GPIX - Surmount Adolescents 2
Research type
Research Study
Full title
Efficacy and Safety of Tirzepatide Once Weekly versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-ADOLESCENTS-2)
IRAS ID
1009481
Contact name
Eli Lilly
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
This is a Phase 3, randomised, double-blind, multicenter, placebo-controlled, parallel group study to investigate the efficacy and safety of QW tirzepatide MTD treatment compared to placebo in adolescent participants (12-17 years of age) living with obesity and at least 2 of 3 predefined weight related comorbidities. Obesity in childhood can have long-term consequences into adulthood, which also increases future health risks. Currently, there are limited globally approved medications available for weight management in paediatric patients with obesity. This study will investigate the effect of tirzepatide on BMI, improvement in predefined comorbidities, waist circumference, blood pressure, lipid levels, glycaemic control, and quality of life. The treatment duration will be approximately 72 weeks, including a dose escalation and maintenance period. The visit frequency will be every 4 weeks. The study duration will be approximately 82 weeks, including screening, treatment, and follow-up periods. The study will enrol approximately 300 participants to treatment with placebo or tirzepatide. All participants will be offered a health behaviour and lifestyle program focusing on healthy diet and physical activity. The study is being paid for by Eli Lilly and Company Limited.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
24/ES/0032
Date of REC Opinion
4 Jun 2024
REC opinion
Further Information Favourable Opinion