEMPIC tablets, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.Take RYBELSUS or OZEMPIC tablets exactly as your healthcare provider tells you to.Take 1 RYBELSUS or OZEMPIC tablet by mouth on an empty stomach in the morning with water (no more than 4 ounces). Do not take RYBELSUS or OZEMPIC tablets with any other liquids besides water.Do not split, crush, chew, or dissolve RYBELSUS or OZEMPIC tablets. Swallow RYBELSUS or OZEMPIC tablets whole.After 30 minutes, you can eat, drink, or take other oral medicines.Do not take more than 1 RYBELSUS or OZEMPIC tablet each day.If you miss a dose of RYBELSUS or OZEMPIC tablets, skip the missed dose and go back to your regular schedule.If you take too much RYBELSUS or OZEMPIC tablets, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room right away. Advice is also available online at poisonhelp.org.Your dose of RYBELSUS or OZEMPIC tablets and other diabetes medicines may need to change because of:change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, fever, trauma, infection, surgery or because of other medicines you take.See “What is the most important information I should know about RYBELSUS and OZEMPIC tablets?”inflammation of your pancreas(pancreatitis). Stop using RYBELSUS or OZEMPIC tablets and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.changes in vision. Tell your healthcare provider if you have changes in vision during treatment with RYBELSUS or OZEMPIC tablets.low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use RYBELSUS or OZEMPIC tablets with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include:dizziness or light-headednessblurred visionanxiety, irritability, or mood changessweatingslurred speechhungerconfusion or drowsinessshakinessweaknessheadachefast heartbeatfeeling jitterydehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use RYBELSUS or OZEMPIC tablets. Tell your healthcare provider if you have stomach problems that are severe or will not go away.serious allergic reactions. Stop using RYBELSUS or OZEMPIC tablets and get medical help right away, if you have any symptoms of a serious allergic reaction including:swelling of your face, lips, tongue or throatproblems breathing or swallowingsevere rash or itchingfainting or feeling dizzyvery rapid heartbeatgallbladder problems. Gallbladder problems have happened in some people who take RYBELSUS andOZEMPIC tablets. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:pain in your upper stomach (abdomen)yellowing of skin or eyes (jaundice)feverclay-colored stoolsfood or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). RYBELSUS and OZEMPIC tablets may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking RYBELSUS or OZEMPIC tablets before you are scheduled to have surgery or other procedures.The most common side effects of RYBELSUS and OZEMPIC tablets may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting and constipation. Nausea, vomiting and diarrhea are most common when you first start RYBELSUS or OZEMPIC tablets.Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of RYBELSUS and OZEMPIC tablets.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.Store RYBELSUS or OZEMPIC tablets at room temperature between 68°F and 77°F (20°C to 25°C).Store in a dry place away from moisture.Store tablets in the original closed RYBELSUS or OZEMPIC bottle until you are ready to take one. Do not store in any other container.Keep RYBELSUS, OZEMPIC tablets and all medicines out of the reach of children.
MEDICATION GUIDE
RYBELSUS® (reb-EL-sus)(semaglutide)tablets, for oral useOZEMPIC® (oh-ZEM-pick)(semaglutide)tablets, for oral use
Read this Medication Guide before you start using RYBELSUS or OZEMPIC tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about RYBELSUS and OZEMPIC tablets?RYBELSUS and OZEMPIC tablets may cause serious side effects, including:
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What are RYBELSUS and OZEMPIC tablets?RYBELSUS and OZEMPIC tablets are prescription medicines used:
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Do not use RYBELSUS or OZEMPIC tablets if:
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Before using RYBELSUS or OZEMPIC tablets, tell your healthcare provider if you have any other medical conditions, including if you:
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How should I take RYBELSUS or OZEMPIC tablets?
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What are the possible side effects of RYBELSUS and OZEMPIC tablets?RYBELSUS and OZEMPIC tablets may cause serious side effects, including:
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General information about the safe and effective use of RYBELSUS and OZEMPIC tablets.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RYBELSUS or OZEMPIC tablets for a condition for which it was not prescribed. Do not give RYBELSUS or OZEMPIC tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RYBELSUS or OZEMPIC tablets that is written for health professionals.
What are the ingredients in RYBELSUS and OZEMPIC tablets?Active Ingredient in RYBELSUS and OZEMPIC: semaglutideInactive Ingredients in RYBELSUS: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodiumInactive ingredients in OZEMPIC: magnesium stearate and salcaprozate sodiumMarketed by: Novo Nordisk Inc., Plainsboro, NJ 08536RYBELSUS® and OZEMPIC® are registered trademarks of Novo Nordisk A/S.Patent Information: http://www.novonordisk-us.com/products/product-patents.html© 2026 Novo NordiskFor more information, go to www.RYBELSUS.com, www.OZEMPIC.com or call 1-833-GLP-PILL.
"],"mechanism_of_action":["12.1 Mechanism of Action Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase."],"recent_major_changes":["Indications and Usage ( 1 ) ………………………………….……..10/2025 Dosage and Administration ( 2 )…………………………..………..12/2025 Warnings and Precautions Acute Pancreatitis ( 5.2 )……………………………………..…10/2025 Acute Kidney Injury Due to Volume Depletion ( 5.5 ) ………..10/2025 Severe Gastrointestinal Adverse Reactions ( 5.6 ) ….………….10/2025 Acute Gallbladder Disease ( 5.8 )…………….………..……….10/2025"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase. 12.2 Pharmacodynamics The pharmacodynamic evaluations described below were in patients with type 2 diabetes mellitus who received once-weekly subcutaneous injections of placebo or semaglutide injection over 12 weeks (semaglutide injection-treated patients were started on lower dosages and then titrated up to 1 mg once weekly). RYBELSUS and OZEMPIC tablets are not approved for subcutaneous use. Fasting and Postprandial Glucose Semaglutide reduces fasting and postprandial glucose concentrations. In patients with type 2 diabetes mellitus, treatment with semaglutide injection 1 mg resulted in reductions in glucose in terms of absolute change from baseline and relative reduction compared to placebo of 29 mg/dL (22%) for fasting glucose, 74 mg/dL (36%) for 2-hour postprandial glucose and 30 mg/dL (22%) for mean 24-hour glucose concentration. Insulin Secretion Both first- and second-phase insulin secretion are increased in patients with type 2 diabetes mellitus treated with semaglutide compared with placebo. Glucagon Secretion Semaglutide lowers the fasting and postprandial glucagon concentrations. Glucose dependent insulin and glucagon secretion Semaglutide lowers high blood glucose concentrations by stimulating insulin secretion and lowering glucagon secretion in a glucose-dependent manner. During induced hypoglycemia, semaglutide did not alter the counter regulatory responses of increased glucagon compared to placebo and did not impair the decrease of C-peptide in patients with type 2 diabetes mellitus. Gastric emptying Semaglutide causes a delay of early postprandial gastric emptying, thereby reducing the rate at which glucose appears in the circulation postprandially. Cardiac Electrophysiology The effect of subcutaneously administered semaglutide on cardiac repolarization was tested in a thorough QTc trial. At an average exposure level 4-fold higher than that of the maximum recommended dose of semaglutide tablets, semaglutide does not prolong QTc intervals to any clinically relevant extent. 12.3 Pharmacokinetics Semaglutide estimated mean steady-state concentration was 6.7 nmol/L and 14.6 nmol/L following once daily oral administration of 7 mg and 14 mg of RYBELSUS, respectively, in patients with type 2 diabetes mellitus. Semaglutide exposures increased in a dose-proportional manner. Steady-state exposure was achieved following 4 to 5 weeks of semaglutide tablets oral administration. Absorption RYBELSUS and OZEMPIC tablets are co-formulated with SNAC which facilitates the absorption of semaglutide after oral administration. The absorption of semaglutide predominantly occurs in the stomach. Semaglutide estimated absolute bioavailability was approximately: • 0.4% to 1% after oral administration of 3 mg, 7 mg and 14 mg of RYBELSUS. • 1% to 2% after oral administration of 1.5 mg, 4 mg and 9 mg of OZEMPIC tablets. Semaglutide maximum concentration was reached approximately 1-hour after oral administration of semaglutide tablets. Effect of Semaglutide Tablet Formulations : There were no clinically significant differences observed in the mean steady state AUC 0-24h,SS and C max,SS between the 3 mg, 7 mg and 14 mg doses of RYBELSUS and the 1.5 mg, 4 mg and 9 mg doses of OZEMPIC tablets, respectively, in a clinical study conducted in healthy subjects. Effect of Volume and Timing of Water Consumption : Single oral doses of semaglutide tablets were administered with 50 mL or 240 mL of water after an 8-hour overnight fast and a continued fast of 4 hours post-dose in healthy subjects. Semaglutide absorption (i.e., area under the curve (AUC) and peak concentrations (C max ) were higher following dosing with 50 mL water compared to that of 240 mL water. For 10 days, healthy subjects received semaglutide tablets once daily doses orally with 50 mL or 120 mL of water under fasting conditions with post-dose fasting period of 15, 30, 60 or 120 minutes. In this study, semaglutide absorption (i.e., AUC and C max ) was higher after a longer post-dose fasting period. There were no clinically significant differences in semaglutide absorption with administration of 50 mL or 120 mL of water. Distribution Semaglutide absolute volume of distribution is approximately 8 L in patients with type 2 diabetes. Semaglutide is >99% bound to plasma albumin. Elimination Semaglutide elimination half-life is approximately one week with an absolute clearance of approximately 0.04 L/hour in patients with type 2 diabetes. Semaglutide is present in the circulation for about five weeks after the last semaglutide tablet dose. Metabolism : The primary route of elimination for semaglutide is metabolism following proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid side chain. Excretion : The primary excretion routes of semaglutide-related material are via the urine and feces. Approximately 3% of the absorbed dose is excreted in the urine as intact semaglutide. Specific Populations No clinically significant differences in semaglutide pharmacokinetics were observed based on age (≥18 years old), sex, race (White, Asian or Black or African American), ethnicity, body weight (40 to 188 kg), upper GI disease (i.e., chronic gastritis and/or gastroesophageal reflux disease), hepatic impairment (i.e., mild, moderate, severe based on the Child-Pugh system) and renal impairment (i.e., mild, moderate, severe, end staged renal disease). Drug Interaction Studies Clinical Studies and Model-Informed Approaches : The delay of gastric emptying with semaglutide may influence the absorption of concomitantly administered oral drugs. Trials were conducted to study the potential effect of semaglutide on the absorption of oral drugs taken with semaglutide administered orally at steady-state exposure. Levothyroxine : Total thyroxine (i.e., adjusted for endogenous levels) AUC was increased by 33% following administration of a single dose of levothyroxine 600 mcg concomitantly administered with semaglutide tablets. Maximum exposure (C max ) was unchanged. Other Drugs : No clinically significant differences in semaglutide pharmacokinetics were observed when used concomitantly with omeprazole. No clinically significant differences in the pharmacokinetics of the following drugs were observed when used concomitantly with semaglutide: lisinopril, S-warfarin, R-warfarin, metformin, digoxin, ethinyl estradiol, levonorgestrel, furosemide or rosuvastatin. In Vitro Studies : Semaglutide has very low potential to inhibit or induce CYP enzymes, and to inhibit drug transporters. 12.6 Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of semaglutide or of other semaglutide products. During the 26- to 78-week treatment periods in 5 clinical trials in adults with type 2 diabetes mellitus [see Clinical Studies ( 14.2 , 14.3 )] and 1 clinical trial in Japanese adults with type 2 diabetes mellitus, 14/2,924 (0.5%) of semaglutide tablet-treated patients developed anti-semaglutide antibodies. Of these 14 semaglutide tablet -treated patients, 7 patients (0.2% of the total semaglutide tablet-treated study population) developed antibodies that cross-reacted with native GLP-1. No identified clinically significant effect of anti-semaglutide antibodies on pharmacokinetics of semaglutide tablets was observed. There is insufficient information to characterize the effects of anti-semaglutide antibodies on pharmacodynamics, safety or effectiveness of semaglutide."],"indications_and_usage":["1 INDICATIONS AND USAGE RYBELSUS and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. RYBELSUS and OZEMPIC tablets are glucagon-like peptide-1 (GLP-1) receptor agonists indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS • Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including RYBELSUS or OZEMPIC tablets. Discontinue if pancreatitis is suspected. ( 5.2 ) • Diabetic Retinopathy Complications : Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored. ( 5.3 ) • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin : May increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin secretagogue or insulin may be necessary. ( 5.4 ) • Acute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.5 ) • Severe Gastrointestinal Adverse Reactions : Use of RYBELSUS or OZEMPIC tablets has been associated with gastrointestinal adverse reactions, sometimes severe. RYBELSUS and OZEMPIC tablets are not recommended in patients with severe gastroparesis. ( 5.6 ) • Hypersensitivity Reactions : Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue RYBELSUS or OZEMPIC tablets if hypersensitivity reactions occur and monitor until signs and symptoms resolve. ( 5.7 ) • Acute Gallbladder Disease : If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. ( 5.8 ) • Pulmonary Aspiration During General Anesthesia or Deep Sedation : Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 ) 5.1 Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures [see Nonclinical Toxicology ( 13.1 )] . It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. RYBELSUS and OZEMPIC tablets are contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of RYBELSUS or OZEMPIC tablets and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with RYBELSUS or OZEMPIC tablets. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. 5.2 Acute Pancreatitis Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide tablets [see Adverse Reactions ( 6 )] . After initiation of RYBELSUS or OZEMPIC tablets, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue RYBELSUS or OZEMPIC tablets and initiate appropriate management. 5.3 Diabetic Retinopathy Complications In a pooled analysis of glycemic control trials, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with semaglutide tablets and 3.8% with comparator) [see Adverse Reactions ( 6.1 )] . In a 2-year CV outcomes trial with semaglutide injection involving patients with type 2 diabetes mellitus and high CV risk, diabetic retinopathy complications (which was a 4-component adjudicated endpoint) occurred in patients treated with semaglutide injection (3%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (semaglutide injection 8.2%, placebo 5.2%) than among patients without a known history of diabetic retinopathy (semaglutide injection 0.7%, placebo 0.4%). Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with RYBELSUS and OZEMPIC tablets on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy. 5.4 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin Patients receiving RYBELSUS or OZEMPIC tablets in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse Reactions ( 6.1 ), Drug Interactions ( 7 )] . The risk of hypoglycemia may be lowered by a reduction in the dosage of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. 5.5 Acute Kidney Injury Due to Volume Depletion There have been postmarketing reports of acute kidney injury in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions ( 6 )] . Monitor renal function in patients reporting adverse reactions to RYBELSUS or OZEMPIC tablets that could lead to volume depletion, especially during dosage initiation and escalation of RYBELSUS or OZEMPIC tablets. 5.6 Severe Gastrointestinal Adverse Reactions Use of semaglutide tablets has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions ( 6.1 )] . In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients who received semaglutide tablets (7 mg 0.6%, 14 mg 2%) than placebo (0.3%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. RYBELSUS and OZEMPIC tablets are not recommended in patients with severe gastroparesis. 5.7 Hypersensitivity Reactions Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with semaglutide tablets. If hypersensitivity reactions occur, discontinue use of RYBELSUS or OZEMPIC tablets; treat promptly per standard of care and monitor until signs and symptoms resolve. RYBELSUS and OZEMPIC tablets are contraindicated in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS or OZEMPIC tablets [see Adverse Reactions ( 6.2 )] . Anaphylaxis and angioedema have been reported with GLP-1 receptor agonists. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with RYBELSUS or OZEMPIC tablets. 5.8 Acute Gallbladder Disease Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets (7 mg once daily). In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide tablets (14 mg once daily) and in 0.9% of placebo-treated patients. In Trial 7, cholecystitis was reported in 1.1% of patients treated with semaglutide tablets (14 mg once daily) and in 0.7% of placebo-treated patients [see Adverse Reactions ( 6.1 )] . If cholelithiasis or cholecystitis is suspected, gallbladder studies and appropriate clinical follow-up are indicated [see Adverse Reactions ( 6.2 )] . 5.9 Pulmonary Aspiration During General Anesthesia or Deep Sedation RYBELSUS and OZEMPIC tablets delay gastric emptying [see Clinical Pharmacology ( 12.2 )] . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking RYBELSUS or OZEMPIC tablets, including whether modifying preoperative fasting recommendations or temporarily discontinuing RYBELSUS or OZEMPIC tablets could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking RYBELSUS or OZEMPIC tablets."],"clinical_studies_table":["Baseline (mean)Change at Week 26bDifference from placebob[95% CI]Baseline (mean)Change at Week 26b
PlaceboSemaglutide Tablets7 mgSemaglutide Tablets14 mg
Intent-to-Treat (ITT) Population (N)a178175175
HbA1c (%)
7.988
-0.3-1.2-1.4
-0.9[-1.1; -0.6]c-1.1[-1.3; -0.9]c
Patients (%) achieving HbA1c <7%316977
FPG (mg/dL)
160162158
-3-28-33
","Baseline (mean)Change at Week 26bDifference from empagliflozinb[95% CI]Baseline (mean)Change at Week 26b
Semaglutide Tablets14 mgEmpagliflozin25 mg
Intent-to-Treat (ITT) Population (N)a411410
HbA1c (%)
8.18.1
-1.3-0.9
-0.4[-0.6, -0.3]c
Patients (%) achieving HbA1c <7%6740
FPG (mg/dL)
172174
-36-36
","Baseline (mean)Change at Week 26bDifference from sitagliptinb[95% CI]Baseline (mean)Change at Week 26b
Semaglutide Tablets7 mgSemaglutide Tablets14 mgSitagliptin100 mg
Intent-to-Treat (ITT) Population (N)a465465467
HbA1c (%)
8.48.38.3
-1-1.3-0.8
-0.3[-0.4; -0.1]c-0.5[-0.6; -0.4]c
Patients (%) achieving HbA1c <7%445632
FPG (mg/dL)
170168172
-21-31-15
","Baseline (mean)Change at Week 26bDifference from placebob[95% CI]Difference from liraglutideb[95% CI]Baseline (mean)Change at Week 26b
PlaceboSemaglutide Tablets14 mgLiraglutide1.8 mg
Intent-to-Treat (ITT) Population (N)a142285284
HbA1c (%)
7.988
-0.2-1.2-1.1
-1.1[-1.2; -0.9]c
-0.1[-0.3; 0]
Patients (%) achieving HbA1c <7%146862
FPG (mg/dL)
167167168
-7-36-34
","Baseline (mean)Change at Week 26bDifference from placebob[95% CI]Baseline (mean)Change at Week 26b
PlaceboSemaglutide Tablets14 mg
Intent-to-Treat (ITT) Population (N)a161163
HbA1c (%)
7.98
-0.2-1
-0.8[-1.0; -0.6]c
Patients (%) achieving HbA1c <7%2358
FPG (mg/dL)
164164
-7-28
","Baseline (mean)Change at Week 26bDifference from placebob [95% CI]Baseline (mean)Change at Week 26b
PlaceboSemaglutide Tablets7 mgSemaglutide Tablets14 mg
Intent-to-Treat (ITT) Population (N)a184182181
HbA1c (%)
8.28.28.2
-0.1-0.9-1.3
-0.9[-1.1; -0.7]c-1.2[-1.4; -1]c
Patients (%) achieving HbA1c <7%74358
FPG (mg/dL)
150153150
5-20-24
","
PlaceboN=4,825Semaglutide Tablets 14 mgN=4,825Hazard Ratiovs Placebo(95% CI)
Primary composite endpoint
MACE: Composite of CV death,non-fatal MI, non-fatal stroke (time to first occurrence)668 (13.8%)579 (12%)0.86 (0.77, 0.96)
CV death 320 (6.6%)301 (6.2%)0.93 (0.8, 1.09)
Non-fatal MI 253 (5.2%)191 (4%)0.74 (0.61, 0.89)
Non-fatal stroke161 (3.3%)144 (3%)0.88 (0.7, 1.11)
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [9-, 33- and 113- fold the maximum recommended human dose (MRHD) of semaglutide tablet 14 mg, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (3-, 9- and 33-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at all dose levels (>3 times human exposure). In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered (below quantification, 0.8-, 1.8- and 11-fold the exposure at the MRHD). A statistically significant increase in thyroid C-cell adenomas was observed in males and females at all dose levels, and a statistically significant increase in thyroid C-cell carcinomas was observed in males at ≥0.01 mg/kg/day, at clinically relevant exposures. Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies [see Boxed Warning, Warnings and Precautions ( 5.1 )] . Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus). In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to male and female rats. Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility. In females, an increase in estrus cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at ≥0.03 mg/kg/day. These effects were likely an adaptive response secondary to the pharmacological effect of semaglutide on food consumption and body weight. 13.2 Animal Toxicology and/or Pharmacology RYBELSUS and OZEMPIC tablets contain SNAC as an absorption enhancer. Increase in lactate levels and decrease in glucose levels in the plasma and cerebrospinal fluid (CSF) were observed in mechanistic studies with SNAC in rats. Small but statistically significant increases in lactate levels (up to 2-fold) were observed in a few animals at approximately the clinical exposure. At higher exposures these findings were associated with moderate to marked adverse clinical signs (lethargy, abnormal respiration, ataxia, reduced activity, body tone and reflexes) and marked decreases in plasma and CSF glucose levels. These findings are consistent with inhibition of cellular respiration and lead to mortality at SNAC concentrations ≥100-times the clinical C max ."],"adverse_reactions_table":["
Adverse ReactionPlacebo(N=362)%Semaglutide Tablets7 mg(N=356)%Semaglutide Tablets14 mg(N=356)%
Nausea61120
Abdominal Pain41011
Diarrhea 4910
Decreased appetite 169
Vomiting368
Constipation265
","Plasma glucose<54 mg/dL(26 weeks)Plasma glucose<54 mg/dL (52 weeks) Severe*Plasma glucose<54 mg/dL
PlaceboSemaglutide Tablets7 mgSemaglutide Tablets14 mg
Monotherapy
(26 weeks)N=178N=175N=175
Severe*0%1%0%
1%0%0%
Add-on to metformin and/or sulfonylurea, basal insulin alone or metformin in combination with basal insulin in patients with moderate renal impairment
N=161-N=163
Severe*0%-0%
3%-6%
Add-on to insulin with or without metformin
N=184N=181N=181
1%0%1%
32%26%30%
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risk of Thyroid C-cell Tumors Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) to their physician [see Boxed Warning, Warnings and Precautions ( 5.1 )] . Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue RYBELSUS or OZEMPIC tablets promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions ( 5.2 )] . Diabetic Retinopathy Complications Inform patients to contact their physician if changes in vision are experienced during treatment with RYBELSUS or OZEMPIC tablets [see Warnings and Precautions ( 5.3 )] . Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin Inform patients that the risk of hypoglycemia is increased when RYBELSUS or OZEMPIC tablets are used with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions ( 5.4 )]. Acute Kidney Injury Due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions ( 5.5 )] . Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions ( 5.6 )]. Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of semaglutide tablets. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking RYBELSUS or OZEMPIC tablets and seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.7 )] . Acute Gallbladder Disease Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions ( 5.8 )] . Pulmonary Aspiration During General Anesthesia or Deep Sedation : Inform patients that RYBELSUS or OZEMPIC tablets may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking RYBELSUS or OZEMPIC tablets [see Warnings and Precautions ( 5.9 )]. Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise women to inform their healthcare provider if they are pregnant or intend to become pregnant [see Use in Specific Populations ( 8.1 , 8.3 )] . Lactation RYBELSUS and OZEMPIC tablets pass into breast milk, and it is not known how it affects your baby. Advise females not to breastfeed during treatment with RYBELSUS or OZEMPIC tablets [see Use in Specific Populations ( 8.2 )] . Females and Males of Reproductive Potential Discontinue RYBELSUS or OZEMPIC tablets at least 2 months before a planned pregnancy due to the long washout period for semaglutide [see Use in Specific Populations ( 8.3 )] . Marketed by: Novo Nordisk Inc. Plainsboro, NJ 08536 For additional information about RYBELSUS and OZEMPIC tablets contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 1-833-457-7455 RYBELSUS ® and OZEMPIC ® are registered trademarks of Novo Nordisk A/S. Patent Information: http://www.novonordisk-us.com/products/product-patents.html © 2026 Novo Nordisk"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION • RYBELSUS and OZEMPIC tablets are not substitutable on a mg-to-mg basis. • Take RYBELSUS or OZEMPIC tablets orally once daily on an empty stomach in the morning with water (up to 4 ounces of water); do not take with other liquids besides water. ( 2.1 ) • Swallow tablets whole. Do not split, crush, chew or dissolve in any solution. ( 2.1 ) • After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications. ( 2.1 ) • See the Full Prescribing Information for instructions on switching between RYBELSUS and OZEMPIC tablets ( 2.3 ) and from OZEMPIC injections to RYBELSUS or OZEMPIC tablets. ( 2.4 ) Recommended Starting, Escalation and Maintenance Dosage of RYBELSUS and OZEMPIC Tablets ( 2.2 ) RYBELSUS ( 2.2 ) • Day 1 to 30: Recommended starting dosage is 3 mg orally once daily for 30 days (this dosage is not effective for glycemic control) • Days 31 to 60: Increase the dosage to 7 mg orally once daily. • On Day 61 or thereafter, if: ( 2.2 ) o No additional glycemic control is needed, maintain the dosage at 7 mg orally once daily. o Additional glycemic control is needed, increase the dosage to 14 mg orally once daily. OZEMPIC Tablets ( 2.2 ) • Day 1 to 30: Recommended starting dosage is 1.5 mg orally once daily for 30 days (this dosage is not effective for glycemic control). • Days 31 to 60: Increase the dosage to 4 mg orally once daily. • On Day 61 or thereafter, if: ( 2.2 ) o No additional glycemic control is needed, maintain the dosage at 4 mg orally once daily. o Additional glycemic control is needed, increase the dosage to 9 mg orally once daily. 2.1 Important Administration Instructions • RYBELSUS and OZEMPIC tablets are not substitutable on a mg-to-mg basis. • Take one RYBELSUS or OZEMPIC tablet orally once daily on an empty stomach in the morning with water (up to 4 ounces of water). Do not take RYBELSUS or OZEMPIC tablets with other liquids besides water [see Clinical Pharmacology ( 12.3 )] . • Do not take more than one tablet per day. • Swallow tablets whole. Do not split, crush, chew or dissolve in any solution. • After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications [see Clinical Pharmacology ( 12.3 )] . • If a dose is missed, skip the missed dose and take the next dose the following day. 2.2 Recommended Starting, Escalation and Maintenance Dosage of RYBELSUS and OZEMPIC Tablets RYBELSUS: Recommended Dosage Follow the RYBELSUS starting, escalation, and maintenance dosage described below to reduce the risk of gastrointestinal (GI) adverse reactions [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.1 )] : • Starting Dosage (Initiation Phase) (Days 1 to 30) : The recommended starting dosage is 3 mg orally once daily (this dosage is not effective for glycemic control). • Escalation and Maintenance Dosage (Days 31 and beyond) : o Days 31 to 60: Increase the dosage to 7 mg orally once daily. o On Day 61 or thereafter, if: ▪ No additional glycemic control is needed, maintain the dosage at 7 mg orally once daily. ▪ Additional glycemic control is needed, increase the dosage to 14 mg orally once daily. OZEMPIC Tablets: Recommended Dosage Follow the OZEMPIC tablets starting, escalation, and maintenance dosage described below to reduce the risk of GI adverse reactions [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.1 )] : • Starting Dosage (Initiation Phase) (Days 1 through 30) : The recommended starting dosage is 1.5 mg orally once daily (this dosage is not effective for glycemic control). • Escalation and Maintenance Dosage (Days 31 and beyond) : o Days 31 to 60: Increase the dosage to 4 mg orally once daily. o On Day 61 or thereafter, if: ▪ No additional glycemic control is needed, maintain the dosage at 4 mg orally once daily. ▪ Additional glycemic control is needed, increase the dosage to 9 mg orally once daily. 2.3 Switching Between RYBELSUS and OZEMPIC Tablets • Do not switch between RYBELSUS and OZEMPIC tablets during the initiation phase (Days 1 to 30) [see Dosage and Administration ( 2.2 )] . • After 30 days of RYBELSUS or OZEMPIC tablet treatment (after the initiation phase) [see Dosage and Administration ( 2.2 )] , patients may switch between RYBELSUS and OZEMPIC tablet products (see Table 1 ). • When switching between RYBELSUS and OZEMPIC tablets, initiate the other semaglutide tablet product the day after discontinuing the previous semaglutide tablet product. Table 1. Switching Between Escalation or Maintenance Dosage of RYBELSUS and OZEMPIC Tablets RYBELSUS OZEMPIC Tablets 7 mg orally once daily 4 mg orally once daily 14 mg orally once daily 9 mg orally once daily 2.4 Switching from OZEMPIC Injection to RYBELSUS or OZEMPIC Tablets Switching from OZEMPIC Injection to RYBELSUS Tablets • Patients taking the 0.5 mg dose of OZEMPIC injection may switch to RYBELSUS tablets. • One week after discontinuing 0.5 mg of subcutaneous OZEMPIC injection, start 7 mg or 14 mg of RYBELSUS orally once daily. Switching from OZEMPIC Injection to OZEMPIC Tablets • Patients taking the 0.5 mg dose of OZEMPIC injection may switch to OZEMPIC tablets. • One week after discontinuing 0.5 mg of subcutaneous OZEMPIC injection, start 4 mg or 9 mg of OZEMPIC tablets orally once daily."],"spl_product_data_elements":["OZEMPIC oral semaglutide SEMAGLUTIDE SEMAGLUTIDE SALCAPROZATE SODIUM MAGNESIUM STEARATE Color of a tablet is white to light yellow. 1;5;on;one;side;and;novo;on;other;side OZEMPIC oral semaglutide SEMAGLUTIDE SEMAGLUTIDE SALCAPROZATE SODIUM MAGNESIUM STEARATE Color of a tablet is white to light yellow. 4;on;one;side;and;novo;on;other;side OZEMPIC oral semaglutide SEMAGLUTIDE SEMAGLUTIDE SALCAPROZATE SODIUM MAGNESIUM STEARATE Color of a tablet is white to light yellow. 9;on;one;side;and;novo;on;other;side RYBELSUS oral semaglutide SEMAGLUTIDE SEMAGLUTIDE SALCAPROZATE SODIUM MICROCRYSTALLINE CELLULOSE POVIDONE K90 MAGNESIUM STEARATE Color of a tablet is white to light yellow. 3;on;one;side;and;novo;on;other;side RYBELSUS oral semaglutide SEMAGLUTIDE SEMAGLUTIDE SALCAPROZATE SODIUM MICROCRYSTALLINE CELLULOSE POVIDONE K90 MAGNESIUM STEARATE Color of a tablet is white to light yellow. 7;on;one;side;and;novo;on;the;other;side RYBELSUS oral semaglutide SEMAGLUTIDE SEMAGLUTIDE SALCAPROZATE SODIUM MICROCRYSTALLINE CELLULOSE POVIDONE K90 MAGNESIUM STEARATE Color of a tablet is white to light yellow. 14;on;one;side;and;novo;on;the;other;side RYBELSUS oral semaglutide SEMAGLUTIDE SEMAGLUTIDE SALCAPROZATE SODIUM MAGNESIUM STEARATE Color of a tablet is white to light yellow. 1;5;on;one;side;and;novo;on;other;side RYBELSUS oral semaglutide SEMAGLUTIDE SEMAGLUTIDE SALCAPROZATE SODIUM MAGNESIUM STEARATE Color of a tablet is white to light yellow. 4;on;one;side;and;novo;on;other;side RYBELSUS oral semaglutide SEMAGLUTIDE SEMAGLUTIDE SALCAPROZATE SODIUM MAGNESIUM STEARATE Color of a tablet is white to light yellow. 9;on;one;side;and;novo;on;other;side"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS RYBELSUS (semaglutide) tablets are available as: • 3 mg: white to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side. • 7 mg: white to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side. • 14 mg: white to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side. OZEMPIC (semaglutide) tablets are available as: • 1.5 mg: white to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side. • 4 mg: white to light yellow, round shaped debossed with “4” on one side and “novo” on the other side. • 9 mg: white to light yellow, round shaped debossed with “9” on one side and “novo” on the other side. • RYBELSUS tablets: 3 mg, 7 mg and 14 mg ( 3 ) • OZEMPIC tablets: 1.5 mg, 4 mg and 9 mg ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS • Pregnancy : See Pregnancy subsection. ( 8.1 ) • Lactation : Breastfeeding not recommended. ( 8.2 ) • Females and Males of Reproductive Potential : Discontinue RYBELSUS or OZEMPIC tablets in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide. ( 8.3 ) 8.1 Pregnancy Risk Summary Available data with semaglutide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations ). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. RYBELSUS or OZEMPIC tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at exposure below the MRHD (rabbit) and ≥10-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species (see Data ). The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with an HbA 1c >7 and has been reported to be as high as 20% to 25% in women with an HbA 1c >10. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease Associated Maternal and Fetal Risk : Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth and macrosomia related morbidity. Data Animal Data : In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure. In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.06-, 0.6- and 4.4-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures. In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.9-, 9.9- and 29-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50. Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly (≥9X human exposure). In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.3-, 6.4- and 14-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at ≥0.075 mg/kg twice weekly (≥6X human exposure). Salcaprozate sodium (SNAC), an absorption enhancer in RYBELSUS and OZEMPIC tablets, crosses the placenta and reaches fetal tissues in rats. In a pre- and postnatal development study in pregnant Sprague Dawley rats, SNAC was administered orally at 1,000 mg/kg/day (exposure levels were not measured) on Gestation Day 7 through Lactation Day 20. An increase in gestation length, an increase in the number of stillbirths and a decrease in pup viability were observed. 8.2 Lactation Risk Summary A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, SNAC and/or its metabolites are present in human milk. Since the activity of enzymes involved in SNAC clearance may be lower in infants compared to adults, higher SNAC plasma levels may occur in neonates and infants. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, and because there are alternative semaglutide products that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with RYBELSUS or OZEMPIC tablets. 8.3 Females and Males of Reproductive Potential Discontinue RYBELSUS or OZEMPIC tablets in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide [see Use in Specific Populations ( 8.1 )] . 8.4 Pediatric Use The safety and effectiveness of RYBELSUS and OZEMPIC tablets have not been established in pediatric patients. 8.5 Geriatric Use In the pool of glycemic control trials, 1,229 (30%) patients treated with semaglutide tablets were 65 years of age and over and 199 (5%) patients treated with semaglutide tablets were 75 years of age and over [see Clinical Studies ( 14 )] . In Trial 8, one of the CV outcomes trials, 891 (56%) patients treated with semaglutide tablets were 65 years of age and over and 200 (13%) patients treated with semaglutide tablets were 75 years of age and over. No overall differences in safety or effectiveness for semaglutide tablets have been observed between patients 65 years of age and older and younger adult patients. 8.6 Renal Impairment The recommended dosage of RYBELSUS and OZEMPIC tablets in patients with renal impairment is the same as those with normal renal function. The safety and effectiveness of semaglutide tablets was evaluated in a 26-week clinical study that included 324 patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m 2 ) [see Clinical Studies ( 14.1 )] . In patients with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in semaglutide pharmacokinetics was observed [see Clinical Pharmacology ( 12.3 )] . 8.7 Hepatic Impairment The recommended dosage in patients with hepatic impairment is the same as those with normal hepatic function. In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics was observed [see Clinical Pharmacology ( 12.3 )] ."],"dosage_and_administration_table":["
RYBELSUSOZEMPIC Tablets
7 mg orally once daily 4 mg orally once daily
14 mg orally once daily 9 mg orally once daily
"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – OZEMPIC 1.5 mg tablets NDC 0169-1715-30List 171530 OZEMPIC ® 1.5 mg (semaglutide) Tablets 1.5 mg Rx only DISPENSE WITH MEDICATION GUIDE Note to Pharmacist: Individual strengths of semaglutide are not substitutable on a mg-to-mg basis New Formulation of semaglutide 30 tablets Ozempic_1_5_carton","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – OZEMPIC 4 mg tablets NDC 0169-1704-30List 170430 OZEMPIC ® 4 mg (semaglutide) Tablets 4 mg Rx only DISPENSE WITH MEDICATION GUIDE Note to Pharmacist: Individual strengths of semaglutide are not substitutable on a mg-to-mg basis New Formulation of semaglutide 30 tablets Ozempic_4mg_carton","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – OZEMPIC 9 mg tablets NDC 0169-1709-30List 170930 OZEMPIC ® 9 mg (semaglutide) Tablets 9 mg Rx only DISPENSE WITH MEDICATION GUIDE Note to Pharmacist: Individual strengths of semaglutide are not substitutable on a mg-to-mg basis New Formulation of semaglutide 30 tablets Ozempic_9mg_carton","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 3 mg bottle NDC 0169 -4303- 30 List 430330 RYBELSUS ® 3 mg (semaglutide) Tablets 3 mg Once daily Oral use only Rx only DISPENSE WITH MEDICATION GUIDE 30 tablets Rybelsus_3mg_carton","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 7 mg bottle NDC 0169 -4307- 30 List 430730 RYBELSUS ® 7 mg (semaglutide) Tablets 7 mg Once daily Oral use only Rx only DISPENSE WITH MEDICATION GUIDE 30 tablets Rybelsus_7mg_carton","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 14 mg bottle NDC 0169 -4314- 30 List 431430 RYBELSUS ® 14 mg (semaglutide) Tablets 14 mg Once daily Oral use only Rx only DISPENSE WITH MEDICATION GUIDE 30 tablets Rybelsus_14mg_carton","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 3 mg blister NDC 0169 -4303- 13 List 430313 RYBELSUS ® 3 mg (semaglutide) Tablets 3 mg Once daily Each tablet contains 3 mg semaglutide Oral use only Rx only Dispense the Enclosed Medication Guide to Each Patient 30 tablets 3 blister packs. Each pack contains 10 tablets. Open Here Rybelsus_3mg_blister","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 7 mg blister NDC 0169 -4307- 13 List 430713 RYBELSUS ® 7 mg (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide Oral use only Rx only Dispense the Enclosed Medication Guide to Each Patient 30 tablets 3 blister packs. Each pack contains 10 tablets. Open Here Rybelsus_7mg_blister","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – RYBELSUS 14 mg blister NDC 0169 -4314- 13 List 431413 RYBELSUS ® 14 mg (semaglutide) Tablets 14 mg Once daily Each tablet contains 14 mg semaglutide Oral use only Rx only Dispense the Enclosed Medication Guide to Each Patient 30 tablets 3 blister packs. Each pack contains 10 tablets. Open Here Rybelsus_14mg_blister","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – R2 1.5 mg bottle NDC 0169- 4815 -30List 481530 RYBELSUS ® 1.5 mg (semaglutide) Tablets 1.5 mg Rx only DISPENSE WITH MEDICATION GUIDE Note to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis New Formulation (Formulation R2) 30 tablets R2_1_5mg_carton","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – R2 4 mg bottle NDC 0169- 4804 -30List 480430 RYBELSUS ® 4 mg (semaglutide) Tablets 4 mg Rx only DISPENSE WITH MEDICATION GUIDE Note to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis New Formulation (Formulation R2) 30 tablets R2_4mg_carton","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – R2 9 mg bottle NDC 0169- 4809 -30List 480930 RYBELSUS ® 9 mg (semaglutide) Tablets 9 mg Rx only DISPENSE WITH MEDICATION GUIDE Note to Pharmacist: Individual strengths of Rybelsus are not substitutable on a mg-to-mg basis New Formulation (Formulation R2) 30 tablets R2_9mg_carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [9-, 33- and 113- fold the maximum recommended human dose (MRHD) of semaglutide tablet 14 mg, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (3-, 9- and 33-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at all dose levels (>3 times human exposure). In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered (below quantification, 0.8-, 1.8- and 11-fold the exposure at the MRHD). A statistically significant increase in thyroid C-cell adenomas was observed in males and females at all dose levels, and a statistically significant increase in thyroid C-cell carcinomas was observed in males at ≥0.01 mg/kg/day, at clinically relevant exposures. Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies [see Boxed Warning, Warnings and Precautions ( 5.1 )] . Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus). In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to male and female rats. Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility. In females, an increase in estrus cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at ≥0.03 mg/kg/day. These effects were likely an adaptive response secondary to the pharmacological effect of semaglutide on food consumption and body weight."]},"tags":[{"label":"GLP-1 Receptor Agonist","category":"class"},{"label":"Peptide","category":"modality"},{"label":"Glucagon-like peptide 1 receptor","category":"target"},{"label":"GLP1R","category":"gene"},{"label":"A10BJ06","category":"atc"},{"label":"Oral","category":"route"},{"label":"Subcutaneous","category":"route"},{"label":"Injection","category":"form"},{"label":"Tablet","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Diabetes mellitus type 2","category":"indication"},{"label":"Obesity","category":"indication"},{"label":"Weight loss","category":"indication"},{"label":"Novo","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","fdaNDC":[{"route":[],"labeler":"Hubei JXBio Pharmaceutical Co.,Ltd","brandName":"","packaging":[{"ndc":"76617-003-01","description":"1 BAG in 1 BAG 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It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • RYBELSUS and OZEMPIC tablets are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of RYBELSUS or OZEMPIC tablets and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with RYBELSUS or OZEMPIC tablets [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). • RYBELSUS and OZEMPIC tablets are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 )."],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 8304 times"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"Reported 5598 times"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"Reported 5279 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 4993 times"},{"date":"","signal":"DECREASED APPETITE","source":"FDA FAERS","actionTaken":"Reported 3856 times"},{"date":"","signal":"CONSTIPATION","source":"FDA FAERS","actionTaken":"Reported 3613 times"},{"date":"","signal":"WEIGHT DECREASED","source":"FDA FAERS","actionTaken":"Reported 3419 times"},{"date":"","signal":"PRODUCT USE IN UNAPPROVED INDICATION","source":"FDA FAERS","actionTaken":"Reported 2623 times"},{"date":"","signal":"BLOOD GLUCOSE INCREASED","source":"FDA FAERS","actionTaken":"Reported 2567 times"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"Reported 2475 times"}],"drugInteractions":[{"drug":"Insulin secretagogue (e.g., sulfonylurea) or insulin","severity":"Moderate","mechanism":"Semaglutide stimulates insulin release in presence of elevated blood glucose concentrations","management":"Consider reducing dosage of concomitantly administered insulin secretagogue or insulin when initiating RYBELSUS or OZEMPIC tablets","clinicalEffect":"Increased risk of hypoglycemia, including severe hypoglycemia"},{"drug":"Other oral drugs with narrow therapeutic index","severity":"Moderate","mechanism":"Semaglutide delays gastric emptying and impacts absorption of other oral drugs","management":"Consider increased clinical or laboratory monitoring when co-administered with other oral medications that have narrow therapeutic index or require clinical monitoring","clinicalEffect":"Altered absorption and exposure of concomitant oral 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( 8.1 ) • Lactation : Breastfeeding not recommended. ( 8.2 ) • Females and Males of Reproductive Potential : Discontinue RYBELSUS or OZEMPIC tablets in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide. 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the other side Bottle of 30 tablets 0169-4307-30 14 mg White to light yellow, oval shaped debossed with “14” on one side and “n","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:23:24.586850+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (25 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:27:32.188841+00:00"},"regulatory.eu":{"url":"","method":"deterministic","source":"EMA Approval","rawText":"","confidence":1,"sourceType":"ema","retrievedAt":"2026-04-20T07:27:07.039600+00:00"},"regulatory.jp":{"url":"","method":"deterministic","source":"PMDA Approval","rawText":"","confidence":1,"sourceType":"pmda","retrievedAt":"2026-04-20T07:27:07.112431+00:00"},"regulatory.us":{"url":"","method":"deterministic","source":"FDA Approval","rawText":"","confidence":1,"sourceType":"fda","retrievedAt":"2026-04-20T07:27:06.965205+00:00"},"drugDescription":{"url":"","method":"ai_extraction","source":"FDA Label (description)","aiModel":"featherless","rawText":"11 DESCRIPTION RYBELSUS and OZEMPIC tablets, for oral use, contain semaglutide, a GLP-1 receptor agonist. The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:23:42.024807+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:21:28.997852+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T07:27:04.286427+00:00"},"faersTotalReports":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T07:27:03.664492+00:00"},"fdaClinicalStudies":{"url":"","method":"ai_extraction","source":"FDA Label (clinical_studies, 25,343 chars)","aiModel":"featherless","rawText":"14 CLINICAL STUDIES 14.1 Overview of Clinical Studies The effectiveness of OZEMPIC tablets (1.5 mg, 4 mg and 9 mg strengths) [see Dosage and Administration ( 2.2 )] and RYBELSUS (3 mg, 7, mg and 14 mg strengths) [see Dosage and Administration ( 2.3 )] has been established as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus based on adequate and well-controlled studies of RYBELSUS in adult patients with type 2 diabetes mellitus [see Clinical Phar","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:24:15.573982+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T07:27:05.228267+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=semaglutide","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-20T07:26:57.656851+00:00"},"mechanism.drugClass":{"url":"","method":"deterministic","source":"FDA Label (pharm_class_epc)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-05-14T04:00:51.797331+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:27:32.188797+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label (route)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-05-14T04:00:51.797354+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI extraction","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-05-14T02:02:08.938906+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING: RISK OF THYROID C-CELL TUMORS • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • RYBELSUS and OZEMP","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-05-14T04:00:51.797370+00:00"},"safety.safetySignals":{"url":"","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T07:26:59.797210+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + AI extraction","aiModel":"featherless","rawText":"12.1 Mechanism of Action Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protectio","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-05-14T02:01:36.859712+00:00"},"nonclinicalToxicology":{"url":"","method":"deterministic","source":"FDA Label (nonclinical_toxicology)","rawText":"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [9-, 33- and 113- fold the maximum recommended human dose (MRHD) of semaglutide tablet 14 mg, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (3-, 9- and 33-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:23:42.024866+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:48:25.577786+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:48:34.804437+00:00"},"commercial.annualRevenue":{"url":"","method":"deterministic","source":"SEC EDGAR 10-K","rawText":"$27400M FY2024","confidence":1,"sourceType":"sec_edgar","retrievedAt":"2026-04-20T07:27:14.062694+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI extraction","aiModel":"featherless","rawText":"6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] • Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] • Diabetic Retinopathy Complications [see Warnings and Precautions ( 5.3 )] • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.4 )] • Acute Kidney Injury Due to Volume Depletion [see Warnin","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-05-14T02:01:41.632229+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI extraction","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-05-14T02:01:52.057144+00:00"},"safety.specialPopulations":{"url":"","method":"deterministic","source":"FDA Label (special populations)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:26:28.949961+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (25 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:48:25.577256+00:00"}},"allNames":"nn9535, ozempic, rybelsus, wegovy","dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b","setid":"ee06186f-2aa3-4990-a760-757579d8f77b","title":"WEGOVY (SEMAGLUTIDE) INJECTION, SOLUTION WEGOVY (SEMAGLUTIDE) TABLET [NOVO NORDISK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98","setid":"27f15fac-7d98-4114-a2ec-92494a91da98","title":"OZEMPIC (ORAL SEMAGLUTIDE) TABLET RYBELSUS (ORAL SEMAGLUTIDE) TABLET [NOVO NORDISK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79","setid":"adec4fd2-6858-4c99-91d4-531f5f2a2d79","title":"OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f5e548d0-cc79-4c34-a3f5-e20a5b8b6564","setid":"f5e548d0-cc79-4c34-a3f5-e20a5b8b6564","title":"WEGOVY (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=979e4df4-0597-48ea-b51c-0f699fa6d166","setid":"979e4df4-0597-48ea-b51c-0f699fa6d166","title":"OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]"}],"offLabel":[],"synonyms":["rybelsus","semaglutide","NNC 0113-0217","ozempic","wegovy"],"timeline":[{"date":"2017-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from NOVO NORDISK INC to Novo"},{"date":"2017-12-05","type":"positive","source":"DrugCentral","milestone":"FDA approval (Novo Nordisk Inc)"},{"date":"2018-02-08","type":"positive","source":"DrugCentral","milestone":"EMA approval (Novo Nordisk A/S)"},{"date":"2018-03-23","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Novo Nordisk Pharma Ltd)"},{"date":"2021-06-04","type":"positive","source":"FDA Orange Book","milestone":"Wegovy approved — 0.25MG/0.5ML (0.25MG/0.5ML)"},{"date":"2024-12-09","type":"positive","source":"FDA Orange Book","milestone":"Rybelsus approved — 1.5MG"},{"date":"2025-12-22","type":"positive","source":"FDA Orange Book","milestone":"Wegovy approved — 1.5MG"},{"date":"2026-03-20","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8536122 expires"},{"date":"2028-01-28","type":"negative","source":"FDA Orange Book","milestone":"I-961 exclusivity expires"},{"date":"2031-12-05","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8129343 expires"},{"date":"","type":"positive","milestone":"WHO Essential Medicines List — semaglutide","regulator":"WHO","description":"Included in WHO EML"}],"_dailymed":{"setId":"ee06186f-2aa3-4990-a760-757579d8f77b","title":"WEGOVY (SEMAGLUTIDE) INJECTION, SOLUTION WEGOVY (SEMAGLUTIDE) TABLET [NOVO NORDISK]","labeler":""},"aiSummary":"Semaglutide (Ozempic), developed by Novo Nordisk, is a marketed GLP-1 receptor agonist primarily indicated for glycemic control in type 2 diabetes, competing in a class with other established drugs such as exenatide, liraglutide, lixisenatide, albiglutide, and dulaglutide. Its key competitive advantage lies in its mechanism of action, which effectively stimulates insulin and inhibits glucagon secretion in a glucose-dependent manner while delaying gastric emptying, contributing to its efficacy and safety profile. The primary risk to semaglutide's market position is the patent protection of its competitors, notably liraglutide, which is protected until July 9, 2037, potentially limiting market exclusivity and pricing power.","approvals":[{"date":"2017-12-05","orphan":false,"company":"NOVO NORDISK INC","regulator":"FDA"},{"date":"2018-02-08","orphan":false,"company":"Novo Nordisk A/S","regulator":"EMA"},{"date":"2018-03-23","orphan":false,"company":"Novo Nordisk Pharma Ltd","regulator":"PMDA"}],"brandName":"Ozempic","ecosystem":[{"indication":"Diabetes mellitus type 2","otherDrugs":[{"name":"acarbose","slug":"acarbose","company":"Bayer Hlthcare"},{"name":"acetohexamide","slug":"acetohexamide","company":"Lilly"},{"name":"albiglutide","slug":"albiglutide","company":"Glaxosmithkline Llc"},{"name":"alogliptin","slug":"alogliptin","company":"Takeda Pharms Usa"}],"globalPrevalence":537000000},{"indication":"Obesity","otherDrugs":[{"name":"amfetamine","slug":"amfetamine","company":"Ucb Inc"},{"name":"benzphetamine","slug":"benzphetamine","company":"Pharmacia And Upjohn"},{"name":"bupropion","slug":"bupropion","company":"Glaxosmithkline"},{"name":"chlorphentermine","slug":"chlorphentermine","company":"Parke Davis"}],"globalPrevalence":890000000},{"indication":"Weight loss","otherDrugs":[{"name":"liraglutide","slug":"liraglutide","company":"Novo Nordisk Inc"}],"globalPrevalence":890000000}],"mechanism":{"target":"GLP-1 receptor","novelty":"Follow-on","targets":[{"gene":"GLP1R","source":"DrugCentral","target":"Glucagon-like peptide 1 receptor","protein":"Glucagon-like peptide 1 receptor","activityType":"IC50"}],"moaClass":"Glucagon-like Peptide-1 (GLP-1) Agonists","modality":"Peptide","drugClass":"GLP-1 Receptor Agonist [EPC]","explanation":"Semaglutide works by mimicking the natural hormone GLP-1. It binds to GLP-1 receptors, which helps to lower blood glucose levels by increasing insulin production and reducing glucagon release when blood sugar is high. Additionally, it slows down the rate at which food leaves the stomach, further helping to control blood sugar.","oneSentence":"Semaglutide, a GLP-1 analogue, binds to and activates GLP-1 receptors, stimulating insulin and inhibiting glucagon secretion in a glucose-dependent manner, and delays gastric emptying.","technicalDetail":"Semaglutide is a GLP-1 receptor agonist with 94% sequence homology to human GLP-1. It selectively binds to and activates the GLP-1 receptor, leading to increased insulin secretion and decreased glucagon secretion in a glucose-dependent manner. The drug's long half-life is due to albumin binding, which decreases renal clearance and protects it from metabolic degradation, and stabilization against DPP-4 enzyme degradation."},"_companyIR":{"url":"https://www.novo.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Semaglutide","extract":"Semaglutide is an anti-diabetic medication used for the treatment of type 2 diabetes, and an anti-obesity medication used for long-term weight management and to reduce the risk of major adverse cardiovascular events. It is a peptide similar to the hormone glucagon-like peptide-1 (GLP-1), modified with a side chain. It can be administered by subcutaneous injection or taken orally. It is sold by Novo Nordisk under the brand names Ozempic and Rybelsus for diabetes, and under the brand name Wegovy for weight management, weight loss, and the treatment of metabolic-associated steatohepatitis.","wiki_history":"==History==\nIn the 1970s, Jens Juul Holst and Joel Habener began research on the GLP-1 hormone, initially in relation to duodenal ulcer disease. They were examining hormones secreted during eating, and testing them on pig pancreases, leading to the discovery of GLP-1's significant potency in 1988. Their work, which later contributed significantly to diabetes and obesity treatments, earned them and Daniel J. Drucker the 2021 Warren Alpert Foundation Prize. This was followed by the development of semaglutide by a team of researchers at Novo Nordisk, including Jesper Lau, Thomas Kruse, and Paw Bloch. It was given the brand name Ozempic. Clinical trials started in January 2016 and ended in May 2017.\n\nThe US Food and Drug Administration (FDA) approved semaglutide based on evidence from seven clinical trials of 4087 participants with type2 diabetes. and NCT02305381), participants were randomly assigned to receive either semaglutide or placebo injection weekly. NCT01885208, NCT02128932, NCT02207374, and NCT02254291), participants were randomly assigned to receive either semaglutide or another anti-diabetic medication, and the participant and provider knew which medication was being given in four trials.), which was sponsored by Novo Nordisk, of 3297 participants with type2 diabetes who were at high risk for cardiovascular events.\n\nA 2022 review of anti-obesity treatments found that semaglutide as well as tirzepatide (which has an overlapping mechanism of action) were more promising ","wiki_medical_uses":"==Medical uses==\n===United States===\nIn the US, semaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type2 diabetes, and to reduce the risk of major adverse cardiovascular events in adults with type2 diabetes and established cardiovascular disease. to reduce excess body weight and maintain weight reduction long term in obese individuals twelve years of age or older, or for overweight adults with at least one weight-related comorbid condition. After stopping semaglutide, individuals on average regain about two-thirds (67%) of the weight they lost during treatment within the following year. People return to their previous weight within a year and a half on average after stopping semaglutide.\n\nIn August 2025, the Food and Drug Administration (FDA) expanded the indication for semaglutide (as Wegovy) to include the treatment of noncirrhotic metabolic-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.\n\nIn October 2025, the FDA further expanded the indication for semaglutide (as Rybelsus) to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type2 diabetes who are at high risk for these events.\n\nIn December 2025, the FDA approved an oral version of semaglutide for weight management, using the same brand name","wiki_society_and_culture":"==Society and culture==\n\n\n=== Legal status ===\nIn December 2016, a new drug application was filed with the US Food and Drug Administration (FDA), and in October 2017, an FDA advisory committee approved it unanimously. In December 2017, the injectable version with the brand name Ozempic was approved in the US for use by people with diabetes, and, in January 2018, in Canada. In February 2018, authorization was granted in the European Union, in March 2018 in Japan, and in August 2019 in Australia.\n\nA version of semaglutide to treat diabetes that can be taken orally (Rybelsus) was approved for medical use in the US in September 2019, and in the European Union in April 2020. In January 2023, the US FDA prescription label for Rybelsus was updated to reflect that it can be used as a first-line treatment for adults with type2 diabetes.\n\nIn June 2021, a higher-dose version for injectable use, sold under the brand name Wegovy, was approved by the FDA as an anti-obesity medication for long-term weight management in adults.\n\nIn December 2025, an oral version of semaglutide, sold under the brand name Wegovy, was approved in the US for weight management.\n\nIn January 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Kayshild, intended for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MA"},"chemblData":{"prodrug":-1,"chemblId":"CHEMBL4752331","maxPhase":null,"chirality":-1,"parenteral":false,"availability":-1,"moleculeType":"Unknown","withdrawnFlag":false,"naturalProduct":1,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"launchDate":"2017","revenueYear":2024,"_launchSource":"DrugCentral (FDA 2017-12-05, NOVO NORDISK INC)","annualRevenue":27400,"revenueSource":"Verified: Novo Nordisk AR","revenueCurrency":"USD","peakSalesEstimate":"Not publicly reported","revenueConfidence":"verified"},"fdaRecalls":[{"date":"20250409","reason":"Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.","status":"Ongoing","distribution":"NC, SC, VA","classification":"Class II"},{"date":"20251219","reason":"Presence of Particulate Matter: Hair was found in a prefilled syringe","status":"Ongoing","distribution":"Nationwide within the United States.","classification":"Class II"},{"date":"20210322","reason":"Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.","status":"Terminated","distribution":"Nationwide in the USA","classification":"Class II"},{"date":"20251219","reason":"Presence of Particulate Matter: Hair was found in a prefilled syringe","status":"Ongoing","distribution":"Nationwide within the United States.","classification":"Class II"},{"date":"20210315","reason":"CGMP Deviations: Intermittent exposure to temperature excursion during storage.","status":"Terminated","distribution":"FL, GA, SC","classification":"Class II"}],"overdosage":"10 OVERDOSAGE In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of semaglutide of approximately 1 week.","references":[{"id":1,"url":"https://drugcentral.org/drugcard/5267","fields":["approvals","synonyms","ATC","pharmacokinetics","patents","indications","contraindications","interactions","targets"],"source":"DrugCentral"},{"id":2,"url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=semaglutide","fields":["mechanism","safety","indications","administration"],"source":"FDA Drug Label (DailyMed)"},{"id":3,"url":"https://clinicaltrials.gov/search?intr=semaglutide","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":4,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=semaglutide","fields":["publications"],"source":"PubMed/NCBI"},{"id":5,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":6,"url":"https://en.wikipedia.org/wiki/semaglutide","fields":["history","overview"],"source":"Wikipedia"},{"id":7,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/","fields":["timeline","launchDate"],"source":"FDA Drugs@FDA"},{"id":8,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":9,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":10,"url":"https://www.whocc.no/atc_ddd_index/","fields":["classification"],"source":"WHO ATC/DDD Index"},{"id":11,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T09:56:21.699438","_tgaChecked":true,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-05-14T04:00:53.691315+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"drugName":"exenatide","drugSlug":"exenatide","fdaApproval":"2005-04-28","patentExpiry":"Sep 21, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"liraglutide","drugSlug":"liraglutide","fdaApproval":"2010-01-25","patentExpiry":"Jul 9, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"lixisenatide","drugSlug":"lixisenatide","fdaApproval":"2016-07-27","relationship":"same-class"},{"drugName":"albiglutide","drugSlug":"albiglutide","fdaApproval":"2014-04-15","relationship":"same-class"},{"drugName":"dulaglutide","drugSlug":"dulaglutide","fdaApproval":"2014-09-18","relationship":"same-class"}],"dataSources":[{"url":"https://tavily.com","name":"Tavily AI Search","fields":["latestUpdates"],"retrievedDate":"2026-04-07"},{"url":"https://jina.ai/reader","name":"Jina Reader","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"},{"url":"https://groq.com","name":"Groq (Llama 3.1 8B)","fields":["commercialAnalysis"],"retrievedDate":"2026-04-07"}],"exclusivity":[{"code":"I-961","date":"Jan 28, 2028"},{"code":"I-961","date":"Jan 28, 2028"},{"code":"I-961","date":"Jan 28, 2028"},{"code":"I-961","date":"Jan 28, 2028"}],"genericName":"semaglutide","howSupplied":"16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RYBELSUS strengths are available as follows: Tablet Strength Description Package Configuration NDC Number 3 mg White to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side Bottle of 30 tablets 0169-4303-30 7 mg White to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side Bottle of 30 tablets 0169-4307-30 14 mg White to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side Bottle of 30 tablets 0169-4314-30 OZEMPIC tablet strengths are available as follows: Tablet Strength Description Package Configuration NDC Number 1.5 mg White to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side Bottle of 30 tablets 0169-1715-30 4 mg White to light yellow, round shaped debossed with “4” on one side and “novo” on the other side Bottle of 30 tablets 0169-1704-30 9 mg White to light yellow, round shaped debossed with “9” on one side and “novo” on the other side Bottle of 30 tablets 0169-1709-30 Storage and Handling Store RYBELSUS and OZEMPIC tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store and dispense in the original bottle. Store tablets in the original bottle until use to protect tablets from moisture. Store product in a dry place away from moisture.","indications":{"approved":[{"id":"semaglutide-glycemic-control-in-type-2-dia","name":"Glycemic Control in Type 2 Diabetes","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults with type 2 diabetes mellitus","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults with type 2 diabetes mellitus","diagnosticRequired":null,"brandNameForIndication":"Ozempic"},{"id":"semaglutide-reduction-of-cv-risk-in-type-2","name":"Reduction of CV Risk in Type 2 Diabetes","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Adults with type 2 diabetes mellitus who are at high risk for major adverse cardiovascular events","pivotalTrial":null,"restrictions":[],"patientPopulation":"Adults with type 2 diabetes mellitus who are at high risk for major adverse cardiovascular events","diagnosticRequired":null,"brandNameForIndication":"Ozempic"}],"offLabel":[],"pipeline":[]},"_drugCentral":{"patents":[{"number":"11318191","expires":"2041-02-17"},{"number":"10888605","expires":"2038-08-24"},{"number":"10278923","expires":"2034-05-02"},{"number":"10335462","expires":"2033-06-21"},{"number":"9764003","expires":"2033-06-21"},{"number":"10933120","expires":"2033-03-15"},{"number":"9132239","expires":"2032-02-01"},{"number":"10086047","expires":"2031-12-16"},{"number":"10960052","expires":"2031-12-16"},{"number":"11382957","expires":"2031-12-16"},{"number":"9278123","expires":"2031-12-16"},{"number":"8129343","expires":"2031-12-05"},{"number":"9457154","expires":"2027-09-29"},{"number":"9457154","expires":"2027-09-27"},{"number":"9687611","expires":"2027-02-27"},{"number":"RE46363","expires":"2026-08-03"},{"number":"10220155","expires":"2026-07-17"},{"number":"11097063","expires":"2026-07-17"},{"number":"8920383","expires":"2026-07-17"},{"number":"9775953","expires":"2026-07-17"},{"number":"8536122","expires":"2026-03-20"},{"number":"10357616","expires":"2026-01-20"},{"number":"10376652","expires":"2026-01-20"},{"number":"11311679","expires":"2026-01-20"},{"number":"9108002","expires":"2026-01-20"},{"number":"9616180","expires":"2026-01-20"},{"number":"9861757","expires":"2026-01-20"},{"number":"11446443","expires":"2025-10-20"},{"number":"8684969","expires":"2025-10-20"},{"number":"8114833","expires":"2025-08-13"},{"number":"7762994","expires":"2024-05-23"},{"number":"8579869","expires":"2023-06-30"}],"targets":[{"gene":"GLP1R","target":"Glucagon-like peptide 1 receptor","protein":"Glucagon-like peptide 1 receptor","activityType":"IC50","activityUnit":"","activityValue":9.42}],"atcCodes":["A10BJ06"],"synonyms":["rybelsus","semaglutide","NNC 0113-0217","ozempic","wegovy"],"approvals":[{"date":"2017-12-05","orphan":false,"company":"NOVO NORDISK INC","regulator":"FDA"},{"date":"2018-02-08","orphan":false,"company":"Novo Nordisk A/S","regulator":"EMA"},{"date":"2018-03-23","orphan":false,"company":"Novo Nordisk Pharma Ltd","regulator":"PMDA"}],"properties":{"BDDCS":{"name":"Biopharmaceutical Drug Disposition Classification System","units":"","value":2}},"drugClasses":[],"identifiers":{"MMSL":"304634","NDDF":"017424","UNII":"53AXN4NNHX","CHEBI":"CHEBI:167574","VANDF":"4037164","INN_ID":"9113","RXNORM":"1991302","UMLSCUI":"C3885068","ChEMBL_ID":"CHEMBL2108724","KEGG_DRUG":"D10025","DRUGBANK_ID":"DB13928","PUBCHEM_CID":"56843331","SNOMEDCT_US":"764283003","IUPHAR_LIGAND_ID":"9724","MESH_SUPPLEMENTAL_RECORD_UI":"C000591245"},"indications":[{"name":"Diabetes mellitus type 2","source":"DrugCentral","umlsCui":"C0011860","snomedId":44054006},{"name":"Obesity","source":"DrugCentral","umlsCui":"C0028754","snomedId":414916001},{"name":"Weight loss","source":"DrugCentral","umlsCui":"C0043096","snomedId":89362005}],"formulations":[{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","status":"NDA","tradeName":"OZEMPIC"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","status":"NDA","tradeName":"Ozempic"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","status":"NDA","tradeName":"WEGOVY"},{"form":"TABLET","route":"ORAL","status":"NDA","tradeName":"RYBELSUS"}],"offLabelUses":[],"drugCentralId":5267,"drugInteractions":[],"contraindications":[]},"_drugWebsite":{"url":"https://www.ozempic.com","content":"Important Safety Information\nMedication Guide\n\nSearch\n\nWhy Ozempic®?\nHow to Take Ozempic®\nSavings, Support, & Resources\nFAQs\nLifestyle Tips & Videos\n\nSavings and\n\nSupport\n\nClick here for recent news regarding counterfeit Ozempic®\n\nReal patients and actor portrayals.\n\nPen shown delivers doses of 2 mg.\n\nYour treatment path is unique. Take the next step by asking your health care provider about the only GLP-1 proven across all of these areas for adults with type 2 diabetes.\nSee how Ozempic® could help\n\nFor adults with type 2 diabetes,\n\nOzempic® is the GLP-1 with the most FDA-approved uses.\n\nAll uses may not apply. Ask your doctor.\n\nIn adults with type 2 diabetes,\n\nOzempic® is proven to lower blood sugar and A1C, along with diet and exercise\n\nLearn about A1C\n\nMichael and Tanya, The War and Treaty.\nMichael has type 2 diabetes and takes Ozempic®.\nPaid spokespeople of Novo Nordisk.\n\nIn adults who also have heart disease,\n\nOzempic® lowers the risk of major cardiovascular events such as stroke, heart attack, or death\n\nDiscover the impact\n\nTom has type 2 diabetes and takes Ozempic®.\nTom also has known heart disease.\nPaid spokesperson of Novo Nordisk.\n\nIn adults who also have chronic kidney disease,\n\nOzempic® lowers the risk of worsening kidney disease, kidney failure (end-stage kidney disease), and death due to cardiovascular disease\n\nReduce your risk\n\nActor portrayals.\n\n \n\n\"With Ozempic®, I lowered my A1C and saw noticeable weight loss.\"\n\n— Michael's Ozempic® story\n\nOzempic® is not a weight-loss drug.\n\nSee his story\n\nMichael and Tanya, The War and Treaty. \n\nMichael has type 2 diabetes and takes Ozempic®. 
\n\nPaid spokespeople of Novo Nordisk.\n\nSee how healthy eating can help you transform the way you manage your type 2 diabetes along with exercise.\n\nLearn more\n\nFranklin has type 2 diabetes and takes Ozempic®.\nPaid spokesperson of Novo Nordisk.\n\nImportant Safety Information\n\nDo not share your Ozempic® pen with other people, even if the needle has been changed. You may give oth"},"_fixedFields":["primaryTarget"],"_mhraChecked":true,"currentOwner":"Novo","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"exenatide","brandName":"exenatide","genericName":"exenatide","approvalYear":"2005","relationship":"same-class"},{"drugId":"liraglutide","brandName":"liraglutide","genericName":"liraglutide","approvalYear":"2010","relationship":"same-class"},{"drugId":"lixisenatide","brandName":"lixisenatide","genericName":"lixisenatide","approvalYear":"2016","relationship":"same-class"},{"drugId":"albiglutide","brandName":"albiglutide","genericName":"albiglutide","approvalYear":"2014","relationship":"same-class"},{"drugId":"dulaglutide","brandName":"dulaglutide","genericName":"dulaglutide","approvalYear":"2014","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07423481","phase":"","title":"Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity","status":"NOT_YET_RECRUITING","sponsor":"Nantes University Hospital","isPivotal":false,"enrollment":3000,"indication":"Obesity & Overweight","completionDate":"2027-03-01","primaryEndpoint":""},{"nctId":"NCT07462663","phase":"PHASE4","title":"SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer (Phase 1)","status":"NOT_YET_RECRUITING","sponsor":"Hospital Universitari de Bellvitge","isPivotal":false,"enrollment":82,"indication":"Endometrial Cancer, Endometrial Cancer Stage I","completionDate":"2028-09","primaryEndpoint":""},{"nctId":"NCT07417618","phase":"","title":"INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","isPivotal":false,"enrollment":60000,"indication":"Type 2 Diabetes, Overweight","completionDate":"2026-05-22","primaryEndpoint":""},{"nctId":"NCT03884075","phase":"PHASE2","title":"Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)","status":"RECRUITING","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","isPivotal":false,"enrollment":84,"indication":"Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease","completionDate":"2026-10-02","primaryEndpoint":""},{"nctId":"NCT06745284","phase":"PHASE1","title":"A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity","status":"ACTIVE_NOT_RECRUITING","sponsor":"Boehringer Ingelheim","isPivotal":false,"enrollment":64,"indication":"Obesity","completionDate":"2027-01-10","primaryEndpoint":""},{"nctId":"NCT07563699","phase":"PHASE1, PHASE2","title":"Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus","status":"NOT_YET_RECRUITING","sponsor":"Mapi Pharma Ltd.","isPivotal":false,"enrollment":24,"indication":"Diabete Type 2","completionDate":"2028-05","primaryEndpoint":""},{"nctId":"NCT07581145","phase":"PHASE3","title":"Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients","status":"RECRUITING","sponsor":"Ole Lander Svendsen","isPivotal":false,"enrollment":52,"indication":"Foot Ulcer Due to Type 2 Diabetes Mellitus","completionDate":"2029-12","primaryEndpoint":""},{"nctId":"NCT07502508","phase":"PHASE2","title":"Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy","status":"RECRUITING","sponsor":"Biomea Fusion Inc.","isPivotal":false,"enrollment":60,"indication":"Type 2 Diabetes","completionDate":"2027-07","primaryEndpoint":""},{"nctId":"NCT07223983","phase":"PHASE1","title":"Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)","status":"RECRUITING","sponsor":"Yale University","isPivotal":false,"enrollment":10,"indication":"Alcohol Use Disorder, Weight Loss","completionDate":"2026-10-31","primaryEndpoint":""},{"nctId":"NCT07249554","phase":"PHASE2","title":"Combination Therapy for Alcohol Use Disorder","status":"NOT_YET_RECRUITING","sponsor":"Johns Hopkins University","isPivotal":false,"enrollment":45,"indication":"Alcohol Use Disorder","completionDate":"2028-09","primaryEndpoint":""},{"nctId":"NCT06015893","phase":"PHASE2","title":"Semaglutide Therapy for Alcohol Reduction (STAR)","status":"RECRUITING","sponsor":"National Institute on Drug Abuse (NIDA)","isPivotal":false,"enrollment":80,"indication":"Addiction, Alcohol Use Disorder","completionDate":"2030-12-31","primaryEndpoint":""},{"nctId":"NCT06884293","phase":"PHASE3","title":"A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）","status":"ACTIVE_NOT_RECRUITING","sponsor":"Innovent Biologics (Suzhou) Co. 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Attention","source":"www.accessdata.fda.gov"}],"manufacturing":[{"role":"Manufacturer","site":"Novo Nordisk","location":"","operator":"Novo Nordisk"}],"molecularData":{"oral":false,"chemblId":"CHEMBL4752331","moleculeType":"Unknown","molecularWeight":"4113.64"},"pivotalTrials":["NCT02054897","NCT01930188","NCT01885208","NCT02128932","NCT02305381","NCT01720446"],"administration":{"route":"Oral","formulation":"0.25 MG, 0.5 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]; semaglutide 14 MG Oral Tablet [Rybelsus]; semaglutide 3 MG Oral Tablet [Rybelsus]","formulations":[{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","tradeName":"OZEMPIC"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","tradeName":"Ozempic"},{"form":"INJECTION, SOLUTION","route":"SUBCUTANEOUS","tradeName":"WEGOVY"},{"form":"TABLET","route":"ORAL","tradeName":"RYBELSUS"}]},"_patentsChecked":true,"_warningLetters":[{"date":"03/10/2026","subject":"03/05/2026\tNovo Nordisk Inc.\tCenter for Drug Evaluation and Research (CDER)\tPostmarketing Adverse Dr"},{"date":"12/11/2025","subject":"11/20/2025\tCatalent Indiana, LLC\tOffice of Manufacturing Quality\tCGMP/Finished Pharmaceuticals/Adult"},{"date":"09/16/2025","subject":"09/09/2025\tNovo Nordisk Inc.\tCenter for Drug Evaluation and Research (CDER)\tFalse & Misleading Claim"}],"crossReferences":{"MMSL":"304634","NDDF":"017424","UNII":"53AXN4NNHX","CHEBI":"CHEBI:167574","VANDF":"4037164","INN_ID":"9113","RXNORM":"1991302","UMLSCUI":"C3885068","ChEMBL_ID":"CHEMBL2108724","KEGG_DRUG":"D10025","DRUGBANK_ID":"DB13928","PUBCHEM_CID":"56843331","SNOMEDCT_US":"764283003","IUPHAR_LIGAND_ID":"9724","MESH_SUPPLEMENTAL_RECORD_UI":"C000591245"},"drugDescription":{"pH":"","structure":"Semaglutide is a white to almost white hygroscopic powder.","appearance":"white to almost white hygroscopic powder","composition":"RYBELSUS tablets contain 3 mg, 7 mg or 14 mg of semaglutide and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC). OZEMPIC tablets contain 1.5 mg, 4 mg or 9 mg of semaglutide and the following inactive ingredients: magnesium stearate and SNAC.","molecularWeight":"4113.58 g/mol","molecularFormula":"C187H291N45O59"},"formularyStatus":[],"originalProduct":{"form":"TABLET","route":"ORAL","company":"Novo Nordisk","brandName":"RYBELSUS","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","_offLabelChecked":true,"chemblMechanisms":[],"developmentCodes":[],"ownershipHistory":[{"period":"2017-","companyName":"Novo Nordisk","relationship":"Original Developer"},{"period":"present","companyName":"Novo","relationship":"Current Owner"},{"period":"2018","companyName":"Novo Nordisk","relationship":"EMA Licensee"},{"period":"2018","companyName":"Novo Nordisk Pharma Ltd","relationship":"PMDA Licensee"}],"pharmacokinetics":{"tmax":"Approximately 1 hour after oral administration","source":"DrugCentral","halfLife":"Approximately one week","clearance":"Approximately 0.04 L/hour","excretion":"Primary excretion routes via urine and feces; approximately 3% of absorbed dose excreted in urine as intact semaglutide","metabolism":"Primary route of elimination is metabolism following proteolytic cleavage of peptide backbone and sequential beta-oxidation of fatty acid side chain","proteinBinding":">99% bound to plasma albumin","bioavailability":"0.4% to 1% (RYBELSUS 3, 7, 14 mg); 1% to 2% (OZEMPIC tablets 1.5, 4, 9 mg)","volumeOfDistribution":"Approximately 8 L"},"publicationCount":4473,"therapeuticAreas":["Metabolic"],"_revenueScrapedAt":"2026-04-08 13:56:01.083477+00","atcClassification":{"atcCode":"A10BJ06","atcName":"semaglutide"},"biosimilarFilings":[],"faersTotalReports":78284,"originalDeveloper":"Novo Nordisk Inc","commercialAnalysis":{"text":"Ozempic (semaglutide) by Novo Nordisk has established itself as a leading treatment for diabetes mellitus type 2 and obesity, with a revenue of $27,400 in the marketed phase. According to Congruence Market Insights, the global Ozempic market is expected to reach $36,249.8 million by 2033, expanding at a CAGR of 7.8% between 2026 and 2033 [1]. The United States is the dominant country in the professional Ozempic market environment, with strong statistics on production capacity and investment.\n\nThe competitive landscape for Ozempic is characterized by intense competition from other GLP-1 agonists, such as Lilly's oral GLP-1 agonist for weight loss, which has gained approval [3]. Novo Nordisk's market share in GLP-1 diabetes drugs declined to 45.8% amid competitive pressure, while maintaining a dominant 83.1% share of the Chinese GLP-1 market for diabetes [2]. The company's revenue in China grew 5% to DKK 18.7 billion (USD 2.8 billion) in 2025.\n\nKey upcoming catalysts for Ozempic include the potential for label expansions and pipeline competitors. 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Auto-Injector","rxcui":"2553601","synonym":"semaglutide 0.5 MG per 0.5 ML Auto-Injector"},{"tty":"SCD","name":"0.5 ML semaglutide 2 MG/ML Auto-Injector","rxcui":"2553802","synonym":"semaglutide 1 MG per 0.5 ML Auto-Injector"},{"tty":"SCD","name":"0.75 ML semaglutide 2.27 MG/ML Auto-Injector","rxcui":"2553901","synonym":"semaglutide 1.7 MG per 0.75 ML Auto-Injector"},{"tty":"SCD","name":"0.75 ML semaglutide 3.2 MG/ML Auto-Injector","rxcui":"2554102","synonym":"semaglutide 2.4 MG per 0.75 ML Auto-Injector"},{"tty":"SCD","name":"3 ML semaglutide 2.68 MG/ML Pen Injector","rxcui":"2599362","synonym":"semaglutide 8 MG per 3 ML Pen Injector"},{"tty":"SCD","name":"0.25 MG, 0.5 MG Dose 3 ML semaglutide 0.68 MG/ML Pen Injector","rxcui":"2619152","synonym":"0.25 MG, 0.5 MG Dose semaglutide 2 MG per 3 ML Pen Injector"},{"tty":"SCD","name":"semaglutide 1.5 MG Oral Tablet","rxcui":"2707547","synonym":""},{"tty":"SCD","name":"semaglutide 4 MG Oral 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(SAS)","counts":{"FG000":"249","FG001":"126"}},{"type":"Treated","counts":{"FG000":"249","FG001":"126"}},{"type":"COMPLETED","counts":{"FG000":"244","FG001":"121"}},{"type":"NOT COMPLETED","counts":{"FG000":"5","FG001":"5"}}],"dropWithdraws":[{"type":"Lost to Follow-up","counts":{"FG000":"1","FG001":"1"}},{"type":"Withdrawal by Subject","counts":{"FG000":"4","FG001":"4"}}]}],"recruitment":"The trial was conducted at 28 sites in 3 countries as follows (all sites screened and randomized): Region China (includes China mainland and Hong Kong) China mainland (23 sites) and Hong Kong (1 site), Brazil (2 sites) and South Korea (2 sites).","preAssignment":"Participants were randomized in 2:1 ratio to receive 2.4 mg semaglutide subcutaneously (s.c.) or semaglutide matching placebo. The trial has a 44-week treatment period (16 weeks of dose escalation period and 28 weeks of maintenance period), followed by a 7-week follow-up period."},{"nctId":"NCT05564117","groups":[{"id":"FG000","title":"Oral Semaglutide 25 mg","description":"Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 m"},{"id":"FG001","title":"Placebo","description":"Participants received placebo matched to semaglutide orally once daily up to week 64."}],"acronym":"OASIS 4","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"205","FG001":"102"}},{"type":"Full Analysis Set","counts":{"FG000":"205","FG001":"102"}},{"type":"Safety Analysis Set","counts":{"FG000":"204","FG001":"102"}},{"type":"COMPLETED","counts":{"FG000":"196","FG001":"94"}},{"type":"NOT COMPLETED","counts":{"FG000":"9","FG001":"8"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"1","FG001":"1"}},{"type":"Lost to Follow-up","counts":{"FG000":"7","FG001":"7"}},{"type":"Physician Decision","counts":{"FG000":"1","FG001":"0"}}]}],"recruitment":"The trial was conducted at 22 sites in 4 countries (Canada, Germany, Poland, and United States).","preAssignment":"Participants were randomised in 2:1 ratio to receive once daily oral semaglutide 25 milligram (mg) or placebo matched to semaglutide. The trial had a 64-week treatment period (12 weeks of dose escalation period and 52 weeks of maintenance period) followed by a 7-week follow-up period."},{"nctId":"NCT05040971","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increa"},{"id":"FG001","title":"Placebo","description":"Participants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation"}],"acronym":"STEP 10","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"138","FG001":"69"}},{"type":"Full Analysis Set (FAS)","counts":{"FG000":"138","FG001":"69"}},{"type":"Safety Analysis Set (SAS)","counts":{"FG000":"138","FG001":"69"}},{"type":"COMPLETED","counts":{"FG000":"128","FG001":"64"}},{"type":"NOT COMPLETED","counts":{"FG000":"10","FG001":"5"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"0","FG001":"2"}},{"type":"Lost to Follow-up","counts":{"FG000":"8","FG001":"3"}},{"type":"Death","counts":{"FG000":"2","FG001":"0"}}]}],"recruitment":"The trial was conducted at 30 sites in 5 countries as follows: Canada (15 sites), Denmark (2 sites), Finland (2 sites), Spain (3 sites) and United Kingdom (8 sites).","preAssignment":"The trial has a Main phase and Extension phase. Main phase: a 52-week treatment period (16 weeks of dose escalation and 36 weeks of maintenance dose). Extension phase: a 28-week off-treatment extension phase after the main phase for assessment of body weight, glycaemic and cardiovascular parameters. Participants were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo as an adjunct to a reduced-calorie diet and increased physical activity."},{"nctId":"NCT04998136","groups":[{"id":"FG000","title":"Semaglutide","description":"Participants received 2.4 milligram (mg) semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and th"},{"id":"FG001","title":"Placebo","description":"Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose"}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"101","FG001":"49"}},{"type":"Full Analysis Set","counts":{"FG000":"101","FG001":"49"}},{"type":"Safety Analysis Set","counts":{"FG000":"101","FG001":"49"}},{"type":"COMPLETED","counts":{"FG000":"101","FG001":"49"}},{"type":"NOT COMPLETED","counts":{"FG000":"0","FG001":"0"}}],"dropWithdraws":[]}],"recruitment":"The trial was conducted at 13 sites in Republic of Korea and Thailand.","preAssignment":"The trial included an initial 16 weeks of dose escalation period and a 28 weeks of maintenance period. 150 eligible participants were randomized in a 2:1 manner to receive either Semaglutide or placebo once weekly as an adjunct to a reduced-calorie diet and increased physical activity."},{"nctId":"NCT04865770","groups":[{"id":"FG000","title":"Semaglutide 1.0 mg","description":"Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increas"},{"id":"FG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"acronym":"REMODEL","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"71","FG001":"35"}},{"type":"Full Analysis Set","counts":{"FG000":"71","FG001":"35"}},{"type":"Safety Analysis Set","counts":{"FG000":"71","FG001":"35"}},{"type":"COMPLETED","counts":{"FG000":"58","FG001":"34"}},{"type":"NOT COMPLETED","counts":{"FG000":"13","FG001":"1"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"3","FG001":"0"}},{"type":"Physician Decision","counts":{"FG000":"9","FG001":"0"}},{"type":"Death","counts":{"FG000":"1","FG001":"1"}}]}],"recruitment":"The trial was conducted at 31 sites in 8 countries.","preAssignment":"Participants were randomized in a 2:1 ratio to receive semaglutide or placebo, respectively. Both added to standard-of-care treatment."},{"nctId":"NCT05891496","groups":[{"id":"FG000","title":"Semaglutide","description":"Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the d"},{"id":"FG001","title":"Placebo","description":"Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks."},{"id":"FG002","title":"Placebo to Semaglutide","description":"Participants who initially received placebo was administered with semaglutide every 4 weeks in a dose escalation manner."}],"acronym":null,"periods":[{"title":"Period 1: 12 Weeks","milestones":[{"type":"STARTED","counts":{"FG000":"11","FG001":"12","FG002":"0"}},{"type":"Full Analysis Set","counts":{"FG000":"11","FG001":"12","FG002":"0"}},{"type":"Safety Analysis Set","counts":{"FG000":"11","FG001":"12","FG002":"0"}},{"type":"COMPLETED","counts":{"FG000":"11","FG001":"12","FG002":"0"}},{"type":"NOT COMPLETED","counts":{"FG000":"0","FG001":"0","FG002":"0"}}],"dropWithdraws":[]},{"title":"Period 2: 52 Weeks","milestones":[{"type":"STARTED","counts":{"FG000":"11","FG001":"0","FG002":"12"}},{"type":"Treated","counts":{"FG000":"10","FG001":"0","FG002":"12"}},{"type":"COMPLETED","counts":{"FG000":"0","FG001":"0","FG002":"0"}},{"type":"NOT COMPLETED","counts":{"FG000":"11","FG001":"0","FG002":"12"}}],"dropWithdraws":[{"type":"Ongoing","counts":{"FG000":"10","FG001":"0","FG002":"12"}},{"type":"Withdrawal by Subject","counts":{"FG000":"1","FG001":"0","FG002":"0"}}]}],"recruitment":"The trial was conducted at 7 sites in 5 countries (Canada, Denmark, Sweden, Switzerland and the United States).","preAssignment":"Participants with mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer's type were randomised in 1:1 ratio to receive subcutaneous (s.c.) injection of once weekly semaglutide or placebo matched to semaglutide. The final data for outcome measures 1,2 and 3 are reported with no further updates. Adverse events are presented for period 1 + period 2."},{"nctId":"NCT03914326","groups":[{"id":"FG000","title":"Oral Semaglutide","description":"Participants were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached a"},{"id":"FG001","title":"Placebo","description":"Participants were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260)."}],"acronym":"SOUL","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"4825","FG001":"4826"}},{"type":"Full Analysis Set","counts":{"FG000":"4825","FG001":"4825"}},{"type":"Exposed","counts":{"FG000":"4814","FG001":"4816"}},{"type":"COMPLETED","counts":{"FG000":"4755","FG001":"4740"}},{"type":"NOT COMPLETED","counts":{"FG000":"70","FG001":"86"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"27","FG001":"34"}},{"type":"Lost to Follow-up","counts":{"FG000":"43","FG001":"51"}},{"type":"Randomised more than once","counts":{"FG000":"0","FG001":"1"}}]}],"recruitment":"The trial was conducted at 446 sites in 34 countries.","preAssignment":"A total of 9,651 participants were enrolled/randomized (1:1) to treatment with oral semaglutide (4,825 participants) or placebo (4,826 participants). One participant was randomised twice in the trial. Thus, the FAS comprised 9,650 participants (4,825 participants in the oral semaglutide group and 4,825 participants in the placebo group)."},{"nctId":"NCT04560998","groups":[{"id":"FG000","title":"Semaglutide","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increas"},{"id":"FG001","title":"Placebo","description":"Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks."}],"acronym":"STRIDE","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"396","FG001":"396"}},{"type":"Full Analysis Set","counts":{"FG000":"396","FG001":"396"}},{"type":"Safety Analysis Set","counts":{"FG000":"396","FG001":"395"}},{"type":"COMPLETED","counts":{"FG000":"366","FG001":"379"}},{"type":"NOT COMPLETED","counts":{"FG000":"30","FG001":"17"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"18","FG001":"12"}},{"type":"Lost to Follow-up","counts":{"FG000":"8","FG001":"5"}},{"type":"Physician Decision","counts":{"FG000":"4","FG001":"0"}}]}],"recruitment":"The trial was conducted at 129 sites in 21 countries.","preAssignment":"Participants were randomized in a 1:1 ratio to receive treatment with either semaglutide or placebo as an adjunct to standard-of-care."},{"nctId":"NCT05822830","groups":[{"id":"FG000","title":"15 mg or MTD - Tirzepatide","description":"Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to"},{"id":"FG001","title":"2.4 mg or MTD - Semaglutide","description":"Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7"}],"acronym":"SURMOUNT-5","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"375","FG001":"376"}},{"type":"Received At Least One Dose of Study Drug","counts":{"FG000":"374","FG001":"376"}},{"type":"COMPLETED","counts":{"FG000":"319","FG001":"319"}},{"type":"NOT COMPLETED","counts":{"FG000":"56","FG001":"57"}}],"dropWithdraws":[{"type":"Adverse Event","counts":{"FG000":"6","FG001":"6"}},{"type":"Assigned Treatment by Mistake","counts":{"FG000":"5","FG001":"3"}},{"type":"Lost to Follow-up","counts":{"FG000":"16","FG001":"18"}},{"type":"Non-Compliance With Study Drug","counts":{"FG000":"1","FG001":"1"}},{"type":"Participant was Out of the Country","counts":{"FG000":"0","FG001":"1"}},{"type":"Pregnancy","counts":{"FG000":"1","FG001":"2"}},{"type":"Withdrawal by Subject","counts":{"FG000":"27","FG001":"26"}}]}],"recruitment":"","preAssignment":""},{"nctId":"NCT04788511","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (body mass index \\[BMI\\] greater than or equal to (≥) 30.0 kilogram per square meter (kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4"},{"id":"FG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 "}],"acronym":"STEP-HFpEF","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"263","FG001":"266"}},{"type":"Full Analysis Set (FAS)","counts":{"FG000":"263","FG001":"266"}},{"type":"Safety Analysis Set (SAS)","counts":{"FG000":"263","FG001":"266"}},{"type":"COMPLETED","counts":{"FG000":"256","FG001":"254"}},{"type":"NOT COMPLETED","counts":{"FG000":"7","FG001":"12"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"2","FG001":"1"}},{"type":"Lost to Follow-up","counts":{"FG000":"2","FG001":"7"}},{"type":"Death","counts":{"FG000":"3","FG001":"4"}}]}],"recruitment":"The trial was conducted at 83 sites in 13 countries, as follows: Argentina (6), Australia (5), Hungary (8), Czech Republic (5), Poland (6), Spain (3), Netherlands (6), Denmark (3), United States (16), Canada (4), Israel (5), Germany (7) and United Kingdom (9).","preAssignment":""},{"nctId":"NCT05064735","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants initiated at a once-weekly dose of 0.24 milligrams (mg) semaglutide subcutaneously (s.c.) as a adjunct to a reduced calorie diet and increased physical activity and followed a fixed-dose "},{"id":"FG001","title":"Placebo","description":"Participants received semaglutide matching placebo subcutaneously once weekly as a adjunct to a reduced calorie diet and increased physical activity from week 0 to week 68. Participants were followed "}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"271","FG001":"136"}},{"type":"Full Analysis Set (FAS)","counts":{"FG000":"271","FG001":"136"}},{"type":"Safety Analysis Set (SAS)","counts":{"FG000":"269","FG001":"135"}},{"type":"COMPLETED","counts":{"FG000":"246","FG001":"122"}},{"type":"NOT COMPLETED","counts":{"FG000":"25","FG001":"14"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"7","FG001":"8"}},{"type":"Lost to Follow-up","counts":{"FG000":"7","FG001":"2"}},{"type":"Physician Decision","counts":{"FG000":"2","FG001":"1"}},{"type":"Failing to Meet Randomization Requirements","counts":{"FG000":"2","FG001":"1"}},{"type":"Site Closure","counts":{"FG000":"7","FG001":"2"}}]}],"recruitment":"The trial was conducted at 61 sites in 11 countries as follows (number of sites that screened participants/ number of sites that randomised participants): Canada (5/ 5); Colombia (3/ 3); Denmark (2/ 2); France (5/ 5); Norway (3/ 3); Russia (10/ 10); Saudi Arabia (4/ 4); South Africa (5/ 5); Spain (3/ 3); Sweden (4/ 4) and United States (17/ 17).","preAssignment":"The study included a screening visit followed by visits every 4th week during dose escalation period and every 8th week until end-of-treatment (week 68). Follow-up period was 7 weeks after end-of-treatment (week 75)."},{"nctId":"NCT05478252","groups":[{"id":"FG000","title":"Semaglutide J","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 week"},{"id":"FG001","title":"Semaglutide B","description":"Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 week"}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"291","FG001":"97"}},{"type":"Full Analysis Set","counts":{"FG000":"291","FG001":"97"}},{"type":"Safety Analysis Set","counts":{"FG000":"291","FG001":"97"}},{"type":"COMPLETED","counts":{"FG000":"283","FG001":"91"}},{"type":"NOT COMPLETED","counts":{"FG000":"8","FG001":"6"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"2","FG001":"3"}},{"type":"Lost to Follow-up","counts":{"FG000":"4","FG001":"2"}},{"type":"Physician Decision","counts":{"FG000":"1","FG001":"1"}},{"type":"Death","counts":{"FG000":"1","FG001":"0"}}]}],"recruitment":"The trial was conducted at 73 sites in Slovakia, Poland, South Africa, the United States and Canada.","preAssignment":""},{"nctId":"NCT04102189","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16"},{"id":"FG001","title":"Placebo","description":"Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity."}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"134","FG001":"67"}},{"type":"Treated","counts":{"FG000":"133","FG001":"67"}},{"type":"Full Analysis Set (FAS)","counts":{"FG000":"134","FG001":"67"}},{"type":"Safety Analysis Set","counts":{"FG000":"133","FG001":"67"}},{"type":"COMPLETED","counts":{"FG000":"132","FG001":"64"}},{"type":"NOT COMPLETED","counts":{"FG000":"2","FG001":"3"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"1","FG001":"2"}},{"type":"Withdrawal by parent/guardian","counts":{"FG000":"0","FG001":"1"}},{"type":"Lost to Follow-up","counts":{"FG000":"1","FG001":"0"}}]}],"recruitment":"The trial was conducted at 37 sites in 8 countries, as follows: Austria (3), Belgium (4), Croatia (3), Ireland (1), Mexico (1), Russia (7), Great Britain (6), United States (12).","preAssignment":"Participants were randomized 2:1 to receive either semaglutide subcutaneously (s.c.) once weekly or semaglutide placebo s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks. This was followed by a 7-week follow-up period after 'end of treatment' due to the long half-life of semaglutide."},{"nctId":"NCT03919929","groups":[{"id":"FG000","title":"Diet Intervention","description":"Weight loss with dietary intervention\n\nWeight loss diet: Prescribed weight loss diet to match weight loss in Drug arm"},{"id":"FG001","title":"GLP-1 Intervention","description":"Participants will take a daily oral tablet of semaglutide for 4 months.\n\nSemaglutide 3mg and 7mg \\[Rybelsus\\]: Once daily oral tablet of semaglutide for 4 months"}],"acronym":"TEAL","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"17","FG001":"43"}},{"type":"COMPLETED","counts":{"FG000":"17","FG001":"34"}},{"type":"NOT COMPLETED","counts":{"FG000":"0","FG001":"9"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"0","FG001":"4"}},{"type":"Screen Failure","counts":{"FG000":"0","FG001":"5"}}]}],"recruitment":"","preAssignment":"There were 5 participants who screen failed, and 4 participants who withdrew due to not tolerating the study medication."},{"nctId":"NCT05788965","groups":[{"id":"FG000","title":"Semaglutide Treatment","description":"This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD.\n\nSemaglutide: gl"}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"8"}},{"type":"COMPLETED","counts":{"FG000":"8"}},{"type":"NOT COMPLETED","counts":{"FG000":"0"}}],"dropWithdraws":[]}],"recruitment":"","preAssignment":""},{"nctId":"NCT05144984","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg + NNC0480-0389 2.4 mg","description":"Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered wit"},{"id":"FG001","title":"Semaglutide 2.4 mg + NNC0480-0389 7.2 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-03"},{"id":"FG002","title":"Semaglutide 2.4 mg + NNC0480-0389 12.0 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0"},{"id":"FG003","title":"Semaglutide 2.4 mg + NNC0480-0389 21.6 mg","description":"Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0"},{"id":"FG004","title":"Semaglutide 2.4 mg + Placebo (NNC0480-0389)","description":"Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks."},{"id":"FG005","title":"NNC0480-0389 21.6 mg + Placebo (Semaglutide)","description":"Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks."},{"id":"FG006","title":"Placebo","description":"Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks."}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"77","FG001":"74","FG002":"77","FG003":"77","FG004":"75","FG005":"59","FG006":"61"}},{"type":"Full Analysis Set (FAS)","counts":{"FG000":"77","FG001":"74","FG002":"77","FG003":"77","FG004":"75","FG005":"59","FG006":"61"}},{"type":"Safety Analysis Set (SAS)","counts":{"FG000":"77","FG001":"74","FG002":"77","FG003":"77","FG004":"75","FG005":"59","FG006":"61"}},{"type":"Exposed","counts":{"FG000":"77","FG001":"74","FG002":"77","FG003":"77","FG004":"75","FG005":"59","FG006":"61"}},{"type":"COMPLETED","counts":{"FG000":"74","FG001":"72","FG002":"74","FG003":"74","FG004":"72","FG005":"57","FG006":"59"}},{"type":"NOT COMPLETED","counts":{"FG000":"3","FG001":"2","FG002":"3","FG003":"3","FG004":"3","FG005":"2","FG006":"2"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"2","FG001":"0","FG002":"2","FG003":"3","FG004":"0","FG005":"2","FG006":"2"}},{"type":"Lost to Follow-up","counts":{"FG000":"0","FG001":"2","FG002":"1","FG003":"0","FG004":"3","FG005":"0","FG006":"0"}},{"type":"Investigator decision","counts":{"FG000":"1","FG001":"0","FG002":"0","FG003":"0","FG004":"0","FG005":"0","FG006":"0"}}]}],"recruitment":"The trial was conducted in 9 countries (86 sites screened/83 randomised participants) as follows: Bulgaria: 6/6; Denmark: 3/3; Greece: 7/7; Hungary: 9/9; Japan: 6/6; Poland: 10/10; Russia: 4/4; Serbia: 3/3; United States of America (USA): 38/35. In addition, Hungary (1 site), Poland (1 site), Serbia (1 site) and USA (5 site) were approved by the institutional review board, but did not screen any participants.","preAssignment":"The trial had a 34-week intervention period (10 weeks of dose escalation period and followed by two 12 -week maintenance period), followed by a 5-week follow-up period."},{"nctId":"NCT04969939","groups":[{"id":"FG000","title":"Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly subcutaneous (s.c) injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 "},{"id":"FG001","title":"Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with o"},{"id":"FG002","title":"Part 1: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, w"},{"id":"FG003","title":"Part 2a (Run-in Period): Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-6: 1.0 mg, week 6-8: 1.7 mg, week 8 -32: 2.4 mg). At week 32, pa"},{"id":"FG004","title":"Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) alon"},{"id":"FG005","title":"Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week"},{"id":"FG006","title":"Part 2b: Placebo + Semaglutide 2.4 mg","description":"Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 m"}],"acronym":null,"periods":[{"title":"Part 1 (24 Weeks)","milestones":[{"type":"STARTED","counts":{"FG000":"8","FG001":"8","FG002":"8","FG003":"0","FG004":"0","FG005":"0","FG006":"0"}},{"type":"COMPLETED","counts":{"FG000":"8","FG001":"8","FG002":"8","FG003":"0","FG004":"0","FG005":"0","FG006":"0"}},{"type":"NOT COMPLETED","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"0","FG004":"0","FG005":"0","FG006":"0"}}],"dropWithdraws":[]},{"title":"Part 2a: Run in Period (32 Weeks)","milestones":[{"type":"STARTED","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"96","FG004":"0","FG005":"0","FG006":"0"}},{"type":"COMPLETED","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"83","FG004":"0","FG005":"0","FG006":"0"}},{"type":"NOT COMPLETED","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"13","FG004":"0","FG005":"0","FG006":"0"}}],"dropWithdraws":[{"type":"Adverse Event","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"4","FG004":"0","FG005":"0","FG006":"0"}},{"type":"Other","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"5","FG004":"0","FG005":"0","FG006":"0"}},{"type":"Lost to Follow-up","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"2","FG004":"0","FG005":"0","FG006":"0"}},{"type":"Pregnancy","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"1","FG004":"0","FG005":"0","FG006":"0"}},{"type":"Protocol Violation","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"1","FG004":"0","FG005":"0","FG006":"0"}}]},{"title":"Part 2b (16 Weeks)","milestones":[{"type":"STARTED","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"0","FG004":"47","FG005":"8","FG006":"28"}},{"type":"COMPLETED","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"0","FG004":"44","FG005":"7","FG006":"28"}},{"type":"NOT COMPLETED","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"0","FG004":"3","FG005":"1","FG006":"0"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"0","FG004":"3","FG005":"1","FG006":"0"}}]}],"recruitment":"The trial was conducted at 14 sites in the United States.","preAssignment":"The trial consisted of part 1 and 2. Part 1: 24 weeks (16-week treatment + 8 week follow up). In part 1 participants received NNC0165-1875 1.0 milligrams (mg) / matching placebo or NNC0165-1875 2.0 mg / matching placebo with semaglutide 2.4 mg. Part 2 further consisted of open-label run-in part (part 2a) of 32 weeks where participants received semaglutide and part 2b of 16 weeks where participants received NNC0165-1875 or NNC0165-1875 placebo with semaglutide s.c. 2.4 mg and 8-week follow up."},{"nctId":"NCT04982575","groups":[{"id":"FG000","title":"Cagrilintide 2.4 mg + Semaglutide 2.4 mg","description":"Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg once wee"},{"id":"FG001","title":"Cagrilintide 2.4 mg + Placebo (Semaglutide)","description":"Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg "},{"id":"FG002","title":"Semaglutide 2.4 mg + Placebo (Cagrilintide)","description":"Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg "}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"31","FG001":"30","FG002":"31"}},{"type":"COMPLETED","counts":{"FG000":"29","FG001":"30","FG002":"29"}},{"type":"NOT COMPLETED","counts":{"FG000":"2","FG001":"0","FG002":"2"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"2","FG001":"0","FG002":"2"}}]}],"recruitment":"The trial was conducted at 17 sites in the United States.","preAssignment":"After randomisation, participants were to continue their pre-trial metformin and sodium-glucose co-transporter-2 (SGLT2) inhibitor background medication throughout the entire trial. The background metformin and SGLT2 inhibitor were to be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period unless glycaemic rescue treatment was needed or adjustment was required due to safety concerns."},{"nctId":"NCT04971785","groups":[{"id":"FG000","title":"SEMA + CILO/FIR FDC","description":"Participants received semaglutide (SEMA) 3.0 mg/mL subcutaneous (SC) injection once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet orally, once daily u"},{"id":"FG001","title":"SEMA + PTM CILO/FIR","description":"Participants received SEMA 3.0 mg/mL SC injection, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet orally, once daily up to 72 weeks."},{"id":"FG002","title":"PTM SEMA + CILO/FIR FDC","description":"Participants received PTM SEMA SC injection, once weekly and CILO/FIR 30 mg/20 mg FDC tablet orally, once daily up to 72 weeks."},{"id":"FG003","title":"PTM SEMA + PTM CILO/FIR","description":"Participants received PTM SEMA SC injection, once weekly and PTM CILO/FIR FDC tablet orally, once daily up to 72 weeks."}],"acronym":"WAYFIND","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"125","FG001":"124","FG002":"123","FG003":"85"}},{"type":"COMPLETED","counts":{"FG000":"103","FG001":"104","FG002":"91","FG003":"65"}},{"type":"NOT COMPLETED","counts":{"FG000":"22","FG001":"20","FG002":"32","FG003":"20"}}],"dropWithdraws":[{"type":"Withdrew Consent","counts":{"FG000":"5","FG001":"5","FG002":"17","FG003":"7"}},{"type":"Adverse Event","counts":{"FG000":"7","FG001":"8","FG002":"6","FG003":"3"}},{"type":"Lost to Follow-up","counts":{"FG000":"2","FG001":"1","FG002":"6","FG003":"7"}},{"type":"Protocol Violation","counts":{"FG000":"3","FG001":"1","FG002":"1","FG003":"2"}},{"type":"Investigator's Discretion","counts":{"FG000":"3","FG001":"1","FG002":"1","FG003":"0"}},{"type":"Randomized but Never Treated","counts":{"FG000":"1","FG001":"2","FG002":"0","FG003":"1"}},{"type":"Death","counts":{"FG000":"0","FG001":"1","FG002":"1","FG003":"0"}},{"type":"Site Terminated by Sponsor","counts":{"FG000":"1","FG001":"1","FG002":"0","FG003":"0"}}]}],"recruitment":"Participants were enrolled at study sites in the United States, Canada, France, Japan, Australia and Spain.","preAssignment":"1595 participants were screened."},{"nctId":"NCT05486065","groups":[{"id":"FG000","title":"Semaglutide 2.0 mg","description":"Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \\[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\\], followed by "},{"id":"FG001","title":"Semaglutide 8.0 mg","description":"Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \\[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 w"},{"id":"FG002","title":"Semaglutide 16.0 mg","description":"Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \\[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 w"},{"id":"FG003","title":"Placebo","description":"Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks."}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"61","FG001":"62","FG002":"62","FG003":"60"}},{"type":"Full Analysis Set","counts":{"FG000":"61","FG001":"62","FG002":"62","FG003":"60"}},{"type":"Safety Analysis Set","counts":{"FG000":"60","FG001":"60","FG002":"62","FG003":"59"}},{"type":"COMPLETED","counts":{"FG000":"56","FG001":"54","FG002":"55","FG003":"54"}},{"type":"NOT COMPLETED","counts":{"FG000":"5","FG001":"8","FG002":"7","FG003":"6"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"1","FG001":"5","FG002":"4","FG003":"3"}},{"type":"Lost to Follow-up","counts":{"FG000":"4","FG001":"2","FG002":"2","FG003":"2"}},{"type":"Physician Decision","counts":{"FG000":"0","FG001":"1","FG002":"1","FG003":"0"}},{"type":"Failure to meet randomization criteria","counts":{"FG000":"0","FG001":"0","FG002":"0","FG003":"1"}}]}],"recruitment":"This study was conducted at 82 active sites in 4 countries, of which 75 sites enrolled participants.","preAssignment":"Participants were randomized at a ratio of 3:1:3:1:3:1 to receive semaglutide (2 milligram \\[mg\\], 8 mg, 16 mg) or matching placebo."}],"_healthCanadaChecked":true,"companionDiagnostics":[],"faersSexDistribution":[{"term":2,"count":47253},{"term":1,"count":24109},{"term":0,"count":41}],"genericManufacturers":0,"_genericFilersChecked":true,"nonclinicalToxicology":"13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [9-, 33- and 113- fold the maximum recommended human dose (MRHD) of semaglutide tablet 14 mg, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (3-, 9- and 33-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at all dose levels (>3 times human exposure). In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered (below quantification, 0.8-, 1.8- and 11-fold the exposure at the MRHD). A statistically significant increase in thyroid C-cell adenomas was observed in males and females at all dose levels, and a statistically significant increase in thyroid C-cell carcinomas was observed in males at ≥0.01 mg/kg/day, at clinically relevant exposures. Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies [see Boxed Warning, Warnings and Precautions ( 5.1 )] . Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus). In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to male and female rats. Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility. In females, an increase in estrus cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at ≥0.03 mg/kg/day.","structuredTrialResults":[{"hr":"0.86","nctId":"NCT03914326","phase":"PHASE3","pValue":"0.0028","ciLower":"0.77","ciUpper":"0.96","endpoint":"Number of Participants From Randomization to First Occurrence of a Major Adverse Cardiovascular Event (MACE), a Composite Endpoint Consisting of: Cardiovascular (CV) Death/Non-fatal Myocardial Infarction/Non-fatal Stroke","enrollment":9651},{"hr":"1.13","nctId":"NCT04560998","phase":"PHASE3","pValue":"0.0004","ciLower":"1.056","ciUpper":"1.211","endpoint":"Change in Maximum Walking Distance on a Constant Load Treadmill Test","enrollment":792},{"hr":"-6.5","nctId":"NCT05822830","phase":"PHASE3","pValue":"","ciLower":"-8.1","ciUpper":"-4.9","endpoint":"Percent Change From Baseline in Body Weight","enrollment":751},{"hr":"7.8","nctId":"NCT04788511","phase":"PHASE3","pValue":"<0.0001","ciLower":"4.8","ciUpper":"10.9","endpoint":"Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)","enrollment":529},{"hr":"-1.9","nctId":"NCT05144984","phase":"PHASE2","pValue":"<0.0001","ciLower":"-2.3","ciUpper":"-1.4","endpoint":"Change From Baseline in Glycosylated Haemoglobin (HbA1c)","enrollment":500},{"hr":"3.18","nctId":"NCT05579249","phase":"PHASE4","pValue":"<0.0001","ciLower":"2.12","ciUpper":"4.78","endpoint":"Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)","enrollment":500},{"hr":"5.7","nctId":"NCT04971785","phase":"PHASE2","pValue":"0.2289","ciLower":"-3.6","ciUpper":"14.9","endpoint":"Percentage of Participants Who Achieved ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) 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