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 on ClinicalTrials.gov · last registry update 2025-09-26

A small phase 3 — 99 participants, against a typical 424. The sponsor logged completion for 30 July 2024. Primary outcome, as filed: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg). tirzepatide is approved in the US, but not for diabetes — a registration here is not an approval, and most drugs tested in a new condition never get one for it.

Status: COMPLETED
Phase: P3
Drug: tirzepatide
Mounjaro, Zepbound
Sponsor: Eli Lilly and Company
Sponsor type: Industry
Enrollment: 99
Started: 2022-04-13
Primary completion: 2024-07-30 actual

Observed history

No changes recorded since monitoring began on 2026-08-21. This record has held steady. If a reporting date moves, a status changes or enrollment is resized, it will appear here with the previous value alongside the new one.

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)

Conditions studied

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

Every field above is taken directly from the registry record. See all detected changes across the class, or the tirzepatide page for this molecule’s full trial and approval history.