On Friday, Novo Nordisk A/S NVO released headline results from part 1 of the ongoing ESSENCE Phase 3 trial, a 240-week trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3).

周五，诺和诺德公司（Novo Nordisk A/S NVO）发布了正在进行的ESSENCE 3期试验第一部分的标题结果，该试验为期240周，对1200名患有代谢功能障碍相关脂肪性肝炎（MASH）和中度至晚期肝纤维化（2或3期）的成年人进行了试验。

Once-weekly, subcutaneous semaglutide 2.4 mg is marketed under the brand name Wegovy.

每周一次，皮下注射semaglutide 2.4 mg，品牌为Wegovy。

Part 1 of the ESSENCE trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue (histology) compared to placebo on top of standard of care for the first 800 randomized people at 72 weeks.

ESSENCE试验的第1部分评估了在72周时前800名随机人群的标准治疗基础上，与安慰剂相比，每周一次的semaglutide 2.4 mg对肝组织（组织学）的影响。

The trial achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis and resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo.

与安慰剂相比，该试验通过显示肝纤维化的统计学显着和优越的改善而达到其主要终点，脂肪性肝炎没有恶化，脂肪性肝炎的消退也没有肝纤维化的恶化。

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At week 72, 37.0% of people treated with semaglutide 2.4 mg improved liver fibrosis with no worsening of steatohepatitis compared to 22.5% on placebo.

在第72周，37.0%接受semaglutide 2.4 mg治疗的患者改善了肝纤维化，脂肪性肝炎没有恶化，而安慰剂组为22.5%。

62.9% of people treated with semaglutide 2.4 mg achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.1% on placebo.

62.9%接受semaglutide 2.4 mg治疗的患者脂肪性肝炎消退，肝纤维化没有恶化，而安慰剂组为34.1%。

In the trial, semaglutide 2.4 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 2.4 mg trials.

在该试验中，与之前的semaglutide 2.4 mg试验一致，semaglutide 2.4 mg似乎具有安全且耐受性良好的特征。

Novo Nordisk expects to file for regulatory approvals in the U.S. and EU in the first half of 2025.

诺和诺德预计将于2025年上半年在美国和欧盟提交监管审批。

The detailed results from ESSENCE will be presented at a scientific conference in 2024.

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Part 2 of the ESSENCE trial will continue with the expected readout in 2029.

Essential试验的第2部分将继续进行，预计将于2029年读出。

The update comes as the FDA revised its shortage list to note that the .25 mg starter dose of semaglutide-based obesity med Wegovy is now available in the U.S.

最新消息发布之际，美国食品和药物管理局（FDA）修订了短缺清单，指出以semaglutide为基础的0.25毫克起始剂量的肥胖med Wegovy现已在美国上市。

Less than a month ago, the FDA removed Eli Lilly And Co’s LLY tirzepatide from its shortage list.

不到一个月前，美国食品和药物管理局（FDA）将礼来公司（EliLilly）及其合作公司（Co.）的LLY tirzepatide从短缺清单中删除。

In October, Novo Nordisk shared data from the SOUL Phase 3 cardiovascular outcomes trial that evaluated subcutaneous once-weekly (injectable) semaglutide 2.4 mg.

10月，诺和诺德分享了SOUR 3期心血管结局试验的数据，该试验评估了每周一次皮下注射（可注射）semaglutide 2.4 mg。

The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo.

该试验实现了其主要目标，证明与安慰剂相比，口服semaglutide治疗的患者的MACE降低了14%，具有统计学意义。

Major adverse cardiovascular events (MACE) are defined as cardiac arrest, stroke, heart failure, or cardiovascular death.

主要不良心血管事件（MACE）定义为心脏骤停，中风，心力衰竭或心血管死亡。

Price Action: NVO stock is up 0.88% at $112.93 during the premarket session at the last check on Friday.

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