In a phase III, double-blind, placebo-controlled trial, 193 patients with primary biliary cholangitis and an inadequate response to or a history of unacceptable side effects with ursodeoxycholic acid were randomly assigned in a 2:1 ratio to receive daily 10 mg oral seladelpar (a PPARδ agonist) or placebo.

The primary endpoint was set at month 12 as a biochemical response defined as an alkaline phosphatase serum level less than 1.67 times the upper limit of the normal range, with a decrease of 15% or more from baseline, and a normal total bilirubin serum level. Of 193 patients, 93.8% received ursodeoxycholic acid as standard-of-care background therapy.

在一项 III 期、双盲、安慰剂对照试验中，193 名原发性胆汁性胆管炎患者对熊去氧胆酸反应不足或有不可接受的副作用史，按 2:1 的比例随机分配接受每日 10 mg 口服治疗seladelpar（一种 PPARδ 激动剂）或安慰剂。

主要终点设定为第 12 个月时的生化反应，定义为碱性磷酸酶血清水平低于正常范围上限的 1.67 倍，较基线下降 15% 或更多，且总胆红素血清水平正常。在 193 名患者中，93.8% 接受熊去氧胆酸作为标准护理背景治疗。