君圣泰医药-B(02511)完成HTD1801头对头达格列净治疗2型糖尿病III期临床试验患者入组

智通财经
02 Jan

智通财经APP讯,君圣泰医药-B(02511)公布,公司自主研发的肠肝抗炎及代谢调节剂熊去氧胆小檗碱(HTD1801)针对2型糖尿病(T2DM)患者的III期达格列净对照临床试验已完成患者入组。

该试验是一项随机、双盲、阳性药物(达格列净)平行对照的多中心、非劣效性III期临床试验(HARMONY),旨在评估在二甲双胍治疗后血糖控制不佳的成年T2DM受试者中HTD1801相对于达格列净的疗效,主要疗效终点是治疗24周后,糖化血红蛋白相对基线的变化。该试验计划入组358例受试者,于目前已完成全部入组。这项III期试验预计于2025年进行数据读出。

熊去氧胆小檗碱(HTD1801)是一种靶向肠-肝系统的口服抗炎及代谢调节剂,正在开发用于治疗代谢及消化系统疾病。HTD1801为熊去氧胆酸和小檗碱的离子盐,是一种具有独特双机制的新分子实体,通过激活AMPK及抑制NLRP3发挥其生物学活性。这两种关键机制与改善葡萄糖代谢、胰岛素抵抗、脂质代谢和肝脏炎症相关,为T2DM等复杂代谢性疾病的治疗提供综合性解决方案。

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