A 52-week randomized, double-blind, placebo-controlled phase III trial (MAESTRO-NAFLD-1) evaluated the safety of resmetirom in adults with nonalcoholic fatty liver disease and presumed nonalcoholic steatohepatitis. Patients were randomly assigned to either 100 mg resmetirom, 80 mg resmetirom or placebo, or open-label 100 mg resmetirom. Resmetirom was safe and well tolerated (no difference in the primary endpoint of incidence of treatment-emergent adverse events between groups) and key secondary endpoints demonstrated significant reductions in atherogenic lipid levels (LDL-cholesterol, apolipoprotein B and triglycerides), hepatic fat (at 16 weeks and 52 weeks) and liver stiffness (over 52 weeks) in the 80 mg and 100 mg resmetirom groups versus placebo.

一项为期 52 周的随机、双盲、安慰剂对照 III 期试验 (MAESTRO-NAFLD-1) 评估了瑞美隆治疗成人非酒精性脂肪肝病和推测非酒精性脂肪性肝炎的安全性。患者被随机分配接受 100 mg 瑞美罗、80 mg 瑞美罗或安慰剂，或开放标签 100 mg 瑞美罗。瑞美隆是安全的且耐受性良好（组间治疗中出现的不良事件发生率的主要终点没有差异），关键的次要终点显示致动脉粥样硬化的脂质水平（低密度脂蛋白胆固醇、载脂蛋白 B 和甘油三酯）、肝脂肪（在80 mg 和 100 mg resmetirom 组与安慰剂组相比，在 16 周和 52 周）以及肝脏硬度（超过 52 周）。