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 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).
• Key Exclusion Criteria:
• • Invasive septal reduction any time prior to Screening.
• • Documented current or history of obstructive coronary artery disease at any time or myocardial infarction any time prior to Screening.
• • Significant valvular hear disease (moderate-severe aortic stenosis or regurgitation, moderate-severe mitral stenosis or regurgitation not due to systolic anterior motion of the mitral valve)
• • History of LV systolic dysfunction (LVEF \< 0.45) or stress cardiomyopathy at any time.
• • Known or suspected infiltrative or storage disorder causing cardiac hypertrophy that may mimic HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
• • A history of unexplained syncope or sustained ventricular tachyarrhythmia or supraventricular tachycardia \<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
• • History of permanent AF or atrial flutter. Any episode of documented AF or atrial flutter \< 180 days prior to Screening Visit (participants with documented AF or atrial flutter ≥ 180 days prior to Screening require adequate anticoagulation and rate control.)
• • Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator or Medical Monitor to pose a risk to participant safety.
• • Current or prior use of a cardiac myosin inhibitor \<90 days prior to Screening.