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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-09-26

Study results available
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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

DRUG

Tirzepatide Dose 1

Administered SC

DRUG

Tirzepatide Dose 2

Administered SC

DRUG

Placebo

Administered SC

Sponsors & Collaborators

Principal Investigators

  • 1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2024-07-30
Completion
2025-01-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • France
  • India
  • Israel
  • Italy
  • Mexico
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260021 on ClinicalTrials.gov