A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease

This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.

开始日期2026-03-13

申办/合作机构

GSK Plc

NCT07335198

/ Recruiting临床1期

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry

This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry.

开始日期2026-03-05

申办/合作机构

GSK Plc

NCT07221188

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.

开始日期2025-12-12

申办/合作机构

GSK Plc

100 项与 Efimosfermin alfa 相关的临床结果

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100 项与 Efimosfermin alfa 相关的转化医学

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100 项与 Efimosfermin alfa 相关的专利（医药）

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项与 Efimosfermin alfa 相关的文献（医药）

2026-02-01·LANCET

Efimosfermin alfa (BOS-580) once per month in people with metabolic dysfunction-associated steatohepatitis with F2 or F3 fibrosis: results from a 24-week, randomised, double-blind, placebo-controlled, phase 2 trial

Article

作者: Kowdley, Kris V ; Zhao, Jeff ; Odrljin, Tatjana ; Jeglinski, Brenda ; Bain, Gerard ; Loomba, Rohit ; Noureddin, Mazen ; Koziel, Margaret James

BACKGROUND:

The growing prevalence of metabolic dysfunction-associated steatohepatitis (MASH) underscores the unmet need for effective and safe liver-targeted therapies to prevent fibrosis and disease progression. The aim of this study was to evaluate the efficacy and safety of efimosfermin alfa (henceforth referred to as efimosfermin, formerly BOS-580), an FGF21 analogue taken once per month, in patients with MASH and moderate or advanced fibrosis.

METHODS:

This 24-week, randomised, double-blind, placebo-controlled, phase 2 trial evaluated the safety and efficacy of efimosfermin in participants aged 18-75 years with a BMI of at least 27 kg/m² and MASH and F2 or F3 fibrosis present on a diagnostic liver biopsy done either during screening or within 6 months before the first day of dosing, and total activity Nonalcoholic Fatty Liver Disease Activity Score (NAS) of at least 4 with a minimum score of 1 point for all three NAS components (steatosis, hepatocyte ballooning, and lobular inflammation). The trial was conducted at 34 clinical research study sites in the USA. Participants were randomly assigned 1:1 to efimosfermin 300 mg or placebo administered by subcutaneous injection every 4 weeks (Q4W) over 24 weeks, stratified by MASH fibrosis stage (F2 vs F3 stage). Participants, investigators, and those assessing outcomes were masked to group assignment. The primary endpoint was safety and tolerability (ie, treatment-emergent adverse events, changes from baseline to week 24 in blood pressure and heart rate, and the incidence of grade 3 and grade 4 laboratory abnormalities at week 24), analysed in all participants who received at least one dose. This trial is registered with ClinicalTrials.gov (NCT04880031) and was completed on Sept 18, 2024.

FINDINGS:

Between May 4, 2023, and March 22, 2024, of 1171 participants screened, 84 participants were randomly assigned to efimosfermin 300 mg Q4W (n=43) or placebo (n=41); 44 (52%) were female and 40 (48%) were male. 48 (57%) had F2 fibrosis and 36 (43%) had F3 fibrosis; 65 had evaluable week-24 biopsy results. All 43 in the efimosfermin group and 40 of 41 participants in the placebo group received at least one dose. Adverse events were reported in 29 (67%) of 43 participants receiving efimosfermin and 22 (55%) of 40 receiving placebo. The majority of treatment-emergent adverse events were mild (24 [56%] of 43 in the efimosfermin group vs 15 [38%] of 40 in the placebo group) or moderate (18 [42%] vs 14 [35%]) in severity. Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. There were no clinically meaningful changes in vital signs between treatment and placebo groups, and no clinically significant grade 3 or higher laboratory abnormalities observed for either group. No deaths or adverse events greater than grade 3 were observed during the study.

INTERPRETATION:

In this phase 2 trial, treatment with efimosfermin once per month was generally well tolerated in participants with biopsy-confirmed MASH and F2 or F3 fibrosis. These results support the further development of efimosfermin for treatment of MASH-related fibrosis.

FUNDING:

Boston Pharmaceuticals and GSK.

2025-12-01·Gastroenterology & hepatology

Once-Monthly Efimosfermin Alfa for Up to 48 Weeks in MASH With F2/F3 Fibrosis: Results From a Phase 2, Open-Label Extension Study.

Article

2025-08-04·CURRENT PHARMACEUTICAL DESIGN

FGF21 Analogues and MASLD: A Summary of Preclinical and Clinical Data

Article

作者: Papalavrentios, Lavrentis ; Boutari, Chrysoula ; Sinakos, Emmanouil ; Triantafyllou, Achilleas ; Goulis, Ioannis

Abstract::

Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) is the most frequent chronic liver disease, which is closely associated with metabolic syndrome and obesity. Although it has now reached epidemic proportions, the treatment of this disease remains a challenge. Currently, there is only one drug approved for metabolic dysfunction-associated steatohepatitis (MASH), and various pharmaceutical agents have reached phase 3 of clinical trials and appear as potential drugs for the disease. Fibroblast Growth Factor (FGF) 21 has been gaining increasing interest as a possible therapeutic target for MASLD. FGF21 analogues, with an improved pharmacodynamic and pharmacokinetic profile, exert pleiotropic, favorable effects on liver function and histology, as well as systemic metabolism. They also appear to be effective in alleviating hepatic steatosis, steatohepatitis, and fibrosis in MASH. Among various others, efruxifermin, pegozafermin, pegbelfermin, and BOS-580 are FGF-21 analogues that have resulted in significant improvements in liver fat, fibrosis, and measures of liver function in the context of phase 2 clinical trials. This review summarizes the preclinical and clinical data from FGF21 analogues for MASLD and MASH.

项与 Efimosfermin alfa 相关的新闻（医药）

2026-05-07

·BioSpace

GSK goes beyond weight-loss with $1B buyout of Chinese siRNA specialist

iStock, jozefmicic With Siran Biotechnology under its fold, GSK will have access to a long-acting siRNA therapy that could induce weight loss while preserving lean mass, in addition to addressing other weight-related comorbidities. GSK has gone on another shopping trip to China, this time dropping up to just over $1 billion to pick up RNA developer Siran Biotechnology to advance an investigational siRNA therapy for cardiovascular and metabolic diseases. The deal, announced by SiranBio Wednesday , fits with the pharma’s strategy to address the downstream health consequences of weight gain. The $1 billion sum covers the upfront payment and future development, regulatory and commercial milestones, though the companies didn’t provide a more detailed financial breakdown for the deal. SiranBio will also be entitled to tiered royalties on global sales outside of the greater China region. In return for its investment, GSK will gain access to SA030, SiranBio’s long-acting siRNA oligonucleotide that targets the ALK7 receptor, which has been shown in animal models to play a role in various metabolic pathways, including sugar control and weight loss. SiranBio will carry SA030 through ongoing Phase 1 development, after which GSK will take charge. By targeting ALK7, SA030 could lower abdominal fat while preserving lean mass, according to SiranBio, in turn improving insulin sensitivity and blood lipid levels. SA030 could also tamp down fat cell-related inflammation. “SA030 has a complementary and distinct mechanism to GLP-1 agonists,” the Chinese company said on Wednesday, “supporting future combination approaches.” This mode of action fits well with GSK’s overall cardiometabolic strategy of avoiding the GLP-1 modality, which in recent months has gotten increasingly competitive. “I think it’s going to be very crowded,” CEO Luke Miels told reporters in February. “Our focus is more on the downstream effects of obesity rather than addressing the actual obesity itself,” he continued, pointing to weight-related comorbidities such as kidney and heart conditions. Earnings GSK Says No to GLP-1s, Prioritizes ‘Downstream Effects’ of Obesity Instead of joining the increasingly crowded GLP-1 arena, GSK will focus its efforts downstream of obesity—a push currently anchored by its Phase III-ready FGF21 analog efimosfermin alfa for liver fibrosis. February 4, 2026 · 2 min read · Tristan Manalac Read more “People, when they’ve been obese for a very long time, they get fatty liver and then ultimately, if things remain that way, they can get fibrosis of the liver,” Miels said. Wednesday’s SiranBio acquisition helps GSK build its portfolio in this direction, as does its May 2025 pick-up of Boston Pharmaceuticals’ efimosfermin alfa, an FGF21 analog primed for late-stage testing for metabolic dysfunction-associated steatohepatitis (MASH). That deal cost the pharma $1.2 billion upfront and up to $800 million in milestones. GSK has been dealing outside the cardiometabolic space, too, marked by its January partnership with South Korea’s Alteogen. For $20 million upfront and $265 million in milestones, the pharma gained access to the biotech’s platform to enable subcutaneous delivery of the PD-1 blocker Jemperli. In December, GSK linked up with CAMP4 Therapeutics—another RNA developer—to advance multiple candidates for neurodegenerative and kidney disorders.

并购临床1期寡核苷酸

2026-04-28

·药事纵横

每月一次，逆转肝纤维化：efimosfermin为MASH治疗带来新突破

代谢功能障碍相关脂肪性肝炎（MASH）是一种进行性肝病，全球患病率高达5%，已成为欧美地区肝移植的主要原因。该疾病以肝脏脂肪堆积、炎症和纤维化为特征，其中纤维化（瘢痕组织形成）是预测肝硬化、肝衰竭和肝癌等严重后果的关键指标。长期以来，MASH的治疗手段极为有限，主要依赖生活方式干预，针对中晚期纤维化（F2-F4）的肝特异性疗法更是空白，存在巨大的未满足临床需求。近期，一种名为efimosfermin alfa（研究代号BOS-580）的每月一次皮下注射药物，凭借其卓越的II期临床数据和获得的监管突破，为这一领域带来了革命性的希望。 Efimosfermin是一种经工程化改造的长效人类成纤维细胞生长因子21（FGF21）类似物。FGF21是人体内天然的“代谢调节大师”，能够促进脂肪分解、改善胰岛素敏感性、减轻肝脏炎症并调节血脂。然而，天然FGF21半衰期极短（约2小时），限制了其临床应用。通过基因工程技术，efimosfermin的半衰期被延长至约21天，从而实现每月仅需给药一次，极大提升了患者用药的便捷性和依从性。 2024年11月公布的II期临床试验24周核心数据令人振奋。在经肝活检确诊的F2/F3期MASH患者中，与安慰剂相比，每月一次efimosfermin治疗显示出显著的抗纤维化和抗炎效果：纤维化改善：45.2%的用药组患者实现了肝纤维化改善至少1期且MASH无恶化，安慰剂组仅为20.6%。 MASH缓解：67.7%的用药组患者实现了MASH缓解（炎症和肝细胞损伤消失）且纤维化无恶化，安慰剂组为29.4%。肝脏脂肪减少：50%的用药组患者肝脏脂肪含量相对减少超过50%，32%的患者肝脏脂肪恢复正常水平（≤5%）。 2025年美国肝病研究协会（AASLD）肝脏会议上公布的48周开放标签扩展研究数据进一步证实了其疗效的持久性。接受长达48周治疗的患者，在纤维化改善、MASH缓解、肝脏脂肪减少以及血糖、血脂等心血管代谢指标方面均表现出持续获益。安全性方面，efimosfermin整体耐受性良好。最常见的不良事件为轻至中度的胃肠道反应，如恶心、腹泻和呕吐，大多出现在治疗初期并可自行缓解。在扩展研究中，未出现因不良事件导致的停药，也未检测到抗药物抗体。基于这些积极的II期数据，efimosfermin于2026年4月27日同时获得了美国食品药品监督管理局（FDA）的突破性疗法认定和欧洲药品管理局（EMA）的优先药物（PRIME）认定，用于治疗MASH。这两项认定旨在加速针对严重疾病且初步临床证据显示可能比现有疗法有显著改善的药物的开发和审评，标志着监管机构对其潜力的高度认可。目前，efimosfermin针对F2/F3期MASH患者的两项关键III期临床试验（ZENITH-1和ZENITH-2）正在进行中。针对更晚期肝硬化（F4期）MASH患者的III期试验也预计将于今年启动。如果后续研究顺利，该药物最快有望于2029年上市立即扫码加入药事纵横交流群

2026-04-05

·信狐药迅

明慧医药伊托法替布和上海海和艾普美妥司他提交上市申请|新受理（3.30-4.5）

本周药品注册受理数据，分门别类呈现，一目了然。(3.30-4.5）新药上市申请药品名称企业注册分类受理号伊托法替布软膏明慧医药(杭州)有限公司 1 CXHS2600045 艾普美妥司他片上海海和药物研究开发股份有限公司 1 CXHS2600047 艾普美妥司他片上海海和药物研究开发股份有限公司 1 CXHS2600046 司普奇拜单抗注射液成都康诺行生物医药科技有限公司 2.2 CXSS2600062 司普奇拜单抗注射液成都康诺行生物医药科技有限公司 2.2 CXSS2600061 新药临床申请药品名称企业注册分类受理号 D-0120-NA片益方生物科技(上海)股份有限公司 1 CXHL2600406 VC005凝胶江苏威凯尔医药科技股份有限公司 1 CXHL2600405 CB03-154片上海挚盟医药科技有限公司 1 CXHL2600403 ARD-489AD片科辉智药(深圳)新药研究中心有限公司 1 CXHL2600402 ARD-489AD片科辉智药(深圳)新药研究中心有限公司 1 CXHL2600401 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600400 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600399 HRS9531注射液福建盛迪医药有限公司 1 CXHL2600398 注射用WP1302 百明信康生物技术(浙江)股份有限公司 1 CXHL2600395 优替德隆胶囊成都华昊中天药业有限公司 2.2 CXHL2600404 DMET25001缓释片武汉龙升医药科技有限责任公司 2.2;2.4 CXHL2600397 DMET25001缓释片武汉龙升医药科技有限责任公司 2.2;2.4 CXHL2600396 猴痘mRNA疫苗江苏中慧元通生物科技股份有限公司 1.2 CXSL2600362 SK-NK注射液赛奥斯博生物科技(北京)有限公司 1 CXSL2600380 注射用DXC018 杭州多禧生物科技有限公司 1 CXSL2600375 注射用SIM0689 上海先纬医药科技有限公司 1 CXSL2600374 SAR445877注射用浓溶液赛诺菲(中国)投资有限公司 1 CXSL2600378 ATTO-1310注射液艾拓维医药(上海)有限公司 1 CXSL2600377 9MW5211注射液迈威(上海)生物科技股份有限公司 1 CXSL2600376 GT307注射液北京沙砾生物医药股份有限公司 1 CXSL2600379 注射用Efimosfermin alfa 葛兰素史克(中国)投资有限公司 1 CXSL2600372 注射用GenSci136 长春金赛药业有限责任公司 1 CXSL2600371 普那利单抗注射液天境生物药业(杭州)股份有限公司 1 CXSL2600373 GT101注射液苏州沙砾生物科技有限公司 1 CXSL2600365 LNF2401注射液(皮下注射) 山东新时代药业有限公司 1 CXSL2600370 LNF2401注射液(静脉滴注) 山东新时代药业有限公司 1 CXSL2600369 CMG2349注射液成都恩沐生物科技有限公司 1 CXSL2600368 BBT001注射液杉竹曜(北京)生物医药科技有限公司 1 CXSL2600364 ADRX-0405 上海德烽药业有限公司 1 CXSL2600358 注射用BL-M14D1 成都百利多特生物药业有限责任公司 1 CXSL2600361 IBI354 信达生物医药科技(杭州)有限公司 1 CXSL2600360 ICP-B208 北京诺诚健华医药科技有限公司 1 CXSL2600359 注射用QLF4113 齐鲁制药有限公司 1 CXSL2600363 特瑞普利单抗注射液上海君实生物医药科技股份有限公司 2.2 CXSL2600367 特瑞普利单抗注射液上海君实生物医药科技股份有限公司 2.2 CXSL2600366 仿制药申请药品名称企业注册分类受理号盐酸奥洛他定颗粒九华华源药业(桂林)有限公司 3 CYHS2600785 富马酸酮替芬口服溶液安徽远望乐桓药业有限公司 3 CYHS2600784 镥[177Lu]氧奥曲肽注射液天津恒瑞医药有限公司 3 CYHS2600762 比拉斯汀口崩片江西施美药业股份有限公司 3 CYHS2600754 依巴斯汀口服溶液江苏晨牌邦德药业有限公司 3 CYHS2600749 盐酸拉贝洛尔片重庆圣华曦药业股份有限公司 3 CYHS2600756 盐酸拉贝洛尔片重庆圣华曦药业股份有限公司 3 CYHS2600755 利格列汀二甲双胍缓释片南通联亚药业股份有限公司 3 CYHS2600745 利格列汀二甲双胍缓释片南通联亚药业股份有限公司 3 CYHS2600746 精氨酸布洛芬颗粒广州欧化药业有限公司 4 CYHS2600777 精氨酸布洛芬颗粒广州欧化药业有限公司 4 CYHS2600775 他达拉非片江苏万高药业股份有限公司 4 CYHS2600780 他达拉非片江苏万高药业股份有限公司 4 CYHS2600779 他达拉非片江苏万高药业股份有限公司 4 CYHS2600778 氯吡格雷阿司匹林片中曦(福建)药业有限公司 4 CYHS2600776 卡铂注射液辰欣药业股份有限公司 4 CYHS2600782 卡铂注射液辰欣药业股份有限公司 4 CYHS2600781 普托马尼片沈阳红旗制药有限公司 4 CYHS2600783 苯磺酸左氨氯地平片辽宁福源药业有限公司 4 CYHS2600772 褪黑素颗粒大玮(安徽)药业有限公司 4 CYHS2600771 褪黑素颗粒大玮(安徽)药业有限公司 4 CYHS2600770 马来酸非尼拉敏盐酸萘甲唑啉滴眼液浙江视方极医药科技有限公司 4 CYHS2600769 氧氟沙星滴眼液南京帝昌医药科技有限公司 4 CYHS2600768 瑞维那新吸入溶液津药和平(天津)制药有限公司 4 CYHS2600767 塞来昔布胶囊迪沙药业集团有限公司 4 CYHS2600766 乙酰半胱氨酸注射液安徽新世纪药业有限公司 4 CYHS2600765 精氨酸布洛芬颗粒广州欧化药业有限公司 4 CYHS2600774 盐酸美金刚片山东方明药业集团股份有限公司 4 CYHS2600773 碳酸镧咀嚼片湖南华纳大药厂股份有限公司 4 CYHS2600761 依达拉奉右莰醇注射用浓溶液山东百诺医药股份有限公司 4 CYHS2600760 苯磺酸美洛加巴林片九华华源药业(桂林)有限公司 4 CYHS2600759 阿帕他胺片南京正大天晴制药有限公司 4 CYHS2600764 磷酸芦可替尼片湖北长江瑞益医药科技有限公司 4 CYHS2600763 孟鲁司特钠咀嚼片山东普瑞曼药业有限公司 4 CYHS2600753 孟鲁司特钠咀嚼片山东普瑞曼药业有限公司 4 CYHS2600752 盐酸依匹斯汀片山西同达药业有限公司 4 CYHS2600751 盐酸依匹斯汀片山西同达药业有限公司 4 CYHS2600750 双氯芬酸二乙胺乳胶剂贵州联盛药业有限公司 4 CYHS2600758 双氯芬酸二乙胺乳胶剂贵州联盛药业有限公司 4 CYHS2600757 注射用右兰索拉唑南京海纳制药有限公司 4 CYHS2600748 氟比洛芬钠滴眼液朗天药业(湖北)有限公司 4 CYHS2600747 瑞巴派特片浙江英格莱制药有限公司 4 CYHS2600744 糠酸莫米松乳膏江苏盈科生物制药有限公司 4 CYHS2600743 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600060 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600052 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600051 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600059 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600058 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600057 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600056 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600055 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600054 司美格鲁肽注射液成都倍特生物制药有限公司 3.3 CXSS2600053 进口申请药品名称企业注册分类受理号硫酸瑞美吉泮口崩片 Pfizer Inc. 5.1 JXHS2600034 帕博利珠单抗注射液(皮下注射) Merck Sharp & Dohme B.V. 2.2 JXSS2600031 帕博利珠单抗注射液(皮下注射) Merck Sharp & Dohme B.V. 2.2 JXSS2600030 奥妥珠单抗注射液 Roche Pharma (Schweiz) AG 2.2 JXSS2600025 注射用德曲妥珠单抗 Daiichi Sankyo Europe GmbH 2.2 JXSS2600024 帕博利珠单抗注射液(皮下注射) Merck Sharp & Dohme B.V. 3.1 JXSS2600029 帕博利珠单抗注射液(皮下注射) Merck Sharp & Dohme B.V. 3.1 JXSS2600028 帕博利珠单抗注射液(皮下注射) Merck Sharp & Dohme B.V. 3.1 JXSS2600027 帕博利珠单抗注射液(皮下注射) Merck Sharp & Dohme B.V. 3.1 JXSS2600026 Baxdrostat片 AstraZeneca AB 1 JXHL2600099 AZD8965片 AstraZeneca AB 1 JXHL2600098 AZD8965片 AstraZeneca AB 1 JXHL2600097 ASP3082注射液 Astellas Pharma Global Development, Inc. 1 JXHL2600095 硫酸瑞美吉泮口崩片 Pfizer Inc. 2.4 JXHL2600096 PF-08634404 Pfizer Inc. 1 JXSL2600089 注射用维恩妥尤单抗 Astellas Pharma Global Development, Inc. 2.2 JXSL2600091 注射用维恩妥尤单抗 Astellas Pharma Global Development, Inc. 2.2 JXSL2600090 Depemokimab注射液 GlaxoSmithKline Research & Development Limited 2.2 JXSL2600088 中药相关申请药品名称企业注册分类受理号热毒宁颗粒江苏康缘药业股份有限公司 2.1 CXZS2600018 ZYY-768颗粒扬子江药业集团江苏龙凤堂中药有限公司 1.1 CXZL2600033 椿乳凝胶株洲千金药业股份有限公司 2.3 CXZL2600034 注：绿色字体部分为潜在首仿品种；咸达数据2026年1月每月药讯已出！关注“咸达数据”，微信关键词回复 ” 年+月，如202601” 获得最新药迅！不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

疫苗申请上市信使RNA临床申请

100 项与 Efimosfermin alfa 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
代谢功能障碍相关脂肪性肝炎	临床3期	美国	GSK Plc	2025-10-24
代偿期肝硬化	临床2期	美国	Boston Pharmaceuticals, Inc.	2025-04-09
代谢功能障碍相关的脂肪肝病	临床1期	新西兰	GSK Plc	2026-03-05
肥胖	临床1期	美国	Novartis Pharmaceuticals Corp.	2018-02-26

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04880031 (Pubmed \| Lancet)	临床2期	代谢功能障碍相关脂肪性肝炎	84	Efimosfermin 300 mg Q4W	選襯膚衊艱顧鏇觸鹽鬱(鹹壓鬱窪網壓鹹齋醖製) = Most frequent adverse events were gastrointestinal events, which were transient and occurred within the first few weeks of treatment. 夢襯願遞憲築餘蓋構鹽 (齋觸簾廠獵簾夢築糧餘 )	积极	2026-02-01
				Placebo
NCT04880031 (Pubmed \| Lancet Gastroenterol Hepatol) 人工标引	临床2期	代谢功能障碍相关脂肪性肝炎	65	Efimosfermin	構構積網鬱鬱齋醖餘鏇(廠衊範鑰淵積糧顧蓋夢) = 蓋淵鑰製鬱壓構醖窪衊構觸鑰繭獵簾網鏇鬱製 (鏇淵願齋齋積築醖築網 ) 更多	积极	2025-08-01
				Efimosfermin (75 mg every 4 weeks)	構構積網鬱鬱齋醖餘鏇(廠衊範鑰淵積糧顧蓋夢) = 鑰構廠鬱獵糧齋繭憲製構觸鑰繭獵簾網鏇鬱製 (鏇淵願齋齋積築醖築網 ) 更多
NCT04880031 (BOS-580-201, Biospace) 人工标引	临床2期	代谢功能障碍相关脂肪性肝炎	84	Efimosfermin alfa 300 mg	窪鑰網觸構製鏇願遞淵(顧積糧憲廠範簾簾糧築) = 窪窪鏇憲獵遞窪壓範衊淵糧遞獵鑰淵齋獵獵襯 (製遞膚鏇衊膚衊糧鹹憲 ) 更多	积极	2024-11-15
				Placebo	窪鑰網觸構製鏇願遞淵(顧積糧憲廠範簾簾糧築) = 膚醖選遞蓋構遞鑰製觸淵糧遞獵鑰淵齋獵獵襯 (製遞膚鏇衊膚衊糧鹹憲 ) 更多
Phase 2a study (NASH_TAG2024)	临床2期	-	102	BOS-580	觸築簾襯願製構願餘顧(衊鏇艱製廠製願壓艱願) = 鑰築願積範製衊壓鹹構廠觸膚製繭淵艱觸範鹽 (膚構憲觸淵範願壓淵鏇 )	积极	2024-01-04
				Placebo	觸築簾襯願製構願餘顧(衊鏇艱製廠製願壓艱願) = 窪膚選積糧壓選築膚網廠觸膚製繭淵艱觸範鹽 (膚構憲觸淵範願壓淵鏇 )
NCT04880031 (Biospace) 人工标引	临床2期	代谢功能障碍相关脂肪性肝炎	102	overall	繭艱壓鬱鏇蓋鏇鹹願糧(獵蓋衊網廠製憲膚淵窪) = No treatment emergent adverse events of hypoglycemia were reported in any patient enrolled in the study. 窪壓憲憲蓋壓觸窪淵築 (鹹顧醖鹽鏇衊構簾觸廠 ) 更多	积极	2023-11-10
				BOS-580 (HbA1c≥6.5%)
NCT03466203 (Pubmed \| J Clin Endocrinol Metab)	临床1期	高甘油三酯血症 \| 肥胖	64	LLF580 300 mg	壓醖壓獵窪獵膚醖蓋簾(憲齋餘簾壓構齋餘製顧) = higher incidence of generally mild to moderate gastrointestinal adverse effects 齋鏇願簾夢選遞範糧襯 (遞醖繭窪膚範選壓憲遞 )	-	2021-08-25