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

Last updated: December 18, 2024
Sponsor: Edgewise Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Cardiomyopathy

Congestive Heart Failure

Circulation Disorders

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.

  • Body mass index (BMI) ≥18 to <38 kg/m2; weight ≥50 kg at Screening.

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

  • LVOT peak gradient ≥30 mmHg measured at rest and ≥50 mmHg post-Valsalva 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 as assessed by the Investigatorat Screening (Part C and D nHCM only).

  • Maximal exercise peak LVOT gradient < 50 mmHg as determined by echocardiography asassessed by the Investigator (historical documentation < 12 months prior to dosingor confirmed at Screening) (Part C and D nHCM only).

  • Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.

  • New York Heart Association (NYHA) Classification I-III at Screening.

Exclusion

Key Exclusion Criteria:

  • Invasive septal reduction <180 days prior to Screening.

  • Documented current or history of obstructive coronary artery disease at any time ormyocardial infarction <180 days prior to Screening.

  • Known Stage B or higher aortic valve stenosis or regurgitation

  • Documented current or history of cardiac amyloidosis (age ≥ 60 years requiresexclusion of cardiac amyloidosis by radionuclide scan or MRI performed at Screeningor historical scan <3 years prior to Screening).

  • A history of syncope or sustained ventricular tachyarrhythmia <180 days prior toScreening.

  • A history of sudden cardiac arrest at any time or known appropriate implantablecardioverter defibrillator (ICD) discharge <180 days prior to Screening

  • Atrial fibrillation (AF) at Screening; a current diagnosis of permanent AF;paroxysmal or persistent AF <90 days of Screening, or electrical cardioversion orablation for AF <90 days of Screening.

  • Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormalityconsidered by the Investigator to pose a risk to participant safety.

  • Current or prior use of any cardiac myosin inhibitors ≥ 7.5% at the Screening Visit (Part Cand D nHCM only)

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: EDG-7500
Phase: 2
Study Start date:
April 11, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Stanford University Hospital / Stanford Health Care

    Stanford, California 94305
    United States

    Active - Recruiting

  • James A. Haley Veterans' Hospital

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts 01805
    United States

    Active - Recruiting

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • NYU Langone Health Medical Center - HCM Program Office

    New York, New York 10016
    United States

    Active - Recruiting

  • The Lindner Research Center at Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Oregon Health & Science University (OHSU)

    Portland, Oregon 97239
    United States

    Active - Recruiting

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

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Active - Recruiting

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