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

Phase 2

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: icosapent ethyl; Drug: Omega 3 pentaenoic acid

• Registration Number: NCT04177680
• Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.

Brief Summary

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-26
• Study Start: 2020-06-03
• Primary Completion: 2020-11-27
• Study Completion: 2021-01-18
• Status Verified: 2022-02
• Results First Submitted: 2022-02-08
• Results First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Results First Posted: 2022-03-04
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Icosapent ethyl (Vascepa)	icosapent ethyl	2g Vascepa capsules twice daily with meals
Omega-3 pentaenoic acid (MAT9001)	Omega 3 pentaenoic acid	2g MAT9001 capsules twice daily with meals

Primary Outcome Measures

Name	Time	Method
Percent Change in Plasma Triglycerides (Pharmacodynamic Population)	baseline to 28 days	Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Matinas Investigational Site; 🇺🇸 Chicago, Illinois, United States

Matinas Investigational site; 🇺🇸 Richmond, Virginia, United States