Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)

Esperion Therapeutics

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia; Atherosclerotic Cardiovascular Diseases

Treatments: Drug: ETC-1002; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02666664

1002-040

2015-004136-36 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

Enrollment: 2,230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fasting LDL-C ≥ 70 mg/dL
• High cardiovascular risk (diagnosis of HeFH or ASCVD)
• Be on maximally tolerated lipid-modifying therapy

Exclusion criteria

• Total fasting triglyceride ≥500 mg/dL
• Renal dysfunction or nephrotic syndrome or history of nephritis
• Body Mass Index (BMI) ≥50kg/m2
• Significant cardiovascular disease or cardiovascular event in the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,230 participants in 2 patient groups, including a placebo group

ETC-1002

Experimental group

Description:

ETC-1002 180 mg/day

Treatment:

Drug: ETC-1002

Placebo

Placebo Comparator group

Description:

Placebo control

Treatment:

Drug: Placebo