Completed Enrollment

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)

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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.

Trial Summary

Age Range
10 - 18 years
Conditions the trial is for
Type 2 Diabetes
What the trial is testing?
Tirzepatide
Could I receive a Placebo?
Yes
Enrollment Goal
99
Trial Dates
Apr 13, 2022 - Feb 2025
How long will I be in the trial?
Your participation could last about 60 weeks and may include up to 20 visits (6 phone visits and up to 14 clinic visits)
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have type 2 diabetes treated with metformin and/or long-acting insulin

  • Participants must have glycated hemoglobin (HbA1c) greater than 6.5% to no more than 11% at screening visit

  • Participants must be overweight or obese

Participants Must Not:

  • Participants must not have type 1 diabetes mellitus (T1DM)

  • Participants must not have history of inflammation of the pancreas

  • Participants must not be pregnant or breastfeeding

  • Participants must not have had one or more events of very low blood sugar in the past 6 months

  • Participants must not be taking prescription or over the counter weight loss medication

  • Participants must not have a personal or family history of certain neck cancer

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Clinical Trial Resources

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Clinical Trial Participation: What to Expect

A clinical trial is a scientific study. It helps us learn if a new medicine or treatment works and how it works. Clinical trials can also be called clinical research studies. Learn more about clinical research studies and what to expect when taking part in a clinical trial.