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...
Saved in:
Published in | Journal of clinical lipidology Vol. 10; no. 1; pp. 181 - 191.e2 |
---|---|
Main Authors | , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Elsevier Inc
01.01.2016
|
Subjects | |
Online Access | Get full text |
ISSN | 1933-2874 1876-4789 |
DOI | 10.1016/j.jacl.2015.10.012 |
Cover
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. |
---|---|
Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 |
ISSN: | 1933-2874 1876-4789 |
DOI: | 10.1016/j.jacl.2015.10.012 |