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

Phase 2

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: Atorvastatin 20 mg + CKD-519 50 mg; Drug: Atorvastatin 20 mg + CKD-519 200 mg; Drug: Atorvastatin 20mg; Drug: Rosuvastatin 10 mg; Drug: Atorvastatin 20 mg + CKD-519 100 mg; Drug: Rosuvastatin 10 mg + CKD-519 100 mg

• Registration Number: NCT02977065
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-11-27
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-11-30
• Study Start: 2017-03-23
• Primary Completion: 2017-12-30
• Study Completion: 2018-01-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Atorvastatin 20 mg + CKD-519 50 mg	Atorvastatin 20 mg + CKD-519 50 mg	To administrate Atorvastatin 20 mg, CKD-519 50 mg and 3 Placebos, PO, QD for 4weeks
Atorvastatin 20 mg + CKD-519 200 mg	Atorvastatin 20 mg + CKD-519 200 mg	To administrate Atorvastatin 20 mg, CKD-519 200 mg and 2 Placebos, PO, QD for 4weeks
Atorvastatin 20 mg	Atorvastatin 20mg	To administrate Atorvastatin 20 mg and 4 Placebos, PO, QD for 4weeks
Rosuvastatin 10 mg	Rosuvastatin 10 mg	To administrate Rosuvastatin 10 mg and 4 Placebos, PO, QD for 4weeks
Atorvastatin 20 mg + CKD-519 100 mg	Atorvastatin 20 mg + CKD-519 100 mg	To administrate Atorvastatin 20 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks
Rosuvastatin 10 mg + CKD-519 100 mg	Rosuvastatin 10 mg + CKD-519 100 mg	To administrate Rosuvastatin 10 mg, CKD-519 100 mg and 3 Placebos, PO, QD for 4weeks

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline (Visit 3) in LDL-C	at Week 4

Secondary Outcome Measures

Name	Time	Method
Percentage change from baseline in HDL-C	at Weeks 2 and Week 4
Change in concentration from baseline in total cholesterol, TG, and non-HDL-C	at Weeks 2 and 4
Percentage change from baseline in apolipoprotein B (Apo B), apolipoprotein A1 (Apo A1), and apolipoprotein E (Apo E)	at Weeks 2 and 4
Change from baseline in size of HDL particles (HDL-P)	at Weeks 2 and 4
Percentage change from baseline in LDL-C	at Week 2
Change in concentration from baseline in HDL-C	at Weeks 2 and 4
Change in concentration from baseline in LDL-C	at Weeks 2 and 4
Percentage change from baseline in total cholesterol, TG, and non-HDL-C	at Weeks 2 and 4
Percentage change from baseline in concentration of HDL particles (HDL-P)	at Weeks 2 and 4
Change in concentration from baseline in Lp-a	at Weeks 2 and 4
Change in concentration from baseline in Apo B, Apo A1, and Apo E	at Weeks 2 and 4
Percentage change from baseline in lipoprotein(a) (Lp-a)	at Weeks 2 and 4
Change in concentration from baseline in high-sensitivity C-reactive protein at	at Weeks 2 and 4

Trial Locations

Locations (1)

Not provided; 🇦🇺 Adelaide, Australia