A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF

Prior treatment

• 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.
• 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.
• 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.

Other illness

• Diabetes exclusions:
• History of type 1 diabetes.
• Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia.
• History of acute or chronic pancreatitis.
• History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.

Lab values

• HbA1c ≥10% at screening.
• On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening

Other

• BMI \<25 kg/m² at screening.
• Renal exclusions:
• Cardiovascular exclusions:
• GI exclusions:
• Endocrine exclusions:

• 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.