A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)

Condition studied

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.

Investigational medicinal product(s)

Eligibility

Primary endpoint

Time to first occurrence of any component of the composite of cardiovascular (CV) death, hospitalization for heart failure (HHF), or urgent heart failure (HF) visit.

Endpoint detail

1. Total number of HF events (first and recurrent; HHF and urgent HF visit)., 2. Change from baseline to Week 52 in a prespecified heart failure patient‑reported outcome total score among participants with baseline value below a prespecified threshold., 3. Time to first occurrence of composite of all cause death, HHF, myocardial infarction (MI), or stroke (4point MACE).