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 (SURPASS-PEDS)

  • End date
    Dec 31, 2027
  • participants needed
  • sponsor
    Eli Lilly and Company
Updated on 14 September 2022
type 2 diabetes mellitus
hemoglobin a1c


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.

Condition Type2 Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 2, T2D, T2DM (Type 2 Diabetes Mellitus), Glucose Metabolism Disorders, Endocrine System Diseases, Metabolic Disease
Treatment Placebo, Tirzepatide Dose 1, Tirzepatide Dose 2
Clinical Study IdentifierNCT05260021
SponsorEli Lilly and Company
Last Modified on14 September 2022


Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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