A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)

Phase 2

Recruiting

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Drug: EDG-7500

• Registration Number: NCT06347159
• Lead Sponsor: Edgewise Therapeutics, Inc.

Brief Summary

This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy (nHCM).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-04
• Study Start: 2024-04-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Male or nonpregnant female, age ≥18 years to <85 years.
• Body mass index (BMI) ≥18 to <35 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 ≥50 mmHg measured at rest or during the Valsalva maneuver 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 at Screening (Part C and D nHCM only).
• Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
• New York Heart Association (NYHA) Classification II-III at Screening.
• Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) < 85 at Screening.
• NT-proBNP ≥ 300 pg/mL (Part C and D nHCM only).

Key

Exclusion Criteria

• Invasive septal reduction any time prior to Screening.
• Documented current or history of obstructive coronary artery disease at any time or myocardial infarction any time prior to Screening.
• Significant valvular hear disease (moderate-severe aortic stenosis or regurgitation, moderate-severe mitral stenosis or regurgitation not due to systolic anterior motion of the mitral valve)
• History of LV systolic dysfunction (LVEF < 0.45) or stress cardiomyopathy at any time.
• Known or suspected infiltrative or storage disorder causing cardiac hypertrophy that may mimic HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
• A history of unexplained syncope or sustained ventricular tachyarrhythmia or supraventricular tachycardia <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
• History of permanent AF or atrial flutter. Any episode of documented AF or atrial flutter < 180 days prior to Screening Visit (participants with documented AF or atrial flutter ≥ 180 days prior to Screening require adequate anticoagulation and rate control.)
• Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator or Medical Monitor to pose a risk to participant safety.
• Current or prior use of a cardiac myosin inhibitor <90 days prior to Screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy	EDG-7500	EDG-7500 daily for up to 18 months in new participants and participants who have completed Part B or C.
Part A: EDG-7500 Single Dose	EDG-7500	-
Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy	EDG-7500	EDG-7500 once daily for up to 28 days.
Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy	EDG-7500	EDG-7500 once daily for up to 28 days.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	From screening through study completion (Part A: Up to 38 days; Part B and C: Up to 73 days; Part D: Up to 18 months)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in peak left ventricular outflow tract (LVOT) gradient	From baseline through study completion (Part A: Up to 10 days; Part B: Up to 38 days; Part D: Up to 18 months)	Resting and post-Valsalva LVOT gradient by echocardiography
Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax)	From baseline through study completion (Part A: Up to 10 days; Part B and C: Up to 38 days)
Change from baseline in cardiac biomarkers	From baseline through study completion (Part B and C: Up to 38 days; Part D: Up to 18 months)

Trial Locations

Locations (18)

Saint Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

Sanger Heart and Vascular Institute; 🇺🇸 Charlotte, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Virginia Heart and Vascular Center Fontaine; 🇺🇸 Charlottesville, Virginia, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Stanford University Hospital / Stanford Health Care; 🇺🇸 Stanford, California, United States

James A. Haley Veterans' Hospital; 🇺🇸 Tampa, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States

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