This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.
Left ventricular ejection fraction (LVEF) of > 40% within 12 months prior to screening.
Structural heart disease evidence.
HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening.
BMI <25 kg/m² at screening.
History of type 1 diabetes.
HbA1c ≥10% at screening.
Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema.
Parallel
Elecoglipron
DrugElecoglipron tablet
Placebo
DrugPlacebo tablet
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit
Time to first event of the composite of: * CV death * HHF * Urgent HF visit
To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)
Total occurrences (first and recurrent) of: * HF events * HHF * Urgent HF visit
To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.
Change from baseline to Week 52
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke
Time to first event of the composite of: * All-cause death * HHF * MI * Stroke
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