Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
NCT ID: NCT04177680
Last Updated: 2022-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2020-06-03
2021-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Omega-3 pentaenoic acid (MAT9001)
2g MAT9001 capsules twice daily with meals
Omega 3 pentaenoic acid
Encapsulated omega-3 pentaenoic acid
Icosapent ethyl (Vascepa)
2g Vascepa capsules twice daily with meals
icosapent ethyl
Encapsulated omega-3 acid ethyl esters
Interventions
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Omega 3 pentaenoic acid
Encapsulated omega-3 pentaenoic acid
icosapent ethyl
Encapsulated omega-3 acid ethyl esters
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Matinas Biopharma, Inc
INDUSTRY
MB Clinical Research and Consulting LLC
UNKNOWN
Matinas BioPharma Nanotechnologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Maki
Role: STUDY_DIRECTOR
MB Clinical Research and Consulting
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MAT-002
Identifier Type: -
Identifier Source: org_study_id
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