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
Conditions:	High Cholesterol
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	7/27/2018
Start Date:	January 19, 2017
End Date:	July 5, 2017

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Triplet Therapy With Bempedoic Acid (ETC 1002) 180 mg, Ezetimibe 10 mg, and Atorvastatin 20 mg in Patients With Elevated LDL C

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.

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

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