NCT06075667

A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits. Participants who have completed the primary 72-week GPHP 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.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	Tirzepatide	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2023-10-16
• Primary completion: 2026-05-01
• Completion: 2029-07-01
• First posted: 2023-10-10
• Last updated: 2025-06-25

Locations

33 sites across 6 countries: United States, Canada, Czechia, Israel, Italy, Poland

Regulatory

• FDA-regulated drug study