A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF)

A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction

This is a Phase 2 placebo-controlled study to evaluate the safety and tolerability of different doses of EDG-15400 in adults with heart failure with preserved ejection fraction (HFpEF).

Inclusion Criteria:

• Males and nonpregnant females, ages ≥30 to <85 years of age at screening
• Body weight ≥ 45 kg, BMI < 40
• LVEF ≥ 50%
• Diagnosed with Heart Failure per American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Failure Society of America (HFSA) Guidelines for the Management of Heart Failure
• New York Heart Association (NYHA) functional class II or III
• If receiving Guideline-directed Medical Therapy, must be on stable doses
• Participants receiving a GLP-1 agonist prior to Screening must have no anticipated plans to change dose during the study

Exclusion Criteria:

• Known diagnosis of hypertrophic cardiomyopathy (HCM)
• Known or suspected infiltrative or storage disorder (e.g., Noonan syndrome, Fabry disease, amyloidosis)
• Moderate or greater interstitial lung disease (ILD) or ILD requiring chronic supplemental O2 therapy
• Severe or greater chronic obstructive pulmonary disease (COPD) or COPD requiring chronic supplementary O2 therapy
• Hospitalization for any reason within 60 days prior to Screening
• History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Investigator or the Medical Monitor, would be an alternative explanation for heart failure symptoms (e.g., significant lung disease, anemia) and/or would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion