NCT05040971 (STEP 10) is a Phase 3 clinical trial of Semaglutide 2.4 mg in Obesity, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT05040971?

NCT05040971 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT05040971?

Interventions in NCT05040971: Semaglutide 2.4 mg, Placebo.

Is NCT05040971 still recruiting?

NCT05040971 is currently completed. Last updated 29 January 2026.

Are results published for NCT05040971?

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

Last reviewed 2026-01-29 · How we verify

NCT05040971: STEP 10

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

Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

Completed Phase 3 Results posted Last updated 29 January 2026

What this trial tests

Phase 3 trial testing Semaglutide 2.4 mg in Obesity in 207 participants. Completed in 14 July 2023.

Timeline

6 September 2021

Primary endpoint
6 January 2023

14 July 2023

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	207
Start date	6 September 2021
Primary completion	6 January 2023
Estimated completion	14 July 2023
Sites	43 locations across Finland, Spain, United Kingdom, Canada, Denmark

Drugs / interventions tested

Semaglutide 2.4 mg — full drug profile →
Placebo

Conditions studied

Obesity — all drugs for Obesity →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

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

Sponsor's own description

This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes. This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar. Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body. 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 participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection 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 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication. Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Publications & conference data

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

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
Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial.
McGowan BM, Bruun JM, Capehorn M, Pedersen SD, et al · · 2024 · cited 91× · PMID 39089293 · DOI 10.1016/s2213-8587(24)00182-7
Incretin-based therapies for the treatment of obesity-related diseases.
Caruso I, Cignarelli A, Sorice GP, Perrini S, et al · · 2024 · cited 17× · PMID 40604322 · DOI 10.1038/s44324-024-00030-5
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
Comparative Safety of GLP-1/GIP Co-Agonists Versus GLP-1 Receptor Agonists for Weight Loss in Patients with Obesity or Overweight: A Systematic Review.
Xie Z, Liang Z, Xie Y, Zheng G, et al · · 2025 · cited 6× · PMID 40821754 · DOI 10.2147/dmso.s537229
Metabolic rebound after GLP-1 receptor agonist discontinuation: a systematic review and meta-analysis.
Tzang CC, Wu PH, Luo CA, Chen ZT, et al · · 2025 · cited 1× · PMID 41399474 · DOI 10.1016/j.eclinm.2025.103680
Effect of semaglutide on arrhythmic, major cardiovascular, and renal outcomes in patients with overweight or obesity: a systematic review and meta-analysis.
Wu R, Xing B, Zhou Z, Yu L, et al · · 2025 · cited 1× · PMID 40890879 · DOI 10.1186/s40001-025-03124-y
Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists in Obese Patients Without Diabetes: A Systematic Review and Meta-Analysis.
Mohamed Ali Elbashir R, Elbashir A, Urimuke Basake R, Zakaria Ahmed Mohieldin A, et al · · 2025 · PMID 41341350 · DOI 10.7759/cureus.95938

Verify or expand the search:

Other trials of Semaglutide 2.4 mg

Trials testing the same drug.

NCT06934655 — Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth · Phase 3 · not yet recruiting
NCT07275697 — Waiting on Atrial Fibrillation Intervention Therapy (WAIT) Study · Phase 4 · not yet recruiting
NCT04998136 — Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity · Phase 3 · completed
NCT04982575 — Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes · Phase 2 · completed
NCT03552757 — Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obes · Phase 3 · 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 NCT05040971 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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: 29 January 2026

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/NCT05040971.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing