NCT05260021CompletedPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 25 Feb 2022
- Start date
- 13 Apr 2022
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT05260021
- EudraCT number
- 2021-003612-31
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 99
- From 13 Apr 2022 to the primary completion date, 30 Jul 2024
- 51 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had chronic or acute pancreatitis any time prior to study entry
- Using prescription or over the counter medications for weight loss within 90 days of the screening visit.
Other illness
- Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
- After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
Other
- Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
- Female participants who are pregnant or breast feeding or intending to become pregnant.
Who the study is looking for
- Male or female, aged 10 to below 18 years at screening visit
- Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
- Have HbA1c \>6.5% to ≤11% at screening
- Have body weight ≥50 kilogram (kg) 110 pounds and BMI of \>85th percentile of the general age and gender-matched population for that country or region.
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (51)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Children's Health Research Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Perth Children's Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Instituto de Pesquisa Clínica de Campinas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Centro de Diabetes Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Instituto Mederi de Pesquisa e Saude Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Unknown status |
| Instituto da Crianca com Diabetes Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Ruschel Medicina e Pesquisa Clínica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto de Pesquisa Clinica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto da Crianca do Hospital das Clinicas da FMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEPIC - Centro Paulista de Investigação Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEDOES Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hull Royal Infirmary Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| Leicester General Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Yitzhak Shamir Medical Center Coordinator of this site? Confirm its status | Be’er Ya‘aqov | Israel | Unknown status |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Gujarat Endocrin Pvt Ltd Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| M S Ramaiah Medical College and Hospitals Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Postgraduate Institute of Medical Education & Research Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| Kovai Diabetes Speciality Center and Hospital Coordinator of this site? Confirm its status | Coimbatore | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Bhakti Vedanta Hospital and Research Institute Coordinator of this site? Confirm its status | Thane | India | Unknown status |
| Ospedale Pediatrico Salesi Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Campa -T Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Investigacion En Salud Y Metabolismo Sc Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Consultorio Médico de Endocrinología y Pediatría Coordinator of this site? Confirm its status | Puebla City | Mexico | Unknown status |
| Unidad Médica para la Salud Integral Coordinator of this site? Confirm its status | San Nicolás de los Garza | Mexico | Unknown status |
| Clínica Cemain Coordinator of this site? Confirm its status | Tampico | Mexico | Unknown status |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Qualmedica Research, LLC Coordinator of this site? Confirm its status | Evansville | United States | Unknown status |
| AA Medical Research Center Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Indiana University Health University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Children's Hospital of Philadelphia (CHOP) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Center Of Excellence in Diabetes and Endocrinology Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Rady Children's Hospital Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Touro University California Coordinator of this site? Confirm its status | Vallejo | United States | Unknown status |
| Nemours Children's Health, Delaware Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.