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Myosin Inhibitor
EDG-7500 for Hypertrophic Cardiomyopathy
Phase 2
Recruiting
Research Sponsored by Edgewise Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through study completion (part a: up to 10 days; part b: up to 38 days)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate the safety and impact of different amounts of EDG-7500 in adults with a heart condition called obstructive hypertrophic cardiomyopathy, by giving either one dose or multiple
Who is the study for?
This trial is for adults with obstructive hypertrophic cardiomyopathy, a condition where the heart muscle becomes abnormally thick. Participants should not have other serious medical conditions and must be able to follow the study procedures.
What is being tested?
The study tests different doses of EDG-7500, administered either once or multiple times, to see how safe it is and what effects it has on patients with obstructive hypertrophic cardiomyopathy.
What are the potential side effects?
Potential side effects of EDG-7500 are not specified in the provided information. Typically, such drugs may cause dizziness, fatigue, changes in blood pressure or heart rhythm disturbances.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through study completion (part a: up to 10 days; part b: up to 38 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through study completion (part a: up to 10 days; part b: up to 38 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change from baseline in left ventricular outflow tract (LVOT) gradient
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic CardiomyopathyExperimental Treatment1 Intervention
EDG-7500 once daily for up to 28 days.
Group II: Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic CardiomyopathyExperimental Treatment1 Intervention
EDG-7500 once daily for up to 28 days.
Group III: Part A: EDG-7500 Single DoseExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDG-7500
2023
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Edgewise Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
854 Total Patients Enrolled
Medical DirectorStudy DirectorEdgewise Therapeutics, Inc.
2,877 Previous Clinical Trials
8,084,778 Total Patients Enrolled
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