New Survodutide Formulation Tested for Bioavailability in Healthy Adults

Survodutide (BI 456906) is a promising investigational drug being developed to treat obesity and various liver conditions. As new drug formulations are developed, it's critical to understand how they are absorbed and utilized by the body to ensure optimal efficacy and safety. This Phase 1 study specifically addresses how a new formulation of survodutide (B2) is taken up by the body compared to a reference formulation (A).

As this is an active, not-yet-recruiting Phase 1 study (NCT07221591), specific results regarding the relative bioavailability of the two survodutide formulations are not yet available. The primary objective is to assess the relative bioavailability of survodutide formulation B2 compared to survodutide formulation A following repeated subcutaneous administration over 28 weeks. This will involve comprehensive measurement of pharmacokinetic parameters such as maximum concentration (Cmax), area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-t), and AUC extrapolated to infinity (AUC0-inf). > The core finding, once available, will quantitatively compare the systemic exposure of survodutide from formulation B2 against formulation A, aiming to determine if formulation B2 achieves comparable or superior absorption, potentially within a predefined bioequivalence margin (e.g., 80-125%). Secondary objectives include evaluating the safety and tolerability of both formulations, monitoring adverse events, and assessing immunogenicity (the body's immune response to the drug) over the 28-week treatment period in 100 participants.