Icosabutate for the treatment of very high triglycerides: A placebo-controlled, randomized, double-blind, 12-week clinical trial

Background Icosabutate is a structurally enhanced omega-3 fatty acid molecule developed with the aim of achieving improved triglyceride (TG)-lowering efficacy, increased potency, and preserved safety compared with conventional prescription omega-3 fatty acid. Objective To evaluate the efficacy and safety of icosabutate 600 mg once daily in patients with very high TGs. Methods After a 6-8 week run-in period, men and women with TG levels ≥500 mg/dL and ≤1500 mg/dL were randomized to double-blind treatment with placebo or icosabutate 600 mg for 12 weeks. The primary end point was % change from baseline in TGs at 12 weeks. Results A total of 87 subjects were randomized. At baseline, median TG (interquartile range) levels were 611 (543–878) and 688 (596–892) mg/dL, and the median change after 12 weeks of treatment was −51% and −17%, respectively, for a placebo-corrected change of −33% ( P P P P P  = .064); significantly increased high-density lipoprotein cholesterol (18%, P P P  = .054). No changes were observed in total cholesterol, apolipoprotein B, or apolipoprotein A1. Fasting plasma glucose was unchanged, whereas fasting plasma insulin was reduced ( P  = .001) with icosabutate. Icosabutate was generally well tolerated. Conclusion 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. This trial was registered at www.clinicaltrials.gov as NCT01893515.