Clinical trial NCT04177680: Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Lead sponsor: Matinas BioPharma Nanotechnologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Matinas Biopharma, Inc
name: MB Clinical Research and Consulting LLC
First posted: 2019-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
timeFrame: baseline to 28 days
Secondary outcomes:
measure: Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
timeFrame: baseline to 28 days
measure: Percent Change in Lipoprotein Lipids (Per Protocol Population)
timeFrame: baseline to 28 days
measure: Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)
timeFrame: baseline to 28 days
measure: Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)
timeFrame: Baseline to 28 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Matinas Investigational Site
state: Florida
city: Jupiter
country: United States
facility: Matinas Investigational site
state: Florida
city: Port Saint Lucie
country: United States
facility: Matinas Investigational Site
state: Florida
city: Addison
country: United States
facility: Matinas Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Matinas Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Matinas Investigational site
state: Indiana
city: Louisville
country: United States
facility: Matinas Investigational site
state: Kentucky
city: Richmond
country: United States
facility: Matinas Investigational site
state: Virginia
Study officials:
affiliation: MB Clinical Research and Consulting
name: Kevin Maki
role: STUDY_DIRECTOR
References:
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.