Study S000988

Effect and Safety of Semaglutide 2.4 mg Once-weekly as Adjunct to Intensive Behavioural Therapy 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: NCT03611582
Acronym: STEP 3
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 611
Start: 2018-08-01
Primary completion: 2020-03-18
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: OTHER:U1111-1200-8199

Registered primary outcomes

Change in Body Weight (%) [Baseline (week 0) to week 68]
Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5% [After 68 weeks]

Linked records (8)

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:NCT03611582; registry reference DERIVED:39226070
R0019870	Effect of semaglutide 2.4 mg on physical functioning and weight- and health-related quality of life in adults with overweight or obesity: Patient-reported outcomes from the STEP 1-4 trials. Rubino D, Diabetes, obesity & metabolism	2024	Randomized trial	PMID 38698650 DOI	cites ClinicalTrials.gov:NCT03611582; registry reference DERIVED:38698650
R0020858	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, Diabetes care	2023	Nonrandomized study	PMID 36801984 DOI	cites ClinicalTrials.gov:NCT03611582; registry reference DERIVED:36801984
R0021798	Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Perreault L, Diabetes care	2022	Randomized trial	PMID 35724304 DOI	cites ClinicalTrials.gov:NCT03611582; registry reference DERIVED:35724304
R0023506	Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. Wadden TA, JAMA	2021	Randomized trial	PMID 33625476 DOI	cites ClinicalTrials.gov:NCT03611582; registry reference RESULT:33625476
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:NCT03611582; 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:NCT03611582
R0018235	Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. O'Neil PM, Lancet (London, England)	2018	Randomized trial	PMID 30122305 DOI	cites ClinicalTrials.gov:NCT03611582; registry reference DERIVED:30122305