An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of EDG-7500 in Adults With Obstructive Hypertrophic Cardiomyopathy

EDG-7500-102

This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 either as a single or multiple dose in adult patients with obstructive hypertrophic cardiomyopathy.

2024-04-11

2025-03-01

2025-03-01

Recruiting

Early phase I

30

Key Inclusion Criteria: * Male or nonpregnant female, age ≥18 years. * Body mass index (BMI) ≥18 to \<35 kg/m2; weight ≥50 kg at Screening. * Diagnosed with HCM 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. * Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening. * New York Heart Association (NYHA) Classification I-III at Screening. Key Exclusion Criteria: * 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 * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-05-08