A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Drug Interaction Study to Evaluate the Safety, Tolerability and Effect on Atorvastatin Pharmacokinetics of ETC-1002 Added to Atorvastatin 10 mg/Day in Subjects With Hypercholesterolemia

This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.

Inclusion Criteria:

• For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides <350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit,
• For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL

Exclusion Criteria:

• Acute significant cardiovascular disease
• Uncontrolled hypertension