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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omega 3 pentaenoic acid
icosapent ethyl
Sponsored by
Matinas BioPharma Nanotechnologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Matinas Investigational Site
  • Matinas Investigational site
  • Matinas Investigational Site
  • Matinas Investigational Site
  • Matinas Investigational Site
  • Matinas Investigational site
  • Matinas Investigational site
  • Matinas Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Omega-3 pentaenoic acid (MAT9001)

Icosapent ethyl (Vascepa)

Arm Description

2g MAT9001 capsules twice daily with meals

2g Vascepa capsules twice daily with meals

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
Percent change in other lipoprotein lipids from baseline to end of treatment in the pharmacodynamic population
Percent Change in Lipoprotein Lipids (Per Protocol Population)
Percent change from baseline in lipoprotein lipids in the per protocol population
Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)
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)
The percent change from baseline in Omega-3 fatty acid concentrations in the Pharmacodynamic population

Full Information

First Posted
November 22, 2019
Last Updated
March 3, 2022
Sponsor
Matinas BioPharma Nanotechnologies, Inc.
Collaborators
Matinas Biopharma, Inc, MB Clinical Research and Consulting LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04177680
Brief Title
Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
Acronym
ENHANCE-IT
Official Title
Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acid to ENHANCE Efficacy in Adults With Hypertriglyceridemia: The ENHANCE-IT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
January 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Matinas BioPharma Nanotechnologies, Inc.
Collaborators
Matinas Biopharma, Inc, MB Clinical Research and Consulting LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 pentaenoic acid (MAT9001)
Arm Type
Experimental
Arm Description
2g MAT9001 capsules twice daily with meals
Arm Title
Icosapent ethyl (Vascepa)
Arm Type
Active Comparator
Arm Description
2g Vascepa capsules twice daily with meals
Intervention Type
Drug
Intervention Name(s)
Omega 3 pentaenoic acid
Other Intervention Name(s)
MAT9001
Intervention Description
Encapsulated omega-3 pentaenoic acid
Intervention Type
Drug
Intervention Name(s)
icosapent ethyl
Other Intervention Name(s)
Vascepa
Intervention Description
Encapsulated omega-3 acid ethyl esters
Primary Outcome Measure Information:
Title
Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
Description
Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population
Time Frame
baseline to 28 days
Secondary Outcome Measure Information:
Title
Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
Description
Percent change in other lipoprotein lipids from baseline to end of treatment in the pharmacodynamic population
Time Frame
baseline to 28 days
Title
Percent Change in Lipoprotein Lipids (Per Protocol Population)
Description
Percent change from baseline in lipoprotein lipids in the per protocol population
Time Frame
baseline to 28 days
Title
Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)
Description
The percent change from baseline in Apolipoproteins, PCSK9 and hs-CRP in the PD Population
Time Frame
baseline to 28 days
Title
Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)
Description
The percent change from baseline in Omega-3 fatty acid concentrations in the Pharmacodynamic population
Time Frame
Baseline to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Maki
Organizational Affiliation
MB Clinical Research and Consulting
Official's Role
Study Director
Facility Information:
Facility Name
Matinas Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Matinas Investigational site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Matinas Investigational Site
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Matinas Investigational Site
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Matinas Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Matinas Investigational site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Matinas Investigational site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Matinas Investigational site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35232215
Citation
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.
Results Reference
derived

Learn more about this trial

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

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