Veru表示，节省肌肉的肥胖药物安全进入第3阶段试验Muscle-sparing obesity drug safe for Phase 3 trial, Veru says

动脉网2025-05-28

Dive Brief:简报：Veru’s muscle-preserving obesity drug enobosarm, when combined with Novo Nordisk’s Wegovy, may have less gastrointestinal side effects at the dose planned for pivotal testing than Wegovy...

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However, the company reported more volunteers given enobosarm had elevated liver enzymes, although levels subsequently dropped during the trial..Veru表示，接受两种剂量的enobosarm和Wegovy治疗的患者中，出现恶心或胃灼热的人数比单独使用Wegovy的患者少，而在计划用于第三阶段测试的enobosarm剂量下，出现腹泻或呕吐的人数也较少。然而，该公司报告称，更多接受enobosarm治疗的志愿者肝酶升高，尽管在试验期间水平随后下降。Veru shares rose significantly in morning trading Wednesday, although at around 60 cents a share they remain well below the $1.28 hit before release of周三早盘交易中，Veru的股价显著上涨，尽管每股约60美分的价格仍远低于发布前的1.28美元。topline weight-loss data in January一月份的减肥数据头条. That data suggested enobosarm helps with body composition, but doesn’t increase weight loss when used with Wegovy.. 数据表明，enobosarm 有助于改善身体组成，但与 Wegovy 一起使用时并不能增加体重减轻。Dive Insight:深度洞察：The safety data from the trial had remained “blinded” to the company and researchers until participants could complete an extension to the main 16-week stage of the trial. The 168-person trial sought to show that adding enobosarm to Wegovy could result in less loss of lean muscle mass than Wegovy.在参与者完成试验主要的16周阶段的扩展之前，该试验的安全数据对公司和研究人员保持“盲态”。这项涉及168人的试验旨在证明，在Wegovy中加入enobosarm可以减少瘦肌肉质量的损失，相较于单独使用Wegovy。Body composition is an emerging issue in obesity treatment as Wegovy and Eli Lilly’s Zepbound also cut lean muscle mass alongside fat, which in older patients could raise the risk of premature frailty. Veru’s trial focused specifically on people with obesity at least 60 years old.身体组成是肥胖治疗中的一个新兴问题，因为Wegovy和Eli Lilly的Zepbound在减少脂肪的同时也会削减瘦肌肉量，这在老年患者中可能会增加过早虚弱的风险。Veru的试验特别针对至少60岁以上的肥胖人群。While adding enobosarm to Wegovy didn’t increase weight loss versus Wegovy and a placebo, it kept lean body mass loss to 1.2%,虽然将恩诺司他加入Wegovy并未比Wegovy和安慰剂增加更多的体重减轻，但它将瘦体质量的损失控制在了1.2%，significantly less显著减少than the 4.1% lean body mass loss seen with the Wegovy plus placebo arm. Fewer people who took enobosarm and a placebo also saw substantial losses in their stair-climb power, a measure of physical function.比使用Wegovy加安慰剂组的4.1%瘦体重损失要少。服用恩诺沙姆和安慰剂的人中，也有较少人出现楼梯攀爬力量的显著下降，这是身体功能的一项指标。Veru tested two doses of enobosarm, 3 and 6 milligrams daily, alongside weekly shots of Wegovy. Based on the data seen so far, Veru will take the 3 milligram dose into a Phase 3 trial because the 6 milligram dose “did not provide any additional benefit.” At that 3 milligram level, only one trial participant experienced elevated liver enzymes — a mild case in which the individual’s levels returned to baseline while they were still taking the drug..Veru测试了两种剂量的enobosarm，分别是每日3毫克和6毫克，并与每周一次的Wegovy注射联合使用。根据目前看到的数据，Veru将把3毫克剂量推进到第三阶段试验，因为6毫克剂量“没有提供任何额外益处”。在3毫克的剂量下，只有一名试验参与者出现了肝酶升高的情况——这是一个轻微的案例，该参与者的肝酶水平在继续服药期间已恢复到基线。Meanwhile, the company also said it is preparing a “novel, patentable, modified release oral formulation” for Phase 3 testing and potential commercialization that will undergo Phase 1 trials in coming weeks. The company said it believes the formulation patent from the new version will extend its market exclusivity to 2045..同时，该公司还表示，它正在准备一种“新颖的、可申请专利的、改良释放口服制剂”，用于第三阶段测试和潜在的商业化。该制剂将在未来几周内进行第一阶段试验。公司表示，它认为新版本的制剂专利将使其市场独占期延长至2045年。Enobosarm has been tested in the past as a drug to恩博司他过去曾作为药物进行过测试，以prevent muscle wasting in people with lung cancer防止肺癌患者的肌肉萎缩and other disease settings.和其他疾病环境。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2539701174","isCrawlerRequest":true}