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

Launched by EDGEWISE THERAPEUTICS, INC. · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial, called CIRRUS-HCM, is exploring a new drug named EDG-7500 for adults with a condition known as hypertrophic cardiomyopathy (HCM), which is a heart muscle disease that can make it hard for the heart to pump blood. The study aims to evaluate how safe the drug is and how well it works at different doses. It is open to adults aged 18 and older who have been diagnosed with HCM and meet certain health criteria.

To participate, individuals should have specific measures of heart function, and their overall health should be stable. Participants can expect to receive either a single dose or multiple doses of the study drug, depending on whether they have obstructive or non-obstructive HCM. The trial is currently recruiting participants, and it is important for potential volunteers to discuss their health history with their doctor to see if they meet the criteria for joining the study. This research could help pave the way for new treatment options for people living with HCM.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Male or nonpregnant female, age ≥18 years.
• • Body mass index (BMI) ≥18 to \<38 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 ≥30 mmHg measured at rest and ≥50 mmHg post-Valsalva 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 as assessed by the Investigator at Screening (Part C and D nHCM only).
• • Maximal exercise peak LVOT gradient \< 50 mmHg as determined by echocardiography as assessed by the Investigator (historical documentation \< 12 months prior to dosing or confirmed at Screening) (Part C and D nHCM only).
• • Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
• • New York Heart Association (NYHA) Classification I-III at Screening.
• Key Exclusion Criteria:
• • 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
• • Documented current or history of cardiac amyloidosis (age ≥ 60 years requires exclusion of cardiac amyloidosis by radionuclide scan or MRI performed at Screening or historical scan \<3 years prior to Screening).
• • 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
• • A history of diabetes with a hemoglobin A1C ≥ 7.5% at the Screening Visit (Part C and D nHCM only)