A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)

Last updated: February 26, 2026
Sponsor: Edgewise Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Cardiomyopathy

Cardiac Disease

Heart Disease

Treatment

EDG-7500

Clinical Study ID

NCT06347159
EDG-7500-102
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 < 40kg/m2 is permitted for participants < 50 years).

  • Diagnosed with hypertrophic cardiomyopathy at the time of Screening consistent withcurrent American College of Cardiology Foundation/American Heart AssociationGuidelines.

  • LVOT peak gradient ≥ 50 mmHg measured at rest or during the Valsalva maneuver asdetermined by echocardiography at Screening (Part A, B and D oHCM only).

  • LVOT peak gradient < 30 mmHg measured at rest and < 50 mmHg measured during theValsalva maneuver as determined by echocardiography at Screening (Part C and D nHCMonly).

  • 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 atScreening.

  • NT-proBNP ≥ 300 pg/mL (NT-proBNP ≥ 225 pg/mL is permitted for African Americanparticipants) (Part C and D nHCM only).

Exclusion

Key Exclusion Criteria:

  • Invasive septal reduction therapy < 180 days prior to or during Screening.

  • Documented history of active or untreated obstructive coronary artery disease duringScreening or treated for obstructive coronary artery disease < 180 days prior toScreening.

  • 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 orregurgitation, moderate or greater mitral stenosis or regurgitation not due tosystolic anterior motion of the mitral valve)

  • History of LV systolic dysfunction (LVEF < 0.45) or stress cardiomyopathy at anytime.

  • Known or suspected infiltrative or storage disorder causing cardiac hypertrophy thatmay mimic HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LVhypertrophy.

  • A history of unexplained syncope <180 days prior to or during Screening.

  • A history of sustained ventricular tachyarrhythmia or sudden cardiac arrest < 180days 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 toScreening.

  • History of permanent AF or atrial flutter. Documented AF or atrial flutter requiringrhythm restoring treatment < 180 days prior to Screening Visit (participants withdocumented AF or atrial flutter requiring rhythm restoring treatment ≥ 180 daysprior to Screening require adequate anticoagulation.)

  • Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormalityconsidered by the Investigator or Medical Monitor to pose a risk to participantsafety at Screening (QTcF < 530 ms is permitted for participants with documentedbundle branch blockage (BBB) and/or cardiac pacing).

  • Receiving a CMI (e.g., Camzyos® [mavacamten] or aficamten) < 90 days prior toScreening.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: EDG-7500
Phase: 2
Study Start date:
April 11, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Stanford University Hospital / Stanford Health Care

    Stanford, California 94305
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • Stanford University Hospital / Stanford Health Care

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • James A. Haley Veterans' Hospital

    Tampa, Florida 33612
    United States

    Site Not Available

  • James A. Haley Veterans' Hospital

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Emory Clinic

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Lahey Hospital and Medical Center

    Burlington 4931737, Massachusetts 6254926 01805
    United States

    Site Not Available

  • Michigan Medicine - Michigan Clinical Research Unit

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Site Not Available

  • Morristown Medical Center (Atlantic Health System)

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Morristown Medical Center (Atlantic Health System)

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • NYU Langone Health Medical Center - HCM Program Office

    New York, New York 10016
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset 5125766, New York 5128638 11030
    United States

    Site Not Available

  • NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Sanger Heart and Vascular Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Sanger Heart and Vascular Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Duke Health Center Arringdon

    Morrisville 4480285, North Carolina 4482348 27560
    United States

    Site Not Available

  • The Lindner Research Center at Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Lindner Research Center at Christ Hospital

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 33612
    United States

    Site Not Available

  • Oregon Health & Science University (OHSU)

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science University (OHSU)

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • University of Virginia Heart and Vascular Center Fontaine

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • University of Virginia Heart and Vascular Center Fontaine

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle 5809844, Washington 5815135 98101
    United States

    Site Not Available

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