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Clinical Trials in the USA / NCT07817875
Starting soon Phase 3

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 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2026-09
Last updated
2026-09-14

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

TirzepatidePlacebo

Tirzepatide: Administered SC

Placebo: Administered SC

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria: J4M-MC-PW02 * Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive) * Have: * a body weight of ≥ 40 kilograms (kg) (88 pounds), and * been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart J4M-MC-PWMP * Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening. * Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]) Exclusion Criteria: J4M-MC-PW02 * Have a history of * proliferative diabetic retinopathy * diabetic macular edema, or * nonproliferative diabetic retinopathy that requires acute treatment J4M-MC-PWMP * Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to: * gastric bypass * sleeve gastrectomy * restrictive bariatric surgery, such as Lap-Band® gastric banding, or * any other procedure intended to result in weight reduction. * Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes. * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state. * Have HbA1c \>9.0% (75 mmol/mol) as measured by central laboratory at screening. * Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.

Primary outcome measure(s)

Trial sites (84)

FacilityCityRegionStatus
University of Arizona Tucson Arizona
Loma Linda University School of Medicine Loma Linda California
Childrens Hospital of Los Angeles Los Angeles California
UCLA Mattel Children's Hospital Los Angeles California
Children's Hospital of Orange County Orange California
Carey Chronis MD Pediatric, Infant and Adolescent Medicine Oxnard California
Children's Hospital Colorado Colorado Springs Colorado
Yale New Haven Children's Hospital New Haven Connecticut
William A. Shands Hospital at the University of Florida Gainesville Florida
Florida Hospital- Center for Pediatric Research Orlando Florida
Nemours Children's Health Orlando Florida
All Childrens Hospital Saint Petersburgh Florida
Children's Healthcare of Atlanta - Center for Advanced Pediatrics Atlanta Georgia
Ann and Robert H Lurie Children's Hospital of Chicago Chicago Illinois
University of Illinois at Chicago Chicago Illinois
Riley Hospital for Children Indianapolis Indiana
Norton Children's Endocrinology Louisville Kentucky
Johns Hopkins Children's Center Baltimore Maryland
Boston Children's Hospital Boston Massachusetts
Helen Devos Childrens' Hospital - PIN Grand Rapids Michigan
University of Minnesota Masonic Children's Hospital Minneapolis Minnesota
Mayo Clinic - PIN Rochester Minnesota
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center Saint Paul Minnesota
Children's Hospital & Medical Center Omaha Nebraska
Hackensack University Medical Center Hackensack New Jersey
UBMD Pediatrics Buffalo New York
UNC Children's Hospital Chapel Hill North Carolina
Duke Children's Primary Care Durham North Carolina
Lucas Research, Inc Morehead City North Carolina
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Cleveland Clinic Cleveland Ohio
Nationwide Children's Hospital Columbus Ohio
Oklahoma Childrens Memorial Hospital Oklahoma City Oklahoma
Coastal Pediatric Associates Charleston South Carolina
Medical University of South Carolina Children Hospital - PIN Charleston South Carolina
Vanderbilt Health One Hundred Oaks Nashville Tennessee
Dell Children's Medical Center - PIN Austin Texas
Driscoll Children's Hospital Corpus Christi Texas
McGovern Medical School Houston Texas
Texas Childrens Hospital Houston Texas

+ 44 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07817875 on ClinicalTrials.gov ↗ ← All trials in the USA