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Active, not recruitingNCT06347159Updated Jul 31, 2026

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

A Phase 2 interventional study of EDG-7500 and EDG-7500 in Hypertrophic Cardiomyopathy, sponsored by Edgewise Therapeutics, Inc.. Active, not recruiting at 21 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Edgewise Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
79
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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).

02

Conditions studied

  • Hypertrophic Cardiomyopathy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
79 participants (estimated)

Study arms

  • Experimental
    Part A: EDG-7500 Single Dose

    Drug: EDG-7500

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

    EDG-7500 once daily for up to 28 days.

    Drug: EDG-7500

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

    EDG-7500 once daily for up to 28 days.

    Drug: EDG-7500

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

    EDG-7500 daily for up to 24 months in new participants and participants who have completed Part B or C.

    Drug: EDG-7500

Interventions

  • DrugEDG-7500

    Liquid suspension formulation of EDG-7500

  • DrugEDG-7500

    Solid oral formulation of EDG-7500

05

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: 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

  1. Change from baseline in left ventricular outflow tract (LVOT) gradient

    Resting and post-Valsalva LVOT gradient by echocardiography

    Time frame: From baseline through study completion (Part A: Up to 10 days; Part B: Up to 38 days; Part D: Up to 18 months)

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

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

  3. Change from baseline in cardiac biomarkers

    Time frame: From baseline through study completion (Part B and C: Up to 38 days; Part D: Up to 18 months)

06

Study locations

21 sites
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • Stanford University Hospital / Stanford Health Care
    Stanford, California 94305, United States
  • Emory Clinic
    Atlanta, Georgia 30322, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Brigham and Womens Hospital
    Boston, Massachusetts 02115, United States
  • Lahey Hospital and Medical Center
    Burlington, Massachusetts 01805, United States
  • Michigan Medicine - Michigan Clinical Research Unit
    Ann Arbor, Michigan 48109, United States
  • Saint Luke's Hospital of Kansas City
    Kansas City, Missouri 64111, United States
  • Morristown Medical Center (Atlantic Health System)
    Morristown, New Jersey 07960, United States
  • North Shore University Hospital
    Manhasset, New York 11030, United States
  • NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)
    New York, New York 10016, United States
  • Sanger Heart and Vascular Institute
    Charlotte, North Carolina 28204, United States
  • Duke Health Center Arringdon
    Morrisville, North Carolina 27560, United States
  • The Lindner Research Center at Christ Hospital
    Cincinnati, Ohio 45219, United States
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 33612, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Oregon Health & Science University (OHSU)
    Portland, Oregon 97239, United States
  • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
    Philadelphia, Pennsylvania 19104, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • University of Virginia Heart and Vascular Center Fontaine
    Charlottesville, Virginia 22903, United States
  • Virginia Mason Medical Center
    Seattle, Washington 98101, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06347159
Lead sponsor
Edgewise Therapeutics, Inc.
Responsible party
Sponsor
First posted
Apr 4, 2024
Start date
Apr 11, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 31, 2026

Study contacts

Medical Director
study director · Edgewise Therapeutics, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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