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

Last updated: February 24, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetes And Hypertension

Treatment

Placebo

Tirzepatide Dose 1

Tirzepatide Dose 2

Clinical Study ID

NCT05260021
17121
I8F-MC-GPGV
  • Ages 10-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 basalinsulin. Metformin and/or basal insulin dose must be stable for at least 90 daysprior 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 thegeneral age and gender-matched population for that country or region.

Exclusion

Exclusion Criteria:

  • Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies

  • After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolarsyndrome

  • Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemicunawareness within the last 6 months.

  • Have family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN2).

  • Had chronic or acute pancreatitis any time prior to study entry

  • Female participants who are pregnant or breast feeding or intending to becomepregnant.

  • Using prescription or over the counter medications for weight loss within 90 days ofthe screening visit.

Study Design

Total Participants: 99
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 13, 2022
Estimated Completion Date:
January 28, 2025

Connect with a study center

  • Institute of Diabetes and Endocrinology

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • The Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Centre for Children's Health Research

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Perth Children's Hospital

    Perth, Western Australia 6009
    Australia

    Site Not Available

  • CEDOES

    Vitória, Espírito Santo 29055450
    Brazil

    Site Not Available

  • Centro de Diabetes Curitiba

    Curitiba, Paraná 80810-040
    Brazil

    Site Not Available

  • Instituto Méderi de Pesquisa e Saúde

    Passo Fundo, Rio Grande Do Sul 99010-120
    Brazil

    Site Not Available

  • Instituto da Crianca com Diabetes

    Porto Alegre, Rio Grande Do Sul 91350-250
    Brazil

    Site Not Available

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo 13034-685
    Brazil

    Site Not Available

  • Instituto de Pesquisa clinica de Campinas

    Campinas, São Paulo 13060-080
    Brazil

    Site Not Available

  • Instituto da Crianca do Hospital das Clinicas da FMUSP

    Sao Paulo, São Paulo 05403-000
    Brazil

    Site Not Available

  • Instituto de Pesquisa Clinica

    Sao Paulo, São Paulo 01223-001
    Brazil

    Site Not Available

  • Ruschel Medicina e Pesquisa Clínica

    Rio De Janeiro, 22270-060
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • Hospital das Clinicas FMUSP

    São Paulo, 04266-010
    Brazil

    Active - Recruiting

  • Centre Hospitalier Universitaire d'Angers

    Angers, Maine-et-Loire 49933
    France

    Site Not Available

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T

    Paris, 75019
    France

    Site Not Available

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (CHU)

    Paris, 75019
    France

    Site Not Available

  • All India Institute of Medical Sciences

    New Delhi, Delhi 110029
    India

    Site Not Available

  • Clinical and Research department

    Ahmedabad, Gujarat 380052
    India

    Site Not Available

  • Gujarat Endocrin Pvt Ltd

    Ahmedabad, Gujarat 380052
    India

    Site Not Available

  • Gujarat Endocrine Center

    Ahmedabad, Gujarat 380052
    India

    Active - Recruiting

  • M S Ramaiah Medical College and Hospitals

    Bangalore, Karnataka 560054
    India

    Site Not Available

  • Bhakti Vedanta Hospital and Research Institute

    Thane, Maharashtra 401107
    India

    Site Not Available

  • Kovai Diabetes Speciality Center and Hospital

    Coimbatore, Tamil Nadu 641009
    India

    Site Not Available

  • Post Graduate Institute of Medical Education & Research (PGIMER)

    Chandigarh, 160012
    India

    Active - Recruiting

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, 160012
    India

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva, HaDarom 8410101
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Be'er Ya'aqov, HaMerkaz 70300
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Beer Yaacov, HaMerkaz 70300
    Israel

    Site Not Available

  • Pediatric Endocrinology and Diabetes Unit, Edmond and Lily Safra Children's Hospital

    Ramat Gan, HaMerkaz 5262100
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, HaTsafon 3109601
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9013102
    Israel

    Site Not Available

  • Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Campa -T

    Napoli, Campania 80138
    Italy

    Site Not Available

  • Universita degli Studi della Campania Luigi Vanvitelli

    Napoli, Campania 80138
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, Veneto 37126
    Italy

    Site Not Available

  • Ospedale Pediatrico Salesi

    Ancona, 60123
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia

    Perugia, 06132
    Italy

    Site Not Available

  • Unidad Médica para la Salud Integral

    San Nicolás de los Garza, Nuevo León 66465
    Mexico

    Site Not Available

  • Clínica Cemain

    Tampico, Tamaulipas 89170
    Mexico

    Site Not Available

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua, 31217
    Mexico

    Site Not Available

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla, 72190
    Mexico

    Site Not Available

  • Arké SMO S.A de C.V

    Veracruz, 91910
    Mexico

    Site Not Available

  • Endocrinology Research Center of Rosmedtechnologies

    Moscow, Moskva 117292
    Russian Federation

    Site Not Available

  • Saratov State Medical University named after V.I. Razumovsky under Ministry of Health of the Russian Federation

    Saratov, Saratovskaya Oblast' 410054
    Russian Federation

    Site Not Available

  • Siberian State Medical University

    Tomsk, Tomskaya Oblast' 634050
    Russian Federation

    Site Not Available

  • City Children Polyclinic No. 44

    Saint Petersburg, 191144
    Russian Federation

    Site Not Available

  • Clínica Juaneda

    Palma de Mallorca, Balears [Baleares] 7014
    Spain

    Site Not Available

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona] 08950
    Spain

    Site Not Available

  • Leicester Royal Infirmary

    Leicester, England LE1 5WW
    United Kingdom

    Site Not Available

  • Research Space

    Leicester, England LE1 5WW
    United Kingdom

    Active - Recruiting

  • Hereford County Hospital

    Hereford, Herefordshire HR1 2ER
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary - MAIN

    Hull, Kingston U HU3 2JZ
    United Kingdom

    Active - Recruiting

  • Hull Royal Infirmary

    Hull, Kingston Upon Hull HU3 2JZ
    United Kingdom

    Site Not Available

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, Kingston Upon Hull HU3 2JZ
    United Kingdom

    Site Not Available

  • Leicester Diabetes Centre

    Leicester, Leicestershire LE5 4PW
    United Kingdom

    Active - Recruiting

  • Leicester General Hospital

    Leicester, Leicestershire LE5 4PW
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Center Of Excellence in Diabetes and Endocrinology

    Sacramento, California 95821
    United States

    Site Not Available

  • Rady Children's Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Touro University California

    Vallejo, California 94592
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Nemours Children's Health - Delaware

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Nemours Childrens Clinic - Delaware Valley of The Nemours Foundation

    Wilmington, Delaware 19803
    United States

    Active - Recruiting

  • Qualmedica Research, LLC

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Indiana University Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • AA Medical Research Center

    Flint, Michigan 48504
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • SUNY Downstate Health Sciences University

    Brooklyn, New York 11203
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia (CHOP)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

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