Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

Inclusion Criteria: * Men or naturally postmenopausal or surgically menopausal women * 18 to 80 years of age * Baseline HDL-C \<35 mg/dL (0.9 mmol/L) Exclusion Criteria: * Creatine phosphokinase (CPK) \>3 × the upper limit of normal (ULN) * Body Mass Index (BMI) \>35 kg/m2 * Uncontrolled Hypertension \>95 mm Hg * 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) * Uncontrolled hypothyroidism (TSH \>1.5 × 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 3 months