NCT06439277

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Detailed description

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.

Conditions

• Obesity
• Weight Gain

Interventions

Type	Name	Description
DRUG	Tirzepatide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2024-06-03
• Primary completion: 2027-10-01
• Completion: 2030-12-01
• First posted: 2024-06-03
• Last updated: 2026-03-24

Locations

75 sites across 12 countries: United States, Argentina, Australia, Canada, France, Germany, Israel, Mexico, Puerto Rico, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study