A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM) (NCT06347159) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
United States100 participantsStarted 2024-04-11
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 (BMI ≥ 18 to \< 40 kg/m2 is permitted for participants \< 50 years).
* 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 (NT-proBNP ≥ 225 pg/mL is permitted for African American participants) (Part C and D nHCM only).
Key Exclusion Criteria:
* Invasive septal reduction therapy \< 180 days prior to or during Screening.
* Documented history of active or untreated obstructive coronary artery disease during Screening or treated for obstructive coronary artery disease \< 180 days prior to Screening.
* Documented history of myocardial infarction with residual wall motion abnormalities \< 180 days prior to or during Scre…
What they're measuring
1
Incidence of treatment-emergent adverse events
Timeframe: From screening through study completion (Part A: Up to 38 days; Part B and C: Up to 73 days; Part D: Up to 18 months)