Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk (CLEAR Wisdom)

Esperion Therapeutics

Status and phase: Completed; Phase 3

Conditions: Atherosclerotic Cardiovascular Disease; Hypercholesterolemia

Treatments: Drug: placebo; Drug: bempedoic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02991118

1002-047

2016-003486-26 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 779 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fasting LDL-C ≥100 mg/dL
• High cardiovascular risk (diagnosis of HeFH and/or ASCVD)
• Be on maximally tolerated lipid-modifying therapy (LMT), including maximally tolerated statin either alone or in combination with other LMTs

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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779 participants in 2 patient groups, including a placebo group

bempedoic acid

Experimental group

Description:

bempedoic acid 180 mg/day

Treatment:

Drug: bempedoic acid

Placebo

Placebo Comparator group

Description:

Placebo control

Treatment:

Drug: placebo