Active, not recruiting
Phase 2
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
Condition(s) studied
Hypertrophic Cardiomyopathy
Investigational drug(s) / intervention(s)
EDG-7500EDG-7500
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
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 |
|
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