Liraglutide study to assess weight reduction and safety in pubertal adolescents with obesity

Childhood and adolescent obesity represent a significant global health challenge, increasing the risk of numerous comorbidities like type 2 diabetes, cardiovascular disease, and non-alcoholic fatty liver disease later in life. Current interventions often involve lifestyle modifications, but pharmacological options specifically approved and effective for this younger population are limited. GLP-1 receptor agonists, such as liraglutide, have demonstrated substantial weight loss benefits and improved metabolic health in adults with obesity. This study aims to bridge the therapeutic gap by evaluating liraglutide's potential as a safe and effective treatment for weight management in pubertal adolescents, addressing a critical unmet need.

This double-blind, randomized, parallel-group, placebo-controlled multi-national trial will enroll pubertal adolescent subjects with obesity. Participants will be randomly assigned to receive either liraglutide or a placebo via 1 injection every day. The study duration is approximately 96 weeks (almost 2 years), followed by a 26-week period off study drug. Throughout the trial, participants will attend 18 clinic visits and engage in 10 phone or video calls with study staff. Beyond medication, all participants will receive counseling on healthy food choices and increased physical activity. Key assessments include regular body weight measurements, blood samples, a heart check, and a hand X-ray, alongside diary completion between visits to monitor progress and potential side effects.