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.

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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 is 1 Location for this study

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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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