A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)

Open to people ages 18 years and up

• Male or nonpregnant female, age ≥18 years to <85 years.
• Body mass index (BMI) ≥18 to <35 kg/m2; weight ≥50 kg at Screening.
• Diagnosed with hypertrophic cardiomyopathy at the time of Screening consistent with current American College of Cardiology Foundation/American Heart Association Guidelines
• LVOT peak gradient ≥50 mmHg measured at rest or during the Valsalva maneuver as determined by echocardiography at Screening (Part A, B and D oHCM only).
• LVOT peak gradient < 30 mmHg measured at rest and < 50 mmHg measured during the Valsalva maneuver as determined by echocardiography at Screening (Part C and D nHCM only).
• Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
• New York Heart Association (NYHA) Classification II-III at Screening.
• Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) < 85 at Screening.
• NT-proBNP ≥ 300 pg/mL (Part C and D nHCM only).

• Invasive septal reduction any time prior to Screening.
• Documented current or history of obstructive coronary artery disease at any time or myocardial infarction any time prior to Screening.
• Significant valvular hear disease (moderate-severe aortic stenosis or regurgitation, moderate-severe mitral stenosis or regurgitation not due to systolic anterior motion of the mitral valve)
• History of LV systolic dysfunction (LVEF < 0.45) or stress cardiomyopathy at any time.
• Known or suspected infiltrative or storage disorder causing cardiac hypertrophy that may mimic HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
• A history of unexplained syncope or sustained ventricular tachyarrhythmia or supraventricular tachycardia <180 days prior to Screening.
• A history of sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator (ICD) discharge <180 days prior to Screening
• History of permanent AF or atrial flutter. Any episode of documented AF or atrial flutter < 180 days prior to Screening Visit (participants with documented AF or atrial flutter ≥ 180 days prior to Screening require adequate anticoagulation and rate control.)
• Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator or Medical Monitor to pose a risk to participant safety.
• Current or prior use of a cardiac myosin inhibitor <90 days prior to Screening.