The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

Phase 2 Completed 87 enrolled Pronova BioPharma

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of this study is * To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameters from baseline after 12 weeks of treatment. * To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters

Timeline

Start: 2013-07
Primary completion: 2014-07
Completion: 2014-07

Outcome

Met primary endpoint

paper median change after 12 weeks of treatment was -51% and -17%, respectively, for a placebo-corrected change of -33% (P < .001). PMID 26892135 ↗

paper Treatment with icosabutate once daily significantly reduced TG, very low-density lipoprotein cholesterol, and Apo C-III levels in patients with very high TG levels. PMID 26892135 ↗

Publications

Bays HE, Hallen J, Vige R, Fraser D, Zhou R, Hustvedt SO, Orloff DG, Kastelein JJ. Icosabutate for the treatment of very high triglycerides: A placebo-controlled, randomized, double-blind, 12-week clinical trial. J Clin Lipidol. 2016 Jan-Feb;10(1):181-91.e1-2. doi: 10.1016/j.jacl.2015.10.012. Epub 2015 Nov 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Icosabutate	Small molecule	600 mg	Oral