一项评价MK-3655有效性和安全性的2b期随机对照研究
[Translation] A Phase 2b Randomized Controlled Study to Evaluate the Efficacy and Safety of MK-3655
研究的主要目标之一是证明MK-3655在治疗肝硬化前期NASH患者中的有效性。主要有效性终点是治疗52周后NASH消退且无纤维化恶化。关键次要有效性终点是评估治疗24周后通过MRI-PDFF测得的LFC相对于基线的相对减少百分比均值。以及通过AE,生命体征,实验室检测等对比安慰剂,评估MK-3655的安全性和耐受性。
[Translation] One of the primary goals of the study was to demonstrate the efficacy of MK-3655 in the treatment of patients with pre-cirrhotic NASH. The primary efficacy endpoint was resolution of NASH without worsening fibrosis after 52 weeks of treatment. The key secondary efficacy endpoint was to assess the mean relative percent reduction from baseline in LFC measured by MRI-PDFF after 24 weeks of treatment. As well as comparing the safety and tolerability of MK-3655 with placebo through AE, vital signs, laboratory tests, etc.
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