NCT04177680

Brief Summary

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

June 3, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 4, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

November 22, 2019

Results QC Date

February 8, 2022

Last Update Submit

March 3, 2022

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • Percent Change in Plasma Triglycerides (Pharmacodynamic Population)

    Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population

    baseline to 28 days

Secondary Outcomes (4)

  • Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)

    baseline to 28 days

  • Percent Change in Lipoprotein Lipids (Per Protocol Population)

    baseline to 28 days

  • Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)

    baseline to 28 days

  • Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)

    Baseline to 28 days

Study Arms (2)

Omega-3 pentaenoic acid (MAT9001)

EXPERIMENTAL

2g MAT9001 capsules twice daily with meals

Drug: Omega 3 pentaenoic acid

Icosapent ethyl (Vascepa)

ACTIVE COMPARATOR

2g Vascepa capsules twice daily with meals

Drug: icosapent ethyl

Interventions

Omega 3 pentaenoic acidDRUG

Encapsulated omega-3 pentaenoic acid

Also known as: MAT9001
Omega-3 pentaenoic acid (MAT9001)
icosapent ethylDRUG

Encapsulated omega-3 acid ethyl esters

Also known as: Vascepa
Icosapent ethyl (Vascepa)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Matinas Investigational Site

Jacksonville, Florida, 32216, United States

Location

Matinas Investigational site

Jupiter, Florida, 33458, United States

Location

Matinas Investigational Site

Port Saint Lucie, Florida, 34952, United States

Location

Matinas Investigational Site

Addison, Illinois, 60101, United States

Location

Matinas Investigational Site

Chicago, Illinois, 60640, United States

Location

Matinas Investigational site

Indianapolis, Indiana, 46260, United States

Location

Matinas Investigational site

Louisville, Kentucky, 40213, United States

Location

Matinas Investigational site

Richmond, Virginia, 23294, United States

Location

Related Publications (1)

  • Maki KC, Bays HE, Ballantyne CM, Underberg JA, Kastelein JJP, Johnson JB, Ferguson JJ. A Head-to-Head Comparison of a Free Fatty Acid Formulation of Omega-3 Pentaenoic Acids Versus Icosapent Ethyl in Adults With Hypertriglyceridemia: The ENHANCE-IT Study. J Am Heart Assoc. 2022 Mar 15;11(6):e024176. doi: 10.1161/JAHA.121.024176. Epub 2022 Mar 1.

    PMID: 35232215DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

MAT9001eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. James J Ferguson, MD
Organization
Matinas BioPharma
jferguson@matinasbiopharma.com
(908) 505-0964

Study Officials

  • Kevin Maki

    MB Clinical Research and Consulting

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 26, 2019

Study Start

June 3, 2020

Primary Completion

November 27, 2020

Study Completion

January 18, 2021

Last Updated

March 4, 2022

Results First Posted

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(8)