Study S000521

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period

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: NCT03548987
Acronym: STEP 4
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 902
Start: 2018-06-04
Primary completion: 2020-02-22
Lead sponsor: Novo Nordisk A/S
Conditions: Metabolism and Nutrition Disorder; Obesity
Interventions: DRUG:Semaglutide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1201-0898; REGISTRY:2017-003473-34; NIH:2017

Registered primary outcomes

Change From Randomisation to Week 68 in Body Weight (%) [Randomisation (week 20) to week 68]

Linked records (11)

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
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:NCT03548987; registry reference DERIVED:38698650
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:NCT03548987; registry reference DERIVED:37605636
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:NCT03548987; registry reference DERIVED:36200477
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:NCT03548987; registry reference DERIVED:35724304
R0013102	Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. Rubino D, JAMA	2021	Randomized trial	PMID 33755728 DOI	cites ClinicalTrials.gov:NCT03548987; registry reference RESULT:33755728
R0019021	Clinically-Relevant Weight Loss is Achieved Independently of Early Weight Loss Response to Once-Weekly Subcutaneous Semaglutide 2.4 MG (STEP 4) Mosenzon O, Journal of the Endocrine Society	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03548987
R0019147	Weight Loss Maintenance With Once-Weekly Semaglutide 2.4 MG in Adults With Overweight or Obesity Reaching Maintenance Dose (STEP 4) Rubino D, Journal of the Endocrine Society	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03548987
R0033659	Weight Loss Maintenance With Once-Weekly Semaglutide 2.4 MG in Adults With Overweight or Obesity Reaching Maintenance Dose (STEP 4) Endocrine Society 2021, Underline Science Inc.	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT03548987
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:NCT03548987; 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:NCT03548987
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:NCT03548987; registry reference DERIVED:30122305