奥贝胆酸治疗肝脏纤维化疗效如何？

Data from the pivotal Phase III REGENERATE study. This study is the first successful Phase III study of obeticholic acid in the treatment of non-alcoholic steatohepatitis (NASH).

More than 2,000 patients were enrolled in the trial. This study was conducted in patients with stage 2/3 liver fibrosis due to NASH. Preventing or reversing fibrosis is the main treatment goal for NASH patients. The trial evaluated the efficacy and safety of two doses of OCA (10 mg and 25 mg once daily) compared with placebo.

Clinical trial results show that the previous primary efficacy analysis showed that obeticholic acid significantly improved fibrosis compared with placebo, meeting the primary endpoint of improvement in fibrosis and no worsening of NASH. Other important liver health indicators were also improved, including key underlying drivers of NASH, as well as biochemical test indicators that clinicians frequently monitor when managing patients in the real world.