Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 either as a single or multiple dose in adult patients with obstructive hypertrophic cardiomyopathy.

Official Title

An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of EDG-7500 in Adults With Obstructive Hypertrophic Cardiomyopathy

Keywords

Hypertrophic Cardiomyopathy, Cardiomyopathies, Hypertrophy, EDG-7500

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or nonpregnant female, age ≥18 years.
  • Body mass index (BMI) ≥18 to <35 kg/m2; weight ≥50 kg at Screening.
  • Diagnosed with HCM at the time of Screening consistent with current American College of Cardiology Foundation/American Heart Association Guidelines
  • LVOT peak gradient ≥30 mmHg measured at rest and ≥50 mmHg post-Valsalva as determined by echocardiography at Screening.
  • Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
  • New York Heart Association (NYHA) Classification I-III at Screening.

You CAN'T join if...

  • Invasive septal reduction <180 days prior to Screening.
  • Documented current or history of obstructive coronary artery disease at any time or myocardial infarction <180 days prior to Screening.
  • Known Stage B or higher aortic valve stenosis or regurgitation
  • A history of syncope or sustained ventricular tachyarrhythmia <180 days prior to Screening.
  • A history of sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator (ICD) discharge <180 days prior to Screening
  • Atrial fibrillation (AF) at Screening; a current diagnosis of permanent AF; paroxysmal or persistent AF <90 days of Screening, or electrical cardioversion or ablation for AF <90 days of Screening.
  • Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator to pose a risk to participant safety.
  • Current or prior use of any cardiac myosin inhibitors

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • The Lindner Research Center at Christ Hospital accepting new patients
    Cincinnati Ohio 45219 United States
  • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine) accepting new patients
    Philadelphia Pennsylvania 19104 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edgewise Therapeutics, Inc.
ID
NCT06347159
Phase
Phase 2 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated