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埃拉菲布拉诺在原发性硬化性脑膜炎中的安全性和有效性:ELMWOODII期随机对照试验

Cynthia Levy¹, George F Abouda², Bahri M Bilir³

¹Schiff Center for Liver Diseases, University of Miami, Miami, Florida, USA; Division of Digestive Health and Liver Diseases, University of Miami School of Medicine, Miami, Florida, USA.

Journal of hepatology

|May 11, 2025

概括

埃拉非布拉诺是一种双PPAR-α/δ激动剂,在原发性硬化性胆道炎 (PSC) 患者中显示出良好的安全性. 与安慰剂相比,该药物在12周内显著改善了肝脏生物化学和纤维化标志物.

科学领域:

肝病学和胃肠病学肝病学和胃肠学
药理学和药物开发领域
临床试验和医学研究

背景情况:

初级硬化性胆道炎 (PSC) 是一种罕见的慢性肝病,治疗选择有限.
埃拉非布拉诺是一种双重过氧体增殖器激活受体-α/δ (PPAR-α/δ) 激动剂,目前正在研究其在PSC中的治疗潜力.
第二阶段ELMWOOD试验 (NCT05627362) 的目的是评估elafibranor在PSC患者中的疗效和安全性.

研究的目的:

评估与安慰剂相比,elafibranor在患PSC的成年人中的安全性和耐受性.
评估elafibranor的生化疗效,特别是其对性酸酶 (ALP) 水平和增强性肝纤维化 (ELF) 评分的影响.
探索elafibranor (80毫克与120毫克) 在改善PSC相关生物标志物的剂量反应关系.

主要方法:

一项为期12周的双盲,安慰剂对照试验,涉及患有PSC和ALP水平升高 (≥1.5×ULN) 的成年人.
参与者被随机分配到接受elafibranor 80 mg,elafibranor 120 mg或安慰剂.
主要终点:安全性和耐受性. 二级终点:与基线相比,ALP和ELF得分的平均变化.

主要成果:

与安慰剂相比,Elafibranor表现出良好的安全性,治疗出现的不良事件 (TEAE) 的发生率与安慰剂相似.
与安慰剂相比,elafibranor组和安慰剂组都观察到ALP水平的显著降低 (例如,120毫克-54.7%).
治疗elafibranor导致了ELF得分的改善趋势,在120毫克剂量下观察到更大的生化改善.

结论:

在12周的治疗期间,Elafibranor在PSC患者中耐受良好.
与安慰剂相比,Elafibranor治疗导致显著的生化改善,包括减少ALP水平.
这些发现支持进一步调查elafibranor,特别是120毫克剂量,用于PSC治疗的更大,更长期的研究.

关键词:

胆固醇性疾病胆固醇性疾病临床试验临床试验临床试验临床试验临床试验这是elafibranor.肝脏疾病是一种肝脏疾病.一次性硬化性胆管炎.

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