• Revisiting Seamless 2/3 Trial for GLP-1 Agonist

  • Apr 28 2025
  • Duración: 43 m
  • Podcast

Revisiting Seamless 2/3 Trial for GLP-1 Agonist

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  • Resumen

  • In this episode of "In the Interim..." we revisit the ground-breaking seamless phase 2/3 clinical trial for the GLP-1 agonist, dulaglutide—better known as Trulicity. We discuss the intricacies of the adaptive trial design, and the unique features that helped expedite development by 12-18 months. Listeners will gain insight into how Bayesian algorithms and innovative statistical methods were pivotal in navigating a complex trial design, benefiting Eli Lilly's pipeline and changing the landscape of diabetes treatment.

    Key Highlights:

    • Outline of the trial design and the barriers faced during its inception in 2007-2008.
    • Explanation of the Clinical Utility Index and its role in adaptive randomization.
    • The DSMB's role and interaction with Bayesian decision-making models.
    • Simulation-based design to optimize development efficiencies.
    • Insights into the predictive power of the trial on weight loss outcomes in subsequent trials.


    Quotes:

    • "The trial was run entirely by Bayesian algorithms." – Scott Berry
    • "They believed this utility function was absolutely the right way to go forward." – Scott Berry
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