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Amgen Reveals Data From Closely Watched Monthly Obesity Drug, With Weight Loss Of Up To 20% At One Year And No Plateau

Amgen Reveals Data From Closely Watched Monthly Obesity Drug, With Weight Loss Of Up To 20% At One Year And No Plateau

安進公佈了備受關注的每月肥胖藥物數據,一年內體重減少最多達20%,並且沒有出現停滯期。
Benzinga ·  11/26 21:36

On Tuesday, Amgen Inc (NASDAQ:AMGN) stock fell during the premarket session after the company released long-anticipated data from the Phase 2 study of MariTide (maridebart cafraglutide, formerly AMG 133) in obese patients.

週二,安進公司(納斯達克:AMGN)股票在盤前交易中下跌,此前該公司發佈了備受期待的MariTide(maridebart cafraglutide,原AMG 133)第2期肥胖病人研究數據。

The company said that MariTide demonstrated up to ~20% average weight loss at one year (52 weeks) without a weight loss plateau, indicating the potential for further weight loss beyond 52 weeks.

公司表示MariTide在一年(52周)內顯示出最多20%的平均減重,沒有減重平台,這表明在52周後可能會進一步減輕體重。

Amgen's stock dropped as the results seemed to fall short of Wall Street's high expectations. CNBC noted that analysts had hoped MariTide would achieve at least 20% weight loss in the Phase 2 trial, with some aiming for as much as 25%.

由於結果似乎未達到華爾街的高預期,安進股價下跌。 CNBC指出,分析師們希望MariTide在第2期試驗中至少能達到20%的減重,有些人甚至希望達到25%。

The study also showed that a subset of patients who typically lose less weight on GLP-1 therapies achieved up to ~17% average weight loss without a weight loss plateau, lowering their average hemoglobin A1C (HbA1c) by up to 2.2 percentage points at week 52.

該研究還顯示,一部分通常在GLP-1治療中減輕體重較少的患者在52周內平均減輕了約17%,沒有減重平台,使其平均血紅蛋白A1c(HbA1c)降低了高達2.2個百分點。

MariTide also demonstrated improvements in cardiometabolic parameters, including blood pressure, triglycerides, and high-sensitivity C-reactive protein (hs-CRP) across doses. There were no significant increases in free fatty acids.

MariTide還改善了心臟代謝參數,包括血壓、甘油三酯和高敏C-反應蛋白(hs-CRP),在各劑量下皆有改喼。血脂沒有顯著增加。

There was no association between the administration of MariTide and bone mineral density changes.

MariTide的使用與骨密度變化之間沒有關聯。

Also Read: Amgen Defends Its Investigational Monthly Weight Loss Injection After Analyst Cites MariTide's Impact on Bone Density

此外閱讀:安進捍衛其調查中的每月減重注射,分析師指出MariTide對骨密度的影響

The most common side effects were gastrointestinal, including vomiting, nausea, and constipation. Amgen said the discontinuation rate in the dose escalation arms due to any AE was ~11% and less than 8% for GI-related events. No additional safety signals were identified.

最常見的副作用是胃腸道問題,包括嘔吐、噁心和便秘。 安進表示,由於任何不良事件,劑量增加的患者停藥率約爲11%,而胃腸道相關事件的停藥率低於8%。 沒有發現額外的安全信號。

In a separate ongoing Phase 1 pharmacokinetic study, additional dosing regimens have been evaluated in a planned preliminary analysis.

在正在進行的第一階段藥代動力學研究中,額外的用藥方案已經在計劃的初步分析中得到評估。

The ongoing Part 2 of the Phase 2 study is investigating MariTide beyond 52 weeks to evaluate further weight loss with continued treatment, weight maintenance through less frequent or lower dosing and durability of weight loss after discontinuation of MariTide.

第2階段研究的進行中是爲了超過52周繼續評估MariTide,以進一步減重、通過減少注射頻率或劑量減少進行維持體重以及在停止MariTide後持續減重的耐久性。

MariTide is expected to be delivered as a single dose in a handheld, autoinjector device with a monthly or less frequent single-injection administration.

預計MariTide將以手持式自動注射器設備的單次劑量形式提供,每月或更少頻繁地進行單次注射。

Amgen is also advancing its obesity pipeline, including oral and injectable approaches composed of incretin and non-incretin mechanisms.

安進還在推進其肥胖研究項目,包括由胰肽激素和非胰肽激素機制組成的口服和注射治療方法。

Price Action: AMGN stock is down 11.6% at $259.88 during the premarket session at last check Tuesday.

價格走勢:AMGN股價在盤前交易中下跌11.6%,至259.88美元,在上週二的最後一次檢查時。

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Photo via Shutterstock.

圖片來自shutterstock。

譯文內容由第三人軟體翻譯。


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