NCT05260021

A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.

Conditions

• Type2 Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• T2D
• T2DM (Type 2 Diabetes Mellitus)
• Glucose Metabolism Disorders
• Endocrine System Diseases
• Metabolic Disease

Interventions

Type	Name	Description
DRUG	Tirzepatide Dose 1	Administered SC
DRUG	Tirzepatide Dose 2	Administered SC
DRUG	Placebo	Administered SC

Timeline

• Start date: 2022-04-13
• Primary completion: 2024-07-30
• Completion: 2025-01-28
• First posted: 2022-03-02
• Last updated: 2025-09-26
• Results posted: 2025-09-26

Locations

51 sites across 9 countries: United States, Australia, Brazil, France, India, Israel, Italy, Mexico, United Kingdom

Regulatory

• FDA-regulated drug study