Amarin Corporation announced the enrollment of patients in their two Phase 3 trials of AMR101 for the treatment of patients with high triglycerides. These trials are designed to demonstrate that AMR101 lowers triglyceride levels in patients with very high triglycerides (>500 mg/dL) (MARINE Study) and high triglycerides (≥200 mg/dL and <500 mg/dL) in patients with mixed dyslipidemia being treated with statins (ANCHOR Study).

The MARINE Study is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dL. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12.  

The ANCHOR Study is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels between 200 mg/dL and 500 mg/dL who are on statin therapy. The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12.

AMR101 is an ultra-pure omega-3 form being developed with ethyl ester of eicosapentaenoic acid (ethyl-EPA).  Numerous independent studies have demonstrated the lowering of plasma triglycerides with ethyl-EPA in patients with high triglyceride levels of varying degrees of severity.


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