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

NCT06439277 · Recruiting

Last updated 2026-05-28

This clinical trial is testing the medication tirzepatide in teenagers who have obesity and weight-related health issues to see how it affects their body mass index (BMI).

Status Recruiting Currently enrolling participants.
Phase Phase 3 Confirms effectiveness in a large group before approval.
Type Interventional (clinical trial)
Design Randomized, double-blind treatment study
Participants 300 people Planned (estimated).
Who can join Ages 12–17 · all sexes
Timeline Started 2024-06 · est. completion 2030-12
Where 73 sites · Argentina, Australia, Canada, France, Germany, Israel, Mexico, Puerto Rico, Spain, Taiwan, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT06439277 ↗

Description as written by the study sponsor.

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.

Treatments tested

Main thing measuredPercent Change from Baseline in Body Mass Index (BMI)
SponsorEli Lilly and Company
Conditions studiedObesity, Weight Gain
GLP-1 drugs tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06439277 ↗