Core Viewpoint - The article discusses the initiation of a Phase III clinical trial for BGM0504, a drug developed by Borui Pharmaceutical for the treatment of type 2 diabetes, highlighting its potential efficacy and safety compared to semaglutide [2][4]. Group 1: Clinical Trial Details - The Phase III clinical trial is a randomized, open-label study comparing the subcutaneous injection of BGM0504 with weekly semaglutide in conjunction with metformin for type 2 diabetes patients [4]. - The trial will take place in Indonesia and aims to recruit 477 participants, with the primary endpoint being the change in glycated hemoglobin (HbA1c) from baseline [4]. Group 2: Drug Profile - BGM0504 is a dual agonist of GLP-1 and GIP receptors, designed to activate both GIP and GLP-1 downstream pathways, which may improve blood sugar control, promote weight loss, and treat metabolic dysfunction-related fatty liver disease (MASH, formerly known as NASH) [4]. - The drug shows significant potential in treating various metabolic diseases [4]. Group 3: Current Progress - According to the Insight database, BGM0504 has initiated four Phase III clinical trials, with three conducted in China (two for type 2 diabetes and one for obesity) and one in Indonesia (for type 2 diabetes) [6].

整理 | GLP1减重宝典内容团队 在今年年初的二期临床试验中，HRS9531在36周时曾以8毫克更高剂量实现了22.8%的平均体重减轻，但该剂量未纳入此次三期研究。 恒瑞在美国的合作伙伴Kailera Therapeutics在今日的公告中表示，将在全球临床试验中探索更高剂量的治疗潜力。 Kailera首席执行官Ron Renaud表示："我们对这项三期研究结果感到振奋，它进一步验证了HRS9531（KAI-9531）的潜力。Kailera将 启动全球临床项目，并评估更高剂量及更长治疗周期，以拓展其'同类最佳'的可能性。" 与此同时，恒瑞正加快推进HRS9531在中国的注册申请工作。如果顺利获批，该药物将成为继信达生物的双重激动剂mazdutide之后， 又一款获批的国产减重药。 "本次HRS9531-301研究的数据表明该药物能带来显著、持续的体重减轻，"恒瑞负责人在公告中表示。 恒瑞医药研发的可注射GLP-1/GIP受体双重激动剂HRS9531，在48周的临床三期试验中实现了平均接近18%的体重减轻，公司计划"尽 快"在中国申请上市。 该三期临床研究在中国进行，评估了每周皮下注射2毫克、4毫克和6毫克的 ...