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

Matinas BioPharma

Status and phase: Completed; Phase 2

Conditions: Hypertriglyceridemia

Treatments: Drug: icosapent ethyl; Drug: Omega 3 pentaenoic acid

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04177680

MAT-002

Details and patient eligibility

About

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Omega-3 pentaenoic acid (MAT9001)

Experimental group

Description:

2g MAT9001 capsules twice daily with meals

Treatment:

Drug: Omega 3 pentaenoic acid

Icosapent ethyl (Vascepa)

Active Comparator group

Description:

2g Vascepa capsules twice daily with meals

Treatment:

Drug: icosapent ethyl