Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy

An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin

The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.

Inclusion Criteria:

• Males and Females
• 18 to 65 years of age
• Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)

Exclusion Criteria:

• If female, postmenopausal or surgically menopausal
• Triglycerides (TG) >400 mg/dL
• Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
• Body Mass Index (BMI) >35 kg/m2
• Uncontrolled diabetes mellitus (HbA1c >10%)
• Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN)
• Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN)
• Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month