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Not yet recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT07817875

Public ClinicalTrials.gov record NCT07817875. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 26, 2026, 10:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07817875
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eli Lilly and Company
Industry
Enrollment
150 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 11 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2032
Last update posted
Sep 24, 2026

2026 – 2032

United States locations

U.S. sites
43
U.S. states
24
U.S. cities
38
Facility City State ZIP Site status
University of Arizona Tucson Arizona 85721 —
Loma Linda University School of Medicine Loma Linda California 92354 —
Childrens Hospital of Los Angeles Los Angeles California 90027 —
UCLA Mattel Children's Hospital Los Angeles California 90095 —
Children's Hospital of Orange County Orange California 92868 —
Carey Chronis MD Pediatric, Infant and Adolescent Medicine Oxnard California 93003-5314 —
Children's Hospital Colorado Colorado Springs Colorado 80920-7843 —
Yale New Haven Children's Hospital New Haven Connecticut 06504 —
William A. Shands Hospital at the University of Florida Gainesville Florida 32610-3003 —
Florida Hospital- Center for Pediatric Research Orlando Florida 32803 —
Nemours Children's Health Orlando Florida 32827 —
All Childrens Hospital St. Petersburg Florida 33701 —
Children's Healthcare of Atlanta - Center for Advanced Pediatrics Atlanta Georgia 30329 —
Ann and Robert H Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
University of Illinois at Chicago Chicago Illinois 60612 —
Riley Hospital for Children Indianapolis Indiana 46202 —
Norton Children's Endocrinology Louisville Kentucky 40202 —
Johns Hopkins Children's Center Baltimore Maryland 21287 —
Boston Children's Hospital Boston Massachusetts 02115 —
Helen Devos Childrens' Hospital - PIN Grand Rapids Michigan 49503-2560 —
University of Minnesota Masonic Children's Hospital Minneapolis Minnesota 55454 —
Mayo Clinic - PIN Rochester Minnesota 55905-0001 —
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center Saint Paul Minnesota 55102-3354 —
Children's Hospital & Medical Center Omaha Nebraska 68114 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
UBMD Pediatrics Buffalo New York 14203 —
UNC Children's Hospital Chapel Hill North Carolina 27514 —
Duke Children's Primary Care Durham North Carolina 27704-2102 —
Lucas Research, Inc Morehead City North Carolina 28557 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Cleveland Clinic Cleveland Ohio 44195 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Oklahoma Childrens Memorial Hospital Oklahoma City Oklahoma 73104-5008 —
Coastal Pediatric Associates Charleston South Carolina 29414 —
Medical University of South Carolina Children Hospital - PIN Charleston South Carolina 29425 —
Vanderbilt Health One Hundred Oaks Nashville Tennessee 37204-3609 —
Dell Children's Medical Center - PIN Austin Texas 78723-3079 —
Driscoll Children's Hospital Corpus Christi Texas 78411 —
McGovern Medical School Houston Texas 77030-1521 —
Texas Childrens Hospital Houston Texas 77030 —
VCU Health - Center for Endocrinology Diabetes and Metabolism Richmond Virginia 23229-3156 —
Seattle Children's Research Institute - Hughes Building - PIN Seattle Washington 98101 —
MultiCare Health System - Mary Bridge Children's Health Center Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07817875, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 24, 2026 · Synced Sep 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07817875 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →