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

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of EDG-7500 in Adults With Obstructive Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06347159
• Other study ID #: EDG-7500-102
• Status: Recruiting
• Phase: Phase 2
• Start date: April 11, 2024
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Edgewise Therapeutics, Inc.
• Contact: Edgewise Therapeutics
• Phone: 720-262-7002
• Email: cardiacstudies[@]edgewisetx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Drug:
• EDG-7500
Liquid suspension formulation of EDG-7500
• EDG-7500
Solid oral formulation of EDG-7500

Locations

Country	Name	City	State
United States	The Lindner Research Center at Christ Hospital	Cincinnati	Ohio
United States	Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Edgewise Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events		From screening through study completion (Part A: Up to 38 days; Part B: Up to 66 days)
Secondary	Change from baseline in left ventricular outflow tract (LVOT) gradient	Resting and post-Valsalva LVOT gradient by doppler echocardiography	From baseline through study completion (Part A: Up to 10 days; Part B: Up to 38 days)
Secondary	Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax)		Part A: Up to 10 days; Part B: Up to 38 days