Study S000144

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: NCT03548935
Acronym: STEP 1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 1961
Start: 2018-06-04
Primary completion: 2020-03-30
Lead sponsor: Novo Nordisk A/S
Conditions: Metabolism and Nutrition Disorder; Overweight or Obesity
Interventions: DRUG:Semaglutide; DRUG:Placebo (semaglutide)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1200-8053; REGISTRY:2017-003436-36; NIH:2017

Registered primary outcomes

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

Linked records (17)

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:NCT03548935; 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:NCT03548935; 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:NCT03548935; 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:NCT03548935; registry reference DERIVED:36801984
R0021243	Impact of BMI and comorbidities on efficacy of once-weekly semaglutide: Post hoc analyses of the STEP 1 randomized trial. McGowan BM, Obesity (Silver Spring, Md.)	2023	Randomized trial	PMID 36876594 DOI	cites ClinicalTrials.gov:NCT03548935; registry reference DERIVED:36876594
R0021791	Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Kosiborod MN, Diabetes, obesity & metabolism	2023	Randomized trial	PMID 36200477 DOI	cites ClinicalTrials.gov:NCT03548935; registry reference DERIVED:36200477
R0018204	Abstract 9: Once-weekly subcutaneous semaglutide 2.4 mg reduces body weight in adults with overweight or obesity regardless of baseline characteristics (STEP 1) , Indian Journal of Endocrinology and Metabolism	2022	Randomized trial		cites ClinicalTrials.gov:NCT03548935
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:NCT03548935; registry reference DERIVED:35724304
R0022757	Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Wilding JPH, Diabetes, obesity & metabolism	2022	Randomized trial	PMID 35441470 DOI	cites ClinicalTrials.gov:NCT03548935; registry reference DERIVED:35441470
R0050401	Abstract 9: Once-weekly subcutaneous semaglutide 2.4 mg reduces body weight in adults with overweight or obesity regardless of baseline characteristics (STEP 1) Swaroop H Suresh, Indian Journal of Endocrinology and Metabolism	2022	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03548935
R0019035	Efficacy and Safety of Once-Weekly Subcutaneous Semaglutide 2.4 MG in Adults With Overweight or Obesity (STEP 1) Wilding J, Journal of the Endocrine Society	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03548935
R0019285	Once-weekly Subcutaneous Semaglutide 2.4 mg Reduces Body Weight in Adults with Overweight or Obesity Regardless of Baseline Characteristics (STEP 1) Kushner R, Journal of the Endocrine Society	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03548935
R0023399	Once-Weekly Semaglutide in Adults with Overweight or Obesity. Wilding JPH, The New England journal of medicine	2021	Randomized trial	PMID 33567185 DOI	cites ClinicalTrials.gov:NCT03548935; registry reference RESULT:33567185
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:NCT03548935
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:NCT03548935; 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:NCT03548935
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:NCT03548935; registry reference DERIVED:30122305