Testing EDG-7500 for adults with hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Edgewise Therapeutics, Inc.
• Email: cardiacstudies@edgewisetx.com
• Phone: 720-262-7002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.