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诺和诺德通过Wegovy组合疗法肥胖症试验向礼来反击

Novo fights back at Lilly with Wegovy combo trial in obesity

Fierce Pharma 等信源发布 2023-11-15 23:55

可切换为仅中文


In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.

为了应对礼来公司的冲击,诺和诺德正在升级肥胖市场斗争,对其主要对手进行新的正面对比试验。

Novo has unveiled a new phase 3 trial pitting CagriSema, a fixed-dose combination of Wegovy and the investigational drug cagrilintide, against Lilly’s Zepbound in people with obesity, according to a clinicaltrials.gov entry.

根据clinicaltrials.gov的一项条目,Novo推出了一项新的3期临床试验,针对Lilly's Zepbound,一种固定剂量的Wegovy和研究药物cagrilintide的组合,用于治疗肥胖患者。

The study plans to enroll 800 patients, and those with diabetes are excluded. Its primary goal is to evaluate how well the two companies’ therapies could help people lose weight relative to each other after 72 weeks of treatment.

该研究计划招募800名患者,排除糖尿病患者。其主要目标是评估两家公司的疗法在治疗72周后能够帮助人们相对于彼此减肥的程度。

In addition, the trial will measure the number of patients in each arm who’ve achieved at least 25% or 30% weight reduction at the end of treatment. Other secondary endpoints include change in cholesterol levels, triglycerides, waist circumference, systolic blood pressure and serious side effects.

此外,该试验将测量每个手臂在治疗结束时体重减轻至少25%或30%的患者人数。其他次要终点包括胆固醇水平,甘油三酯,腰围,收缩压和严重副作用的变化。

The Novo trial comes about seven months after Lilly launched a head-to-head phase 3 study testing Zepbound—also known as Mounjaro in diabetes treatment—against Wegovy in obese patients or those who’re overweight with certain health conditions.

Novo试验大约在礼来公司推出头对头3期研究后的7个月内进行,该研究测试了Zepbound也被称为Mounjaro,用于治疗肥胖患者或某些健康状况超重的Wegovy糖尿病患者。

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In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy

在重度肥胖斗争中,礼来公司针对诺和诺德公司的韦戈韦发起了Mounjaro头对头的试验

Zepbound, a.k.a. tirzepatide, gained an FDA nod last week for chronic weight management in people with obesity or who are overweight. The GIP/GLP-1 duo agonist has shown better weight reduction results than Wegovy did in separate trials.

Zepbound,a.k.a。tirzepatide,上周获得了FDA的点头,用于肥胖或超重人群的慢性体重管理。GIP/GLP-1双重激动剂显示出比Wegovy在单独试验中更好的减肥效果。

Novo believes that the addition of cagrilintide could turn the tide for Wegovy in this weight loss rivalry. CagriSema coadministers 2.4mg cagrilintide with 2.4mg Wegovy as a fixed-dose, once-weekly injection. The new obesity trial pits CagriSema against the highest, 15mg dose of Zepbound.

Novo认为,在这种减肥竞争中,添加cagrilintide可能会改变Wegovy的潮流。CagriSema共同给药2.4mg cagrilintide和2.4mg Wegovy作为固定剂量,每周一次注射。新的肥胖试验将CagriSema与最高剂量的15mg剂量的Zepbound进行了对比。

Cagrilintide is a long-acting amylin analog. Phase 2 data published in June showed that once-weekly CagriSema led to an average 15.6% bodyweight reduction at week 32 among Type 2 diabetes patients who were overweight or obese. By comparison, people on cagrilintide alone achieved an average 8.1% loss, while Wegovy hit a 5.1% decrease.

Cagrilintide是一种长效胰岛淀粉样多肽类似物。6月公布的第2阶段数据显示,在超重或肥胖的2型糖尿病患者中,每周一次的CagriSema导致第32周平均体重减轻15.6%。相比之下,单独使用cagrilintide的人平均损失8.1%,而Wegovy则下降了5.1%。

The study was small with only 92 participants..

这项研究很小,只有92名参与者。。

Before the new CagriSema-Zepbound obesity trial, Novo had already kicked off a series of phase 3 program for CagriSema in Type 2 diabetes in 2022. One of the planned trials, REIMAGINE 4, is expected to be a head-to-head between CagriSema and Lilly’s Mounjaro.

在新的CagriSema-Zepbound肥胖试验之前,Novo已经在2022年启动了一系列针对2型糖尿病CagriSema的3期计划。其中一项计划中的试验,REIMAGINE 4,预计将成为CagriSema和Lilly's Mounjaro之间的正面对比。

One important difference between the current Novo trial and Lilly’s is that the CagriSema study only allows obese people with a body mass index (BMI) of at least 30kg/m2, while the SURMOUNT-5 trial between Zepbound and Wegovy includes overweight people with BMI of 27kg/m2 and weight-related comorbidities..

目前的Novo试验和礼来公司之间的一个重要区别是,CagriSema研究仅允许体重指数(BMI)至少为30kg/m2的肥胖人群,而Zepbound和Wegovy之间的UNCERVENT-5试验包括超重人群BMI为27kg/m2和体重相关的合并症。。

Novo didn’t immediately respond to a Fierce Pharma request for comment on the trial design and the Danish company’s regulatory plan for CagriSema in obesity.

Novo没有立即回应激烈的制药公司对试验设计和丹麦公司关于肥胖症CagriSema监管计划发表评论的请求。

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Novo Nordisk says Wegovy can help heart disease patients—and not just because it produces weight loss

诺和诺德说,Wegovy可以帮助心脏病患者,而不仅仅是因为它可以减轻体重

Lilly also has a long-acting amylin agonist in phase 1 testing, according to the company’s website. It’s not clear if Lilly will or can combine the candidate with tirzepatide.

根据该公司的网站,礼来公司还在第一阶段测试中使用长效胰岛淀粉样多肽激动剂。目前尚不清楚礼来公司是否会或可以将候选人与tirzepatide联合使用。

The weight loss market is getting increasingly competitive with Lilly’s launch of Zepbound. Also last week, AstraZeneca unveiled a deal to purchase an oral GLP-1 drug from China’s Ecoogene. At least the market looks big enough for multiple players. Both Novo and Lilly are struggling to meet demand, and major manufacturing expansions are underway at both firms..

随着礼来公司推出Zepbound,减肥市场越来越具有竞争力。同样在上周,阿斯利康公布了一项从中国Ecoogene购买口服GLP-1药物的协议。至少市场看起来足够大,适合多个玩家。Novo和Lilly都在努力满足需求,两家公司正在进行重大制造业扩张。。