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)

September 8, 2025 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • The Children's Hospital at Westmead
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Centre for Children's Health Research
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Perth Children's Hospital
  • Brazil
      • Rio de Janeiro, Brazil, 22270-060
        • Ruschel Medicina e Pesquisa Clínica
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055450
        • CEDOES
    • Paraná
      • Curitiba, Paraná, Brazil, 80810-040
        • Centro de Diabetes Curitiba
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-120
        • Instituto Méderi de Pesquisa e Saúde
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-250
        • Instituto da Crianca com Diabetes
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-080
        • Instituto de Pesquisa clinica de Campinas
      • Campinas, São Paulo, Brazil, 13034-685
        • Centro de Pesquisa São Lucas
      • São Paulo, São Paulo, Brazil, 01223-001
        • Instituto de Pesquisa Clinica
      • São Paulo, São Paulo, Brazil, 05403-000
        • Instituto da Crianca do Hospital das Clinicas da FMUSP
  • France
      • Paris, France, 75019
        • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Centre Hospitalier Universitaire D'Angers
  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education & Research
    • Gujarat
      • Ahmedabad, Gujarat, India, 380052
        • Gujarat Endocrin Pvt Ltd
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • M S Ramaiah Medical College and Hospitals
    • Maharashtra
      • Thāne, Maharashtra, India, 401107
        • Bhakti Vedanta Hospital and Research Institute
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • All India Institute of medical Sciences
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641009
        • Kovai Diabetes Speciality Center and Hospital
  • Israel
    • Central District
      • Be’er Ya‘aqov, Central District, Israel, 70300
        • Yitzhak Shamir Medical Center
      • Ramat Gan, Central District, Israel, 5262100
        • Sheba Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9013102
        • Shaare Zedek Medical Center
    • Northern District
      • Haifa, Northern District, Israel, 3109601
        • Rambam Health Care Campus
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Soroka Medical Center
  • Italy
      • Ancona, Italy, 60123
        • Ospedale Pediatrico Salesi
    • Campania
      • Napoli, Campania, Italy, 80138
        • Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Campa -T
    • Veneto
      • Verona, Veneto, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
  • Mexico
      • Chihuahua City, Mexico, 31217
        • Investigacion En Salud Y Metabolismo Sc
      • Puebla City, Mexico, 72190
        • Consultorio Médico de Endocrinología y Pediatría
      • Veracruz, Mexico, 91910
        • Arké SMO S.A de C.V
    • Nuevo León
      • San Nicolás de los Garza, Nuevo León, Mexico, 66465
        • Unidad Médica para la Salud Integral
    • Tamaulipas
      • Tampico, Tamaulipas, Mexico, 89170
        • Clínica Cemain
  • United Kingdom
    • England
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
    • Kingston Upon Hull
      • Hull, Kingston Upon Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Leicester General Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • Sacramento, California, United States, 95821
        • Center of Excellence in Diabetes and Endocrinology
      • San Diego, California, United States, 92123
        • Rady Children's Hospital
      • Vallejo, California, United States, 94592
        • Touro University California
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours Children's Health - Delaware
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research, LLC
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health University Hospital
    • Michigan
      • Flint, Michigan, United States, 48504
        • AA Medical Research Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia (CHOP)
    • Texas
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide Dose 1

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
Administered SC
Experimental: Tirzepatide Dose 2

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
Administered SC
Placebo Comparator: Placebo

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: Placebo
Administered SC
Drug: Tirzepatide Dose 1
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)
Time Frame: Baseline, Week 30
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Individual Doses)
Time Frame: Baseline, Week 30
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. 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
Percentage of Participants Who Achieve ≤6.5% of HbA1c
Time Frame: Week 30
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
Week 30
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)
Time Frame: Baseline, Week 30

BMI SDS (age and sex matched), calculated using the World Health Organization (WHO) growth reference standards. BMI is calculated as weight in kilograms divided by height in meters squared (kg/m²) and converted to a Z-score (SDS) based on WHO reference data. A Z-score of 0 represents the population mean for a given age and sex. A BMI SDS between -1 and +1 is considered normal. Obesity is defined as BMI SDS > +2. Reductions in BMI SDS indicate improvement in weight status for individuals with obesity.

LS mean was determined by the ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)
Baseline, Week 30
Change From Baseline in Fasting Serum Glucose (FSG)
Time Frame: Baseline, Week 30
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
Percent Change From Baseline in BMI
Time Frame: Baseline, Week 30
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
Percentage of Participants Who Achieve <5.7% of HbA1c
Time Frame: Week 30
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
Week 30
Percentage of Participants Who Achieve <7.0% of HbA1c
Time Frame: Week 30
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
Week 30
Percent Change From Baseline for Serum Lipid Levels
Time Frame: Baseline, Week 30
Geometric LS mean was determined by the MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline Antihyperglycemic medication + Baseline Age group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Baseline, Week 30
Change From Baseline in Height Standard Deviation Score (SDS)
Time Frame: Baseline, Week 30

Height SDS (age and sex-matched), calculated using the World Health Organization (WHO) growth reference standards. Height SDS is derived by comparing a child's height to the median height for their age and sex in the WHO reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean. A Height SDS below -2 indicates short stature. Positive changes in Height SDS from baseline reflect improvement in growth velocity or catch-up growth.

LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + Treatment + Time + Treatment*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Baseline, Week 30
Change From Baseline in Weight SDS
Time Frame: Baseline, Week 30

Weight SDS, calculated using Centers for Disease Control and Prevention (CDC) growth reference standards. Weight SDS is derived by comparing a child's weight to median weight for their age and sex in the CDC reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean for a given age and sex. A Weight SDS below -2 may indicate underweight status, while a Weight SDS above +2 may indicate overweight or obesity. Change from baseline Weight SDS reflects shifts in growth trajectory, with positive changes indicating weight gain and negative changes indicating weight reduction.

LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + Treatment + Time + Treatment*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Baseline, Week 30
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
Time Frame: Baseline, Week 52
The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children (ages 8 to 12) and teenagers (ages 13 to 18). The 23-item PedsQL Generic Core Scale includes physical, emotional, social, and school functioning dimensions. The PedsQL Generic Core yields two summary scores: Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning. Each item is scored from 0 (never) to 4 (almost always). Items are reverse scored and linearly transformed to a 0-100 scale so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best). Higher scores indicate better health-related quality of life. LS mean was determined by the MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic Medication + Baseline Age Group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured.
Baseline, Week 52
Change From Baseline PedsQL (3.2) Diabetic Module
Time Frame: Baseline, Week 52
The PedsQL 3.2 Diabetes Module has 33 items for ages 13 years and older, and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms (15 items), treatment barriers (5 items), treatment adherence (6 items), worry [2 items (3 for teens and adults)] and communication (4 items). Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores reflect fewer problems and better functioning. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment + Time + Treatment*Time(Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance- Covariance structure (Change from Baseline) = Unstructured.
Baseline, Week 52
Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide
Time Frame: Week 0: after the first dose anytime on the same day. Weeks 7, 16, and 29: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post-dose, as assigned by IWRS.
The steady-state AUCs were estimated from Tirzepatide concentrations at Weeks 0, 7, 16, and 29 using the population PK model by treatment group.
Week 0: after the first dose anytime on the same day. Weeks 7, 16, and 29: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post-dose, as assigned by IWRS.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2022

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

January 28, 2025

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17121
  • I8F-MC-GPGV (Other Identifier: Eli Lilly and Company)
  • 2021-003612-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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