Hypertrophic Cardiomyopathy Clinical Trial

A Study of EDG-7500 in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (CIRRUS-HCM)

Summary

This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 either as a single or multiple dose in adult patients with obstructive hypertrophic cardiomyopathy.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Male or nonpregnant female, age ≥18 years.
Body mass index (BMI) ≥18 to <35 kg/m2; weight ≥50 kg at Screening.
Diagnosed with HCM 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.
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
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

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT06347159

Recruitment Status:

Recruiting

Sponsor:

Edgewise Therapeutics, Inc.

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There are 2 Locations for this study

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The Lindner Research Center at Christ Hospital
Cincinnati Ohio, 45219, United States More Info
Edgewise Therapeutics, Inc.
Contact
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia Pennsylvania, 19104, United States More Info
Edgewise Therapeutics, Inc.
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How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT06347159

Recruitment Status:

Recruiting

Sponsor:


Edgewise Therapeutics, Inc.

How clear is this clinincal trial information?

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