A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
- Registration Number
- NCT06347159
- Lead Sponsor
- Edgewise Therapeutics, Inc.
- Brief Summary
This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy (nHCM).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- Male or nonpregnant female, age ≥18 years.
- Body mass index (BMI) ≥18 to <38 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, 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 as assessed by the Investigator at Screening (Part C and D nHCM 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 and D nHCM only).
- Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
- New York Heart Association (NYHA) Classification I-III at Screening.
Key
- 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 ≥ 7.5% at the Screening Visit (Part C and D nHCM only)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: EDG-7500 Single Dose EDG-7500 - Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy EDG-7500 EDG-7500 once daily for up to 28 days. Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy EDG-7500 EDG-7500 once daily for up to 28 days. Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy EDG-7500 EDG-7500 daily for up to 48 weeks in participants who have completed Part B or C.
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events From screening through study completion (Part A: Up to 38 days; Part B and C: Up to 66 days; Part D: Up to 53 weeks)
- Secondary Outcome Measures
Name Time Method Change from baseline in left ventricular outflow tract (LVOT) gradient From baseline through study completion (Part A: Up to 10 days; Part B: Up to 38 days; Part D: Up to 49 weeks) Resting and post-Valsalva LVOT gradient by doppler echocardiography
Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax) From baseline through study completion (Part A: Up to 10 days; Part B and C: Up to 38 days) Change from baseline in cardiac biomarkers From baseline through study completion (Part B and C: Up to 38 days; Part D: Up to 49 weeks)
Trial Locations
- Locations (14)
Morristown Medical Center (Atlantic Health System)
🇺🇸Morristown, New Jersey, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Stanford University Hospital / Stanford Health Care
🇺🇸Stanford, California, United States
James A. Haley Veterans' Hospital
🇺🇸Tampa, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Womens Hospital
🇺🇸Boston, Massachusetts, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
NYU Langone Health Medical Center - HCM Program Office
🇺🇸New York, New York, United States
The Lindner Research Center at Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Oregon Health & Science University (OHSU)
🇺🇸Portland, Oregon, United States
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States