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

Completed · Phase 2

Conditions studied: Hypertriglyceridemia

In brief

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

Key facts

Study ID

NCT04177680

Run by

Matinas BioPharma Nanotechnologies, Inc.

People needed

100

Starts

2020-06-03

Expected to finish

2021-01-18

Last updated by the study team

2022-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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