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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

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 (BMI ≥ 18 to < 40 kg/m2 is permitted for participants < 50 years). - 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 (NT-proBNP ≥ 225 pg/mL is permitted for African American participants) (Part C and D nHCM only).

Exclusion Criteria

  • Invasive septal reduction therapy < 180 days prior to or during Screening. - Documented history of active or untreated obstructive coronary artery disease during Screening or treated for obstructive coronary artery disease < 180 days prior to Screening. - Documented history of myocardial infarction with residual wall motion abnormalities < 180 days prior to or during Screening. - Significant valvular heart disease (moderate or greater aortic stenosis or regurgitation, moderate or greater 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 <180 days prior to or during Screening. - A history of sustained ventricular tachyarrhythmia or sudden cardiac arrest < 180 days prior or during Screening. - A history of known appropriate implantable cardioverter defibrillator (ICD) discharge <180 days prior to or during Screening or ICD implanted < 14 days prior to Screening. - History of permanent AF or atrial flutter. Documented AF or atrial flutter requiring rhythm restoring treatment < 180 days prior to Screening Visit (participants with documented AF or atrial flutter requiring rhythm restoring treatment ≥ 180 days prior to Screening require adequate anticoagulation.) - 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 at Screening (QTcF < 530 ms is permitted for participants with documented bundle branch blockage (BBB) and/or cardiac pacing). - Receiving a CMI (e.g., Camzyos® [mavacamten] or aficamten) < 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

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
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.
  • Drug: EDG-7500
    Solid oral formulation of EDG-7500

More Details

Status
Active, not recruiting
Sponsor
Edgewise Therapeutics, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.