RecruitingPhase 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)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 11 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares once-weekly tirzepatide with a placebo in children ages 6 to 11 who have obesity. Along with healthy lifestyle changes, it tests how well the drug works, its safety, and how the body processes it. The study lasts about 104 weeks, with a chance to receive tirzepatide and continue lifestyle changes for 156 more weeks after finishing.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 6 to 11 years old.
  • Weigh at least 88 pounds (40 kilograms).
  • Have obesity, with a BMI at or above the 95th percentile for age and sex. BMI is a measure based on height and weight; this cutoff means it is as high as or higher than that of 95 out of 100 children of the same age and sex.
  • Have tried at least one structured diet and exercise counseling program for at least 3 months before screening without losing enough weight.

Who can't join

  • Have a history of certain eye problems from diabetes: abnormal blood vessel growth, swelling in the part of the eye used for sharp vision, or other damage that needs immediate treatment.
  • Have had a weight-loss procedure, such as stomach surgery or a stomach band, or plan to have one during the study.
  • Have another condition that causes obesity, or sudden weight gain that suggests another cause, such as a brain, gene, or hormone condition.
  • Have type 1 diabetes or a history of ketoacidosis or a hyperosmolar state—serious problems involving acid buildup or very high blood sugar.
  • Have an HbA1c above 9.0% at screening. This blood test measures average blood sugar over time.
  • Have a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia Type 2, a condition that can cause tumors in hormone-making glands.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (41)

AZ

CA

CO

CT

FL

GA

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics · Atlanta, GA 30329 · Study contact · 404-785-5686Daniel Hsia · Principal investigatorMore trials in Atlanta

IL

IN

KY

MA

  • Boston Children's Hospital · Boston, MA 02115Margaret Stefater-Richards · Principal investigatorMore trials in Boston

MD

MI

MN

NC

NE

  • Children's Hospital & Medical Center · Omaha, NE 68114Alvaro Flores Lopez · Principal investigatorMore trials in Omaha

NY

OH

OK

SC

TN

  • Vanderbilt Health One Hundred Oaks · Nashville, TN 37204-3609Jennifer Kelley · Principal investigatorMore trials in Nashville

TX

VA

  • VCU Health - Center for Endocrinology Diabetes and Metabolism · Richmond, VA 23229-3156 · Study contact · 804-628-6674Edmond Wickham · Principal investigatorMore trials in Richmond

WA

  • Seattle Children's Research Institute - Hughes Building - PIN · Seattle, WA 98101 · Study contact · 425-786-3784Kalie Tommerdale · Principal investigatorMore trials in Seattle
  • MultiCare Health System - Mary Bridge Children's Health Center · Tacoma, WA 98405 · Study contact · 253-403-0776Bhuvana Sunil · Principal investigatorMore trials in Tacoma