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
NCT ID: NCT05260021
Last Updated: 2025-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
99 participants
INTERVENTIONAL
2022-04-13
2025-01-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Tirzepatide Dose 1
Administered SC
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
Tirzepatide Dose 2
Administered SC
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.
Tirzepatide Dose 1
Administered SC
Placebo
Administered SC
Interventions
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Tirzepatide Dose 1
Administered SC
Tirzepatide Dose 2
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Center Of Excellence in Diabetes and Endocrinology
Sacramento, California, United States
Rady Children's Hospital
San Diego, California, United States
Touro University California
Vallejo, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Children's Health - Delaware
Wilmington, Delaware, United States
Qualmedica Research, LLC
Evansville, Indiana, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
AA Medical Research Center
Flint, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Centre for Children's Health Research
Brisbane, Queensland, Australia
Perth Children's Hospital
Perth, Western Australia, Australia
CEDOES
Vitória, Espírito Santo, Brazil
Centro de Diabetes Curitiba
Curitiba, Paraná, Brazil
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, Rio Grande do Sul, Brazil
Instituto da Crianca com Diabetes
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, Brazil
Instituto de Pesquisa clinica de Campinas
Campinas, São Paulo, Brazil
Instituto de Pesquisa Clinica
São Paulo, São Paulo, Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, São Paulo, Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, , Brazil
CPQuali Pesquisa Clínica
São Paulo, , Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, , Brazil
Centre Hospitalier Universitaire d'Angers
Angers, Maine-et-Loire, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
Paris, , France
Gujarat Endocrin Pvt Ltd
Ahmedabad, Gujarat, India
M S Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India
Bhakti Vedanta Hospital and Research Institute
Thāne, Maharashtra, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Kovai Diabetes Speciality Center and Hospital
Coimbatore, Tamil Nadu, India
Postgraduate Institute of Medical Education & Research
Chandigarh, , India
Yitzhak Shamir Medical Center
Be’er Ya‘aqov, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Soroka Medical Center
Beersheba, Southern District, Israel
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Campa -T
Napoli, Campania, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Veneto, Italy
Ospedale Pediatrico Salesi
Ancona, , Italy
Unidad Médica para la Salud Integral
San Nicolás de los Garza, Nuevo León, Mexico
Clínica Cemain
Tampico, Tamaulipas, Mexico
Investigacion En Salud Y Metabolismo Sc
Chihuahua City, , Mexico
Consultorio Médico de Endocrinología y Pediatría
Puebla City, , Mexico
Arké SMO S.A de C.V
Veracruz, , Mexico
Leicester Royal Infirmary
Leicester, England, United Kingdom
Hull Royal Infirmary
Hull, Kingston Upon Hull, United Kingdom
Leicester General Hospital
Leicester, Leicestershire, United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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)
Other Identifiers
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I8F-MC-GPGV
Identifier Type: OTHER
Identifier Source: secondary_id
2021-003612-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17121
Identifier Type: -
Identifier Source: org_study_id
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