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

Hypertriglyceridemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177680
• Other study ID #: MAT-002
• Status: Completed
• Phase: Phase 2
• Start date: June 3, 2020
• Est. completion date: January 18, 2021

Study information

• Verified date: February 2022
• Source: Matinas BioPharma Nanotechnologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 18, 2021
• Est. primary completion date: November 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• Omega 3 pentaenoic acid
Encapsulated omega-3 pentaenoic acid
• icosapent ethyl
Encapsulated omega-3 acid ethyl esters

Locations

Country	Name	City	State
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	Jacksonville	Florida
United States	Matinas Investigational site	Jupiter	Florida
United States	Matinas Investigational site	Louisville	Kentucky
United States	Matinas Investigational Site	Port Saint Lucie	Florida
United States	Matinas Investigational site	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Matinas BioPharma Nanotechnologies, Inc.	Matinas Biopharma, Inc, MB Clinical Research and Consulting LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	baseline to 28 days
Secondary	Percent Change in Lipoprotein Lipids (Per Protocol Population)	Percent change from baseline in lipoprotein lipids in the per protocol population	baseline to 28 days
Secondary	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	baseline to 28 days
Secondary	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	Baseline to 28 days