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

Multicenter, Parallel-group, Double-blind, Randomized, Active-controlled, Dose-ranging Study to Assess the Safety, Efficacy, and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors, in Subjects With Dyslipidemia

A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.

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:

1. Age 18 to 80 years.

2. 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.

3. HDL-C <45 mg/dL (males) or <50 mg/dL (females).

4. Fasting TG <400 mg/dL.

5. 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%.

6. Willing and able to sign the informed consent form (ICF).

Exclusion Criteria:

1. Chronic heart failure as defined by New York Heart Association classes III and IV.

2. Uncontrolled cardiac arrhythmias.

3. Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina in past 3 months before Visit 1.

4. Stroke or transient ischemic attack within 3 months before Visit 1.

5. Uncontrolled hypertension.

6. 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.

7. Any active nephropathy or estimated glomerular filtration rate <60 mL/min/1.73m2 or on kidney dialysis.

8. Poorly controlled (thyroid-stimulating hormone [TSH] >2 times upper limit of normal) hyperthyroidism.

9. Homozygous familial hypercholesterolemia.

10. Intolerance or hypersensitivity to atorvastatin or rosuvastatin.

11. Prior treatment with any CETP inhibitor.

12. Positive for human immunodeficiency virus (HIV) positive, hepatitis B or hepatitis C.