Study S001288

Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity.

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04251156
Acronym: STEP7
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 375
Start: 2020-12-08
Primary completion: 2022-08-23
Lead sponsor: Novo Nordisk A/S
Conditions: Overweight; Obesity; Diabetes Mellitus, Type 2
Interventions: DRUG:Semaglutide; DRUG:Placebo (semaglutide)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1212-2189

Registered primary outcomes

Change From Baseline in Body Weight (Percentage [%]) [Baseline (week 0), week 44]
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No) [At week 44]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0017470	Efficacy and safety of once-weekly semaglutide 2.4 mg for weight management in participants from China: A prespecified analysis of the STEP 7 randomized clinical trial. Gu W, Diabetes, obesity & metabolism	2025	Randomized trial	PMID 40069849 DOI	cites ClinicalTrials.gov:NCT04251156
R0015914	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, The lancet. Diabetes & endocrinology	2024	Randomized trial	PMID 38330988 DOI	cites ClinicalTrials.gov:NCT04251156; registry reference RESULT:38330988