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

NCT05260021 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 17121I8F-MC-GPGV2021-003612-31
• Study Type: interventional
• Target: 99
• Locations: 9 countries
• Sites: 51

Brief 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.

Conditions

Type2 Diabetes; Diabetes Mellitus; Diabetes Mellitus, Type 2; T2D; T2DM (Type 2 Diabetes Mellitus); Glucose Metabolism Disorders; Endocrine System Diseases; Metabolic Disease

Keywords

GLP-1 RA; Glucose-dependent insulinotropic polypeptide (GIP); glucagon-like peptide-1 (GLP-1); GIP/GLP-1 dual receptor agonist; Incretins

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)

  HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)

  Baseline, Week 30

Secondary Outcomes (13)

• Change From Baseline in HbA1c (Individual Doses)

  Baseline, Week 30

• Percentage of Participants Who Achieve ≤6.5% of HbA1c

  Week 30

• Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)

  Baseline, Week 30

• Change From Baseline in Fasting Serum Glucose (FSG)

  Baseline, Week 30

• Percent Change From Baseline in BMI

  Baseline, Week 30

Study Arms (3)

Tirzepatide Dose 1

EXPERIMENTAL

Double-Blind: Participants receive Tirzepatide by weekly subcutaneous (SC) injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level

Drug: Tirzepatide Dose 1

Tirzepatide Dose 2

EXPERIMENTAL

Double-Blind: Participants receive Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 2 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level

Drug: Tirzepatide Dose 2

Placebo

PLACEBO COMPARATOR

Double-Blind: Participants receive placebo during the 30-week double-blind period. Open-Label: Participants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached.

Drug: Tirzepatide Dose 1; Drug: Placebo

Interventions

Tirzepatide Dose 1 DRUG

Administered SC

Placebo; Tirzepatide Dose 1

Tirzepatide Dose 2 DRUG

Administered SC

Tirzepatide Dose 2

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (51)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Center Of Excellence in Diabetes and Endocrinology

Sacramento, California, 95821, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Touro University California

Vallejo, California, 94592, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Nemours Children's Health - Delaware

Wilmington, Delaware, 19803, United States

Location

Qualmedica Research, LLC

Evansville, Indiana, 47715, United States

Location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

AA Medical Research Center

Flint, Michigan, 48504, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, 19104, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Centre for Children's Health Research

Brisbane, Queensland, 4101, Australia

Location

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

Location

CEDOES

Vitória, Espírito Santo, 29055450, Brazil

Location

Centro de Diabetes Curitiba

Curitiba, Paraná, 80810-040, Brazil

Location

Instituto Méderi de Pesquisa e Saúde

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

Location

Instituto da Crianca com Diabetes

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

Location

Centro de Pesquisa Sao Lucas

Campinas, São Paulo, 13034-685, Brazil

Location

Instituto de Pesquisa clinica de Campinas

Campinas, São Paulo, 13060-080, Brazil

Location

Instituto de Pesquisa Clinica

São Paulo, São Paulo, 01223-001, Brazil

Location

Instituto da Crianca do Hospital das Clinicas da FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, 22270-060, Brazil

Location

CPQuali Pesquisa Clínica

São Paulo, 01228-000, Brazil

Location

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010, Brazil

Location

Centre Hospitalier Universitaire d'Angers

Angers, Maine-et-Loire, 49933, France

Location

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

Paris, 75019, France

Location

Gujarat Endocrin Pvt Ltd

Ahmedabad, Gujarat, 380052, India

Location

M S Ramaiah Medical College and Hospitals

Bangalore, Karnataka, 560054, India

Location

Bhakti Vedanta Hospital and Research Institute

Thane, Maharashtra, 401107, India

Location

All India Institute of Medical Sciences

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

Location

Kovai Diabetes Speciality Center and Hospital

Coimbatore, Tamil Nadu, 641009, India

Location

Postgraduate Institute of Medical Education & Research

Chandigarh, 160012, India

Location

Yitzhak Shamir Medical Center

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

Location

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Jerusalem, 9013102, Israel

Location

Rambam Health Care Campus

Haifa, Northern District, 3109601, Israel

Location

Soroka Medical Center

Beersheba, Southern District, 8410101, Israel

Location

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

Napoli, Campania, 80138, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, Veneto, 37126, Italy

Location

Ospedale Pediatrico Salesi

Ancona, 60123, Italy

Location

Unidad Médica para la Salud Integral

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

Location

Clínica Cemain

Tampico, Tamaulipas, 89170, Mexico

Location

Investigacion En Salud Y Metabolismo Sc

Chihuahua City, 31217, Mexico

Location

Consultorio Médico de Endocrinología y Pediatría

Puebla City, 72190, Mexico

Location

Arké SMO S.A de C.V

Veracruz, 91910, Mexico

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Hull Royal Infirmary

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

Location

Leicester General Hospital

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

Related Publications (1)

• Hannon TS, Chao LC, Barrientos-Perez M, Pamidipati KC, Lando LF, Lee CJ, Patel H, Bergman BK. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2025 Oct 4;406(10511):1484-1496. doi: 10.1016/S0140-6736(25)01774-X. Epub 2025 Sep 17.

  PMID: 40975112 DERIVED

Related Links

• 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 (SURPASS-PEDS)

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Endocrine System Diseases; Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• 1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 2, 2022
• Study Start: April 13, 2022
• Primary Completion: July 30, 2024
• Study Completion: January 28, 2025
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

AU (3); BR (11); IN (6); IT (3); ME (5); IL (5); US (13); GB (3); FR (2)