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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

诺和诺德的混合减肥药未达预期,股价大跌
Benzinga ·  12/20 19:58

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.

周五,诺和诺德公司(纽交所:NVO)的股票大幅下跌,此前该公司发布了全球REDEFINE计划中REDEFINE 1 III期试验的头条结果。

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是一个68周的有效性和安全性试验,研究了皮下给药的CagriSema(cagrilintide 2.4毫克和semaglutide 2.4毫克的固定剂量组合)与单独的元件cagrilintide 2.4毫克、semaglutide 2.4毫克和安慰剂之间的比较,所有这些均每周一次给药。

Also Read: Novo Nordisk's Ozempic Label Expansion Snags Approval From European Drug Regulator's Advisory Panel

另请阅读:诺和诺德的Ozempic标签扩展获得欧洲药品监管机构咨询小组的批准

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.

该试验包括3,417名随机分配的肥胖或超重患者,他们有一个或多个合并症,平均基础体重为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.

该试验通过在第68周展示CagriSema与安慰剂相比的统计学显著且优越的体重减轻,达到了其主要终点。

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.

在评估治疗效果时,如果所有人都依从治疗,接受CagriSema治疗的人在68周后实现了22.7%的体重减轻,而cagrilintide 2.4毫克的减轻为11.8%,semaglutide 2.4毫克为16.1%,单用安慰剂为2.3%。

In November, Novo Nordisk said its hybrid drug, CagriSema, aims to reduce weight by 25% without added side effects.

诺和诺德在11月表示,其混合药物CagriSema旨在在没有额外副作用的情况下实现25%的体重减轻。

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周后实现了25%或更多的体重减轻,而cagrilintide 2.4毫克为6.0%,semaglutide 2.4毫克为16.2%,安慰剂为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.

应用治疗策略估算时,接受CagriSema治疗的人实现了20.4%的体重减轻,而cagrilintide 2.4 mg的减轻为11.5%,semaglutide 2.4 mg为14.9%,安慰剂为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.

在试验中,CagriSema、cagrilintide 2.4 mg和semaglutide 2.4 mg表现出安全和良好的耐受性。CagriSema最常见的不良事件是胃肠道反应,大多数都是轻微到中等程度,并随着时间的推移减轻,这与GLP-1受体激动剂类一致。

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.

第二项关键性三期试验REDEFINE 2的结果预计将在2025年上半年公布,该试验针对类型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.

由于试验数据低于预期,礼来(纽交所:LLY)的股票交易上涨。礼来自己的肥胖注射剂包含tirzepatide,在三年的治疗期间,针对疗效估算的平均体重减轻达到22.9%(15毫克剂量)。

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,诺和诺德的股票承压,南丹麦大学的两项新研究建议Ozempic(一种糖尿病药物)可能增加发展罕见眼部疾病的风险。

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.

价格动态:NVO股票下跌16.50%,现报$86.33,而LLY股票在上周五盘前交易时上涨8.91%,现报$825。

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