Saroglitazar magnesium是一种新型的过氧化物酶体增殖物活化受体（PPAR）激动剂，它同时具有调节PPARα和PPARγ活性的功能。PPARα/γ是调控机体新陈代谢方面的重要转录因子，在脂肪代谢和胰岛素抗性方面都有重要作用。此前的非临床数据表明，与单纯的PPARα或PPARγ激动剂相比，saroglitazar magnesium独特的双重作用机制对疾病的治疗效果更加显著。该药物于2013年9月在印度获批上市，治疗非他汀类药物无法控制的2型糖尿病患者的糖尿病血脂异常和高甘油三酯血症。今年1月，该药物获得了治疗2型糖尿病患者的批准。在过去的七年中，超过一百万患者受益于这种药物。

▲PPARα在NAFLD疾病发展不同阶段的作用（图片来源：参考资料[3]）

此前，该药物曾在美国进行的一项2期临床研究中接受检验，该研究名为EVIDENCES IV，是一项随机，双盲，含安慰剂对照组的研究，共有106名患者参与。该试验的主要研究终点是在第16周时，与安慰剂组相比，接受saroglitazar magnesium治疗患者的肝脏丙氨酸转氨酶（ALT）水平较基线时的变化。试验的次要终点包括通过无创核磁共振质子密度脂肪分数（MRI-PDFF）测量的肝脂肪含量变化等多项指标。试验结果表明，与安慰剂组相比，saroglitazar magnesium使患者的ALT水平下降了44.39%。此外，通过MRI-PDFF定量评估患者的肝脂肪含量也达到了统计学意义上的显著降低。

“我们很高兴可以为NASH患者开发一种新型药物，满足这一高度未满足的医疗需求，“Zydus公司董事长Pankaj Patel先生说：”Saroglitazar magnesium将为数百万名NASH患者提供新的希望。“

参考资料：

[1] Zydus Announces World's First Drug for the Treatment of Non-Cirrhotic NASH, Retrieved March 05, 2020, from https://www.prnewswire.com/news-releases/zydus-announces-worlds-first-drug-for-the-treatment-of-non-cirrhotic-nash-301017439.html

[2] Zydus Announces Positive Results From EVIDENCES IV Phase 2 Clinical Trial of Saroglitazar Magnesium in NAFLD and NASH. Retrieved March 05, 2020, from https://www.biospace.com/article/releases/zydus-announces-positive-results-from-evidences-iv-phase-2-clinical-trial-of-saroglitazar-magnesium-in-nafld-and-nash/

[3] Pawlak et al., (2015). Molecular mechanism of PPARα action and its impact on lipid metabolism, inflammation and fibrosis in non-alcoholic fatty liver disease. Journal of Hepatology, https://doi.org/10.1016/j.jhep.2014.10.039

参考资料：

[1] Zydus Announces World's First Drug for the Treatment of Non-Cirrhotic NASH, Retrieved March 05, 2020, from https://www.prnewswire.com/news-releases/zydus-announces-worlds-first-drug-for-the-treatment-of-non-cirrhotic-nash-301017439.html

[2] Zydus Announces Positive Results From EVIDENCES IV Phase 2 Clinical Trial of Saroglitazar Magnesium in NAFLD and NASH. Retrieved March 05, 2020, from https://www.biospace.com/article/releases/zydus-announces-positive-results-from-evidences-iv-phase-2-clinical-trial-of-saroglitazar-magnesium-in-nafld-and-nash/

[3] Pawlak et al., (2015). Molecular mechanism of PPARα action and its impact on lipid metabolism, inflammation and fibrosis in non-alcoholic fatty liver disease. Journal of Hepatology, https://doi.org/10.1016/j.jhep.2014.10.039

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