Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia

Study Overview
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Brief Summary
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The objective of this study is To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameter from baseline after 12 weeks of treatment To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters

Detailed Description
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6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled 12-Week Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of PRC-4016 600 mg Once Daily Versus Placebo in Statin-Stable Subjects With Mixed Dyslipidemia

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: PRC-4016
* Drug: Placebo
* Drug: Statins


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Fasting triglycerides 200-499 mg/dl Non-HDL-C > 130 mg/dl Stable statin treatment Exclusion Criteria: Type I diabetes or uncontrolled type II diabetes Recent cardiovascular or coronary event History of pancreatitis History or evidence of major and clinically significant diseases that would interfere with the conduct of the study or interpretation of data Uncontrolled hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRC-4016<br>PRC-4016, oral administration once daily, capsule | Drug: PRC-4016<br> <br> Drug: Statins<br>* Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)<br>|
| Placebo Comparator: Placebo<br>Placebo, oral administration once daily, capsule | Drug: Placebo<br> <br> Drug: Statins<br>* Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Non-HDL-C from baseline to Week 12 |  | from baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in triglycerides from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in HDL-C from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in LDL-C from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in VLDL-C from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in total cholesterol from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in ApoA1 from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in ApoB from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in insulin from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in fasting plasma glucose from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in HbA1c from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in Lp-PLA2 from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in hsCRP from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in red blood cell content of EPA and DHA from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in Insulin Resistance (HOMA) from baseline to Week 12 |  | from baseline to Week 12 |