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December 6, 2010
Amarin released positive results from a phase III trial of AMR101 for the treatment of very high triglycerides This international, placebo-controlled, randomized, double-blind, study, dubbed MARINE, enrolled 229 subjects with fasting triglyceride levels of greater than 500 mg/dL. Following a six-to-eight week washout period, the subjects were randomized to AMR101 (2 or 4 grams) or placebo for 12 weeks. The primary endpoint was the percentage change in triglyceride (TG) level from baseline to week 12. Statistical significance was reached in both AMR101 treatment arms. The arm treated with 4 grams of AMR101 showed a significant median TG decrease of 33% (P<0.0001) compared to placebo, and the arm treated with 2 grams showed a significant median TG decrease of 20% (P≡0.0051) compared to placebo. AMR101 did not result in an increase in median LDL-C compared to placebo at either dose. In addition, there were statistically significant reductions in several lipid markers, including Apo B, Lp-PLA2, VLDL-C and Total Cholesterol. AMR101 appeared to be well tolerated.