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

Phase 2 Completed 100 enrolled Matinas BioPharma Nanotechnologies, Inc. MB Clinical Research and Consulting LLC · collab Matinas Biopharma, Inc · collab

RandomizedCrossoverOpen-labelTreatment

Summary

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

Timeline

Start: 2020-06-03
Primary completion: 2020-11-27
Completion: 2021-01-18

Outcome

Missed primary endpoint

paper EPA+DPA-FFA and EPA-EE reduced least squares geometric mean triglycerides from baseline: 20.9% and 18.3%, respectively (P=not significant). PMID 35232215 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omega 3 pentaenoic acid	Unknown	2 g	Oral
Comparator	icosapent ethyl	Small molecule	2 g	Oral