Efruxifermin Is Associated with Improved Glucose Metabolism in Patients with NASH and Type 2 Diabetes

A third of patients with type 2 diabetes (T2D) are estimated to have nonalcoholic steatohepatitis (NASH). There is a high unmet need for safe and effective therapies that can address liver health and metabolic comorbidities in NASH patients. Efruxifermin (EFX), a long-acting Fc-FGF21 fusion protein, demonstrated robust reductions in liver fat content, markers of liver injury and fibrosis, and improved lipid and glucose metabolism in patients with NASH and fibrosis stage 1-3.1Patients (N=80) were randomized to receive placebo or 28, 50, or 70mg EFX for 16 weeks, and continued on their existing antidiabetic medications. The aim of this analysis was to evaluate the effects of EFX on markers of glucose metabolism in patients with NASH and in the subgroup with T2D (N=41).Mean age, BMI and HbA1c at baseline were 52y, 37.6 kg/m2 and 6.3% in the overall study population, and 53y, 38.1 kg/m2, and 7.0% in the T2D subgroup. Clinically meaningful improvements in glycemic control were observed in the T2D subgroup (Table B), consistent with improvements in markers of glucose metabolism in the overall population (Table A), and with the insulin-sensitizing actions of EFX. Considering the prevalence of T2D in NASH, the ability to improve glycemic control over existing medications is a desirable attribute for future NASH therapies.1Harrison et. al. 2020. Hepatology, 72; 1S; 6AView largeDownload slideView largeDownload slide DisclosureJ. Frias: Consultant; Self; 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pfizer Inc., Sanofi, Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, CymaBay Therapeutics, Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi, Speaker’s Bureau; Self; Merck & Co., Inc., Sanofi. S. A. Harrison: Consultant; Self; Axcella Health Inc. R. Shringarpure: Employee; Self; Akero Therapeutics, Inc., Stock/Shareholder; Self; Akero Therapeutics, Inc. E. J. Tillman: Employee; Self; Akero Therapeutics, Inc., Stock/Shareholder; Self; Akero Therapeutics, Inc. C. Hu: None. E. Fong: Employee; Self; Akero Therapeutics, Inc. B. De temple: Employee; Self; Akero Therapeutics, Inc. T. Rolph: Employee; Self; Akero Therapeutics, Inc., Stock/Shareholder; Self; Pfizer Inc. A. Cheng: Employee; Self; Akero Therapeutics, Inc. K. Yale: Employee; Self; Akero Therapeutics, Inc.