Novo Nordisk's Hybrid Weight Loss Drug Falls Short On Expectations, Stock Plunges
Novo Nordisk's Hybrid Weight Loss Drug Falls Short On Expectations, Stock Plunges
The trial included 3,417 randomized people with obesity or overweight with one or more comorbidities and a mean baseline body weight of 106.9 kg.On Friday, Novo Nordisk A/S (NYSE:NVO) stock plunged after the company released headline results from the REDEFINE 1 Phase 3 trial in the global REDEFINE program.
週五，諾和諾德公司（紐交所：NVO）的股票大幅下跌，此前該公司發佈了全球REDEFINE計劃中REDEFINE 1 III期試驗的頭條結果。
REDEFINE 1 is a 68-week efficacy and safety trial investigating subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg, and placebo, all administered once-weekly.
REDEFINE 1是一個68周的有效性和安全性試驗，研究了皮下給藥的CagriSema（cagrilintide 2.4毫克和semaglutide 2.4毫克的固定劑量組合）與單獨的元件cagrilintide 2.4毫克、semaglutide 2.4毫克和安慰劑之間的比較，所有這些均每週一次給藥。
Also Read: Novo Nordisk's Ozempic Label Expansion Snags Approval From European Drug Regulator's Advisory Panel
另請閱讀：諾和諾德的Ozempic標籤擴展獲得歐洲藥品監管機構諮詢小組的批准
The trial included 3,417 randomized people with obesity or overweight with one or more comorbidities and a mean baseline body weight of 106.9 kg.
該試驗包括3,417名隨機分配的肥胖或超重患者，他們有一個或多個合併症，平均基礎體重爲106.9公斤。
The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss with CagriSema versus placebo at week 68.
該試驗通過在第68周展示CagriSema與安慰劑相比的統計學顯著且優越的體重減輕，達到了其主要終點。
When evaluating the effects of treatment if all people adhered to treatment, people treated with CagriSema achieved a weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone.
在評估治療效果時，如果所有人都依從治療，接受CagriSema治療的人在68周後實現了22.7%的體重減輕，而cagrilintide 2.4毫克的減輕爲11.8%，semaglutide 2.4毫克爲16.1%，單用安慰劑爲2.3%。
In November, Novo Nordisk said its hybrid drug, CagriSema, aims to reduce weight by 25% without added side effects.
諾和諾德在11月表示，其混合藥物CagriSema旨在在沒有額外副作用的情況下實現25%的體重減輕。
In addition, 40.4% of patients who received CagriSema reached a weight loss of 25% or more after 68 weeks, compared to 6.0% with cagrilintide 2.4 mg, 16.2% with semaglutide 2.4 mg, and 0.9% with placebo.
此外，接受CagriSema的患者中，有40.4%在68周後實現了25%或更多的體重減輕，而cagrilintide 2.4毫克爲6.0%，semaglutide 2.4毫克爲16.2%，安慰劑爲0.9%。
When applying the treatment policy estimand, people treated with CagriSema achieved a weight loss of 20.4% compared to a reduction of 11.5% with cagrilintide 2.4 mg, 14.9% with semaglutide 2.4 mg and 3.0% with placebo.
應用治療策略估算時，接受CagriSema治療的人實現了20.4%的體重減輕，而cagrilintide 2.4 mg的減輕爲11.5%，semaglutide 2.4 mg爲14.9%，安慰劑爲3.0%。
In the trial, CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class.
在試驗中，CagriSema、cagrilintide 2.4 mg和semaglutide 2.4 mg表現出安全和良好的耐受性。CagriSema最常見的不良事件是胃腸道反應，大多數都是輕微到中等程度，並隨着時間的推移減輕，這與GLP-1受體激動劑類一致。
The results from the second pivotal phase 3 trial, REDEFINE 2, in adults with type 2 diabetes and either obesity or overweight are expected during the first half of 2025.
第二項關鍵性三期試驗REDEFINE 2的結果預計將在2025年上半年公佈，該試驗針對類型2糖尿病及肥胖或超重成年患者。
In reaction to lower-than-expected trial data, Eli Lilly And Co (NYSE:LLY) stock is trading higher. Lilly's own obesity injection containing tirzepatide demonstrated sustained average weight loss of 22.9% (15 mg dose) through the three-year treatment period for the efficacy estimandi.
由於試驗數據低於預期，禮來（紐交所：LLY）的股票交易上漲。禮來自己的肥胖注射劑包含tirzepatide，在三年的治療期間，針對療效估算的平均體重減輕達到22.9%（15毫克劑量）。
Recently, Novo Nordisk stock came under pressure when two new studies from the University of Southern Denmark suggested that Ozempic, a diabetes medication, may increase the risk of developing a rare eye condition.
最近，諾和諾德的股票承壓，南丹麥大學的兩項新研究建議Ozempic（一種糖尿病藥物）可能增加發展罕見眼部疾病的風險。
Price Action: NVO stock is down 16.50% at $86.33, and LLY stock is up 8.91% at $825 during the premarket session at the last check on Friday.
價格動態：NVO股票下跌16.50%，現報$86.33，而LLY股票在上週五盤前交易時上漲8.91%，現報$825。
- Your Healthcare Costs are Soaring! US Spending Reached $5 Trillion In 2023 with Major Increase in Obesity and Diabetes Drugs, Hospital Services
- 您的醫療費用正在飆升！2023年美國支出達到5萬億，與肥胖和糖尿病藥物、醫院服務的重大增加有關。
Photo via Shutterstock
圖片來自Shutterstock
譯文內容由第三人軟體翻譯。
