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

Part of paid clinical trials in San Francisco, California.

Sponsor
Edgewise Therapeutics, Inc.
Study ID
NCT06347159
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EDG-7500 — DRUG
    Liquid suspension formulation of EDG-7500
  • EDG-7500 — DRUG
    Solid oral formulation of EDG-7500

Study Details

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).

Key Dates

Start date
Apr 11, 2024
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: EDG-7500 Single Dose
  • Experimental: Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy
    EDG-7500 once daily for up to 28 days.
  • Experimental: Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy
    EDG-7500 once daily for up to 28 days.
  • Experimental: Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy
    EDG-7500 daily for up to 18 months in new participants and participants who have completed Part B or C.

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) ]

Locations (21)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-
Stanford University Hospital / Stanford Health CareStanfordCalifornia94305-
Emory ClinicAtlantaGeorgia30322-
Brigham and Womens HospitalBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Lahey Hospital and Medical CenterBurlingtonMassachusetts01805-
Michigan Medicine - Michigan Clinical Research UnitAnn ArborMichigan48109-
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111-
Morristown Medical Center (Atlantic Health System)MorristownNew Jersey07960-
North Shore University HospitalManhassetNew York11030-
NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)New YorkNew York10016-
Sanger Heart and Vascular InstituteCharlotteNorth Carolina28204-
Duke Health Center ArringdonMorrisvilleNorth Carolina27560-
The Lindner Research Center at Christ HospitalCincinnatiOhio45219-
Cleveland ClinicClevelandOhio44195-
University Hospitals Cleveland Medical CenterClevelandOhio33612-
Oregon Health & Science University (OHSU)PortlandOregon97239-
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)PhiladelphiaPennsylvania19104-
Medical University of South CarolinaCharlestonSouth Carolina29425-
University of Virginia Heart and Vascular Center FontaineCharlottesvilleVirginia22903-
Virginia Mason Medical CenterSeattleWashington98101-

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CAStanford University Hospital / Stanford Health Care· Stanford, CAEmory Clinic· Atlanta, GABrigham and Womens Hospital· Boston, MAMassachusetts General Hospital· Boston, MALahey Hospital and Medical Center· Burlington, MA

Related Studies