Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT06347159
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2024-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events', 'timeFrame': '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)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in left ventricular outflow tract (LVOT) gradient', 'timeFrame': 'From baseline through study completion (Part A: Up to 10 days; Part B: Up to 38 days; Part D: Up to 18 months)', 'description': 'Resting and post-Valsalva LVOT gradient by echocardiography'}, {'measure': 'Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax)', 'timeFrame': 'From baseline through study completion (Part A: Up to 10 days)'}, {'measure': 'Change from baseline in cardiac biomarkers', 'timeFrame': 'From baseline through study completion (Part B and C: Up to 38 days; Part D: Up to 18 months)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or nonpregnant female, age ≥18 years to \\<85 years.\n* 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).\n* Diagnosed with hypertrophic cardiomyopathy at the time of Screening consistent with current American College of Cardiology Foundation/American Heart Association Guidelines.\n* 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).\n* 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).\n* Documented left ventricular ejection fraction (LVEF) ≥ 0.60 at Screening.\n* New York Heart Association (NYHA) Classification II-III at Screening.\n* Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) \\< 85 at Screening.\n* NT-proBNP ≥ 300 pg/mL (NT-proBNP ≥ 225 pg/mL is permitted for African American participants) (Part C and D nHCM only).\n\nKey Exclusion Criteria:\n\n* Invasive septal reduction therapy \\< 180 days prior to or during Screening.\n* Documented history of active or untreated obstructive coronary artery disease during Screening or treated for obstructive coronary artery disease \\< 180 days prior to Screening.\n* Documented history of myocardial infarction with residual wall motion abnormalities \\< 180 days prior to or during Screening.\n* 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)\n* History of LV systolic dysfunction (LVEF \\< 0.45) or stress cardiomyopathy at any time.\n* 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.\n* A history of unexplained syncope \\<180 days prior to or during Screening.\n* A history of sustained ventricular tachyarrhythmia or sudden cardiac arrest \\< 180 days prior or during Screening.\n* 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.\n* 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.)\n* 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).\n* Receiving a CMI (e.g., Camzyos® \\[mavacamten\\] or aficamten) \\< 90 days prior to Screening.'}, 'identificationModule': {'nctId': 'NCT06347159', 'briefTitle': 'A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edgewise Therapeutics, Inc.'}, 'officialTitle': 'An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults With Hypertrophic Cardiomyopathy', 'orgStudyIdInfo': {'id': 'EDG-7500-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: EDG-7500 Single Dose', 'interventionNames': ['Drug: EDG-7500']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy', 'description': 'EDG-7500 once daily for up to 28 days.', 'interventionNames': ['Drug: EDG-7500']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy', 'description': 'EDG-7500 once daily for up to 28 days.', 'interventionNames': ['Drug: EDG-7500']}, {'type': 'EXPERIMENTAL', 'label': 'Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy', 'description': 'EDG-7500 daily for up to 18 months in new participants and participants who have completed Part B or C.', 'interventionNames': ['Drug: EDG-7500']}], 'interventions': [{'name': 'EDG-7500', 'type': 'DRUG', 'description': 'Liquid suspension formulation of EDG-7500', 'armGroupLabels': ['Part A: EDG-7500 Single Dose']}, {'name': 'EDG-7500', 'type': 'DRUG', 'description': 'Solid oral formulation of EDG-7500', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Pham', 'role': 'CONTACT', 'phone': '415-476-1254'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isabella Voutos', 'role': 'CONTACT', 'phone': '650-725-6911'}], 'facility': 'Stanford University Hospital / Stanford Health Care', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': "James A. Haley Veterans' Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shamim Hasnain', 'role': 'CONTACT', 'phone': '404-712-6635'}], 'facility': 'Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Albree Tower-Rader, MD', 'role': 'CONTACT', 'phone': '617-643-0122'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alyx Vogle', 'role': 'CONTACT', 'phone': '617-732-6320'}], 'facility': 'Brigham and Womens Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ethan Rowin, MD', 'role': 'CONTACT', 'phone': '781-825-8650'}], 'facility': 'Lahey Hospital and Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Wooley', 'role': 'CONTACT', 'phone': '734-615-4369'}], 'facility': 'Michigan Medicine - Michigan Clinical Research Unit', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jaycie Halderman', 'role': 'CONTACT', 'phone': '816-932-5987'}], 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cassie Mojica-Brid, RN', 'role': 'CONTACT', 'phone': '973-971-5951'}], 'facility': 'Morristown Medical Center (Atlantic Health System)', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ronald Wharton, MD', 'role': 'CONTACT', 'phone': '516-562-4100'}, {'name': 'Peter Tricarico', 'role': 'CONTACT', 'phone': '516-600-1430'}], 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isabel Castro Alvarez, MPH', 'role': 'CONTACT', 'phone': '646-784-7096'}], 'facility': 'NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Lang, BSN', 'role': 'CONTACT', 'phone': '704-355-4796'}], 'facility': 'Sanger Heart and Vascular Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27560', 'city': 'Morrisville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua Stablein', 'role': 'CONTACT', 'phone': '919-681-4486'}], 'facility': 'Duke Health Center Arringdon', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kasey Wright, RN', 'role': 'CONTACT', 'phone': '513-585-1777'}], 'facility': 'The Lindner Research Center at Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meghan Khebouz', 'role': 'CONTACT', 'phone': '216-217-2283'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hailey Volk', 'role': 'CONTACT', 'phone': '503-494-2004'}], 'facility': 'Oregon Health & Science University (OHSU)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madeleine Carens', 'role': 'CONTACT', 'phone': '215-662-3768'}], 'facility': 'Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Virginia Theodorof', 'role': 'CONTACT', 'phone': '843-876-9078'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Caroline Flournoy, PhD, CCRP', 'role': 'CONTACT', 'phone': '434-982-1058'}], 'facility': 'University of Virginia Heart and Vascular Center Fontaine', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amelia Johnson', 'role': 'CONTACT', 'phone': '206-287-6260'}], 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Edgewise Therapeutics, Inc.', 'role': 'CONTACT', 'email': 'cardiacstudies@edgewisetx.com', 'phone': '720-262-7002'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Edgewise Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edgewise Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}