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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
Phase 3 trial testing Tirzepatide in Obesity in 751 participants. Completed in 13 November 2024.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 751 |
| Start date | 21 April 2023 |
| Primary completion | 13 November 2024 |
| Estimated completion | 13 November 2024 |
| Sites | 32 locations across Puerto Rico, United States |
Eli Lilly and Company — full company profile →
18 and older, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent change from baseline in body weight was reported. Least Squares (LS) mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| 15 mg or MTD - Tirzepatide | -20.2 | ± 0.59 |
| 2.4 mg or MTD - Semaglutide | -13.7 | ± 0.59 |
Percentage of participants who achieved ≥10% body weight reduction (observed values) was reported.
| Group | Value | 95% CI |
|---|---|---|
| 15 mg or MTD - Tirzepatide | 87.7 | |
| 2.4 mg or MTD - Semaglutide | 66.7 |
Percentage of participants who achieved ≥15% body weight reduction (observed values) was reported.
| Group | Value | 95% CI |
|---|---|---|
| 15 mg or MTD - Tirzepatide | 71.7 | |
| 2.4 mg or MTD - Semaglutide | 45.0 |
Percentage of participants who achieved ≥20% body weight reduction (observed values) was reported.
| Group | Value | 95% CI |
|---|---|---|
| 15 mg or MTD - Tirzepatide | 55.0 | |
| 2.4 mg or MTD - Semaglutide | 31.1 |
Percentage of participants who achieved ≥25% body weight reduction (observed values) was reported.
| Group | Value | 95% CI |
|---|---|---|
| 15 mg or MTD - Tirzepatide | 36.5 | |
| 2.4 mg or MTD - Semaglutide | 18.6 |
Change from baseline in waist circumference in centimeter was reported. LS mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| 15 mg or MTD - Tirzepatide | -18.4 | ± 0.61 |
| 2.4 mg or MTD - Semaglutide | -13.0 | ± 0.66 |
Percentage of participants who achieved ≥30% body weight reduction (observed values) was reported.
| Group | Value | 95% CI |
|---|---|---|
| 15 mg or MTD - Tirzepatide | 23.0 | |
| 2.4 mg or MTD - Semaglutide | 8.2 |
Change from baseline in BMI was reported. LS mean was determined using Mixed Model Repeated Measures (MMRM) model using Baseline + Sex + Pre diabetes status at randomization + Treatment + Time + Treatment\*Time(Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| 15 mg or MTD - Tirzepatide | -8.5 | ± 0.24 |
| 2.4 mg or MTD - Semaglutide | -6.0 | ± 0.24 |
Percent change from baseline in body weight comparing 15mg of Tirzepatide and 2.4 mg Semaglutide was reported. The treatment effect for tirzepatide versus semaglutide for percent change in body weight was also evaluated assuming that participants had stayed on treatment and reached the highest dose of treatment. LS mean was determined by MMRM model using Baseline + Sex + Pre diabetes status at randomization + Baseline BMI Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
| Group | Value | 95% CI |
|---|---|---|
| 15 mg or MTD - Tirzepatide | -21.8 | ± 0.60 |
| 2.4 mg or MTD - Semaglutide | -15.4 | ± 0.60 |
Time frame: Baseline Up To 72 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 15 mg or MTD - Tirzepatide | 2.4 mg or MTD - Semaglutide |
|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | — | — |
| Bile duct stone | Hepatobiliary disorders | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Sinus tachycardia | Cardiac disorders | — | — |
| Colitis ischaemic | Gastrointestinal disorders | — | — |
| Diverticulum intestinal | Gastrointestinal disorders | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — |
| Incarcerated hiatus hernia | Gastrointestinal disorders | — | — |
| Obstructive pancreatitis | Gastrointestinal disorders | — | — |
| Volvulus | Gastrointestinal disorders | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — |
| Cholecystitis acute | Hepatobiliary disorders | — | — |
| Gallbladder disorder | Hepatobiliary disorders | — | — |
| Anaphylactic shock | Immune system disorders | — | — |
| Appendicitis | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Sinusitis | Infections and infestations | — | — |
| Hepatic enzyme increased | Investigations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Benign fasciculation syndrome | Nervous system disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Transient global amnesia | Nervous system disorders | — | — |
| Reaction | System | 15 mg or MTD - Tirzepatide | 2.4 mg or MTD - Semaglutide |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Covid-19 | Infections and infestations | — | — |
| Fatigue | General disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — |
| Eructation | Gastrointestinal disorders | — | — |
| Injection site reaction | General disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Sinusitis | Infections and infestations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Cholelithiasis, Bile duct stone, Osteoarthritis, Atrial fibrillation, Sinus tachycardia, Colitis ischaemic, Diverticulum intestinal, Haemorrhoids.
Data from ClinicalTrials.gov NCT05822830 adverse events section.
The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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