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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 21:52
牛牛AI助理已提取核心訊息
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.
諾和諾德（Novo Nordisk A/S）是一家領先的全球醫療保健公司，已成功完成了針對肥胖症治療的一項2a期臨床試驗，試驗的對象是莫隆南特（monlunabant），一種口服小分子cannabinoid受體1（CB1）的逆激動劑。這項試驗包括243名肥胖和代謝綜合徵患者，結果顯示，在16周後，莫隆南特的所有劑量與安慰劑相比都表現出了統計學上顯著的體重減輕。最高的體重減輕達到了7.1公斤，對應每日10毫克的劑量。儘管更高的劑量並未導致更多額外的體重減輕，但它們與劑量依賴性的輕度到中度的胃腸道和神經精神副作用有關。與神經精神效應有關的嚴重不良事件沒有被報告。諾和諾德的研發執行副總裁Martin Holst Lange強調了需要進一步研究以優化安全性和療效的用量。根據這些結果，諾和諾德計劃在2025年啓動一項更大規模的20億期試驗，以探索全球人群的長期用藥和安全性。莫隆南特的作用機制瞄準新陳代謝和食慾調節，有望解決肥胖治療中的重大未滿足需求。
諾和諾德（Novo Nordisk A/S）是一家領先的全球醫療保健公司，已成功完成了針對肥胖症治療的一項2a期臨床試驗，試驗的對象是莫隆南特（monlunabant），一種口服小分子cannabinoid受體1（CB1）的逆激動劑。這項試驗包括243名肥胖和代謝綜合徵患者，結果顯示，在16周後，莫隆南特的所有劑量與安慰劑相比都表現出了統計學上顯著的體重減輕。最高的體重減輕達到了7.1公斤，對應每日10毫克的劑量。儘管更高的劑量並未導致更多額外的體重減輕，但它們與劑量依賴性的輕度到中度的胃腸道和神經精神副作用有關。與神經精神效應有關的嚴重不良事件沒有被報告。諾和諾德的研發執行副總裁Martin Holst Lange強調了需要進一步研究以優化安全性和療效的用量。根據這些結果，諾和諾德計劃在2025年啓動一項更大規模的20億期試驗，以探索全球人群的長期用藥和安全性。莫隆南特的作用機制瞄準新陳代謝和食慾調節，有望解決肥胖治療中的重大未滿足需求。
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