Study S000214

Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly 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: NCT03693430
Acronym: STEP 5
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 304
Start: 2018-10-05
Primary completion: 2021-01-29
Lead sponsor: Novo Nordisk A/S
Conditions: Overweight; Obesity
Interventions: DRUG:Semaglutide; DRUG:Placebo (Semaglutide)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: REGISTRY:2017-003726-32; OTHER:U1111-1202-1740; NIH:2017

Registered primary outcomes

Percentage Change From Baseline (Week 0) to Week 104 in Body Weight [From Baseline (Week 0) to Week 104]
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% [At Week 104]

Linked records (7)

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
R0019370	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, JAMA internal medicine	2024	Randomized trial	PMID 39226070 DOI	cites ClinicalTrials.gov:NCT03693430; registry reference DERIVED:39226070
R0019926	Effect of semaglutide 2.4 mg once weekly on 10-year type 2 diabetes risk in adults with overweight or obesity. Wilkinson L, Obesity (Silver Spring, Md.)	2023	Randomized trial	PMID 37605636 DOI	cites ClinicalTrials.gov:NCT03693430; registry reference DERIVED:37605636
R0021078	Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Wharton S, Obesity (Silver Spring, Md.)	2023	Randomized trial	PMID 36655300 DOI	registry reference BACKGROUND:36655300
R0021896	Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Garvey WT, Nature medicine	2022	Randomized trial	PMID 36216945 DOI	cites ClinicalTrials.gov:NCT03693430; registry reference DERIVED:36216945
R0055269	Two-year Effect of Semaglutide 2.4 mg on Control of Eating in Adults with Overweight/Obesity: STEP 5 Wharton, S, UCL Discovery (University College London)	2021	Randomized trial		cites ClinicalTrials.gov:NCT03693430
R0024237	Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Kushner RF, Obesity (Silver Spring, Md.)	2020	Randomized trial	PMID 32441473 DOI	cites ClinicalTrials.gov:NCT03693430; registry reference BACKGROUND:32441473
R0052247	Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP 1–5 Randomized Trials Robert F. Kushner, Figshare	2020	Randomized trial		cites ClinicalTrials.gov:NCT03693430