NCT03552757 (STEP 2) is a Phase 3 clinical trial of Semaglutide 1.0 mg in Obesity, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT03552757?

NCT03552757 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT03552757?

Interventions in NCT03552757: Semaglutide 1.0 mg, Semaglutide 2.4 mg, Placebo I (Semaglutide), Placebo II (Semaglutide).

What condition does NCT03552757 study?

NCT03552757 studies Obesity, Overweight.

Is NCT03552757 still recruiting?

NCT03552757 is currently completed. Last updated 9 November 2021.

Are results published for NCT03552757?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-11-09 · How we verify

NCT03552757: STEP 2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

Completed Phase 3 Results posted Last updated 9 November 2021

What this trial tests

Phase 3 trial testing Semaglutide 1.0 mg in Obesity in 1,210 participants. Completed in 1 May 2020.

Timeline

4 June 2018

Primary endpoint
24 March 2020

1 May 2020

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,210
Start date	4 June 2018
Primary completion	24 March 2020
Estimated completion	1 May 2020
Sites	147 locations across South Africa, Japan, Russia, Greece, United Kingdom, Germany, United Arab Emirates, Argentina

Drugs / interventions tested

Semaglutide 1.0 mg — full drug profile →
Semaglutide 2.4 mg — full drug profile →
Placebo I (Semaglutide) — full drug profile →
Placebo II (Semaglutide) — full drug profile →

Conditions studied

Obesity — all drugs for Obesity →
Overweight — all drugs for Overweight →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo Primary · Baseline (week 0) to week 68

Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time peri

In-trial observation period

Group	Value	95% CI
Semaglutide 2.4 mg	-9.9	± 8.0
Placebo	-3.3	± 5.5

On-treatment observation period

Group	Value	95% CI
Semaglutide 2.4 mg	-10.7	± 7.8
Placebo	-3.1	± 5.2

Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo Primary · At week 68

Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. O

In-trial observation period

Group	Value	95% CI
Semaglutide 2.4 mg	267
Placebo	107
Semaglutide 2.4 mg	121
Placebo	269

On-treatment observation period

Group	Value	95% CI
Semaglutide 2.4 mg	257
Placebo	94
Semaglutide 2.4 mg	94
Placebo	246

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg Secondary · Baseline (week 0) to week 68

Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 2.4 mg	-9.9	± 8.0
Semaglutide 1.0 mg	-7.2	± 6.6

Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg Secondary · At week 68

Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 2.4 mg	267
Semaglutide 1.0 mg	217
Semaglutide 2.4 mg	121
Semaglutide 1.0 mg	163

Change in Waist Circumference Secondary · Baseline (week 0) to week 68

Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 1.0 mg	-6.9	± 6.8
Semaglutide 2.4 mg	-9.7	± 8.1
Placebo	-4.3	± 6.5

Change in Body Weight (Kg) Secondary · Baseline (week 0) to week 68

Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 1.0 mg	-7.1	± 6.7
Semaglutide 2.4 mg	-9.9	± 8.5
Placebo	-3.4	± 6.2

Change in BMI Secondary · Baseline (week 0) to week 68

Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 1.0 mg	-2.6	± 2.4
Semaglutide 2.4 mg	-3.6	± 3.1
Placebo	-1.2	± 2.1

Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% Secondary · At week 68

Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 1.0 mg	109
Semaglutide 2.4 mg	177
Placebo	31
Semaglutide 1.0 mg	271
Semaglutide 2.4 mg	211
Placebo	345

Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% Secondary · At week 68

Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 1.0 mg	52
Semaglutide 2.4 mg	100
Placebo	12
Semaglutide 1.0 mg	328
Semaglutide 2.4 mg	288
Placebo	364

Participants Who Achieve (Yes/no): Body Weight Reduction ≥20% Secondary · At week 68

Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 1.0 mg	18
Semaglutide 2.4 mg	51
Placebo	6
Semaglutide 1.0 mg	362
Semaglutide 2.4 mg	337
Placebo	370

Change in HbA1c (%) Secondary · Baseline (week 0) to week 68

Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 1.0 mg	-1.5	± 1.1
Semaglutide 2.4 mg	-1.7	± 1.2
Placebo	-0.3	± 1.3

Change in HbA1c (mmol/Mol) Secondary · Baseline (week 0) to week 68

Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

Group	Value	95% CI
Semaglutide 1.0 mg	-16.9	± 12.3
Semaglutide 2.4 mg	-18.7	± 13.0
Placebo	-3.4	± 14.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 0 to week 75. Results are based on the SAS which included all randomised participants exposed to at least one dose of randomised treatment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Semaglutide 1.0 mg

Serious: 31/402 (8%)

Deaths: 1/402

Semaglutide 2.4 mg

Serious: 40/403 (10%)

Deaths: 1/403

Placebo

Serious: 37/402 (9%)

Deaths: 1/402

Serious adverse events (127 terms)

Reaction	System	Semaglutide 1.0 mg	Semaglutide 2.4 mg	Placebo
Abdominal pain	Gastrointestinal disorders	—	—	—
Gastroenteritis	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—
Ureterolithiasis	Renal and urinary disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Anaemia postoperative	Injury, poisoning and procedural complications	—	—	—
Angina pectoris	Cardiac disorders	—	—	—
Angina unstable	Cardiac disorders	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—
Aortic rupture	Vascular disorders	—	—	—
Appendicitis	Infections and infestations	—	—	—

Other adverse events (15 terms — click to expand)

Reaction	System	Semaglutide 1.0 mg	Semaglutide 2.4 mg	Placebo
Nausea	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Fatigue	General disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—
Gastroenteritis	Infections and infestations	—	—	—

Most-reported serious reactions: Abdominal pain, Gastroenteritis, Sepsis, Acute kidney injury, Acute myocardial infarction, Atrial fibrillation, Cellulitis, Dehydration.

Data from ClinicalTrials.gov NCT03552757 adverse events section.

Sponsor's own description

This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial.
Davies M, Færch L, Jeppesen OK, Pakseresht A, et al · · 2021 · cited 855× · PMID 33667417 · DOI 10.1016/s0140-6736(21)00213-0
Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.
Kushner RF, Calanna S, Davies M, Dicker D, et al · · 2020 · cited 185× · PMID 32441473 · DOI 10.1002/oby.22794
Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss.
Wharton S, Calanna S, Davies M, Dicker D, et al · · 2022 · cited 98× · PMID 34514682 · DOI 10.1111/dom.14551
Comprehensive Review of Current and Upcoming Anti-Obesity Drugs.
Son JW, Kim S. · · 2020 · cited 92× · PMID 33389955 · DOI 10.4093/dmj.2020.0258
The Related Metabolic Diseases and Treatments of Obesity.
Yang M, Liu S, Zhang C. · · 2022 · cited 89× · PMID 36141228 · DOI 10.3390/healthcare10091616
Therapeutic Potential of Semaglutide, a Newer GLP-1 Receptor Agonist, in Abating Obesity, Non-Alcoholic Steatohepatitis and Neurodegenerative diseases: A Narrative Review.
Mahapatra MK, Karuppasamy M, Sahoo BM. · · 2022 · cited 84× · PMID 35650449 · DOI 10.1007/s11095-022-03302-1
Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials.
Heerspink HJL, Apperloo E, Davies M, Dicker D, et al · · 2023 · cited 64× · PMID 36801984 · DOI 10.2337/dc22-1889
Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials.
Wadden TA, Brown GK, Egebjerg C, Frenkel O, et al · · 2024 · cited 57× · PMID 39226070 · DOI 10.1001/jamainternmed.2024.4346

Verify or expand the search:

Other trials of Semaglutide 1.0 mg

Trials testing the same drug.

NCT07223983 — Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS) · Phase 1 · recruiting
NCT07251556 — GLP-1 Receptor Agonists in Non-diabetic Patients With Psoriatic Arthritis · Phase 4 · not yet recruiting
NCT07073053 — The Role of Glucagon-Like Peptide-1 Receptor Agonists in Coronary Artery Diseases and Their Potential Mechanisms · Phase 4 · not yet recruiting
NCT06851962 — Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. · Phase 4 · active not recruiting
NCT03288740 — A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects · Phase 1 · completed

Other recruiting trials for Obesity

Currently open trials in the same condition.

NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03552757 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 9 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03552757.

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