Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)

NCT07817875 · Not yet recruiting

Last updated 2026-09-22

This clinical trial is testing the effects of the medication tirzepatide, given once a week, compared to a placebo in children aged 6 to under 12 who have obesity.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 150 people Planned (estimated).

Who can join Ages 6–11 · all sexes

Timeline Started 2026-09 · est. completion 2032-12

Where 84 sites · Belgium, Israel, Italy, Mexico, Poland, Portugal, South Korea, Spain, Taiwan, United States

What this study is testing ClinicalTrials.gov NCT07817875 ↗

Description as written by the study sponsor.

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks. Participants who have completed the primary 104-week PW02 study (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

Tirzepatide also known as LY3298176 Drug

Administered SC
Placebo Drug

Administered SC

Main thing measured	Percent Change from Baseline in Body Mass Index (BMI)
Sponsor	Eli Lilly and Company
Conditions studied	Obesity
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07817875 ↗