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

Gilead Sciences

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Hypertrophic Cardiomyopathy

Treatments: Drug: Placebo; Drug: Eleclazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02291237

2013-004429-97 (EudraCT Number)

GS-US-361-1157

Details and patient eligibility

About

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).

Enrollment: 172 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 2 patient groups

Eleclazine

Experimental group

Description:

Eleclazine 30 mg single loading dose followed by 3 mg daily maintenance dose up until Week 12, then 6 mg daily maintenance dose from Week 12 at least Week 24, followed by eleclazine 6 mg in an open-label extension period.

Treatment:

Drug: Eleclazine

Placebo

Experimental group

Description:

Placebo to match eleclazine until at least Week 24, followed by active eleclazine 6 mg in an open-label extension period.

Treatment:

Drug: Placebo

Drug: Eleclazine