Study S001740

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes

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: NCT03552757
Acronym: STEP 2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 1210
Start: 2018-06-04
Primary completion: 2020-03-24
Lead sponsor: Novo Nordisk A/S
Conditions: Obesity; Overweight
Interventions: DRUG:Semaglutide 1.0 mg; DRUG:Semaglutide 2.4 mg; DRUG:Placebo I (Semaglutide); DRUG:Placebo II (Semaglutide)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1200-8148; OTHER:2017-003414-10; NIH:2017

Registered primary outcomes

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo [Baseline (week 0) to week 68]
Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo [At week 68]

Linked records (15)

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
R0017195	Proteomic signatures reflect effects of semaglutide treatment for MASH. Schattenberg JM, JHEP reports : innovation in hepatology	2025	Randomized trial	PMID 40980163 DOI	cites ClinicalTrials.gov:NCT03552757; registry reference DERIVED:40980163
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:NCT03552757; 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:NCT03552757; 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:NCT03552757; registry reference DERIVED:36801984
R0022203	Abstract 10: Efficacy and safety of semaglutide 2.4 mg once- weekly in adults with overweight or obesity and type 2 diabetes (STEP 2) , Indian Journal of Endocrinology and Metabolism	2022	Randomized trial		cites ClinicalTrials.gov:NCT03552757
R0044357	Abstract 10: Efficacy and safety of semaglutide 2.4 mg once- weekly in adults with overweight or obesity and type 2 diabetes (STEP 2) Sri Khaerani Rahman, Indian Journal of Endocrinology and Metabolism	2022	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03552757
R0020651	Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Davies M, Lancet (London, England)	2021	Randomized trial	PMID 33667417 DOI	cites ClinicalTrials.gov:NCT03552757; registry reference RESULT:33667417
R0022984	Efficacy and Safety of Semaglutide 2.4 MG Once-Weekly in Adults With Overweight or Obesity and Type 2 Diabetes (STEP 2) Davies M, Journal of the Endocrine Society	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03552757
R0027030	Confirmatory psychometric evaluations of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT). Kolotkin RL, Clinical obesity	2021	Other	PMID 34296522 DOI	cites ClinicalTrials.gov:NCT03552757
R0031571	84-OR: Semaglutide 2.4 mg Improves Health-Related Quality of Life in Adults with Overweight/Obesity and Type 2 Diabetes in the STEP 2 Trial Domenica Rubino, Diabetes	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03552757
R0032050	85-OR: Semaglutide 2.4 mg Improves Patient Reported Outcome Measures of Physical Functioning in Adults with Overweight/Obesity and Type 2 Diabetes in the STEP 2 Trial Sean Wharton, Diabetes	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03552757
R0053391	83-OR: Influence of Baseline Characteristics on Weight Loss with Semaglutide 2.4 mg in Adults with Overweight/Obesity and Type 2 Diabetes (STEP 2) Ildiko Lingvay, Diabetes	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03552757
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:NCT03552757; 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:NCT03552757
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:NCT03552757; registry reference DERIVED:30122305