Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Bempedoic acid 180mg; Other: Placebo; Drug: Atorvastatin 20mg; Drug: Ezetimibe 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03051100

1002-038

Details and patient eligibility

About

The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fasting LDL-cholesterol between 130 - 189 mg/dL at screening following washout of all LDL-C-lowering drugs and nutritional supplements
• Men and nonpregnant, nonlactating women
• Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and nutritional supplements for 12 weeks

Exclusion criteria

• Fasting blood triglycerides greater than or equal to 400 mg/dL
• Body Mass Index (BMI) greater than 50 kg/m2
• History of clinically significant cardiovascular disease
• History of type 1 or type 2 diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 2 patient groups, including a placebo group

Triplet Therapy

Experimental group

Description:

Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.

Treatment:

Drug: Ezetimibe 10mg

Drug: Atorvastatin 20mg

Drug: Bempedoic acid 180mg

placebo

Placebo Comparator group

Description:

Matching placebos taken orally, daily.

Treatment:

Other: Placebo