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.
• 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 ≥30 mmHg measured at rest and ≥50 mmHg post-Valsalva as determined by echocardiography at Screening (Part A and B only).
• LVOT peak gradient < 30 mmHg measured at rest and < 50 mmHg measured during the Valsalva maneuver as determined by echocardiography as assessed by the Investigator at Screening (Part C only).
• Maximal exercise peak LVOT gradient < 50 mmHg as determined by echocardiography as assessed by the Investigator (historical documentation < 12 months prior to dosing or confirmed at Screening) (Part C only).
• Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
• New York Heart Association (NYHA) Classification I-III at Screening.

• Invasive septal reduction <180 days prior to Screening.
• Documented current or history of obstructive coronary artery disease at any time or myocardial infarction <180 days prior to Screening.
• Known Stage B or higher aortic valve stenosis or regurgitation
• Documented current or history of cardiac amyloidosis (age ≥ 60 years requires exclusion of cardiac amyloidosis by radionuclide scan or MRI performed at Screening or historical scan < 3 years prior to Screening).
• A history of syncope or sustained ventricular tachyarrhythmia <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
• Atrial fibrillation (AF) at Screening; a current diagnosis of permanent AF; paroxysmal or persistent AF <90 days of Screening, or electrical cardioversion or ablation for AF <90 days of Screening.
• Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator to pose a risk to participant safety.
• Current or prior use of any cardiac myosin inhibitors
• A history of diabetes with a hemoglobin A1C ≥ 7.0% at the Screening Visit (Part C only)