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 Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
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 18 months in new participants and 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.