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

Description

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).

Conditions

Hypertrophic Cardiomyopathy

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Study Overview

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Study Details

Study overview

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).

An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults with Hypertrophic Cardiomyopathy

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

Condition
Hypertrophic Cardiomyopathy
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Stanford

Stanford University Hospital / Stanford Health Care, Stanford, California, United States, 94305

Tampa

James A. Haley Veterans' Hospital, Tampa, Florida, United States, 33612

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Brigham and Womens Hospital, Boston, Massachusetts, United States, 02115

Burlington

Lahey Hospital and Medical Center, Burlington, Massachusetts, United States, 01805

Manhasset

North Shore University Hospital, Manhasset, New York, United States, 11030

New York

NYU Langone Health Medical Center - HCM Program Office, New York, New York, United States, 10016

Cincinnati

The Lindner Research Center at Christ Hospital, Cincinnati, Ohio, United States, 45219

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 with current American College of Cardiology Foundation/American Heart Association Guidelines
  • * LVOT peak gradient ≥30 mmHg measured at rest and ≥50 mmHg post-Valsalva 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 as assessed by the Investigator at Screening (Part C and D nHCM only).
  • * Maximal exercise peak LVOT gradient \< 50 mmHg as determined by echocardiography as assessed by the Investigator (historical documentation \< 12 months prior to dosing or 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.
  • * Invasive septal reduction \<180 days prior to Screening.
  • * Documented current or history of obstructive coronary artery disease at any time or myocardial 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 requires exclusion of cardiac amyloidosis by radionuclide scan or MRI performed at Screening or historical scan \<3 years prior to Screening).
  • * A history of syncope or sustained ventricular tachyarrhythmia \<180 days prior to Screening.
  • * A history of sudden cardiac arrest at any time or known appropriate implantable cardioverter 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 or ablation for AF \<90 days of Screening.
  • * Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator to pose a risk to participant safety.
  • * Current or prior use of any cardiac myosin inhibitors
  • * A history of diabetes with a hemoglobin A1C ≥ 7.5% at the Screening Visit (Part C and D nHCM only)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Edgewise Therapeutics, Inc.,

Medical Director, STUDY_DIRECTOR, Edgewise Therapeutics, Inc.

Study Record Dates

2026-03