A Study of EDG-7500 in Adults with Hypertrophic Cardiomyopathy (CIRRUS-HCM)
Purpose
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).
Condition
- Hypertrophic Cardiomyopathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
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 - 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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A: EDG-7500 Single Dose |
|
|
|
Experimental Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy |
EDG-7500 once daily for up to 28 days. |
|
|
Experimental Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy |
EDG-7500 once daily for up to 28 days. |
|
|
Experimental Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy |
EDG-7500 daily for up to 48 weeks in participants who have completed Part B or C. |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Contact:
Edgewise Therapeutics, Inc.
Edgewise Therapeutics, Inc.
More Details
- Status
- Recruiting
- Sponsor
- Edgewise Therapeutics, Inc.