Phase 2
N=100
Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia
Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT04177680 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Percent Change in Plasma Triglycerides (Pharmacodynamic Population) — -20.9; -18.3 Percent Change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omega 3 pentaenoic acid (Drug); icosapent ethyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Matinas BioPharma Nanotechnologies, Inc.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Plasma Triglycerides (Pharmacodynamic Population) |
-20.9; -18.3 | — |
| SECONDARY Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population) |
-5.6; -4.1; -4.8; -3.1; -1.7; -1.1 | — |
| SECONDARY Percent Change in Lipoprotein Lipids (Per Protocol Population) |
-20; -15.1; -5.7; -3.5; -4.8; -2.8 | — |
| SECONDARY Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population) |
-4; -3.1; -3.5; -2.5; -12.4; -11.1 | — |
| SECONDARY Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population) |
848; 692; 1.7; -3.3; 177; 140 | — |
Summary
Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia
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
Data sourced from ClinicalTrials.gov (NCT04177680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.