Recruiting
Phase 3

Tirzepatide

Sponsor:

Eli Lilly and Company

Code:

NCT07817875

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Placebo

Study Details

Brief 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.

Conditions

Obesity

Study ID

NCT07817875

Start date

Sep 25, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 11

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

Participants will receive tirzepatide subcutaneously (SC)

placebo comparator: Placebo

Participants will receive placebo SC

Interventions

Tirzepatide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Percent Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 84 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Carey Chronis MD Pediatric, Infant and Adolescent Medicine

Recruiting

Oxnard, California, United States, 93003-5314

Contacts

805-483-1185 x.947

Principal Investigator:

Carey Chronis

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Pediatric
  • Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.