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

March 3, 2022 updated by: Matinas BioPharma Nanotechnologies, Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Matinas Investigational site
      • Jupiter, Florida, United States, 33458
        • Matinas Investigational site
      • Port Saint Lucie, Florida, United States, 34952
        • Matinas Investigational site
    • Illinois
      • Addison, Illinois, United States, 60101
        • Matinas Investigational site
      • Chicago, Illinois, United States, 60640
        • Matinas Investigational site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Matinas Investigational site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Matinas Investigational site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Matinas Investigational site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Omega-3 pentaenoic acid (MAT9001)
2g MAT9001 capsules twice daily with meals
Drug: Omega 3 pentaenoic acid
Encapsulated omega-3 pentaenoic acid
Other Names:
  • MAT9001
ACTIVE_COMPARATOR: Icosapent ethyl (Vascepa)
2g Vascepa capsules twice daily with meals
Drug: icosapent ethyl
Encapsulated omega-3 acid ethyl esters
Other Names:
  • Vascepa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
Time Frame: baseline to 28 days
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
baseline to 28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matinas BioPharma Nanotechnologies, Inc.

Collaborators

MB Clinical Research and Consulting LLC
Matinas Biopharma, Inc

Investigators

  • Study Director: Kevin Maki, MB Clinical Research and Consulting

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 3, 2020

Primary Completion (ACTUAL)

November 27, 2020

Study Completion (ACTUAL)

January 18, 2021

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (ACTUAL)

November 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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