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

NCT06347159 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: EDG-7500-102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 21

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).

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in 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)

• Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax)

  From baseline through study completion (Part A: Up to 10 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)

Study Arms (4)

Part A: EDG-7500 Single Dose

EXPERIMENTAL

Drug: EDG-7500

Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy

EXPERIMENTAL

EDG-7500 once daily for up to 28 days.

Drug: EDG-7500

Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy

EXPERIMENTAL

EDG-7500 once daily for up to 28 days.

Drug: EDG-7500

Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy

EXPERIMENTAL

EDG-7500 daily for up to 18 months in new participants and participants who have completed Part B or C.

Drug: EDG-7500

Interventions

EDG-7500 DRUG

Liquid suspension formulation of EDG-7500

Part A: EDG-7500 Single Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or nonpregnant female, age ≥18 years to \<85 years.
• Body mass index (BMI) ≥18 to \<35 kg/m2; weight ≥50 kg at Screening (BMI ≥ 18 to \< 40 kg/m2 is permitted for participants \< 50 years).
• 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 (NT-proBNP ≥ 225 pg/mL is permitted for African American participants) (Part C and D nHCM only).

You may not qualify if:

• Invasive septal reduction therapy \< 180 days prior to or during Screening.
• Documented history of active or untreated obstructive coronary artery disease during Screening or treated for obstructive coronary artery disease \< 180 days prior to Screening.
• Documented history of myocardial infarction with residual wall motion abnormalities \< 180 days prior to or during Screening.
• Significant valvular heart disease (moderate or greater aortic stenosis or regurgitation, moderate or greater 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 \<180 days prior to or during Screening.
• A history of sustained ventricular tachyarrhythmia or sudden cardiac arrest \< 180 days prior or during Screening.
• A history of known appropriate implantable cardioverter defibrillator (ICD) discharge \<180 days prior to or during Screening or ICD implanted \< 14 days prior to Screening.
• History of permanent AF or atrial flutter. Documented AF or atrial flutter requiring rhythm restoring treatment \< 180 days prior to Screening Visit (participants with documented AF or atrial flutter requiring rhythm restoring treatment ≥ 180 days prior to Screening require adequate anticoagulation.)
• 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 at Screening (QTcF \< 530 ms is permitted for participants with documented bundle branch blockage (BBB) and/or cardiac pacing).
• Receiving a CMI (e.g., Camzyos® \[mavacamten\] or aficamten) \< 90 days prior to Screening.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (21)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University Hospital / Stanford Health Care

Stanford, California, 94305, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Michigan Medicine - Michigan Clinical Research Unit

Ann Arbor, Michigan, 48109, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Morristown Medical Center (Atlantic Health System)

Morristown, New Jersey, 07960, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)

New York, New York, 10016, United States

Location

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

Duke Health Center Arringdon

Morrisville, North Carolina, 27560, United States

Location

The Lindner Research Center at Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 33612, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Virginia Heart and Vascular Center Fontaine

Charlottesville, Virginia, 22903, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Medical Director

  Edgewise Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 4, 2024
• Study Start: April 11, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)