Novo Nordisk today announced the headline results from part 1 of the ongoing ESSENCE trial, a pivotal phase 3, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3)1. 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 randomised people at 72 weeks.The trial achieved its primary endpoints by demonstrating a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis with semaglutide 2.4 mg compared to placebo.

诺和诺德今天宣布了正在进行的ESSENCE试验第一部分的主要结果，这是一项关键的3240周双盲试验，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1。ESSENCE试验的第1部分评估了每周一次的semaglutide 2.4 mg对肝组织（组织学）的影响，与安慰剂相比，在72周时对前800名随机人群进行了标准护理。该试验通过证明肝纤维化的统计学显着和优越的改善而达到了其主要终点，与安慰剂相比，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。

At week 72, 37.0% of people treated with semaglutide 2.4 mg achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.5% on placebo2. 62.9% of people treated with semaglutide 2.4 mg achieved resolution of steatohepatitis3 with no worsening of liver fibrosis compared to 34.1% on placebo2.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.“We are very pleased about the ESSENCE clinical trial results and the potential of semaglutide to help people living with MASH” said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.

在第72周，37.0%接受semaglutide 2.4 mg治疗的患者肝纤维化得到改善，脂肪性肝炎没有恶化，而安慰剂组为22.5%。62.9%接受semaglutide 2.4 mg治疗的患者脂肪性肝炎消退3，肝纤维化没有恶化，而安慰剂组为34.1%。在试验中，semaglutide 2.4 mg似乎具有安全且耐受性良好的特征，与之前的semaglutide 2.4 mg试验一致。诺和诺德执行副总裁兼开发主管马丁·霍尔斯特·兰格（MartinHolstLange）表示：“我们对Essential临床试验结果和semaglutide帮助MASH患者的潜力感到非常高兴。”。

“Among people with overweight or obesity, one in three live with MASH. This has a serious impact on their health and represents a significant unmet need.”Novo Nordisk expects to file for regulatory approvals in the US and EU in the first half of 2025. The detailed results from ESSENCE will be presented at a scientific conference in 2024.

“在超重或肥胖的人群中，三分之一的人患有MASH。这对他们的健康产生了严重影响，并且是一个严重的未满足需求。”诺和诺德预计将于2025年上半年在美国和欧盟提交监管批准。。

Part 2 of the ESS.

ESS的第2部分。