默克公布肝病新药2b期试验积极结果：efinopegdutide使63%患者脂肪性肝炎消退，安慰剂组为13%
默克（Merck & Co.，纽交所代码 MRK）11月9日公布，其在研药物 efinopegdutide（研发代号 MK-6024）在患有代谢功能障碍相关脂肪性肝炎（MASH）并伴2至3期肝纤维化的成年人中进行的2b期临床试验取得积极结果。
Efinopegdutide 是一种同时作用于 GLP-1 受体与胰高血糖素受体的双重激动剂，每周一次皮下注射，最初由韩国韩美药品（Hanmi Pharmaceutical）开发，默克依独家授权协议引进其用于治疗脂肪性肝炎的权益。MASH 是代谢功能障碍相关脂肪性肝病（MASLD）中较重的一型，肝脏出现炎症与损伤，可逐步发展为肝纤维化、肝硬化乃至肝癌，目前获批疗法有限。
efinopegdutide 的2b期研究以经肝活检确认的 MASH 患者为对象，主要终点是第52周时实现 MASH 消退且肝纤维化未恶化的患者比例，另一项关键指标是纤维化至少改善一期且脂肪性肝炎未恶化的比例。据在美国肝病研究学会（AASLD）2026年年会上公布的肝活检数据，接受7毫克剂量的患者中，63%实现 MASH 消退，安慰剂组这一比例为13%，试验达到主要目标。
默克表示，公司将按计划推进该药的后续开发。Efinopegdutide 此前在较早期的研究中已显示出降低肝脏脂肪含量的作用，并曾获美国食品药品管理局（FDA）快速通道资格认定。默克总部位于新泽西州 Rahway，其美国与加拿大以外地区以 MSD 之名运营。
（来源：默克）
Merck Reports Positive Phase 2b Results for Efinopegdutide in MASH: 63% of Patients on the 7 mg Dose Achieved MASH Resolution vs. 13% on Placebo
Merck & Co. (NYSE: MRK) announced on November 9 positive results from a Phase 2b clinical trial of its investigational drug efinopegdutide (MK-6024) in adults with metabolic dysfunction-associated steatohepatitis (MASH) and stage 2 to 3 liver fibrosis.
Efinopegdutide is a dual agonist of the GLP-1 and glucagon receptors, given by subcutaneous injection once a week. It was originally developed by South Korea's Hanmi Pharmaceutical, and Merck holds rights to it for the treatment of fatty liver disease under an exclusive licensing agreement. MASH is the more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD), in which inflammation and liver damage can progress to fibrosis, cirrhosis and liver cancer, and approved treatment options remain limited.
The Phase 2b study enrolled patients with biopsy-confirmed MASH. Its primary endpoint was the proportion of patients achieving MASH resolution without worsening of fibrosis at Week 52, with a key secondary measure of at least one stage of fibrosis improvement without worsening of steatohepatitis. In biopsy data presented at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting 2026, 63% of patients receiving the 7 mg dose achieved MASH resolution, compared with 13% on placebo, meeting the trial's main goal.
Merck said it will advance the program as planned. In earlier studies, efinopegdutide had already shown an ability to reduce liver fat content, and the drug previously received Fast Track designation from the U.S. Food and Drug Administration. Merck is headquartered in Rahway, New Jersey, and operates as MSD outside the United States and Canada.
(Source: Merck)
来源：默克
发布：GSM·美国（发布链接）
图片来源：图：默克（在美国与加拿大以外称 MSD）位于北京的办公大楼。N509FZ 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / Photo: The Merck Sharp & Dohme (MSD) building in Beijing. Photo by N509FZ, CC BY-SA 4.0, via Wikimedia Commons.
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