Tests tirzepatide against placebo in children with obesity
Tests tirzepatide with healthy lifestyle in children aged 6 to 11 with obesity.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Atlanta, Austin, Baltimore, Boston, Buffalo, Chapel Hill, Charleston, Chicago, Cincinnati, Cleveland, Colorado Springs, Columbus, Corpus Christi, Durham, Grand Rapids, Houston, Indianapolis, Loma Linda, Los Angeles, Louisville, Minneapolis, Morehead City, Nashville, New Haven, Oklahoma City, Omaha, Orange, Orlando, Oxnard, Richmond, Rochester, Saint Paul, Seattle, St. Petersburg, Tacoma, and Tucson, United StatesSee the 41 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 11 years old?
Source: NCT07817875, who can take part
Where in United States
- Children's Healthcare of Atlanta Center for Advanced PediatricsAtlanta, United StatesNot yet recruiting
- Dell Children's Medical Center - PINAustin, United StatesNot yet recruiting
- Johns Hopkins Children's CenterBaltimore, United StatesNot yet recruiting
- Boston Children's HospitalBoston, United StatesNot yet recruiting
- UBMD PediatricsBuffalo, United StatesNot yet recruiting
- UNC Children's HospitalChapel Hill, United StatesNot yet recruiting
- Coastal Pediatric AssociatesCharleston, United StatesNot yet recruiting
- Medical University of South Carolina Children HospitalCharleston, United StatesNot yet recruiting
- Ann and Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesNot yet recruiting
- University of Illinois at ChicagoChicago, United StatesNot yet recruiting
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesNot yet recruiting
- Cleveland ClinicCleveland, United StatesNot yet recruiting
- Children's Hospital ColoradoColorado Springs, United StatesNot yet recruiting
- Nationwide Children's HospitalColumbus, United StatesNot yet recruiting
- Driscoll Children's HospitalCorpus Christi, United StatesNot yet recruiting
- Duke Children's Primary CareDurham, United StatesNot yet recruiting
- Helen Devos Childrens' Hospital - PINGrand Rapids, United StatesNot yet recruiting
- McGovern Medical SchoolHouston, United StatesNot yet recruiting
- Texas Childrens HospitalHouston, United StatesNot yet recruiting
- Riley Hospital for ChildrenIndianapolis, United StatesNot yet recruiting
- Loma Linda University School of MedicineLoma Linda, United StatesNot yet recruiting
- Childrens Hospital of Los AngelesLos Angeles, United StatesNot yet recruiting
- UCLA Mattel Children's HospitalLos Angeles, United StatesNot yet recruiting
- Norton Children's EndocrinologyLouisville, United StatesNot yet recruiting
- University of Minnesota/Masonic Children's HospitalMinneapolis, United StatesNot yet recruiting
- Lucas Research, Inc.Morehead City, United StatesTaking people
- Vanderbilt Health One Hundred OaksNashville, United StatesNot yet recruiting
- Yale-New Haven Children's HospitalNew Haven, United StatesNot yet recruiting
- Oklahoma Childrens Memorial HospitalOklahoma City, United StatesNot yet recruiting
- Children'S Hospital & Medical CenterOmaha, United StatesNot yet recruiting
- Children's Hospital of Orange CountyOrange, United StatesNot yet recruiting
- Florida Hospital- Center for Pediatric ResearchOrlando, United StatesNot yet recruiting
- Nemours Children's HealthOrlando, United StatesNot yet recruiting
- Carey Chronis MD Pediatric, Infant and Adolescent MedicineOxnard, United StatesTaking people
- VCU Health - Center for Endocrinology Diabetes and MetabolismRichmond, United StatesNot yet recruiting
- Mayo Clinic - PINRochester, United StatesNot yet recruiting
- Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes CenterSaint Paul, United StatesNot yet recruiting
- Seattle Children's Research Institute - Hughes Building - PINSeattle, United StatesNot yet recruiting
- All Childrens HospitalSt. Petersburg, United StatesNot yet recruiting
- MultiCare Health System - Mary Bridge Children's Health CenterTacoma, United StatesNot yet recruiting
- University of ArizonaTucson, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07817875EU 2025-522020-27-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 history of; proliferative diabetic retinopathy; diabetic macular edema, or; nonproliferative diabetic retinopathy that requires acute treatment; J4M-MC-PWMP; 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 a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2; Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening; J4M-MC-PW02.