Hypertrophic CardiomyopathyPhase 2NCT06347159
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
A Phase 2 study testing EDG-7500 in people with Hypertrophic Cardiomyopathy, run by Edgewise Therapeutics, Inc. at 21 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- EDG-7500
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 21 sitesUnited States
- Study dates
- 11 Apr 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Michigan Medicine - Michigan Clinical Research Unit
Ann Arbor, Michigan, 48109
Emory Clinic
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Medical University of South Carolina
Charleston, South Carolina, 29425
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
University of Virginia Heart and Vascular Center Fontaine
Charlottesville, Virginia, 22903
The Lindner Research Center at Christ Hospital
Cincinnati, Ohio, 45219
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 33612
Cleveland Clinic
Cleveland, Ohio, 44195
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
North Shore University Hospital
Manhasset, New York, 11030
Morristown Medical Center (Atlantic Health System)
Morristown, New Jersey, 07960
Duke Health Center Arringdon
Morrisville, North Carolina, 27560
NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)
New York, New York, 10016
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
University of California, San Francisco
San Francisco, California, 94143
Virginia Mason Medical Center
Seattle, Washington, 98101
Stanford University Hospital / Stanford Health Care
Stanford, California, 94305
About this study
Official title: An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults With Hypertrophic Cardiomyopathy
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
- Being tested
- EDG-7500
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDG-7500Drug
Liquid suspension formulation of EDG-7500
EDG-7500Drug
Solid oral formulation of EDG-7500
| Study group | Role | What they receive |
|---|---|---|
| Part A: EDG-7500 Single Dose | Experimental | Not described Receives: 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. Receives: 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. Receives: Drug: EDG-7500 |
| Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy | Experimental | EDG-7500 daily for up to 24 months in new participants and participants who have completed Part B or C. Receives: Drug: EDG-7500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Measured: 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
Resting and post-Valsalva LVOT gradient by echocardiography
Measured: 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)
Measured: From baseline through study completion (Part A: Up to 10 days)
Change from baseline in cardiac biomarkers
Measured: From baseline through study completion (Part B and C: Up to 38 days; Part D: Up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start11 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edgewise Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Edgewise Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347159
- Sponsor's protocol ID
- EDG-7500-102
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06347159
- Acronym / sponsor ID
- EDG-7500-102
- Conditions
- Hypertrophic Cardiomyopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Edgewise Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: EDG-7500 Single Dose | Experimental | Drug: EDG-7500 |
| Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy | Experimental | Drug: EDG-7500EDG-7500 once daily for up to 28 days. |
| Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy | Experimental | Drug: EDG-7500EDG-7500 once daily for up to 28 days. |
| Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy | Experimental | Drug: EDG-7500EDG-7500 daily for up to 24 months in new participants and participants who have completed Part B or C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDG-7500Liquid suspension formulation of EDG-7500 | Drug | Part A: EDG-7500 Single Dose |
| EDG-7500Solid oral formulation of EDG-7500 | Drug | Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy, Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy, Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy |
Primary outcome
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)
3 secondary outcomes
Change from baseline in left ventricular outflow tract (LVOT) gradient
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Edgewise Therapeutics, Inc.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDG-7500 in people with Hypertrophic Cardiomyopathy, run by Edgewise Therapeutics, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.