Testing EDG-7500 for adults with hypertrophic cardiomyopathy

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

This study is testing a new medication called EDG-7500 to see if it can improve heart function in adults with hypertrophic cardiomyopathy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Edgewise Therapeutics, Inc. (Industry-sponsored)
• Locations: 14 sites (San Francisco, California and 13 other locations)
• Trial ID: NCT06347159 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of EDG-7500 in adults diagnosed with hypertrophic cardiomyopathy, focusing on both obstructive and nonobstructive forms of the condition. Participants will receive either a single or multiple doses of the medication, with assessments made based on echocardiographic measurements of left ventricular outflow tract (LVOT) gradients. The study aims to determine the optimal dosing and its effects on heart function in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of hypertrophic cardiomyopathy and specific echocardiographic findings.

Not a fit: Patients with non-diagnosed hypertrophic cardiomyopathy or those with contraindications to the study medication may not benefit.

Why it matters

Potential benefit: If successful, this treatment could improve heart function and quality of life for patients with hypertrophic cardiomyopathy.

How similar studies have performed: Other studies have explored treatments for hypertrophic cardiomyopathy, but the specific approach of using EDG-7500 is novel.

Eligibility criteria

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 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.

Key Exclusion Criteria:

* 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)

Where this trial is running

San Francisco, California and 13 other locations

• University of California, San Francisco — San Francisco, California, United States (Recruiting)
• Stanford University Hospital / Stanford Health Care — Stanford, California, United States (Recruiting)
• James A. Haley Veterans' Hospital — Tampa, Florida, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Brigham and Womens Hospital — Boston, Massachusetts, United States (Recruiting)
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States (Recruiting)
• Morristown Medical Center (Atlantic Health System) — Morristown, New Jersey, United States (Recruiting)
• North Shore University Hospital — Manhasset, New York, United States (Recruiting)
• NYU Langone Health Medical Center - HCM Program Office — New York, New York, United States (Recruiting)
• The Lindner Research Center at Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States (Recruiting)
• Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine) — Philadelphia, Pennsylvania, United States (Recruiting)
• Virginia Mason Medical Center — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Edgewise Therapeutics, Inc.

Conditions Hypertrophic Cardiomyopathy