A study to investigate CV outcomes with elecoglipron compared with placebo in adult participants with HFpEF or HFmrEF - Elevate-HF

Inclusion Criteria

• Inclusion Criteria:
• - 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.
• Exclusion Criteria:
• - BMI <25 kg/m² at screening. 
• - Diabetes exclusions: 
• - History of type 1 diabetes. 
• - HbA1c ≥10% at screening. 
• - Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema. 
• - more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition. 
• - Renal exclusions: 
• - On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening 
• - Cardiovascular exclusions: 
• - Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization. 
• - Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia. 
• - GI exclusions: 
• - Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery. 
• - History of acute or chronic pancreatitis. 
• - Endocrine exclusions: 
• - History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.