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Clinical Trials in the USA / NCT06347159
Active, not recruiting Phase 2

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

NCT06347159 · tracked via the Priya Life Science USA tracker
Sponsor
Edgewise Therapeutics, Inc.
Phase
Phase 2
Started
2024-04-11
Last updated
2026-07-31

Condition(s) studied

Hypertrophic Cardiomyopathy

Investigational drug(s) / intervention(s)

EDG-7500EDG-7500

EDG-7500: Liquid suspension formulation of EDG-7500

EDG-7500: Solid oral formulation of EDG-7500

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key 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 (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). Key Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
University of California, San Francisco San Francisco California
Stanford University Hospital / Stanford Health Care Stanford California
Emory Clinic Atlanta Georgia
Massachusetts General Hospital Boston Massachusetts
Brigham and Womens Hospital Boston Massachusetts
Lahey Hospital and Medical Center Burlington Massachusetts
Michigan Medicine - Michigan Clinical Research Unit Ann Arbor Michigan
Saint Luke's Hospital of Kansas City Kansas City Missouri
Morristown Medical Center (Atlantic Health System) Morristown New Jersey
North Shore University Hospital Manhasset New York
NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only) New York New York
Sanger Heart and Vascular Institute Charlotte North Carolina
Duke Health Center Arringdon Morrisville North Carolina
The Lindner Research Center at Christ Hospital Cincinnati Ohio
University Hospitals Cleveland Medical Center Cleveland Ohio
Cleveland Clinic Cleveland Ohio
Oregon Health & Science University (OHSU) Portland Oregon
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine) Philadelphia Pennsylvania
Medical University of South Carolina Charleston South Carolina
University of Virginia Heart and Vascular Center Fontaine Charlottesville Virginia
Virginia Mason Medical Center Seattle Washington

More Edgewise Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06347159 on ClinicalTrials.gov ↗ ← All trials in the USA