Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant (CLEAR Serenity)

Esperion Therapeutics

Status and phase: Completed; Phase 3

Conditions: Atherosclerotic Cardiovascular Disease; Statin Adverse Reaction; Hypercholesterolemia

Treatments: Other: placebo; Drug: bempedoic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02988115

1002-046

Details and patient eligibility

About

The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.

Enrollment: 345 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
• Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
• Be statin-intolerant (unable to tolerate 2 or more statins)

Exclusion criteria

• Total fasting triglyceride ≥500 mg/dL
• Renal dysfunction or nephrotic syndrome or history of nephritis
• Body Mass Index (BMI) ≥50 kg/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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345 participants in 2 patient groups, including a placebo group

bempedoic acid

Experimental group

Description:

bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)

Treatment:

Drug: bempedoic acid

placebo

Placebo Comparator group

Description:

Matching placebo tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)

Treatment:

Other: placebo