A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

Esperion Therapeutics

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemias

Treatments: Drug: Placebos; Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination; Drug: Bempedoic Acid; Drug: Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT03337308

1002FDC-053

Details and patient eligibility

About

The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.

Enrollment: 382 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)
• Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening

Exclusion criteria

• Total Fasting Triglyceride ≥ 400 mg/dL
• Renal Dysfunction or nephrotic syndrome or history of nephritis
• Significant cardiovascular disease or cardiovascular event within the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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382 participants in 4 patient groups, including a placebo group

BA 180 mg + EZE 10 mg FDC

Experimental group

Description:

Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks

Treatment:

Drug: Placebos

Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination

BA 180 mg

Experimental group

Description:

Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks

Treatment:

Drug: Bempedoic Acid

Drug: Placebos

EZE 10 mg

Active Comparator group

Description:

Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks

Treatment:

Drug: Ezetimibe

Drug: Placebos

Placebos

Placebo Comparator group

Description:

Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks

Treatment:

Drug: Placebos