NCT04251156: STEP7

Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.

Completed Phase 3 Results posted Last updated 29 January 2026

What this trial tests

Phase 3 trial testing Semaglutide in Overweight in 375 participants. Completed in 23 August 2022.

Timeline

8 December 2020

Primary endpoint
23 August 2022

23 August 2022

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	375
Start date	8 December 2020
Primary completion	23 August 2022
Estimated completion	23 August 2022
Sites	33 locations across Brazil, South Korea, Hong Kong, China

Drugs / interventions tested

• Semaglutide (semaglutide) — full drug profile →
• Placebo (semaglutide)

Conditions studied

• Overweight — all drugs for Overweight →
• Obesity — all drugs for Obesity →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

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

Sponsor's own description

This study will look at the change in body weight from the start to the end of the study. The purpose of the study 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 medicine participants will have talks with study staff about healthy food choices, how to be more physically active and what else they can do to lose weight. Participants will either get semaglutide or "dummy medicine" - which treatment is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm.• The study will last for about 1 year. Participants will have 11 clinic visits and 8 phone calls with the study doctor. Participants will have 3 clinic visits where they cannot eat and drink (water is allowed) for up to 8 hours before the visit and 1 clinic visit where they cannot eat and drink for up to 2 hours before the visit. (4 visits and 1 visit, respectively, if they have type 2 diabetes (T2D)). Participants will have 4 clinic visits where they will have blood samples taken. (5 visits if they have T2D). For China: Participants will have 9 clinic visits where they will have blood samples taken. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Publications & conference data

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

1. Pharmacotherapy of obesity: an update on the available medications and drugs under investigation.
   Chakhtoura M, Haber R, Ghezzawi M, Rhayem C, et al · · 2023 · cited 260× · PMID 36992862 · DOI 10.1016/j.eclinm.2023.101882
2. 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
3. Semaglutide for the treatment of obesity.
   Chao AM, Tronieri JS, Amaro A, Wadden TA. · · 2023 · cited 121× · PMID 34942372 · DOI 10.1016/j.tcm.2021.12.008
4. 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
5. Efficacy and safety of once weekly semaglutide 2·4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial.
   Mu Y, Bao X, Eliaschewitz FG, Hansen MR, et al · · 2024 · cited 81× · PMID 38330988 · DOI 10.1016/s2213-8587(23)00388-1
6. A narrative review of approved and emerging anti-obesity medications.
   Abdi Beshir S, Ahmed Elnour A, Soorya A, Parveen Mohamed A, et al · · 2023 · cited 30× · PMID 37712012 · DOI 10.1016/j.jsps.2023.101757
7. Pharmacological Support for the Treatment of Obesity-Present and Future.
   Kosmalski M, Deska K, Bąk B, Różycka-Kosmalska M, et al · · 2023 · cited 26× · PMID 36767008 · DOI 10.3390/healthcare11030433
8. Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer?
   Colin IM, Gérard KM. · · 2022 · cited 14× · PMID 35949360 · DOI 10.17925/ee.2022.18.1.35