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歌礼制药-B(01672):ASC41片治疗经肝穿活检证实的非酒精性脂肪性肝炎患者52周II期临床试验取得积极期中结果

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歌礼制药-B(01672)公布,公司全资附属公司甘莱制药有限公司的候选药物甲状腺激素受体β(THRβ)激动剂ASC41片用于治疗经肝穿活检证实的非酒精性脂肪性肝炎(NASH)患者的52周II期临床试验取得积极期中结果。ASC41 具有肝脏靶向性和高度的THRβ选择性。一日服用一次的ASC41片剂由歌礼专有制剂技术开发。ASC41片剂制剂专利已在美国获得授权。

该项随机、双盲、安慰剂对照及多中心的II期临床试验(ClinicalTrials.gov : NCT05462353) 正在中国开展,预计入组约180名经肝穿活检证实的NASH患者,以1:1:1的比例随机分配进入两个ASC41片治疗队列(2毫克或4毫克,一日一次)和一个安慰剂对照队列,治疗52周并随访4周。预设的期中分析在42名入组患者完成为期12周的 ASC41片或安慰剂治疗后进行。



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