Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

Phase 3 Completed 251 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.

Timeline

Start: 2016-09-29
Primary completion: 2019-02-14
Completion: 2019-08-08

Outcome

Met primary endpoint

registry analysis (superiority test); Liraglutide 3.0 mg vs Placebo; p = 0.0022; Treatment difference -0.22 (95% CI -0.37 to -0.08) NCT02918279 ↗

paper Liraglutide was superior to placebo with regard to the change from baseline in the BMI standard-deviation score at week 56 PMID 32233338 ↗

Publications

Results Kelly AS, Auerbach P, Barrientos-Perez M, Gies I, Hale PM, Marcus C, Mastrandrea LD, Prabhu N, Arslanian S; NN8022-4180 Trial Investigators. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020 May 28;382(22):2117-2128. doi: 10.1056/NEJMoa1916038. Epub 2020 Mar 31.
Bensignor MO, Bramante CT, Bomberg EM, Fox CK, Hale PM, Kelly AS, Mamadi R, Prabhu N, Harder-Lauridsen NM, Gross AC. Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial. Pediatr Obes. 2023 Sep;18(9):e13061. doi: 10.1111/ijpo.13061. Epub 2023 Jun 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	3 mg	Subcutaneous