The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

Study Overview
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Brief Summary
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The objectives of this study is To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameters 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 Once Daily Versus Placebo in Statin-Naïve or Statin-Stable Hypertriglyceridemic Subjects

Conditions
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Dyslipidemia

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


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Fasting triglycerides 500-1500 mg/dl Not on other lipid altering therapy, OR on stable lipid altering therapy Main 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRC-4016<br>PRC-4016, oral administration once daily, capsule | Drug: PRC-4016<br> <br> |
| Placebo Comparator: Placebo<br>Placebo, oral administration once daily, capsule | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in triglycerides from baseline to week 12 |  | from baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HDL-C from baseline to Week 12 |  | from baseline to Week 12 | 
| Change in non-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 Apo B 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 insulin resistance (HOMA) 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; |