Study S000388

Phase II Trial of Liraglutide (Saxenda(R), Novo Nordisk) in Adolescents With Obesity After Sleeve Gastrectomy: A Pilot Open-Label Study

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)Informed Consent Form: Consent that Parents signed (PDF)Informed Consent Form: Assent that children signed (PDF)

Registration

Registration: NCT04883346
Study type: INTERVENTIONAL
Phase: PHASE2
Masking: NONE
Status: COMPLETED
Enrollment: 34
Start: 2021-06-21
Primary completion: 2024-03-15
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions: Obesity; Status Post Sleeve Gastrectomy
Interventions: DRUG:Liraglutide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:000241-CH

Registered primary outcomes

Cohen's d (the Standardized Mean Difference) [16 weeks]

Linked records (4)

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
R0018546	LBODP002 Phase II Open-label Pilot Trial Of Liraglutide In Adolescents With Obesity After Vertical Sleeve Gastrectomy: Interim Results From 8-weeks Of Treatment , Journal of the Endocrine Society	2022	Randomized trial		cites ClinicalTrials.gov:NCT04883346
R0047831	LBODP002 Phase II Open-label Pilot Trial Of Liraglutide In Adolescents With Obesity After Vertical Sleeve Gastrectomy: Interim Results From 8-weeks Of Treatment Syeda Shamim Fatima, Journal of the Endocrine Society	2022	Randomized trial	DOI	cites ClinicalTrials.gov:NCT04883346
R0023922	A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. Kelly AS, The New England journal of medicine	2020	Randomized trial	PMID 32233338 DOI	registry reference BACKGROUND:32233338
R0022927	A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. Pi-Sunyer X, The New England journal of medicine	2015	Randomized trial	PMID 26132939 DOI	registry reference BACKGROUND:26132939