在NASH中对FGF21模拟Pegozafermin进行随机对照试验
Rohit Loomba1, Arun J Sanyal1, Kris V Kowdley1
1From the NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, La Jolla (R.L.), Velocity Clinical Research, Los Angeles (J.P.F.), and 89bio, San Francisco (M.D.G., S.F., G.D.A., C.L.H., H.M.); the Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University, Richmond (A.J.S.); Liver Institute Northwest, Seattle (K.V.K.); Mount Sinai Heart, Icahn School of Medicine at Mount Sinai Health System, New York (D.L.B.); Arizona Liver Health, Chandler (N.A.); Liverpat, Paris (P.B.); Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom (S.A.H.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); ObjectiveHealth-Digestive Health Research, Nashville (D.L.); Ocala GI Research, Ocala, FL (R.B.); 89bio, Rehovot, Israel (M.M.); and the Division of Hepatobiliary Disease, Mayo Clinic, Rochester, MN (M.F.A.).
在2b期试验中, Pegozafermin在肝纤维化和非酒精性脂肪肝炎 (NASH) 解决方面显著改善. 这些发现支持其进一步开发用于治疗NASH.
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:
- 佩戈扎费明是一种非酒精性脂肪肝炎 (NASH) 的研究性纤维细胞生长因子21 (FGF21) 模拟剂.
- 在活检证明的NASH患者中,其疗效和安全性需要进一步确定.
研究的目的:
- 评估pegozafermin在活检确认的NASH和中度至重度纤维化患者的疗效和安全性.
- 评估纤维化改善和NASH解决作为主要终点.
主要方法:
- 这是一项为期24周的2b期随机化,安慰剂对照试验,涉及222名活检确认的纳氏淋病患者.
- 患者每周或每两周接受皮下佩戈扎费明 (15毫克,30毫克或44毫克) 或安慰剂.
- 主要终点包括纤维化改善 (≥1阶段减少) 和NASH解脱而没有纤维化恶化.
主要成果:
- 与安慰剂相比, Pegozafermin 在所有测试剂量 (P ≤ 0.009) 中显示出纤维化病的统计学显著改善.
- 在接受pegozafermin治疗的患者中,在23-37%的患者中观察到NASH的缓解,而在安慰剂组中仅为2%.
- 恶心和腹是与 pegozafermin 相关的最常见的不良事件.
结论:
- 在NASH患者中, Pegozafermin治疗导致肝纤维化显著改善.
- 这项研究支持将pegozafermin推进到NASH治疗临床开发的第三阶段.
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