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New heart drug EDG-7500 enters Mid-Stage trial for thick heart muscle

NCT ID NCT06347159

Disease control Sponsor: Edgewise Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a new drug called EDG-7500 in 100 adults with hypertrophic cardiomyopathy, a condition where the heart muscle is abnormally thick. The goal is to check the drug's safety and how it affects heart function. Participants receive single or multiple doses, and researchers measure side effects, drug levels, and changes in heart pressure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EDG-7500 (a drug taken as a liquid or pill)
What this could lead to
If it works, this could point toward a new treatment option for hypertrophic cardiomyopathy, potentially easing symptoms and improving heart function.
What could go wrong
This is an early Phase 2 study with only 100 participants, so results may not apply to everyone. The drug could cause side effects or fail to show meaningful benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 79 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hypertrophic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertrophic cardiomyopathy

Contacts and locations

Locations

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke Health Center Arringdon

    Morrisville, North Carolina, 27560, United States

  • Emory Clinic

    Atlanta, Georgia, 30322, United States

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

    Philadelphia, Pennsylvania, 19104, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Michigan Medicine - Michigan Clinical Research Unit

    Ann Arbor, Michigan, 48109, United States

  • Morristown Medical Center (Atlantic Health System)

    Morristown, New Jersey, 07960, United States

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

    New York, New York, 10016, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28204, United States

  • Stanford University Hospital / Stanford Health Care

    Stanford, California, 94305, United States

  • The Lindner Research Center at Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 33612, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Virginia Heart and Vascular Center Fontaine

    Charlottesville, Virginia, 22903, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

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