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

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

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.

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