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用于治疗代谢功能障碍相关的脂肪肝炎的Denifanstat:一个多中心,双盲,随机,安慰剂控制的2b期试验

Rohit Loomba¹, Pierre Bedossa², Katharine Grimmer³

¹MASLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, CA, USA.

The lancet. Gastroenterology & hepatology

|October 13, 2024

概括

在患有代谢功能障碍相关的脂肪肝炎 (MASH) 和晚期纤维化症的患者中,Denifanstat显著改善了肝脏健康. 这种脂肪酸合成酶抑制剂在治疗MASH方面表现有前途,因此需要进一步的临床试验.

科学领域:

肝病学肝病学是一种肝病学.
药理学药理学是指药理学的学科.
临床试验临床试验

背景情况:

代谢功能障碍相关的脂肪肝炎 (MASH) 是由脂毒性,炎症和纤维化驱动的.
脂肪酸合成酶 (FASN) 抑制通过阻断de-novo脂质生成提供了一个潜在的治疗策略.
德尼芬斯塔特是一种口服的FASN抑制剂,研究用于MASH治疗.

研究的目的:

评估denifanstat在改善MASH患者肝脏组织学方面的安全性和有效性.
评估denifanstat对疾病活动和纤维化进展的影响.

主要方法:

一个多中心,双盲,随机,安慰剂控制的2b期试验.
168名活检确认的MASH和F2-F3纤维化患者每天接受50毫克口服denifanstat或安慰剂,持续52周.
主要终点包括非酒精性脂肪性肝病活动评分 (NAS) 和MASH分辨率的改善,而没有纤维化恶化.

主要成果:

42%的denifanstat接受者在没有纤维化恶化的情况下实现了2点的NAS改善,而安慰剂组的16% (p=0.0035) 实现了这一点.
与改善的NAS和没有纤维化恶化的MASH分离发生在26%的denifanstat患者中,与11%的安慰剂患者相比 (p=0.0173).
治疗出现的不良事件通常是轻微的;没有严重的不良事件被认为与药物相关.

结论:

德尼芬沙特在MASH活动,分辨率和纤维化方面显示出统计学意义和临床意义上的改善.
积极的结果支持将denifanstat推进到MASH治疗临床开发的第三阶段.

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