[Translation] A multicenter, randomized, randomized controlled trial to evaluate the efficacy and safety of lanifibranor in adult subjects with non-alcoholic steatohepatitis (NASH) and stage 2 (F2)/stage 3 (F3) liver fibrosis without cirrhosis. Double-blind, placebo-controlled phase III study of extended treatment with lanifibranor
本项 III 期研究旨在评价 lanifibranor 在 NASH 伴肝纤维化成人受试者中的作用.
主要队列两个周期的主要目的是:
双盲安慰剂对照(DBPC)期(A 部分)
评估与安慰剂相比,lanifibranor 在 NASH 缓解同时经肝组织学评估纤维化改善方面的效果。
双盲试验药扩展(ATE)治疗期(B 部分)
评估 DBPC 期后 lanifibranor 的安全性。
[Translation] This Phase III study is designed to evaluate lanifibranor in adult subjects with NASH and liver fibrosis.
The main purpose of the two cycles of the main queue is to:
Double-blind placebo-controlled (DBPC) phase (Part A)
To evaluate the effect of lanifibranor compared with placebo in remission of NASH accompanied by improvement in fibrosis as assessed by liver histology.
Double-blind Investigational Agent Extension (ATE) Treatment Period (Part B)
Evaluating the safety of lanifibranor post-DBPC.