1. Efruxifermin was an effective and safe treatment found to significantly reduce hepatic fat fraction in order to treat nonalcoholic steatohepatitis.
2. Participants taking Efruxifermin experienced reduced liver fibrosis, improved lipid profiles, cholesterol, and glycemic controls compared to participants taking the placebo
Evidence Rating Level: 1 (Excellent)
Non-alcoholic steatohepatitis (NASH) is a progressive form of non-alcoholic fatty liver disease (NAFLD) consisting of steatosis, inflammation, and hepatocyte injury. Previous studies have focused on therapeutic mechanisms targeting these characteristics, however there are currently no approved treatments. This study aimed to assess Efruxifermin as a potential treatment for NASH. Efruxifermin, a fusion protein linked to fibroblast growth factor 21 (FGF21), improves lipoprotein profiles, glycemic control, and reduces liver fat. The efficacy and safety of Efruxifermin was assessed using a randomized, placebo-controlled study with participants (n=80) from 27 sites. Participants were evenly distributed into treatment groups after accounting for body mass index, fibrosis stages (F1-F3), hepatic fat fraction (HFF), lipid and glycemic profiles. Participants received either a placebo (n=21), or 28mg (n=19), 50 mg (n=21), or 70mg (n=20) of Efruxifermin for 16 weeks. Treatment was found to significantly reduce HFF by week 12 in all groups receiving Efruxifermin. Specifically, absolute changes from baseline in HFF were 12.3%, 13.4% and 14.1% with the 28mg, 50mg and 70mg of Efruxifermin respectively. Comparatively, the HFF only changed 0.3% in the placebo group. In other words, HFF reductions were significantly greater with Efruxifermin with reductions of 62.9%, 70.6%, and 72.0% in each treatment group respectively compared to the group receiving the placebo (P < 0.0001). Changes in liver injury marker alanine aminotransferase (ALT) was another outcome measured at week 12. Similar to HFF, significant reduction in ALT was seen across all treatment groups compared to the placebo. Furthermore, aspartame amino transferase (AST), Gamma glutamyl transferase (GGT), and alkaline phosphatase (ALP) all followed similar reduction patterns as HFF and ALT. Finally, urate levels also decreased by 14-19% in treatment participants relative to placebo, indicating lower levels of liver stress. Overall, this study presents a potential treatment plan for NASH, however studies at a larger scale are required to continue assessing the efficacy and safety long term.
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