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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)

RecruitingPhase 3

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

Ages 6 to 11 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 150 · Started: Sep 25, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07817875

Locations in the U.S.

ArizonaUniversity of Arizona, Tucson (Not yet recruiting)
CaliforniaLoma Linda University School of Medicine, Loma Linda (Not yet recruiting)
Childrens Hospital of Los Angeles, Los Angeles (Not yet recruiting)
UCLA Mattel Children's Hospital, Los Angeles (Not yet recruiting)
Children's Hospital of Orange County, Orange (Not yet recruiting)
Carey Chronis MD Pediatric, Infant and Adolescent Medicine, Oxnard
ColoradoChildren's Hospital Colorado, Colorado Springs (Not yet recruiting)
ConnecticutYale New Haven Children's Hospital, New Haven (Not yet recruiting)
FloridaFlorida Hospital- Center for Pediatric Research, Orlando (Not yet recruiting)
Nemours Children's Health, Orlando (Not yet recruiting)
All Childrens Hospital, St. Petersburg (Not yet recruiting)
GeorgiaChildren's Healthcare of Atlanta - Center for Advanced Pediatrics, Atlanta (Not yet recruiting)
IllinoisAnn and Robert H Lurie Children's Hospital of Chicago, Chicago (Not yet recruiting)
University of Illinois at Chicago, Chicago (Not yet recruiting)
IndianaRiley Hospital for Children, Indianapolis (Not yet recruiting)
KentuckyNorton Children's Endocrinology, Louisville (Not yet recruiting)
MarylandJohns Hopkins Children's Center, Baltimore (Not yet recruiting)
MassachusettsBoston Children's Hospital, Boston (Not yet recruiting)
MichiganHelen Devos Childrens' Hospital - PIN, Grand Rapids (Not yet recruiting)
MinnesotaUniversity of Minnesota Masonic Children's Hospital, Minneapolis (Not yet recruiting)
Mayo Clinic - PIN, Rochester (Not yet recruiting)
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center, Saint Paul (Not yet recruiting)
NebraskaChildren's Hospital & Medical Center, Omaha (Not yet recruiting)
New YorkUBMD Pediatrics, Buffalo (Not yet recruiting)
North CarolinaUNC Children's Hospital, Chapel Hill (Not yet recruiting)
Duke Children's Primary Care, Durham (Not yet recruiting)
Lucas Research, Inc, Morehead City
OhioCincinnati Children's Hospital Medical Center, Cincinnati (Not yet recruiting)
Cleveland Clinic, Cleveland (Not yet recruiting)
Nationwide Children's Hospital, Columbus (Not yet recruiting)
OklahomaOklahoma Childrens Memorial Hospital, Oklahoma City (Not yet recruiting)
South CarolinaCoastal Pediatric Associates, Charleston (Not yet recruiting)
Medical University of South Carolina Children Hospital, Charleston (Not yet recruiting)
TennesseeVanderbilt Health One Hundred Oaks, Nashville (Not yet recruiting)
TexasDell Children's Medical Center - PIN, Austin (Not yet recruiting)
Driscoll Children's Hospital, Corpus Christi (Not yet recruiting)
McGovern Medical School, Houston (Not yet recruiting)
Texas Childrens Hospital, Houston (Not yet recruiting)
VirginiaVCU Health - Center for Endocrinology Diabetes and Metabolism, Richmond (Not yet recruiting)
WashingtonSeattle Children's Research Institute - Hughes Building - PIN, Seattle (Not yet recruiting)
MultiCare Health System - Mary Bridge Children's Health Center, Tacoma (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.