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

• Status: Completed
• Trial end date: 2017-07-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Esperion Therapeutics; Esperion Therapeutics, Inc.
• Treatments: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Atorvastatin; Atorvastatin Calcium; Ezetimibe

Criteria

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