Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia

Study Overview
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Brief Summary
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Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

Detailed Description
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An open-label, randomized, crossover study to assess the pharmacodynamic effects of MAT-9001, an omega-3 free fatty acid compared to Vascepa (icosapent ethyl) on triglycerides and other lipoprotein lipids in men and women with elevated triglycerides.

Official Title
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Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acid to ENHANCE Efficacy in Adults With Hypertriglyceridemia: The ENHANCE-IT Trial

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Omega 3 pentaenoic acid
* Drug: icosapent ethyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ≥18 y of age Judged to be in generally good health Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening Body mass index of ≥20.0 kg/m2 No clinically significant findings in a 12-lead ECG or physical examination Willing and able to undergo the scheduled study procedures Understands study procedures and signs forms documenting informed consent to participate in the study Exclusion Criteria: Laboratory test result of clinical significance Uncontrolled hypertension Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder History of human immunodeficiency virus, hepatitis B or hepatitis C infection Used any medication intended to alter the lipid profile within 4 weeks of the first qualification visit Active systemic infection A condition the Investigator believes would interfere subject ability to provide informed consent and/or comply with the study protocol

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3 pentaenoic acid (MAT9001)<br>2g MAT9001 capsules twice daily with meals | Drug: Omega 3 pentaenoic acid<br>* Encapsulated omega-3 pentaenoic acid<br>* Other names: MAT9001;|
| Active Comparator: Icosapent ethyl (Vascepa)<br>2g Vascepa capsules twice daily with meals | Drug: icosapent ethyl<br>* Encapsulated omega-3 acid ethyl esters<br>* Other names: Vascepa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Plasma Triglycerides (Pharmacodynamic Population) | Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population | baseline to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) | Percent change in other lipoprotein lipids from baseline to end of treatment in the pharmacodynamic population | baseline to 28 days | 
| Percent Change in Lipoprotein Lipids (Per Protocol Population) | Percent change from baseline in lipoprotein lipids in the per protocol population | baseline to 28 days | 
| Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) | The percent change from baseline in Apolipoproteins, PCSK9 and hs-CRP in the PD Population | baseline to 28 days | 
| Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) | The percent change from baseline in Omega-3 fatty acid concentrations in the Pharmacodynamic population | Baseline to 28 days |