To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors

The purpose of this study is to assess the safety, efficacy, and tolerability of CKD-519, administered with HMG-CoA reductase inhibitors in subjects with dyslipidemia

Inclusion criteria

• Age 18 to 80 years.
• Dyslipidemia with LDL-C

• At screening if untreated: 100 to 190 mg/dL
• At screening if treated with statins or other lipid-lowering drugs: 100 to 170 mg/dL
• At start of double-blind treatment: 100 to 190 mg/dL.
• HDL-C <45 mg/dL (males) or <50 mg/dL (females).
• Fasting TG <400 mg/dL.
• Presence of the following conditions is permitted but not mandatory, at the discretion of the investigator:

• Treated and stable coronary heart disease without acute events in the past 3 months and stable, state-of-the-art medication.
• Treated and stable carotid artery disease or peripheral arterial disease on stable, standard medication for the past 3 months
• Treated and stable Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤9.5%.
• Willing and able to sign the informed consent form (ICF).

Exclusion criteria

• Chronic heart failure as defined by New York Heart Association classes III and IV.
• Uncontrolled cardiac arrhythmias.
• Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina in past 3 months before Visit 1.
• Stroke or transient ischemic attack within 3 months before Visit 1.
• Uncontrolled hypertension.
• Clinically significant laboratory abnormalities

• Aspartate aminotransferase or alanine aminotransferase >2 times upper limit of normal range
• Bilirubin >1.5 times upper limit of normal range
• Creatine kinase >2 times upper limit of normal range.
• Any active nephropathy or estimated glomerular filtration rate <60 mL/min/1.73m2 or on kidney dialysis.
• Poorly controlled (thyroid-stimulating hormone [TSH] >2 times upper limit of normal) hyperthyroidism.
• Homozygous familial hypercholesterolemia.
• Intolerance or hypersensitivity to atorvastatin or rosuvastatin.
• Prior treatment with any CETP inhibitor.
• Positive for human immunodeficiency virus (HIV) positive, hepatitis B or hepatitis C.