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SURPASS-PEDS

  • Research type

    Research Study

  • Full title

    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide inPediatric and Adolescent Participants with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin, or Basal Insulin, or Both (SURPASS-PEDS)

  • IRAS ID

    1004999

  • Contact name

    Carly Anderson

  • Contact email

    anderson_carly@lilly.com

  • Sponsor organisation

    Eli Lilly and Company

  • Eudract number

    2021-003612-31

  • Clinicaltrials.gov Identifier

    NCT05260021

  • Research summary

    Patients with type 2 diabetes mellitus (T2DM) have above normal levels of glucose (sugar) in their blood. T2DM is primarily diagnosed in adults however, there has been a significant increase of T2DM in children and teens in recent years.
    There is an important need for additional safe and effective medicines approved to treat the children and teens with T2DM. Unlike adults, the children and teen population with the disease have fewer glucose-lowering treatment options that are regulatory approved.
    Tirzepatide acts on the pathways of a group of hormones in the intestines called “incretins”. Incretin hormones are released when food is eaten and help to reduce blood glucose levels. Treatment with Tirzepatide has been shown to markedly reduce blood glucose levels in adults.
    Tirzepatide is administered under the skin once weekly and is being investigated for its potential use in the treatment of T2DM.
    The purpose of this study is to learn more about the safety and efficacy of tirzepatide 5 mg and tirzepatide 10 mg once weekly, compared to placebo in children and teens with T2DM taking metformin, or basal insulin or both. The study will last about 60 weeks.
    There will be about 90 participants around the world taking part, including approximately 7 in UK.

  • REC name

    South Central - Hampshire A Research Ethics Committee

  • REC reference

    22/SC/0114

  • Date of REC Opinion

    10 Jun 2022

  • REC opinion

    Further Information Favourable Opinion