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 and as multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy.

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 <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.

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 ≥ 7.0% at the Screening Visit (Part C 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

ArmDescriptionAssigned Intervention
Experimental
Part A: EDG-7500 Single Dose
  • Drug: EDG-7500
    Liquid suspension formulation of EDG-7500
Experimental
Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy 		EDG-7500 once daily for up to 28 days.
  • Drug: EDG-7500
    Solid oral formulation of EDG-7500
Experimental
Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy 		EDG-7500 once daily for up to 28 days.
  • Drug: EDG-7500
    Solid oral formulation of EDG-7500

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Edgewise Therapeutics, Inc.

More Details

Status
Recruiting
Sponsor
Edgewise Therapeutics, Inc.

Study Contact

Edgewise Therapeutics, Inc.
720-262-7002
cardiacstudies@edgewisetx.com