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

NCT05260021 · Completed

Last updated 2026-05-28

This clinical trial is testing the medication tirzepatide in children and teenagers with type 2 diabetes whose blood sugar is not well-controlled with metformin or insulin.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 99 people

Who can join Ages 10–18 · all sexes

Timeline Started 2022-04 · est. completion 2025-01

Where 51 sites · Australia, Brazil, France, India, Israel, Italy, Mexico, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT05260021 ↗

Description as written by the study sponsor.

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.

Treatments tested

Tirzepatide Dose 1 Drug

Administered SC
Tirzepatide Dose 2 Drug

Administered SC
Placebo Drug

Administered SC

Main thing measured	Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)
Sponsor	Eli Lilly and Company
Conditions studied	Type2 Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, T2D, T2DM (Type 2 Diabetes Mellitus), Glucose Metabolism Disorders, Endocrine System Diseases, Metabolic Disease
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05260021 ↗