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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 期肥胖試驗成功完成
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.
全球領先的醫療保健公司諾和諾德已成功完成了一項2a期臨床試驗,該試驗針對治療肥胖症的口服小分子類肽類受體CB1拮抗劑單侖栓。該試驗包括243名肥胖症和代謝綜合徵患者,結果顯示在16周後,與安慰劑相比,單侖栓在所有劑量組中都顯著減重。最大減重達到7.1公斤,每日10毫克劑量。雖然更高劑量沒有帶來更多的減重效果,但它們與劑量相關的輕度到中度胃腸道和神經精神副作用有關。沒有報告與神經精神作用相關的嚴重不良事件。諾和諾德的開發負責人馬丁·霍爾斯特·朗格強調了進一步研究以優化劑量對安全性和療效的影響的必要性。根據這些結果,諾和諾德計劃在2025年啓動一項規模更大的20億期試驗,以探索更長期的劑量和全球人群的安全性。單侖栓的作用機制針對新陳代謝和食慾調節,可以滿足肥胖症治療中的重要未滿足需求。
全球領先的醫療保健公司諾和諾德已成功完成了一項2a期臨床試驗,該試驗針對治療肥胖症的口服小分子類肽類受體CB1拮抗劑單侖栓。該試驗包括243名肥胖症和代謝綜合徵患者,結果顯示在16周後,與安慰劑相比,單侖栓在所有劑量組中都顯著減重。最大減重達到7.1公斤,每日10毫克劑量。雖然更高劑量沒有帶來更多的減重效果,但它們與劑量相關的輕度到中度胃腸道和神經精神副作用有關。沒有報告與神經精神作用相關的嚴重不良事件。諾和諾德的開發負責人馬丁·霍爾斯特·朗格強調了進一步研究以優化劑量對安全性和療效的影響的必要性。根據這些結果,諾和諾德計劃在2025年啓動一項規模更大的20億期試驗,以探索更長期的劑量和全球人群的安全性。單侖栓的作用機制針對新陳代謝和食慾調節,可以滿足肥胖症治療中的重要未滿足需求。
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