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
Public ClinicalTrials.gov record NCT05260021. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05260021
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 99 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 12, 2022
- Primary completion
- Jul 29, 2024
- Completion
- Jan 27, 2025
- Last update posted
- Sep 25, 2025
2022 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Center Of Excellence in Diabetes and Endocrinology | Sacramento | California | 95821 | — |
| Rady Children's Hospital | San Diego | California | 92123 | — |
| Touro University California | Vallejo | California | 94592 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Nemours Children's Health - Delaware | Wilmington | Delaware | 19803 | — |
| Qualmedica Research, LLC | Evansville | Indiana | 47715 | — |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | — |
| AA Medical Research Center | Flint | Michigan | 48504 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | 19104 | — |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05260021, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2025 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05260021 live on ClinicalTrials.gov.