A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
NCT ID: NCT06347159
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2024-04-11
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: EDG-7500 Single Dose
EDG-7500
Liquid suspension formulation of EDG-7500
Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy
EDG-7500 once daily for up to 28 days.
EDG-7500
Solid oral formulation of EDG-7500
Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy
EDG-7500 once daily for up to 28 days.
EDG-7500
Solid oral formulation of EDG-7500
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.
EDG-7500
Solid oral formulation of EDG-7500
Interventions
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EDG-7500
Liquid suspension formulation of EDG-7500
EDG-7500
Solid oral formulation of EDG-7500
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Edgewise Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Edgewise Therapeutics, Inc.
Locations
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University of California, San Francisco
San Francisco, California, United States
Stanford University Hospital / Stanford Health Care
Stanford, California, United States
James A. Haley Veterans' Hospital
Tampa, Florida, United States
Emory Clinic
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Michigan Medicine - Michigan Clinical Research Unit
Ann Arbor, Michigan, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Morristown Medical Center (Atlantic Health System)
Morristown, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)
New York, New York, United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States
Duke Health Center Arringdon
Morrisville, North Carolina, United States
The Lindner Research Center at Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Virginia Heart and Vascular Center Fontaine
Charlottesville, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Ashley Pham
Role: primary
Isabella Voutos
Role: primary
Shamim Hasnain
Role: primary
Albree Tower-Rader, MD
Role: primary
Alyx Vogle
Role: primary
Ethan Rowin, MD
Role: primary
Sara Wooley
Role: primary
Jaycie Halderman
Role: primary
Cassie Mojica-Brid, RN
Role: primary
Ronald Wharton, MD
Role: primary
Peter Tricarico
Role: backup
Isabel Castro Alvarez, MPH
Role: primary
Melissa Lang, BSN
Role: primary
Joshua Stablein
Role: primary
Kasey Wright, RN
Role: primary
Meghan Khebouz
Role: primary
Hailey Volk
Role: primary
Madeleine Carens
Role: primary
Virginia Theodorof
Role: primary
Caroline Flournoy, PhD, CCRP
Role: primary
Amelia Johnson
Role: primary
Other Identifiers
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EDG-7500-102
Identifier Type: -
Identifier Source: org_study_id
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