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

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.

Timeline

Start

2022-04-13

Primary completion

2024-07-30

Completion

2025-01-28

Outcome

Met primary endpoint

paper At week 30, tirzepatide was superior to placebo in reducing HbA1c PMID 40975112 ↗

registry analysis (superiority test); Pooled Doses of Tirzepatide (5 mg, 10 mg) vs Placebo; p <0.001; LS Mean difference (Final Values) -1.80 (95% CI -2.35 to -1.25) NCT05260021 ↗

release “In SURPASS-PEDS, Mounjaro met the primary and all key secondary endpoints at 30 weeks” lilly.com ↗

Publications

• Hannon TS, Chao LC, Barrientos-Perez M, Pamidipati KC, Lando LF, Lee CJ, Patel H, Bergman BK. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2025 Oct 4;406(10511):1484-1496. doi: 10.1016/S0140-6736(25)01774-X. Epub 2025 Sep 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tirzepatide	Peptide	5 mg	Subcutaneous
Subject	Tirzepatide	Peptide	10 mg	Subcutaneous

Indications