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New diabetes drug shows promise for teens in landmark trial

NCT ID NCT05260021

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a medication called tirzepatide in children and teenagers aged 10 to 17 with type 2 diabetes. Participants were already taking metformin or insulin but still had high blood sugar. The goal was to see if tirzepatide could safely lower blood sugar levels better than a placebo over about 60 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

99 people

The number who actually took part.

Started

Apr 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 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 hyperosmolar syndrome * Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months. * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine 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 become pregnant. * Using prescription or over the counter medications for weight loss within 90 days of the screening visit.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus endocrine system disorder glucose metabolism disease metabolic disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus Diabetes mellitus type 2 Endocrine system diseases Glucose metabolism disorders Metabolic disease T2D T2DM (type 2 diabetes mellitus) TYPE2 diabetes

Contacts and locations

Locations

  • AA Medical Research Center

    Flint, Michigan, 48504, United States

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Arké SMO S.A de C.V

    Veracruz, 91910, Mexico

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

    Paris, 75019, France

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, Veneto, 37126, Italy

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

    Naples, Campania, 80138, Italy

  • Bhakti Vedanta Hospital and Research Institute

    Thane, Maharashtra, 401107, India

  • CEDOES

    Vitória, Espírito Santo, 29055450, Brazil

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010, Brazil

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000, Brazil

  • Center Of Excellence in Diabetes and Endocrinology

    Sacramento, California, 95821, United States

  • Centre Hospitalier Universitaire d'Angers

    Angers, Maine-et-Loire, 49933, France

  • Centre for Children's Health Research

    Brisbane, Queensland, 4101, Australia

  • Centro de Diabetes Curitiba

    Curitiba, Paraná, 80810-040, Brazil

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo, 13034-685, Brazil

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia (CHOP)

    Philadelphia, Pennsylvania, 19104, United States

  • Clínica Cemain

    Tampico, Tamaulipas, 89170, Mexico

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla City, 72190, Mexico

  • Gujarat Endocrin Pvt Ltd

    Ahmedabad, Gujarat, 380052, India

  • Hull Royal Infirmary

    Hull, Kingston Upon Hull, HU3 2JZ, United Kingdom

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • Instituto Méderi de Pesquisa e Saúde

    Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

  • Instituto da Crianca com Diabetes

    Porto Alegre, Rio Grande do Sul, 91350-250, Brazil

  • Instituto da Crianca do Hospital das Clinicas da FMUSP

    São Paulo, São Paulo, 05403-000, Brazil

  • Instituto de Pesquisa Clinica

    São Paulo, São Paulo, 01223-001, Brazil

  • Instituto de Pesquisa clinica de Campinas

    Campinas, São Paulo, 13060-080, Brazil

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua City, 31217, Mexico

  • Kovai Diabetes Speciality Center and Hospital

    Coimbatore, Tamil Nadu, 641009, India

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW, United Kingdom

  • M S Ramaiah Medical College and Hospitals

    Bangalore, Karnataka, 560054, India

  • Nemours Children's Health - Delaware

    Wilmington, Delaware, 19803, United States

  • Ospedale Pediatrico Salesi

    Ancona, 60123, Italy

  • Perth Children's Hospital

    Perth, Western Australia, 6009, Australia

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, 160012, India

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715, United States

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601, Israel

  • Ruschel Medicina e Pesquisa Clínica

    Rio de Janeiro, 22270-060, Brazil

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9013102, Israel

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100, Israel

  • Soroka Medical Center

    Beersheba, Southern District, 8410101, Israel

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • Touro University California

    Vallejo, California, 94592, United States

  • Unidad Médica para la Salud Integral

    San Nicolás de los Garza, Nuevo León, 66465, Mexico

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yitzhak Shamir Medical Center

    Be’er Ya‘aqov, Central District, 70300, Israel

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