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礼来减肥药在睡眠障碍研究中显示出益处,指出了新的用途

Lilly obesity drug shows benefit in sleep disorder study, pointing to new use

BioPharma Dive | 2024-04-18 | 翻译由动脉网AI生成,点击反馈

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Fresh clinical trial results for Eli Lilly’s drug Zepbound point to a new use for the weight loss medicine in treating a common sleep disorder, adding to evidence the benefits of so-called GLP-1 agonists could extend across a range of conditions.

礼来公司(EliLilly)药物Zepbound的最新临床试验结果表明,减肥药在治疗常见睡眠障碍方面有了新的用途,这进一步证明了所谓的GLP-1激动剂的益处可能会扩展到多种情况。

Zepbound, which is known scientifically as tirzepatide, significantly reduced episodes of obstructive sleep apnea in overweight or obese participants in two late-stage studies run by Lilly. The drug was effective in people who used a breath device that prevents the airway collapse characterizing the disorder, as well as those who didn’t..

在礼来公司进行的两项晚期研究中,Zepbound(科学上称为tirzepatide)显着降低了超重或肥胖参与者的阻塞性睡眠呼吸暂停发作。这种药物对使用呼吸装置的人和不使用呼吸装置的人都有效。。

Sleep apnea is associated with obesity, and weight loss has previously been shown to help sleep apnea symptoms.

睡眠呼吸暂停与肥胖有关,减肥以前已被证明有助于睡眠呼吸暂停症状。

In one Phase 3 trial of people who weren’t using the breathing devices — called continuous positive airway pressure, or CPAP machines — Zepbound reduced the average hourly number of sleep apnea events by 27, or 55%, after one year, compared with a reduction of five for those given a placebo.

在一项针对不使用呼吸装置(称为持续气道正压通气(CPAP)机器)的人的第三阶段试验中,Zepbound在一年后将睡眠呼吸暂停事件的平均每小时次数减少了27次,即55%,而服用安慰剂的人则减少了5次。

In the second Phase 3 study of people on CPAP machines, Zepbound reduced the average number of hourly sleep apnea events by 30, or 63%, compared with an average of six for those who received a placebo.

在CPAP机器上的第二阶段3研究中,Zepbound将每小时睡眠呼吸暂停事件的平均次数减少了30次,即63%,而接受安慰剂的人平均减少了6次。

People treated with Zepbound in the non-CPAP trial lost 18% of their body weight, while those in the CPAP study lost 20%. Participants on placebo in the studies lost 1% or 2% of their body weight, respectively.

在非CPAP试验中接受Zepbound治疗的人体重减轻了18%,而CPAP研究中的人体重减轻了20%。研究中服用安慰剂的参与者分别减轻了1%或2%的体重。

Lilly said it plans to submit the data to the Food and Drug Administration, which has granted the drug Fast Track designation in sleep apnea and obesity, as well as to other drug regulators beginning mid-year. Fuller data from the trials will be revealed at the American Diabetes Association annual meeting in June and published in a medical journal..

礼来表示,计划从年中开始将数据提交给美国食品和药物管理局(FDA),美国食品和药物管理局(FDA)已授予睡眠呼吸暂停和肥胖症药物快速通道的名称,以及其他药物监管机构。这些试验的更全面数据将在6月的美国糖尿病协会年会上公布,并在医学期刊上发表。。

The study findings come as Lilly and GLP-1 rival Novo Nordisk seek to expand the use of their weight loss drugs into disorders that arise from obesity and metabolic dysfunction.

这项研究的发现正值礼来和GLP-1的竞争对手诺和诺德寻求将其减肥药物的使用扩展到肥胖和代谢功能障碍引起的疾病。

Novo recently won FDA approval to begin marketing its drug Wegovy for heart protection after results from a large Phase 3 trial showed it could reduce cardiovascular risk in people with obesity or who were overweight and had heart disease. That data led the U.S. government’s Medicare program for the elderly and disabled to begin covering the drug for some enrollees..

Novo最近获得FDA批准,开始销售其用于心脏保护的药物Wegovy,因为一项大型3期试验的结果表明,它可以降低肥胖或超重并患有心脏病的人的心血管风险。这些数据导致美国政府针对老年人和残疾人的医疗保险计划开始为一些参与者覆盖药物。。

Lilly may not have similar data until 2025.

到2025年,礼来可能没有类似的数据。

Wegovy has also show it can ease symptoms of heart failure in people with obesity. Both Novo and Lilly have tested their drugs in the obesity-related fatty liver inflammation disorder known as MASH, with positive mid-stage data reported so far from both.

Wegovy还表明它可以缓解肥胖人群的心力衰竭症状。Novo和Lilly都在肥胖相关的脂肪肝炎症疾病(MASH)中测试了他们的药物,到目前为止,这两种药物的中期数据均为阳性。

Zepbound is sold under the brand name Mounjaro for use in treating diabetes.

Zepbound以Mounjaro品牌出售,用于治疗糖尿病。

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