Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Encapsulated omega-3 pentaenoic acid
Encapsulated omega-3 acid ethyl esters
Matinas Investigational Site
Jacksonville, Florida, United States
Matinas Investigational site
Jupiter, Florida, United States
Matinas Investigational Site
Port Saint Lucie, Florida, United States
Matinas Investigational Site
Addison, Illinois, United States
Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
Time frame: baseline to 28 days
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
Time frame: baseline to 28 days
Percent Change in Lipoprotein Lipids (Per Protocol Population)
Percent change from baseline in lipoprotein lipids in the per protocol population
Time frame: 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
Time frame: 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
Time frame: Baseline to 28 days
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Matinas Investigational Site
Chicago, Illinois, United States
Matinas Investigational site
Indianapolis, Indiana, United States
Matinas Investigational site
Louisville, Kentucky, United States
Matinas Investigational site
Richmond, Virginia, United States