CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 99 enrolled
Drug / intervention
Tirzepatide Dose 1 +2 moredrug
Likely dose
Tirzepatide Dose 1 and Dose 2 (subcutaneous) - specific doses not stated in available textAI-extracted
Key inclusion· 4
  • ✓Age 10 to below 18 years at screening visit
  • ✓Type 2 diabetes treated with diet and exercise plus metformin and/or basal insulin with stable dosing for ≥90 days prior to screening
  • ✓HbA1c >6.5% to ≤11% at screening
  • ✓Body weight ≥50 kg (110 pounds) and BMI >85th percentile for age and gender
Key exclusion· 7
  • ✕Type 1 diabetes mellitus or positive GAD65 or IA2 antibodies
  • ✕History of diabetic ketoacidosis or hyperosmolar syndrome since T2DM diagnosis
  • ✕≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months
  • ✕Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05260021
NCT05260021Phase 3Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Mar 2, 2022·Updated Sep 26, 2025

In Brief

A Phase 3 clinical trial evaluating Tirzepatide Dose 1, Tirzepatide Dose 2, and 1 other intervention for Type2 Diabetes and 7 related conditions. Completed, enrolled 99 participants across 51 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType2 Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, T2D, T2DM (Type 2 Diabetes Mellitus), Glucose Metabolism Disorders, Endocrine System Diseases, Metabolic Disease
CountriesAustralia, Brazil, France, India, Israel, Italy, Mexico, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMar 2, 2022
Enrollment StartApr 13, 2022
Primary CompletionJul 30, 2024
Study CompletionJan 28, 2025
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.3 years ago

Interventions

Tirzepatide Dose 1drug

Administered SC

Tirzepatide Dose 2drug

Administered SC

Placebodrug

Administered SC