[Translation] A randomized, single-blind, placebo-controlled, multicenter, phase 2 clinical trial evaluating TVB 2640 (ASC40) for the treatment of patients with nonalcoholic steatohepatitis.
1.通过磁共振成像质子密度脂肪分数(MRI-PDFF)测定非酒精性脂肪性肝炎(NASH)患者每日一次(QD)服用TVB-2640治疗12周,与安慰剂相比,对肝脂肪分数自基线变化的影响; 2.确定每日一次TVB-2640与安慰剂相比在NASH患者中的安全性,包括对丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST)的影响。
[Translation] 1. To determine the effect of TVB-2640 once daily (QD) for 12 weeks on the change from baseline in liver fat fraction in patients with nonalcoholic steatohepatitis (NASH), as measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF), compared with placebo. 2. To determine the safety of TVB-2640 once daily compared with placebo in patients with NASH, including the effects on alanine aminotransferase (ALT) and aspartate aminotransferase (AST).