Weekly tirzepatide vs placebo for pediatric obesity (6 to <12 years)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3, randomized trial, children with obesity who have not achieved sufficient weight loss after prior lifestyle efforts receive either tirzepatide or placebo weekly, alongside standard lifestyle advice, to evaluate safety, efficacy, and how the drug behaves in the body. The study is conducted under a master protocol and follows a 104-week primary period, with an option for an extended treatment phase after completion. Participants are monitored for growth, metabolic effects, and potential adverse events to determine tolerability and overall benefit. Eligible ages span Tanner stages 1 through 5, with weight and BMI criteria confirming obesity by age- and sex-specific standards.

Why it matters

Who can join: the full rules

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.

Where it's running

• Carey Chronis MD Pediatric, Infant and Adolescent Medicine
  Oxnard, California, United States Recruiting
• Lucas Research, Inc
  Morehead City, North Carolina, United States Recruiting
• University of Arizona
  Tucson, Arizona, United States Not yet recruiting
• Loma Linda University School of Medicine
  Loma Linda, California, United States Not yet recruiting
• Childrens Hospital of Los Angeles
  Los Angeles, California, United States Not yet recruiting
• UCLA Mattel Children's Hospital
  Los Angeles, California, United States Not yet recruiting

+32 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.