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

Open the official record

This page only displays public information reproduced from the official ClinicalTrials.gov record NCT07817875. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Nov 15, 2026, 6:59 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Eli Lilly and Company; Industry
Enrollment: 150 participants

Conditions and interventions

Conditions

Obesity

Interventions

Tirzepatide Drug
Placebo Drug

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: Sep 25, 2026 (Actual)
Primary completion: Dec 2029 (Estimated)
Completion: Dec 2032 (Estimated)
Last update posted: Nov 4, 2026

2026 – 2032

United States locations

U.S. sites: 41
U.S. states: 23
U.S. cities: 36

Facility	City	State	ZIP	Site status
University of Arizona	Tucson	Arizona	85721	Not yet recruiting
Loma Linda University School of Medicine	Loma Linda	California	92354	Not yet recruiting
Childrens Hospital of Los Angeles	Los Angeles	California	90027	Not yet recruiting
UCLA Mattel Children's Hospital	Los Angeles	California	90095	Not yet recruiting
Children's Hospital of Orange County	Orange	California	92868	Not yet recruiting
Carey Chronis MD Pediatric, Infant and Adolescent Medicine	Oxnard	California	93003-5314	Recruiting
Children's Hospital Colorado	Colorado Springs	Colorado	80920-7843	Not yet recruiting
Yale New Haven Children's Hospital	New Haven	Connecticut	06504	Not yet recruiting
Florida Hospital- Center for Pediatric Research	Orlando	Florida	32803	Not yet recruiting
Nemours Children's Health	Orlando	Florida	32827	Not yet recruiting
All Childrens Hospital	St. Petersburg	Florida	33701	Not yet recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics	Atlanta	Georgia	30329	Not yet recruiting
Ann and Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois	60611	Not yet recruiting
University of Illinois at Chicago	Chicago	Illinois	60612	Not yet recruiting
Riley Hospital for Children	Indianapolis	Indiana	46202	Not yet recruiting
Norton Children's Endocrinology	Louisville	Kentucky	40202	Not yet recruiting
Johns Hopkins Children's Center	Baltimore	Maryland	21287	Not yet recruiting
Boston Children's Hospital	Boston	Massachusetts	02115	Not yet recruiting
Helen Devos Childrens' Hospital - PIN	Grand Rapids	Michigan	49503-2560	Not yet recruiting
University of Minnesota Masonic Children's Hospital	Minneapolis	Minnesota	55454	Not yet recruiting
Mayo Clinic - PIN	Rochester	Minnesota	55905-0001	Not yet recruiting
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center	Saint Paul	Minnesota	55102-3354	Not yet recruiting
Children's Hospital & Medical Center	Omaha	Nebraska	68114	Not yet recruiting
UBMD Pediatrics	Buffalo	New York	14203	Not yet recruiting
UNC Children's Hospital	Chapel Hill	North Carolina	27514	Not yet recruiting
Duke Children's Primary Care	Durham	North Carolina	27704-2102	Not yet recruiting
Lucas Research, Inc	Morehead City	North Carolina	28557	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Not yet recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Not yet recruiting
Nationwide Children's Hospital	Columbus	Ohio	43205	Not yet recruiting
Oklahoma Childrens Memorial Hospital	Oklahoma City	Oklahoma	73104-5008	Not yet recruiting
Coastal Pediatric Associates	Charleston	South Carolina	29414	Not yet recruiting
Medical University of South Carolina Children Hospital	Charleston	South Carolina	29425	Not yet recruiting
Vanderbilt Health One Hundred Oaks	Nashville	Tennessee	37204-3609	Not yet recruiting
Dell Children's Medical Center - PIN	Austin	Texas	78723-3079	Not yet recruiting
Driscoll Children's Hospital	Corpus Christi	Texas	78411	Not yet recruiting
McGovern Medical School	Houston	Texas	77030-1521	Not yet recruiting
Texas Childrens Hospital	Houston	Texas	77030	Not yet recruiting
VCU Health - Center for Endocrinology Diabetes and Metabolism	Richmond	Virginia	23229-3156	Not yet recruiting
Seattle Children's Research Institute - Hughes Building - PIN	Seattle	Washington	98101	Not yet recruiting
MultiCare Health System - Mary Bridge Children's Health Center	Tacoma	Washington	98405	Not yet recruiting

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 Nov 4, 2026 · Synced Nov 15, 2026