EDG-7500: Liquid suspension formulation of EDG-7500
EDG-7500: Solid oral formulation of EDG-7500
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key 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).
Key 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.
Primary outcome measure(s)
Incidence of treatment-emergent adverse events — From screening through study completion (Part A: Up to 38 days; Part B and C: Up to 73 days; Part D: Up to 18 months)
Trial sites (21)
Facility
City
Region
Status
University of California, San Francisco
San Francisco
California
Stanford University Hospital / Stanford Health Care
Stanford
California
Emory Clinic
Atlanta
Georgia
Massachusetts General Hospital
Boston
Massachusetts
Brigham and Womens Hospital
Boston
Massachusetts
Lahey Hospital and Medical Center
Burlington
Massachusetts
Michigan Medicine - Michigan Clinical Research Unit
Ann Arbor
Michigan
Saint Luke's Hospital of Kansas City
Kansas City
Missouri
Morristown Medical Center (Atlantic Health System)
Morristown
New Jersey
North Shore University Hospital
Manhasset
New York
NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)
New York
New York
Sanger Heart and Vascular Institute
Charlotte
North Carolina
Duke Health Center Arringdon
Morrisville
North Carolina
The Lindner Research Center at Christ Hospital
Cincinnati
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Ohio
Cleveland Clinic
Cleveland
Ohio
Oregon Health & Science University (OHSU)
Portland
Oregon
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia
Pennsylvania
Medical University of South Carolina
Charleston
South Carolina
University of Virginia Heart and Vascular Center Fontaine
Charlottesville
Virginia
Virginia Mason Medical Center
Seattle
Washington
More Edgewise Therapeutics, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.