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)

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

6 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Tirzepatide — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC

Study Details

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.

Key Dates

First listed

Sep 14, 2026

Start date

Sep 30, 2026

Status verified

Sep 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2032

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tirzepatide
  Participants will receive tirzepatide subcutaneously (SC)
• Placebo Comparator: Placebo
  Participants will receive placebo SC

Primary Outcome Measure

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

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (43)

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