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Roche has reported early-stage clinical data with an oral GLP-1 agonist acquired as part of its $3.1 billion takeover of Carmot Therapeutics as it tries to catch up with the leaders in the fast-growing category.The new results are from a phase 1 trial of a once-daily pill called CT-966, which revealed an average weight loss of 7.3% at four weeks in the study population of obese patients without diabetes, compared to a 1.2% reduction with placebo.The drug was also well tolerated, with mostly mild or moderate gastrointestinal-related adverse events that Roche said were 'consistent with the safety profile of the incretin drug class,' and will now progress to phase 2.The results come just a few weeks after a once-weekly injectable GLP-1 drug CT-388 – also sourced from Carmot – achieved an average weight loss of 18.8% at 24 weeks in a phase 1b trial, which the company said pointed to a potential 'best-in-class' profile.That result sparked a near-5% increase in Roche's share price, and the latest announcement had a similar effect, with the stock up just over 5% at the time of writing.The group's chief medical officer, Levi Garraway, said that the new oral data reveals 'clinically meaningful' weight loss 'which could eventually help patients address both chronic weight management and glycaemic control.'There were no treatment discontinuations with the drug, and blood levels were similar in patients who were in a fasting state as well as those who had just consumed a high-fat meal.
罗氏(Roche)报告了一种口服GLP-1激动剂的早期临床数据,该激动剂是其31亿美元收购Carmot Therapeutics的一部分,因为它试图赶上快速增长类别的领导者。新结果来自一项名为CT-966的每日一次药丸的第一阶段试验,该试验显示,无糖尿病肥胖患者的研究人群在四周时平均体重减轻了7.3%,而安慰剂组则减少了1.2%。该药物的耐受性也很好,罗氏说,大多数与胃肠道相关的轻度或中度不良事件“与肠降血糖素类药物的安全性相一致”,现在将进入第二阶段。结果仅在几周前,每周注射一次的GLP-1药物CT-388(也来自Carmot)在1b期试验中在24周时平均体重减轻了18.8%,该公司表示这是一种潜在的“同类最佳”药物。这一结果引发了罗氏股价上涨近5%,而最新的公告也产生了类似的效果,在撰写本文时,罗氏股价上涨略高于5%。该组织首席医疗官列维·加拉韦(LeviGarraway)说,新的口服数据显示“临床上有意义的”减肥”,最终可能帮助患者解决慢性体重管理和血糖控制问题没有停药治疗,处于禁食状态的患者和刚吃过高脂肪食物的患者的血液水平相似。
That means it could be dosed without considering meal timings, which is a consideration with some drugs in the oral GLP-1 class.For example, Novo Nordisk's oral formulation of semaglutide for diabetes – Rybelsus – needs to be dosed in the fasting state, with patients not eating or drinking for at lea.
这意味着它可以在不考虑进餐时间的情况下服用,这是口服GLP-1类药物的考虑因素。例如,诺和诺德(Novo Nordisk)治疗糖尿病的口服semaglutide制剂Rybelsus需要在禁食状态下服用,患者在lea时不进食或饮酒。