Study S001694

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

ClinicalTrials.gov record

Registration

Registration: NCT07817875
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: RECRUITING
Enrollment: 150
Start: 2026-09-25
Primary completion: 2029-12
Lead sponsor: Eli Lilly and Company
Conditions: Obesity
Interventions: DRUG:Tirzepatide; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:J4M-MC-PW02; OTHER:J4M-MC-PWMP Master Protocol; CTIS:2025-522020-27-00; NIH:2025

Registered primary outcomes

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

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