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

Completed · Phase 3 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT05260021

Run by

Eli Lilly and Company

People needed

99

Starts

2022-04-13

Expected to finish

2025-01-28

Last updated by the study team

2025-09-26

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• Children's Hospital Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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