Study S001529

Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents 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: NCT04102189
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 201
Start: 2019-10-07
Primary completion: 2022-03-25
Lead sponsor: Novo Nordisk A/S
Conditions: Overweight; Obesity
Interventions: DRUG:Semaglutide; OTHER:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1215-7560; EUDRACT_NUMBER:2018-002431-18; NIH:2018

Registered primary outcomes

Change in Body Mass Index (BMI) (Percentage [%]) [Baseline (week 0), week 68]

Linked records (5)

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
R0014127	Effect of Semaglutide on Insulin Sensitivity and Cardiometabolic Risk Factors in Adolescents With Obesity: The STEP TEENS Study. Arslanian S, Diabetes care	2026	Randomized trial	PMID 41296499 DOI	cites ClinicalTrials.gov:NCT04102189
R0008053	Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg. Kelly AS, Obesity (Silver Spring, Md.)	2023	Randomized trial	PMID 37196421 DOI	cites ClinicalTrials.gov:NCT04102189; registry reference DERIVED:37196421
R0020989	Semaglutide treatment for obesity in teenagers: a plain language summary of the STEP TEENS research study. Weghuber D, Journal of comparative effectiveness research	2023	Other trial	PMID 36534451 DOI	cites ClinicalTrials.gov:NCT04102189; registry reference DERIVED:36534451
R0009964	Once-Weekly Semaglutide in Adolescents with Obesity. Weghuber D, The New England journal of medicine	2022	Randomized trial	PMID 36322838 DOI	cites ClinicalTrials.gov:NCT04102189; registry reference RESULT:36322838
R0025747	Progress in pediatric obesity: new and advanced therapies. Cuda S, Current opinion in pediatrics	2022	Narrative review	PMID 35797460 DOI	cites ClinicalTrials.gov:NCT04102189; registry reference DERIVED:35797460