Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy

Study Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy

The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with symptomatic hypertrophic cardiomyopathy (HCM).

Key Inclusion Criteria:

• Established diagnosis of hypertrophic cardiomyopathy defined by standard criteria as a maximal left ventricular wall thickness ≥ 15 mm at initial diagnosis

• Exertional symptoms including at least one of the following:

  • New York Heart Association (NYHA) Class ≥ II dyspnea
  • Canadian Cardiovascular Society (CCS) Class ≥ II angina

• Screening (baseline) peak VO2 < 80% of predicted for age, sex, and weight

• Ability to perform an upright treadmill cardiopulmonary exercise test (CPET)

Key Exclusion Criteria:

• Known aortic valve stenosis (moderate or severe)
• Known coronary artery disease
• Left ventricular systolic dysfunction (ejection fraction < 50%)
• Recent septal reduction procedure (ie, surgical myectomy or alcohol septal ablation) within six months prior to screening or such a procedure scheduled to occur during the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.