This randomized controlled trial investigated the safety and efficacy of MF4637, a high concentrate omega-3 fatty acid preparation, in correcting the omega-3 fatty acid nutritional deficiency in non-alcoholic fatty liver disease (NAFLD). The primary end point of the study was set as the change of red blood cell (RBC) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) by MF4637. Whether the omega-3 concentrate could lower liver fat was evaluated in a subset of patients. Furthermore, 176 subjects with NAFLD were randomized to receive the omega-3 concentrate (n = 87) or placebo (n = 89) for 24 weeks, in addition to following standard-of-care dietary guidelines. The omega-3 index, omega-6: omega-3 fatty acid ratio and quantitative measurements of RBC EPA and DHA were determined at baseline and study completion. Magnetic resonance imaging of liver fat was conducted in a subset of patients. Administration of high concentrate omega-3 for 24 weeks significantly increased the omega-3 index and absolute values of RBC EPA and DHA, and decreased the RBC omega-6: omega-3 fatty acid ratio (p < 0.0001). A significant reduction in liver fat content was reported in both groups.

This RCT investigated the safety and efficacy of MF4637, a high concentrate omega-3 fatty acid preparation, in correcting the omega-3 fatty acid nutritional deficiency in non-alcoholic fatty liver disease (NAFLD). Whether MF4637 could lower liver fat was evaluated in a subset of patients. 176 subjects with NAFLD were randomised to receive MF4637 (n=87) or placebo (n=89) for 24 weeks, in addition to following standard-of-care dietary guidelines. The omega-3 index, omega-6:omega-3 fatty acid ratio and quantitative measurements of red blood cell (RBC) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) were determined at baseline and study completion. Magnetic resonance imaging of liver fat was conducted in a subset of patients. Administration of MF4637 for 24 weeks significantly increased the omega-3 index and absolute values of RBC EPA and DHA, and decreased the omega-6:omega-3 fatty acid ratio (p<0.0001). A significant reduction in liver fat content was reported in both groups. An inverse relationship between change in absolute RBC EPA+DHA and change in liver fat, AST and ALT was observed. Post-hoc analysis demonstrated a significant liver fat-lowering effect of MF4637 in a subset of patients with baseline fatty liver index score ≥ 40. In conclusion, MF4637 corrected the omega-3 fatty acid nutritional deficiency in NAFLD patients.