作者
Jörn M Schattenberg, Albert Pares, Kris V Kowdley, Michael A Heneghan, Stephen Caldwell, Daniel Pratt, Alan Bonder, Gideon M Hirschfield, Cynthia Levy, John Vierling, David Jones, Anne Tailleux, Bart Staels, Sophie Megnien, Remy Hanf, David Magrez, Pascal Birman, Velimir Luketic
发表日期
2021/6/1
期刊
Journal of hepatology
卷号
74
期号
6
页码范围
1344-1354
出版商
Elsevier
简介
Background & Aims
Patients with primary biliary cholangitis (PBC) who have an incomplete response to ursodeoxycholic acid remain at risk of disease progression. We investigated the safety and efficacy of elafibranor, a dual PPARα/δ agonist, in patients with PBC.
Methods
This 12-week, double-blind phase II trial enrolled 45 adults with PBC who had incomplete response to ursodeoxycholic acid (alkaline phosphatase levels ≥1.67-fold the upper limit of normal (ULN). Patients were randomly assigned to elafibranor 80 mg, elafibranor 120 mg or placebo. The primary endpoint was the relative change of ALP at 12 weeks (NCT03124108).
Results
At 12 weeks, ALP was reduced by -48.3±14.8% in the elafibranor 80 mg group (p <0.001 vs. placebo) and by -40.6±17.4% in the elafibranor 120 mg group (p <0.001) compared to a +3.2±14.8% increase in the placebo group. The composite endpoint of ALP ≤1.67-fold the …
学术搜索中的文章
JM Schattenberg, A Pares, KV Kowdley, MA Heneghan… - Journal of hepatology, 2021