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

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. To evaluate the efficacy and safety of icosabutate...

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Published inJournal of clinical lipidology Vol. 10; no. 1; pp. 181 - 191.e2
Main Authors Bays, Harold E., Hallén, Jonas, Vige, Runar, Fraser, David, Zhou, Rong, Hustvedt, Svein Olaf, Orloff, David G., Kastelein, John J.P.
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.01.2016
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ISSN1933-2874
1876-4789
DOI10.1016/j.jacl.2015.10.012

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Summary: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. To evaluate the efficacy and safety of icosabutate 600 mg once daily in patients with very high TGs. 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. 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 < .001). Adjusted for placebo, icosabutate significantly reduced very low–density lipoprotein cholesterol (−36%, P < .001), remnant lipoprotein cholesterol (−34%, P < .001), apolipoprotein (Apo) C-III (−35%, P < .001), trended toward reduced non–high-density lipoprotein cholesterol (−7%, P = .064); significantly increased high-density lipoprotein cholesterol (18%, P < .001) and low-density lipoprotein cholesterol (28%, P < .001), with a trend of an increased lipoprotein (a; 10%, 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. 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. •Icosabutate is a first-in-class structurally enhanced fatty acid.•Icosabutate was tested in hypertriglyceridemic subjects.•Triglycerides were significantly reduced vs placebo.•Icosabutate appeared safe and well tolerated.
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ISSN:1933-2874
1876-4789
DOI:10.1016/j.jacl.2015.10.012