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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
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

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre for Children's Health Research
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BrisbaneAustraliaUnknown status
Perth Children's Hospital
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PerthAustraliaUnknown status
The Children's Hospital at Westmead
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WestmeadAustraliaUnknown status
Centro de Pesquisa Sao Lucas
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CampinasBrazilUnknown status
Instituto de Pesquisa Clínica de Campinas
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CampinasBrazilUnknown status
Centro de Diabetes Curitiba
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CuritibaBrazilUnknown status
Instituto Mederi de Pesquisa e Saude
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Passo FundoBrazilUnknown status
Instituto da Crianca com Diabetes
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Porto AlegreBrazilUnknown status
Ruschel Medicina e Pesquisa Clínica
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Rio de JaneiroBrazilUnknown status
Instituto de Pesquisa Clinica
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São PauloBrazilUnknown status
Instituto da Crianca do Hospital das Clinicas da FMUSP
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São PauloBrazilUnknown status
CEPIC - Centro Paulista de Investigação Clínica
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São PauloBrazilUnknown status
CPQuali Pesquisa Clínica
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São PauloBrazilUnknown status
CEDOES
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VitóriaBrazilUnknown status
Centre Hospitalier Universitaire D'Angers
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AngersFranceUnknown status
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
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ParisFranceUnknown status
Hull Royal Infirmary
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HullUnited KingdomUnknown status
Leicester General Hospital
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LeicesterUnited KingdomUnknown status
Leicester Royal Infirmary
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LeicesterUnited KingdomUnknown status
Soroka Medical Center
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BeershebaIsraelUnknown status
Yitzhak Shamir Medical Center
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Be’er Ya‘aqovIsraelUnknown status
Rambam Health Care Campus
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HaifaIsraelUnknown status
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Gujarat Endocrin Pvt Ltd
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AhmedabadIndiaUnknown status
M S Ramaiah Medical College and Hospitals
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BangaloreIndiaUnknown status
Postgraduate Institute of Medical Education & Research
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ChandigarhIndiaUnknown status
Kovai Diabetes Speciality Center and Hospital
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CoimbatoreIndiaUnknown status
All India Institute of Medical Sciences
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New DelhiIndiaUnknown status
Bhakti Vedanta Hospital and Research Institute
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ThaneIndiaUnknown status
Ospedale Pediatrico Salesi
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AnconaItalyUnknown status
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Campa -T
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NaplesItalyUnknown status
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
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VeronaItalyUnknown status
Investigacion En Salud Y Metabolismo Sc
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Chihuahua CityMexicoUnknown status
Consultorio Médico de Endocrinología y Pediatría
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Puebla CityMexicoUnknown status
Unidad Médica para la Salud Integral
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San Nicolás de los GarzaMexicoUnknown status
Clínica Cemain
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TampicoMexicoUnknown status
Arké SMO S.A de C.V
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VeracruzMexicoUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
Qualmedica Research, LLC
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EvansvilleUnited StatesUnknown status
AA Medical Research Center
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FlintUnited StatesUnknown status
Indiana University Health University Hospital
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IndianapolisUnited StatesUnknown status
Children's Hospital Los Angeles
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Los AngelesUnited StatesUnknown status
Children's Hospital of Philadelphia (CHOP)
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PhiladelphiaUnited StatesUnknown status
Center Of Excellence in Diabetes and Endocrinology
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SacramentoUnited StatesUnknown status
Rady Children's Hospital
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San DiegoUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
SUNY Upstate Medical University
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SyracuseUnited StatesUnknown status
Touro University California
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VallejoUnited StatesUnknown status
Nemours Children's Health, Delaware
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WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.