Study S001692

Young Adults With Early-onset Obesity Treated With Semaglutide -The RESETTLE Study

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record Statistical Analysis Plan (PDF)

Registration

Registration: NCT05574439
Acronym: RESETTLE
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 246
Start: 2022-05-30
Primary completion: 2026-04-01
Lead sponsor: Signe Torekov
Conditions: Obesity, Adolescent
Interventions: BEHAVIORAL:TCOC treatment; DRUG:Semaglutide 3 mg/ml; DRUG:Placebo (Semaglutide 3 mg/ml)
Results posted: FALSE
Secondary identifiers: EUDRACT_NUMBER:2019-002274-31; NIH:2019

Registered primary outcomes

Change in BMI (weight in kg/height in m^2) [Change from baseline to end-of-treatment (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
R0007389	Protocol for a randomised, double-blinded, controlled trial of youth with childhood-onset obesity treated with semaglutide 2.4 mg/week: the RESETTLE trial. Byberg S, BMJ open	2024	Protocol	PMID 39551589 DOI	cites EudraCT:2019-002274-31
R0014535	Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. Rubino DM, JAMA	2022	Randomized trial	PMID 35015037 DOI	registry reference BACKGROUND:35015037
R0017714	Exploratory analysis of eating- and physical activity-related outcomes from a randomized controlled trial for weight loss maintenance with exercise and liraglutide single or combination treatment. Jensen SBK, Nature communications	2022	Randomized trial	PMID 35970829 DOI	registry reference BACKGROUND:35970829
R0023498	Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined. Lundgren JR, The New England journal of medicine	2021	Randomized trial	PMID 33951361 DOI	registry reference BACKGROUND:33951361
R0006511	Patients with Obesity Caused by Melanocortin-4 Receptor Mutations Can Be Treated with a Glucagon-like Peptide-1 Receptor Agonist. Iepsen EW, Cell metabolism	2018	Other trial	PMID 29861388 DOI	registry reference BACKGROUND:29861388
R0018258	Treatment with a GLP-1 receptor agonist diminishes the decrease in free plasma leptin during maintenance of weight loss. Iepsen EW, International journal of obesity (2005)	2015	Randomized trial	PMID 25287751 DOI	registry reference BACKGROUND:25287751
R0028259	Dose response of continuous subcutaneous infusion of recombinant glucagon-like peptide-1 in combination with metformin and sulphonylurea over 12 weeks in patients with type 2 diabetes mellitus. Torekov SS, Diabetes, obesity & metabolism	2014	Other	PMID 24251641 DOI	registry reference BACKGROUND:24251641
R0026573	Obesity - an indication for GLP-1 treatment? Obesity pathophysiology and GLP-1 treatment potential. Torekov SS, Obesity reviews : an official journal of the International Association for the Study of Obesity	2011	Narrative review	PMID 21401851 DOI	registry reference BACKGROUND:21401851