Novo and Lilly Win Again with Positive STEP HFpEF Full Results
Novo Nordisk announced positive full results from the Ph3 STEP HFpEF trial (view CT.gov record) demonstrating QW semaglutide 2.4mg led to reductions in HF-related symptoms, reductions in physical limitations, and improvements in exercise functions vs. placebo. The full results were presented at the ESC 2023 (August 25-28) conference in Amsterdam, Netherlands, and simultaneously published in the NEJM (view publication). Importantly, Novo stated it anticipates filing for the Wegovy label update in H1 2024 following the completion of STEP HFpEF-DM (view CT.gov record) in participants with HFpEF and obesity with T2DM in Q4 2023. Below, FENIX provides an overview of the STEP HFpEF results as well as thoughts on the impact to the HFpEF treatment paradigm, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.