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6-K: Monlunabant Phase 2a Trial in Obesity Successfully Completed

6-K: Monlunabant Phase 2a Trial in Obesity Successfully Completed

6-K:Monlunabant 2a 期肥胖试验成功完成
美股SEC公告 ·  09/20 09:52

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Novo Nordisk A/S, a leading global healthcare company, has successfully completed a phase 2a clinical trial for monlunabant, an oral small molecule cannabinoid receptor 1 (CB1) inverse agonist, aimed at treating obesity. The trial, which included 243 participants with obesity and metabolic syndrome, demonstrated statistically significant weight loss across all doses of monlunabant compared to placebo after 16 weeks. The highest weight loss achieved was 7.1 kg with a 10 mg daily dose. While higher doses did not result in much additional weight loss, they were associated with dose-dependent mild to moderate gastrointestinal and neuropsychiatric side effects. No serious adverse events related to neuropsychiatric effects were reported. Martin Holst Lange, executive vice president and head of Development at Novo Nordisk, highlighted the need for further...Show More
Novo Nordisk A/S, a leading global healthcare company, has successfully completed a phase 2a clinical trial for monlunabant, an oral small molecule cannabinoid receptor 1 (CB1) inverse agonist, aimed at treating obesity. The trial, which included 243 participants with obesity and metabolic syndrome, demonstrated statistically significant weight loss across all doses of monlunabant compared to placebo after 16 weeks. The highest weight loss achieved was 7.1 kg with a 10 mg daily dose. While higher doses did not result in much additional weight loss, they were associated with dose-dependent mild to moderate gastrointestinal and neuropsychiatric side effects. No serious adverse events related to neuropsychiatric effects were reported. Martin Holst Lange, executive vice president and head of Development at Novo Nordisk, highlighted the need for further research to optimize dosing for safety and efficacy. Following these results, Novo Nordisk plans to initiate a larger phase 2b trial in 2025 to explore longer-term dosing and safety in a global population. Monlunabant's mechanism of action targets metabolism and appetite regulation, which could address the significant unmet need in obesity treatment.
全球领先的医疗保健公司诺和诺德已成功完成了一项2a期临床试验,该试验针对治疗肥胖症的口服小分子类肽类受体CB1拮抗剂单侖栓。该试验包括243名肥胖症和代谢综合征患者,结果显示在16周后,与安慰剂相比,单侖栓在所有剂量组中都显著减重。最大减重达到7.1公斤,每日10毫克剂量。虽然更高剂量没有带来更多的减重效果,但它们与剂量相关的轻度到中度胃肠道和神经精神副作用有关。没有报告与神经精神作用相关的严重不良事件。诺和诺德的开发负责人马丁·霍尔斯特·朗格强调了进一步研究以优化剂量对安全性和疗效的影响的必要性。根据这些结果,诺和诺德计划在2025年启动一项规模更大的20亿期试验,以探索更长期的剂量和全球人群的安全性。单侖栓的作用机制针对新陈代谢和食欲调节,可以满足肥胖症治疗中的重要未满足需求。
全球领先的医疗保健公司诺和诺德已成功完成了一项2a期临床试验,该试验针对治疗肥胖症的口服小分子类肽类受体CB1拮抗剂单侖栓。该试验包括243名肥胖症和代谢综合征患者,结果显示在16周后,与安慰剂相比,单侖栓在所有剂量组中都显著减重。最大减重达到7.1公斤,每日10毫克剂量。虽然更高剂量没有带来更多的减重效果,但它们与剂量相关的轻度到中度胃肠道和神经精神副作用有关。没有报告与神经精神作用相关的严重不良事件。诺和诺德的开发负责人马丁·霍尔斯特·朗格强调了进一步研究以优化剂量对安全性和疗效的影响的必要性。根据这些结果,诺和诺德计划在2025年启动一项规模更大的20亿期试验,以探索更长期的剂量和全球人群的安全性。单侖栓的作用机制针对新陈代谢和食欲调节,可以满足肥胖症治疗中的重要未满足需求。
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