10: Revisiting Seamless 2/3 Trial for GLP-1 Agonist

Scott Berry, Ph.D.

President & Senior Statistical Scientist

Don Berry, Ph.D.

Founder & Senior Statistical Scientist

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.

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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