An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults With Hypertrophic Cardiomyopathy
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or nonpregnant female, age ≥18 years to \<85 years.
• Body mass index (BMI) ≥18 to \<35 kg/m2; weight ≥50 kg at Screening.
• 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 (Part C and D nHCM only).
Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Stanford University Hospital / Stanford Health Care
RECRUITING
Stanford
Florida
James A. Haley Veterans' Hospital
RECRUITING
Tampa
Massachusetts
Brigham and Womens Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Lahey Hospital and Medical Center
RECRUITING
Burlington
Missouri
Saint Luke's Hospital of Kansas City
RECRUITING
Kansas City
North Carolina
Sanger Heart and Vascular Institute
RECRUITING
Charlotte
New Jersey
Morristown Medical Center (Atlantic Health System)
RECRUITING
Morristown
New York
North Shore University Hospital
RECRUITING
Manhasset
NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only)
RECRUITING
New York
Ohio
The Lindner Research Center at Christ Hospital
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Oregon
Oregon Health & Science University (OHSU)
RECRUITING
Portland
Pennsylvania
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Virginia
University of Virginia Heart and Vascular Center Fontaine
RECRUITING
Charlottesville
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Contact Information
Primary
Edgewise Therapeutics, Inc.
cardiacstudies@edgewisetx.com
720-262-7002
Time Frame
Start Date:2024-04-11
Estimated Completion Date:2026-03
Participants
Target number of participants:75
Treatments
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.