Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of IVA337 in Healthy Japanese Adults

开始日期2025-02-01

申办/合作机构-

NCT06126562

/ Completed临床1期

A Phase I Clinical Study to Evaluate the Pharmacokinetic Profile and Safety of Lanifibranor After Single Dose and Multiple Doses in Healthy Adult Chinese Subjects

This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.

开始日期2023-10-31

申办/合作机构

正大天晴药业集团股份有限公司

100 项与拉尼兰诺相关的临床结果

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100 项与拉尼兰诺相关的转化医学

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100 项与拉尼兰诺相关的专利（医药）

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项与拉尼兰诺相关的文献（医药）

2026-07-01·ADVANCED MATERIALS

An Extravascular Synergistic Cocktail Therapeutic Strategy Based on Lanifibranor Loaded Self‐Healing Bioelastomer for Abdominal Aortic Aneurysms

Article

作者: Dai, Wufei ; Jia, Zenghui ; Hu, Jiateng ; Zhou, Guangdong ; Lei, Dong ; Liu, Xiaobing ; Chen, Shuo ; Song, Xingqi ; Xu, Zhijue ; Jiang, Yihong ; Li, Fengshi

ABSTRACT:

Abdominal aortic aneurysm (AAA) is a fatal cardiovascular disease with hidden onset and high risk of rupture death, which is a major public health concern worldwide. Notably, aortic adventitia is the earliest lesions and the last barrier to rupture, and adventitial fibroblasts (AFs) are the key cellular components of aortic adventitia. Current treatments mainly focus on surgical resection with prosthetic graft replacement and endovascular stent grafting, yet failed to reconstruct the adventitia and abdominal aorta's natural structure effectively. In this study, we proposed an extravascular synergistic cocktail (ESC) therapeutic strategy to treat AAA by incorporating mechanical supporting and vascular remodeling inhibition based on a self‐healing bioelastomer with antifibrotic drug of lanifibranor. The single‐cell RNA‐sequencing revealed potential myogenic transformation of AFs in AAA with the release of chemokines like monocyte chemoattractant protein‐1 (MCP‐1) . The underlying mechanism of lanifibranor in maintaining the phenotype of AFs via promoting lipid metabolism was disclosed. The bioelastomer with multiple reversible dynamic bonds exhibits remarkable arterial‐like mechanical properties and ultra‐fast self‐healing ability under blood condition, and enables rapid in situ AAA wrapping treatment. In both the rat and dog AAA models, it has been fully demonstrated that the ESC therapy can provide effective mechanical support to prevent vascular dilation while continuously releasing lanifibranor to regulate myogenic transformation of AFs to inhibit the development of AAA. Additionally, we investigated the feasibility of minimally invasive laparoscopic implantation in bama pigs, emphasizing its potential for clinical translation and application.

2026-06-01·Internal and Emergency Medicine

Efficacy of tirzepatide, lanifibranor, and resmetirom in metabolic dysfunction-associated steatotic liver disease: a meta-analysis of high-quality randomized controlled trials

Review

作者: Cui, Shuqing ; Cui, Haozhe ; Zhao, Shuai ; Hou, Jing ; Yu, Lan ; Li, Zhenhua ; Wei, Yaochen ; Ma, Xiangming ; Tian, Fei

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a highly prevalent condition and a leading cause of chronic liver disease worldwide. Several pharmacological agents are currently used in its clinical management. This meta-analysis assesses the comparative efficacy and safety profiles of three novel therapeutic agents-tirzepatide (a dual GIP/GLP-1 receptor agonist), lanifibranor (a pan-PPAR agonist), and resmetirom (a thyroid hormone receptor-β agonist)-in patients with MASLD/MASH.We systematically searched PubMed, Scopus, Web of Science, the Cochrane Library, and Embase from inception to December 31, 2024. Eligible randomized controlled trials (RCTs) were those that enrolled adults with MASLD/MASH and compared tirzepatide, lanifibranor, or resmetirom with placebo. Non-randomized trials, animal studies, trials using only imaging or biomarkers for diagnosis, studies without a placebo arm, and those including subjects aged < 18 years were excluded. Methodological quality was assessed using the Cochrane Risk of Bias 2.0 tool. Data synthesis was performed using RevMan 5.3. The protocol was registered with PROSPERO (CRD 42025637054). Five placebo-controlled trials met the inclusion criteria: one for tirzepatide (NCT04166773), one for lanifibranor (NCT04849728), and three for resmetirom (NCT03900429, NCT04197479, NCT04951219). The analysis included 2497 individuals (1112 [45%] male, mean age 55.6 years [SD 11.6], mean BMI 35.3 kg/m² [SD 6.3], and 1385 [55%] with diabetes). All agents led to MASH resolution without worsening of fibrosis in a proportion of patients, with significant effects observed for tirzepatide and resmetirom. Tirzepatide (mean difference [MD] - 34.90% [95% CI: - 53.31 to - 16.49]) and resmetirom (MD - 31.45% [95% CI: - 35.93 to - 26.97]) significantly reduced hepatic steatosis as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Tirzepatide significantly reduced serum aminotransferase levels (ALT: MD - 30.90%, p < 0.00001; AST: MD - 20.71%, p < 0.00001). Although lanifibranor demonstrated improvements in lipid profiles (HDL-C + 9.87%, triglycerides - 26.90%), it did not achieve a statistically significant improvement in fibrosis (OR 1.26, p = 0.08). Gastrointestinal adverse events were frequently reported across all treatment arms. Tirzepatide and resmetirom significantly improved MASH resolution without worsening of fibrosis and reduced hepatic steatosis. All three agents lowered serum aminotransferase levels, while lanifibranor and resmetirom improved lipid profiles. Gastrointestinal adverse events were common, which may affect tolerability. Due to the limited number of trials for tirzepatide and lanifibranor, further large-scale studies are warranted to confirm their role in MASLD/MASH management.

2026-05-21·Nature

GLP-1R–GIPR–PPARα/γ/δ quintuple agonism corrects obesity and diabetes in mice

Article

作者: Culot, Maxime ; Gosselet, Fabien ; Jastroch, Martin ; Yoshida, Junichi ; Kakimoto, Pamela ; Seeley, Randy J ; Gutgesell, Robert M ; Finan, Brian ; Kusminski, Christine M ; Haas, Daniel T ; Keuper, Michaela ; Akindehin, Seun ; Grandl, Gerald ; Knerr, Patrick J ; Steffens, Sabine ; Horvath, Tamas L ; Krahmer, Natalie ; Douros, Jonathan D ; Tschöp, Matthias H ; Weber, Christian ; Gerhart-Hines, Zachary ; Mowery, Stephanie A ; Candela, Pietra ; Feuchtinger, Annette ; Pfluger, Paul T ; Maity-Kumar, Gandhari ; Castelino, Russell L ; Karaoglu, Ezgi ; Liu, Xue ; Paisley, Marshall ; Garcia-Caceres, Cristina ; Embring, Hannes ; Liskiewicz, Arkadiusz ; Dodson, W Scott ; Campbell, Jonathan E ; Gao, Xiao-Bing ; Novikoff, Aaron ; Tost, Monica ; Kaltenbach, Anna Cristina ; Müller, Timo D ; Wean, Jordan ; Leander, Danielle C ; DiMarchi, Richard D ; Petersen, Patricia S S ; Prakash, Sneha ; Cebrian-Serrano, Alberto ; Nogueiras, Ruben ; Coupland, Callum ; Perez-Tilve, Diego ; Martinez, Sara Martinez ; Liskiewicz, Daniela ; Scherer, Philipp E ; Khalil, Ahmed

Abstract:

There are increasing numbers of effective drugs to improve obesity-linked metabolic dysfunction; GLP-1R–GIPR co-agonism is effective in the management of obesity and type 2 diabetes 1,2 , and lanifibranor—a nuclear-acting small-molecule triple agonist of PPARα, PPARγ and PPARδ—is in clinical phase 3 trials for the treatment of metabolic dysfunction-associated steatohepatitis 3 . Here, seeking to further improve the metabolic efficacy of GLP-1R–GIPR co-agonism, we report the development of a unimolecular quintuple agonist that combines the body weight-reducing and blood glucose-lowering effects of GLP-1R–GIPR co-agonism with the insulin-sensitizing and anti-inflammatory effects of lanifibranor via its targeted delivery into GLP-1R- and GIPR-expressing cells. In vitro, GLP-1–GIP–lanifibranor is indistinguishable from GLP-1–GIP in relation to incretin receptor signalling and shows equal stimulation of insulin secretion in isolated mouse islets. In vivo, however, GLP-1–GIP–lanifibranor outperforms GLP-1R–GIPR co-agonism and semaglutide, further decreasing body weight, food intake and hyperglycaemia in obese and insulin-resistant mice through synergistic incretin and PPAR action. The metabolic action of GLP-1–GIP–lanifibranor is blunted in mice with genetic or pharmacological inhibition of GLP-1R, GIPR or PPARδ and is absent in DIO double incretin receptor-knockout mice, collectively suggesting that GLP-1–GIP–lanifibranor has substantial therapeutic value in the treatment of obesity and diabetes.

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项与拉尼兰诺相关的新闻（医药）

2026-09-02

·肖生客

【肖生客】9月3日创新药全球见闻

1️⃣ Redx任命新任首席医学官强化胃肠病学专长。Redx公司任命新任首席医学官，以加强其在胃肠病学领域的研发实力。此举旨在推进公司消化系统疾病管线，提升临床开发效率。新任高管将主导相关药物临床试验策略，有望加速候选药物上市进程，巩固公司在胃肠病学治疗领域的竞争地位 2️⃣ Vertex股价表现与其他生物科技股对比分析。文章对比了Vertex Pharmaceuticals与其他生物科技股的股价表现。Vertex凭借其囊性纤维化药物组合保持稳健增长，近期股价跑赢行业指数。分析指出，其研发管线和市场地位是投资者信心来源，但面临专利到 3️⃣ 实验性多发性硬化药物两项试验降低复发优于现有疗法。一种实验性多发性硬化（MS）药物在两项临床试验中显示，相比已批准疗法能更有效降低复发率。该药可能成为MS治疗的新选择，改善患者预后。若获监管批准，将加剧MS市场竞争，推动治疗标准升级，为患者提供更多高效方案。 4️⃣ 诺华与Alteogen达成32亿美元药物递送技术合作。诺华与韩国Alteogen签署价值高达32亿美元的协议，获得其药物递送技术授权。该技术有望延长生物制剂半衰期，优化给药频率。此合作将增强诺华在生物药领域的竞争力，并可能推动长效制剂开发，对全球药物递送技术市 5️⃣ ARPA-H投入1.25亿美元支持五团队开发按需RNA药物。美国卫生高级研究计划局（ARPA-H）拨款1.25亿美元，资助五个团队开发按需RNA药物技术。该计划旨在实现快速响应新兴病原体，缩短疫苗和疗法生产周期。此举将加速RNA平台创新，提升疫情应对能力，并推 6️⃣ 阿斯利康从诺和诺德挖角任命北欧区新负责人。阿斯利康任命来自诺和诺德的高管为北欧区负责人，以加强区域业务。此举反映阿斯利康对北欧市场的重视，旨在利用新任领导的经验推动增长。人事变动可能带来战略调整，影响当地竞争格局，并促进两家公司间的人才流动。 7️⃣ 英国新患者无法再获Tavneos，安进等待FDA听证。由于安进公司等待FDA听证，英国新患者已无法获得Tavneos（avacopan）治疗。该药用于ANCA相关血管炎，供应中断将影响患者治疗选择。安进正与监管机构沟通，寻求解决方案，但短期内患者可能面临治疗缺 8️⃣ Inventiva任命Chris Benecchi为首席运营官，迎接关键试验数据。Inventiva任命Chris Benecchi为首席运营官，正值其核心药物lanifibranor关键试验数据公布前夕。此次高管任命旨在加强运营管理，确保试验成功及后续商业化 9️⃣ FDA收紧外国试验数据监管，恰逢中国崛起。FDA宣布将更严格审查外国临床试验数据，此举恰逢中国生物医药崛起。新政策可能影响中国药企的海外申报，要求更高数据质量。这反映了地缘政治对监管的影响，中国药企需提升试验标准，以符合国际要求，保持出海竞争力。 10️⃣ CBER官员推翻评审团队对Replimune黑色素瘤药物的否决。FDA生物制品评价与研究中心（CBER）高级官员推翻了评审团队对Replimune黑色素瘤药物的拒绝决定，允许其继续开发。该药物为溶瘤病毒疗法，显示监管内部对创新疗法的支持。此举可能加速其上市进程 11️⃣ Teva乳糜泻单次注射成功，加热IL-15市场。Teva在乳糜泻治疗中报告单次注射成功，该药靶向IL-15通路。这一积极结果将加剧IL-15抑制剂市场竞争，推动相关疗法研发。若获批准，将为乳糜泻患者提供首个针对性治疗，改变现有管理方式，并可能拓展至其他自身免疫 12️⃣ 特朗普最新药企交易或削弱控费努力。分析指出，特朗普政府与药企的最新交易可能削弱降低药价的努力。这些交易可能包含限制价格谈判的条款，或给予药企专利保护，从而影响药品可负担性。此举引发对政策效果的质疑，可能阻碍医疗成本控制，加剧公众对药价上涨的担忧。 13️⃣ 下一代DSM应关注算法在进食障碍中的作用。文章呼吁精神疾病诊断手册（DSM）更新时纳入算法对进食障碍的影响。随着社交媒体和算法推荐普及，其可能加剧身体形象问题。将算法因素纳入诊断标准有助于更全面理解病因，指导干预措施，并推动科技公司承担社会责任。 CGT001 — GSK推进mRNA流感疫苗进入III期临床。葛兰素史克（GSK）宣布其mRNA流感疫苗将进入III期临床试验。该疫苗利用mRNA技术，有望提供更高效、易更新的流感防护。若成功，将改变流感疫苗市场格局，并验证mRNA平台在非新冠领域的应用，推动技术扩展。 CGT002 — Alumis狼疮试验失败但TYK2抑制剂仍推进III期。Alumis的TYK2抑制剂在狼疮试验中未达主要终点，但公司仍计划推进至III期。尽管受挫，该药可能对部分患者有效，且安全性良好。此举显示公司对药物潜力的信心，但失败数据可能影响投资者信心，未来试验需更精 R001 — 新研究开发de novo泛罗丹明结合蛋白用于荧光显微镜。研究人员设计出de novo泛罗丹明结合蛋白，适用于从哺乳动物细胞到极端微生物的荧光显微镜观察。该蛋白可特异性结合多种罗丹明染料，提高成像对比度。此工具将增强生物成像能力，助力细胞生物学和微生物学研究，推 R002 — 阿替利珠单抗治疗早期三阴性乳腺癌3期试验结果。随机3期NSABP B-59/GeparDouze试验评估了阿替利珠单抗联合化疗治疗早期三阴性乳腺癌的效果。结果显示，该组合可能提高病理完全缓解率，改善患者预后。若获批准，将扩大免疫治疗在早期乳腺癌的应用，改变治疗 R003 — 临床基因组学揭示晚期结直肠癌演变与转移趋向性。一项整合临床基因组学分析揭示了晚期结直肠癌的演变过程及转移趋向性。研究通过测序识别驱动突变和转移相关特征，有助于预测疾病进展。这些发现可为精准治疗提供靶点，改善晚期患者管理，推动结直肠癌个体化治疗。 R004 — 美国南部锥蝽中克氏锥虫遗传多样性综合研究。研究全面分析了美国南部锥蝽媒介中克氏锥虫的遗传多样性，发现地理结构、线粒体基因渐渗和多克隆性。这些结果有助于理解恰加斯病传播动态，为疾病控制提供流行病学依据，并指导监测和干预策略。 R005 — 冷冻电镜解析感染脓肿分枝杆菌的噬菌体Jabs结构。研究利用冷冻电镜解析了噬菌体Jabs的高分辨率结构，该噬菌体感染多重耐药病原体脓肿分枝杆菌。结构信息揭示其组装和感染机制，为开发新型抗菌疗法提供基础，应对耐药性威胁，推动噬菌体治疗应用。 #创新药见闻 #创新药出海 #基因治疗 #ADC

2026-09-02

·今日头条

引用本文王星语, 孙鹤鸣, 高沿航 . 代谢和酒精相关性肝病与脂肪性肝病新药研发的临床试验相关问题思考[J]. 中华肝脏病杂志, 2026, 34(8):738-742. DOI: 10.3760/cma.j.cn501113-20260303-00085. 通信作者：高沿航，吉林大学第一医院肝胆胰内科专家简介高沿航教授吉林大学第一医院主任医师，教授，博士生导师, 博士后合作导师吉林大学第一医院肝胆胰内科主任吉林省肝脏代谢重点实验室主任中华医学会肝病学分会副主任委员中华医学会肝病学分会肝癌学组副组长中华医学会消化病学分会肝胆疾病学组副组长中国研究型医院学会肝病专委会副主任委员全球酒精性肝病指导委员会（Global AlcHep Committee）委员《临床肝胆病杂志》主编，eGastroenterology 编委摘要酒精性肝病的发病率在全球多个国家和地区持续上升。除糖皮质激素外，重症酒精性肝病有效的药物治疗手段有限。随着代谢和酒精相关性肝病（MetALD）概念的提出，其作为代谢功能障碍与酒精暴露协同致肝损伤的疾病实体日益受到关注。然而，与代谢相关脂肪性肝病新药研发的活跃进展相比，酒精性肝病及 MetALD 领域的临床研究推进缓慢。目前全球注册的酒精性肝病药物临床研究较少，且存在患者招募困难、研究终止率高等问题。而作为全新分类，MetALD 目前缺乏监管机构的临床研究指导原则，加之病因高度混杂、患者污名化及依从性差等现实挑战，为药物研发带来了诸多障碍。基于心血管代谢风险因素及肝纤维化分期对研究人群进行分层，可能作为优化临床试验设计、识别潜在获益人群的关键策略。文章旨在综述当前研究现状与核心难点，并探讨以硬终点选择、双重获益评估及研究者发起的临床试验为核心的未来突破方向。全球终末期肝病的病因构成正在发生显著变化：病毒性肝炎发病率逐步下降，而酒精与代谢相关肝病逐年上升。同时，研究证实酒精性肝病（alcohol liver disease，ALD）与代谢相关脂肪性肝病（metabolic associated steatotic liver disease，MASLD）之间并无明确的界限。随着“代谢和酒精相关性肝病”（metabolic and alcohol-associated liver disease，MetALD）概念的提出，针对符合 MASLD 诊断标准的患者融入了对饮酒量的评估。MetALD 强调了代谢功能障碍与酒精暴露在肝损伤中的协同作用。然而，与 MASLD 新药研发的活跃进展形成鲜明对比，ALD 和 MetALD 领域的临床研究推进缓慢。MetALD 目前不论是监管机构（如美国食品药品监督管理局、国家药品监督管理局）还是各大国际肝病学会，均未制定相应的临床研究指导原则。与 MASLD 可通过严格限制饮酒来聚焦代谢病因不同，MetALD 和 ALD 研究中即便规定饮酒量，代谢功能障碍与酒精暴露的协同对肝损伤的作用难以完全分离。加之患者饮酒模式的个体差异、酒精成瘾性的治疗效果不一等混杂因素，使得酒精与代谢对肝损伤的贡献难以明确分层。这给临床试验设计带来巨大挑战，但也为探索多因素致病机制、推动创新疗法研发提供了契机。本文旨在梳理上述问题，综述当前研究面临的主要困境与争议，并为临床试验设计提供思路。一、ALD 新药研发的临床试验相关问题 ALD 治疗策略在以下三方面：（1）戒酒；（2）治疗肝脏疾病本身；（3）治疗相关并发症及共病。目前，针对 ALD 的药物研发主要集中于第二个方面，2000 年 2 月至 2026 年 2 月，以“ALD”和“药物治疗”作为关键词，在 ClinicalTrial 临床试验网站（https：//clinicaltrials.gov）上检索全球注册的药物类干预性研究共有 52 项（含益生菌、细胞疗法等）。其中 16 项为国际多中心，15 项为单中心，22 项显示状态已完成。约近 50% 的临床试验为Ⅰ/Ⅱ期，Ⅳ期研究仅有 7 项，主要针对病因治疗。目前 13 项（25%）临床试验聚焦于糖皮质激素等传统疗法的优化。近期发表的一项随机试验表明，粒细胞集落刺激因子联合泼尼松治疗可改善重症酒精性肝炎（severe alcoholic hepatitis，SAH）患者的感染及 90 d 生存率。另有 12 项（23%）临床试验面向非激素类免疫调节剂，针对肿瘤坏死因子、白细胞介素（interleukin，IL）-1β、IL-23 等细胞因子的药物研发。一项针对酒精性肝炎（alcohol-associated hepatitis，AH）患者的Ⅱ期随机试验显示，卡那单抗（canakinumab）可改善组织学炎症，但并发症发生率或生存率无显著改善，类似的药物还有古塞奇单抗（guselkumab）、利纳西普（rilonacept）等。其余研究涵盖的治疗手段包括生长因子、益生菌、抗氧化剂等。但目前受限于患者招募困难、留存率低、研究终止率高等原因，ALD 新药研发面临重大挑战。为应对上述挑战，临床试验设计需在研究人群、终点选择、遗传因素等方面进行精细化。 1. 研究人群的精准定义及分层：饮酒是 ALD 病因、诊断、治疗应答以及临床结局的核心因素。因此，在临床试验中应根据饮酒量、饮酒频率及持续时间进行量化，统一换算为乙醇克数，并详细记录既往饮酒史。值得注意的是，“重度饮酒”并不等同于酒精使用障碍（alcohol use disorder，AUD），后者需要通过《精神障碍诊断与统计手册》第五版（DSM-5）或《国际疾病分类》第十一版（ICD-11）的诊断标准进行诊断。在临床试验设计中，准确界定研究人群对结果解读至关重要。随着“非酒精性脂肪性肝病”更名为“代谢相关脂肪性肝病”，饮酒与代谢风险因素对脂肪变性的协同作用日益受到关注。ALD 人群应同时纳入伴或不伴有已知心血管代谢风险因素（cardiometabolic risk factor，CMRF）的患者，并且在试验中进行分层。此外，还应收集年龄、性别、种族等人口学特征以及体质量、身高、身体质量指数、腰围、代谢综合征等临床变量，作为筛选潜在临床获益人群的参考依据。临床试验设计的亚组分类应与药物监管批准的适应证相关，这意味着分类标准必须客观且可重复，并能体现影响疾病进展和结果的因素的特异性因素。在临床试验设计中，可使用“进展期慢性肝病（advanced chronic liver disease，ACLD）”这一术语，将长期大量饮酒的患者分为无进展期纤维化的早期 ALD 亚组（脂肪变性和轻度至中度即 0~2 期纤维化）、代偿期 ACLD 亚组（进展期即≥3 期纤维化）、失代偿期 ALD 亚组、AH 亚组 4 个亚组。各亚组间的纳排标准应根据其临床特征分别设定。由于持续大量饮酒的患者的非肝脏相关死亡风险较高，因此应充分考虑肝外合并症的影响。对于因肝外疾病而非肝脏疾病更易出现临床结局的患者，是否将其排除应取决于临床试验的目标。任何旨在降低肝脏相关风险的策略都应重点关注前面定义的代偿期 ACLD 患者。值得注意的是，所有 AH 患者以及多数新发 ACLD 失代偿的患者都有近期饮酒史。 2. 临床试验的终点选择：目前尚无针对 ALD 临床试验的特定终点，终点选择需结合临床开发阶段和试验的总体预期目标，确保其具有临床意义。在早期 ALD 中，失代偿事件发生率低，戒酒后患者预后较好。在此类人群中，更为适宜的疗效评价指标可聚焦于行为学改变，如实现戒酒的参与者比例、戒酒持续时间等。在代偿期 ACLD 中，核心在于预防失代偿事件的首次发生。而对于失代偿期 ALD，治疗的主要目的是降低病死率。肝脏相关死亡率和全因死亡率都是重要的终点。在非重症 AH 中，肝功能恢复是最重要的预后指标，可通过终末期肝病模型（model for end-stage liver disease，MELD）评分改善来评估。而在重症 AH 中，较为公认的主要终点是 90~180 d 的病死率，在Ⅱ期研究中也可通过 Lille评分、MELD 评分改善代替终点事件。 3. 遗传因素应考虑加入研究设计：长期大量饮酒者发生严重 ALD 的个体易感性存在显著差异。这些差异源于环境、遗传及表观遗传等多种因素的共同作用，从而进一步影响临床试验中预期事件发生率。特定遗传位点与发展成严重 ALD 的风险有关，调节基因表达的表观遗传因素也可能影响易感性。鉴于遗传因素对 ALD 患者纤维化、炎症和脂肪变性风险有显著影响，未来针对早期 ALD 和代偿期 ACLD患者的临床试验应考虑根据已知的遗传风险因素对患者进行分层，或采用其他方法来平衡研究人群。 4. 治疗措施的整合与考量：ALD 新药研发需充分认识戒酒带来的临床获益，因此应整合 AUD 的治疗策略，尽可能帮助患者戒酒。行为、认知疗法可以减少患者饮酒或促进其戒酒，与治疗 AUD 的药物联合有望进一步提升整体疗效。同时，任何涉及 ALD 受试者的药物试验均应考虑到饮酒和 ACLD 可能引起的药效学及药代动力学变化。针对 AUD 和 ALD 患者的药物研究，还需关注药物、酒精之间潜在的相互作用，及其带来的疗效偏差与安全性风险。 5. 统计学方法与安全性评估：在 ALD 临床试验中，数据可能不符合正态分布，可应用适当的转换或非参数方法。异常值可以保留，也可以将其重新编码为数据集中相邻的最高值或最低值。对于缺失的数据，可进行最坏情况插补，但该方法存在一定偏倚。建议联合现代缺失数据处理方法（如最大似然法或多重插补法）进行敏感性分析，以替代单一的插补方法。对于并发症高风险的患者，应特别关注不良事件的发生。常见的肝脏相关不良事件包括肝损伤及肝功能恶化；门静脉高压相关肝失代偿事件及其并发症；以及肝衰竭继发的多器官功能障碍。此外，还需评估试验药物的肝毒性、肾毒性等潜在风险，根据需要定期监测血液生物化学指标。研究方案中应预设两类终止规则：试验终止规则和个体终止规则，允许因达到阳性结果（达到主要终点）或阴性结果（疗效不佳及安全性问题）而提前终止研究，有助于提升试验的安全性和有效性。二、MetALD 新药研发的临床试验现状 MetALD 是 2023 年由美国肝病学会、欧洲肝病学会和拉丁美洲肝病学会专家共识提出的新分类，旨在精准识别同时存在代谢功能障碍和中等量饮酒的脂肪性肝病患者。具体而言，MetALD 适用于符合 MASLD 诊断标准（即存在至少一项 CMRF）且饮酒量介于特定区间的个体：每周女性摄入乙醇140~350 g，每周男性摄入乙醇 210~420 g。MetALD的患病率随着饮酒及 CMRF 在一般人群中的增多而逐年增加。尽管 MetALD 发展为肝纤维化的比例与 MASLD 相似，但其发展为肝硬化或肝细胞癌的长期风险较高。这提示中等量饮酒也会加剧代谢性肝损伤，从而产生致病协同作用。截至 2026 年初，全球范围内以 MetALD 为研究对象注册的研究数量极少，仅有 3 项Ⅱ期新药试验涉及。其中，2024 年5月注册的Tirzepatide研究（NCT07046819）是目前唯一在标题及方案中直接采用“MetALD”的研究，其入组对象为符合 MetALD定义且合并中重度 AUD 的肝纤维化患者。另一项关于 efruxifermin 的研究（NCT07024212）虽招募MASLD合并高危饮酒者（饮酒量落入 MetALD 区间），但未使用“MetALD”。而第三项研究拉尼兰诺（lanifibranor）试验（NCT05273853）早于“MASLD/MetALD”概念提出，允许轻度饮酒仅为放宽排除标准。目前尚无任何以 MetALD 为独立入组标准的Ⅲ期关键性药物试验。除药物干预外，另有少量观察性研究及个别非药物干预探索正在开展，但均处于早期阶段，样本量小，尚未形成系统性证据。尤为关键的是，当前所有 MetALD 相关研究均未根据患者的营养状态、代谢风险负荷（如 CMRF 数量）或纤维化分期进行分层。总体而言，现有研究数量有限、设计异质性强，且缺乏专门的指导原则及实践指南。加之患者入组标准尚未统一、酒精暴露量化依赖主观报告、疗效终点未达成共识等现实挑战，MetALD 尚未形成独立的临床研究或药物开发路径。未来亟须通过严谨设计的前瞻性研究，系统建立其临床表型与干预反应特征库，为后续治疗策略提供依据。三、难点和挑战 1. 污名化与依从性困境下的临床试验终点重构：ALD/MetALD 患者的污名化问题，已成为制约临床研究质量的关键隐性障碍。有研究表明 85.1% 的患者认为疾病名称中包含“酒精”一词即带有污名，且ALD 相关讨论中污名化语言的发生率显著高于AUD。由于社会对 AUD 的负面标签，患者在入组及随访过程中普遍存在隐瞒或低估饮酒量的行为。这种信息偏倚直接导致酒精暴露这一核心变量失真，使得研究难以准确区分药物疗效是源于其针对代谢功能障碍与酒精暴露的协同作用，还是单纯归因于饮酒量的减少。此外，ALD/MetALD 患者的高复饮率和低依从性进一步加剧了混杂效应，采用磷脂酰乙醇、碳水化合物缺乏转铁蛋白（carbohydrate-deficient transferrin，CDT）等标志物有助于细化患者饮酒情况。但即使采用磷脂酰乙醇、CDT 等生物标志物进行客观验证，仍难以完全消除行为因素对疗效评估的干扰。这一困境凸显了前文所述 ALD 临床试验终点选择共识的重要性：针对 ACLD 应以首次失代偿事件为终点，SAH 则以 90~180 d 病死率为核心指标。采用“失代偿事件”“无移植生存期”等作为主要终点将饮酒行为变量统一纳入“生存获益”当中，可有效规避因患者隐瞒饮酒量而导致的疗效误判，使研究结果更贴近真实临床获益。 2. 双重获益带来的试验设计复杂性：MetALD 作为代谢功能障碍与酒精暴露协同作用的疾病，针对其开展的临床试验设计面临着独特挑战。与典型MASLD 患者以超重/肥胖为主要特征不同，部分MetALD 患者因长期饮酒存在营养不良、肌肉减少症或微量营养素缺乏的并发症。这一关键差异提示，许多针对 MASLD 设计的减重类药物（如胰高血糖素样肽 1 受体激动剂）可能不适用于营养不良的MetALD 患者。此类药物通过抑制食欲和延缓胃排空起效，在营养不良的 MetALD 患者中可能会加剧肌肉流失，甚至导致肝功能恶化。因此，MetALD 新药研发不能简单沿用 MASLD“降低食欲、促进减重”的治疗策略。理想的试验人群应筛选营养良好、肝功能代偿，且同时存在≥2 项 CMRF 的患者，这类“高代谢负荷”患者最有可能实现改善代谢紊乱和减少酒精摄入的“双重获益”。相反，对于处于失代偿期、伴有营养不良或仅合并单一 CMRF（如 BMI 在25~30 kg/m²）的“低代谢负荷”患者，其疾病进程已不再由代谢紊乱主导。纳入此类人群不仅难以证实药物疗效，还可能因药物副作用导致严重的不良临床结局。鉴于此，亟须在试验设计中建立基于 BMI、营养状态及肝纤维化分期的精细化分层标准。同时，应优先选择失代偿事件、无移植生存期等硬终点，旨在避免饮酒行为的动态变化对替代指标的干扰，从而直接评估药物的临床净获益。 3.ALD/MetALD 新药研发面临“高风险、低回报”的研发困局：患者招募难、依从性差、混杂因素多，导致阳性结果获取风险高；而采用失代偿事件、死亡率等硬终点又需更大样本量和更长随访周期，进一步推高研发成本。相较之下，MASLD 研究可通过严格限制饮酒量有效控制混杂因素，更受制药企业青睐。针对 ALD/MetALD 新药研发所面临的现实挑战，研究策略的选择往往需要根据制药企业的参与度灵活调整。在缺乏企业支持的情况下，相关探索可能更多依赖于回顾性数据分析或研究者发起的临床试验（investigator-initiated trial，IIT），以此为后续研究积累初步证据。通过这些初步探索有望在控制风险的同时，逐步厘清混杂因素、优化终点设计，为更大规模的确证性研究奠定基础。鉴于MetALD 患者更高的疾病进展风险，在药物临床试验中应被重点纳入和评估。同时，在未来的国家战略发展规划中应将 MetALD 防治作为独立且优先的部分予以明确，推动诊疗路径发展的标准化进程。四、结语与展望综上所述，ALD/MetALD 的新药研发因患者污名化、病因高度混杂及药物研发力度不足等多重障碍，整体进展缓慢。尤其是 MetALD 作为新提出的概念，又先天带有代谢与酒精因素叠加的复杂性，导致临床试验设计难度大、研发成本高、监管路径不明，短期内难以获得制药企业的广泛支持。利用经严格分层筛选的 MetALD 人群在机制上具有对双重干预敏感的潜在富集特征，推动相应 IIT，可能成为识别潜在有效干预的重要途径。加快推进针对MetALD 人群的药物临床试验，对于突破 ALD/MetALD 新药研发瓶颈，降低终末期肝病发病率有重要意义。由此积累的试验数据与经验不仅有助于优化 MetALD 治疗策略，也可为 ALD 领域的药物研发提供可迁移的设计参考与候选疗法。参考文献 [1] Dixon W, Corey KE, Luther J, et al. 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[17] Fouad Y, Mostafa AM, Pan Z, et al. Evaluation of stigma toward fatty liver disease[J]. Endocr Metab Immune Disord Drug Targets, 2026, 26:e18715303359141. DOI: 10.2174/0118715303359141250420070406. [18] Torp N, Bech KT, Schnefeld HL, et al. Phosphatidylethanol and self-reported alcohol intake to subclassify individuals at risk of steatotic liver disease: an analysis of data from a prospective cohort study[J]. Lancet Gastroenterol Hepatol,2025, 10(11):975-985. DOI: 10.1016/S2468-1253(25)00187-6. [19] Staufer K, Huber-Schönauer U, Strebinger G, et al. Ethyl glucuronide in hair detects a high rate of harmful alcohol consumption in presumed non-alcoholic fatty liver disease[J]. J Hepatol, 2022, 77(4):918-930. DOI: 10.1016/j.jhep.2022.04.040. [20] Rady ED, Cotter TG. Integrating phosphatidylethanol to enhance alcohol quantification in steatotic liver disease and clinical trials[J]. Liver Int, 2026, 46(1):e70489. DOI: 10.1111/liv.70489. [21] Loomba R, Ratziu V, Harrison SA, et al. 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Lancet Gastroenterol Hepatol, 2025, 10(11): 998-1012.DOI: 10.1016/S2468-1253(25)00188-8. 来源：中华肝脏病杂志医脉通是专业的在线医生平台，“感知世界医学脉搏，助力中国临床决策”是平台的使命。医脉通旗下拥有「临床指南」「用药参考」「医学文献王」「医知源」「e研通」「e脉播」等系列产品，全面满足医学工作者临床决策、获取新知及提升科研效率等方面的需求。本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

2026-09-02

·BioSpace

Inventiva Announces Last Patient Visit in NATiV3 Phase 3 Clinical Trial of Lanifibranor in MASH

Last patient completed final 72-week visit in NATiV3, with 1,009 patients enrolled in the main cohort and 410 patients in the exploratory cohort Topline results of NATiV3 expected in Q4 2026 September investor conference participation and timing of H1 2026 financial results update Daix (France), New York (New York, United States), September 2 nd , 2026 – Inventiva (Euronext Paris and Nasdaq: IVA ) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral small molecule therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the last patient has completed their final 72-week visit in the NATiV3 Phase 3 clinical trial evaluating lanifibranor for the treatment of patients with MASH with moderate and advanced fibrosis. NATiV3 enrolled 1,009 adults with biopsy-proven non-cirrhotic MASH and F2/F3 fibrosis, with an additional 410 patients enrolled in an exploratory cohort. With the last patient having completed their final visit, all patients have completed the 72-week treatment period. Inventiva expects to report topline results from NATiV3 in the fourth quarter of 2026, as previously communicated. If the results are favorable, the Company anticipates regulatory submission in the first half of 2027 and is preparing for a potential U.S. launch of lanifibranor in 2028, subject to FDA approval. Andrew Obenshain, Chief Executive Officer, Inventiva: “ Our ambition is to develop a treatment that can make a meaningful difference for patients, and reaching last patient, last visit in NATiV3 is an important milestone for Inventiva and for the development of lanifibranor in noncirrhotic MASH. We are deeply grateful to the patients who participated in the study and to the investigators and clinical teams who led its execution alongside our dedicated Inventiva team. We now look forward to topline results later this year.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Prof. Arun Sanyal, M.D., Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University and co-principal in vestigator of NATiV3, stated: " Having been involved in the clinical program of lanifibranor over the years, it is particularly meaningful to see the last patient complete their final visit in this important Phase 3 trial. Given the significant unmet need in MASH, where many patients continue to face limited treatment options and the burden of a progressive disease, and the positive results observed in the NATIVE Phase 2b trial, I am looking forward to the topline read-out of the NATiV3 trial and the potential for lanifibranor to become a leading treatment for MASH.” Prof. Sven Francque, M.D., Ph.D., Professor of Gastroenterology and Hepatology at the University of Antwerp and co-principal investigator of NATiV3, stated : “ The completion of NATiV3 marks an important milestone for the MASH field and for the development of next-generation PPAR therapies. Lanifibranor’s pan-PPAR mechanism has the potential to address the complexity of MASH disease, by working on the interconnected pathways through both intrahepatic and extrahepatic effects. The NATIVE Phase 2b results provided compelling clinical evidence of the potential of this broad mechanism, with improvements in both MASH and fibrosis. I very much look forward to the NATiV3 topline results.” NATiV3 is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the long-term efficacy and safety of lanifibranor (800mg/daily and 1200mg/daily) in 1009 adult patients with biopsy-proven non-cirrhotic MASH and F2/F3 stage of liver fibrosis. The effect of lanifibranor will be assessed on several histological endpoints, including MASH resolution and improvement of fibrosis of at least one stage after 72 weeks of treatment. An exploratory cohort has enrolled 410 patients with MASH and F1 through F4 stage of liver fibrosis. Following completion of the 72-week treatment period, patients participating in NATiV3 had the option to continue into a 48-week open-label extension period, during which all patients, including those originally randomized to placebo, receive active treatment with lanifibranor. This extension will provide additional information on the longer-term safety of lanifibranor. September Investor Conference Participation ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); Inventiva leadership will be participating in the following healthcare conferences in September, presentation details are as follows: Conference : Morgan Stanley 24 th Annual Global Healthcare Conference Fireside Chat with Andrew Obenshain, CEO, and Jason Campagna, President of R&D and CMO Date: September 15, 2026 Time: 4:50 – 5:25 pm ET Conference : Stifel 2026 Virtual Cardiometabolic Forum Fireside Chat with Andrew Obenshain, CEO, Jason Campagna, President of R&D and CMO and Axel-Sven Malkomes, CFO Date: Wednesday, September 30, 2026 Conference : Jefferies Healthcare C-Suite "Back to School" Series 2026 Fireside Chat with Andrew Obenshain, CEO, Jason Campagna, President of R&D and CMO and Axel-Sven Malkomes, CFO Date: Wednesday, September 30, 2026 Time: 10:00 – 11:00 am ET Next Financial Results Publication ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); The Company also provided updated timing for financial results for the first half of 2026: Monday September 28, 2026 revised from the previously disclosed date of Friday, September 25, 2026. Inventiva’s management will hold a conference call in English, followed by a Q&A session, on Monday, September 28, 2026, at 8:00 am (New York), 2:00 pm (Paris). Participants wishing to join the conference call by phone and ask questions must register in advance here . Upon registration, participants will receive dial-in details by email. The live webcast may be accessed on the Events section of the Inventiva website. A replay of the conference call will be available after the event on the Company’s website. About Lanifibranor Lanifibranor, Inventiva’s lead product candidate, is an orally available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (“PPAR”) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan-PPAR agonist in clinical development for the treatment of MASH. Inventiva believes that lanifibranor’s moderate and balanced pan-PPAR binding pro to the favorable tolerability pro has been observed in clinical trials and preclinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH. Lanifibranor is an investigational medicine and has not been approved for use by any regulatory authority. Its safety and efficacy have not been established. ezstandalone.cmd.push(function () { ezstandalone.showAds(134); }); About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). Contacts ezstandalone.cmd.push(function () { ezstandalone.showAds(135); }); Media Relations Lisa Buffington: media@inventivapharma.com Investor Relations David Nikodem: IR@inventivapharma.com Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including the quality of trial results, design, duration, timing, costs, and funding, timing of clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and development plans, and Inventiva's future activities, expectations, plans, growth and prospects. Some of these statements, forecasts, and estimates may be identified by the use of words such as, without limitation, “believe,” “anticipate,” “expect,” “intend,” “plan,” “seek,” “estimate,” “may,” “will,” “could,” “should,” “designed,” “hope,” “target,” “potential,” “opportunity,” “possible,” “aim,” and “continue” and other similar expressions. These statements are not historical facts, but rather statements of future expectations and other forward-looking statements based on management's beliefs. These statements reflect the opinions and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva's control. There can be no guarantee, with respect to product candidates, that clinical trial results will be available on schedule, that future clinical trials will be initiated as planned, that product candidates will receive the necessary regulatory approvals, or that the milestones planned by Inventiva or its partners will be achieved on schedule, or even at all. Future results may differ materially from the anticipated future results, performance, or achievements expressed or implied by these statements, forecasts, and estimates due to a number of factors, including the fact that interim data or data from any interim analysis of ongoing clinical trials do not predict the future results of clinical trials, the fact that the DMC's recommendation does not prejudge any eventual marketing authorization, that Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction (SUSAR) on recruitment or the final impact on the results or timing of the NATiV3 trial or related regulatory issues, Inventiva is a clinical-stage company with no approved products and no historical revenue, Inventiva has incurred significant losses since its inception, Inventiva has never generated revenue from product sales, Inventiva will need additional capital to fund its operations, without which Inventiva may be required to significantly reduce its activities, delay or discontinue one or more of its research or development programs, expand its activities or capitalize on its business opportunities, and may not be able to continue as a going concern. Inventiva's ability to obtain financing and complete potential transactions on a timely basis, as well as whether, when, and to what extent dilutive instruments may be exercised and by which holders, Inventiva's future success depends on the successful clinical development, regulatory approvals, and subsequent commercialization of lanifibranor, preclinical studies or previous clinical trials are not necessarily predictive of future results, and the results of Inventiva's and its partners' clinical trials may not support Inventiva's and its partners' claims regarding product candidates, Inventiva's expectations regarding its clinical trials may prove to be incorrect, and regulatory authorities may require additional stops and/or modifications to Inventiva's clinical trials. Inventiva's expectations regarding the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva's ability to implement its commercialization, marketing, and manufacturing capabilities and strategy, Inventiva's ability to successfully cooperate with its existing partners or enter into new partnerships, and to fulfil its obligations under any agreements entered into in connection with such partnerships, the benefits of its current and future partnerships on the clinical development, regulatory approvals, and, if applicable, commercialization of its product candidates, as well as the achievement of milestones and timelines anticipated in connection with such partnerships, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of the applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, the recruitment and retention of patients in clinical trials is a costly and time-consuming process that could be made more difficult or impossible by multiple factors beyond the control of Inventiva and its partners, Inventiva's product candidates may cause adverse reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and Inventiva's activities, preclinical studies, and clinical development programs, as well as timelines, Inventiva's financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, adverse conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and the resulting sanctions, the conflict in the Middle East and the related risk of a wider conflict and ongoing conflicts, epidemics, and macroeconomic conditions, including changes in international trade policies, global inflation, fluctuations in financial and credit markets, customs duties and other trade barriers, political unrest and natural disasters, uncertain financial markets, and disruptions in banking systems. In light of these risks and uncertainties, no representation is made as to the accuracy or completeness of these forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts, and estimates are only valid as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2025 filed with the Autorité des Marchés Financiers on April 8, 2026, and the Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on April 8, 2026 for other risks and uncertainties affecting Inventiva, including those described under the caption "Risk Factors", and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. Attachment Inventiva - PR - Inventiva LVLP - EN 09 02 2026

100 项与拉尼兰诺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D13335	-	-	DB14801

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
肝纤维化	临床3期	美国	Delpharm Reims SAS	2021-08-19
肝纤维化	临床3期	美国	Inventiva SA	2021-08-19
肝纤维化	临床3期	美国	正大天晴药业集团股份有限公司	2021-08-19
肝纤维化	临床3期	阿根廷	Delpharm Reims SAS	2021-08-19
肝纤维化	临床3期	阿根廷	Inventiva SA	2021-08-19
肝纤维化	临床3期	阿根廷	正大天晴药业集团股份有限公司	2021-08-19
肝纤维化	临床3期	澳大利亚	Delpharm Reims SAS	2021-08-19
肝纤维化	临床3期	澳大利亚	Inventiva SA	2021-08-19
肝纤维化	临床3期	澳大利亚	正大天晴药业集团股份有限公司	2021-08-19
肝纤维化	临床3期	奥地利	Delpharm Reims SAS	2021-08-19

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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


NCT03459079 (Pubmed \| J Hepatol) 人工标引	临床2期	2型糖尿病 \| 代谢功能障碍相关的脂肪肝病	38	Lanifibranor 800 mg	鑰鹹築廠壓壓鑰憲構淵(網齋簾簾淵遞鹽簾鹹憲) = 繭鹽繭齋艱艱襯艱簾窪壓鹽蓋鬱膚製範餘築願 (蓋獵膚衊壓糧糧觸醖遞 ) 更多	积极	2025-06-01
				Placebo	鑰鹹築廠壓壓鑰憲構淵(網齋簾簾淵遞鹽簾鹹憲) = 顧顧獵襯窪網窪顧鹽築壓鹽蓋鬱膚製範餘築願 (蓋獵膚衊壓糧糧觸醖遞 ) 更多
NCT03459079 (NATIVE trial, CTgov)	临床2期	2型糖尿病 \| 代谢功能障碍相关的脂肪肝病	128	Lanifibranor (Lanifibranor Arm)	構範齋簾衊廠衊淵夢願(壓願簾構廠顧積壓鹹蓋) = 願選艱窪製觸齋壓繭獵憲糧獵簾鬱製觸構範憲 (繭構夢窪網廠憲鬱築壓, 鹹鏇醖繭鹽顧醖顧鬱獵 ~ 襯壓選遞憲鹽鏇壓餘齋) 更多	-	2024-09-19
				Placebo (Placebo)	構範齋簾衊廠衊淵夢願(壓願簾構廠顧積壓鹹蓋) = 膚蓋積鏇範鹹遞窪襯糧憲糧獵簾鬱製觸構範憲 (繭構夢窪網廠憲鬱築壓, 衊壓鹹網鹹鹹醖繭願蓋 ~ 衊醖廠繭廠獵淵選壓鹽) 更多
NCT03008070 (NATIVE, Pubmed) 人工标引	临床2期	代谢功能障碍相关脂肪性肝炎 insulin \| HOMA-IR \| HbA1c ... 更多	-	Lanifibranor	願蓋遞繭衊繭糧鏇觸築(衊網窪範鏇積衊積顧襯) = 憲觸齋鑰簾鹽膚範壓醖艱憲鬱觸顧積鑰襯餘積 (鹽構鹹醖鏇襯鏇憲願網 ) 更多	积极	2024-05-10
NCT05232071 (LEGEND, GlobeNewswire) 人工标引	临床2期	2型糖尿病 \| 代谢功能障碍相关脂肪性肝炎	63	lanifibranor+empagliflozin	艱簾壓鑰憲鹽鑰憲衊範(觸襯範膚艱繭獵艱獵齋) = 膚簾顧夢鏇積齋窪鹹夢夢遞構憲夢製繭淵簾願 (顧鬱窪築獵憲遞鹽構醖 ) 达到更多	积极	2024-03-18
				lanifibranor	艱簾壓鑰憲鹽鑰憲衊範(觸襯範膚艱繭獵艱獵齋) = 網遞鑰壓鏇鏇蓋餘簾鏇夢遞構憲夢製繭淵簾願 (顧鬱窪築獵憲遞鹽構醖 ) 达到更多
NCT03459079 (NATIVE trial, NASH_TAG2024)	临床2期	2型糖尿病 \| 代谢功能障碍相关的脂肪肝病 HbA1c \| plasma HDL-C \| adiponectin	38	Lanifibranor 800 mg	築構鬱範鏇醖觸顧糧憲(夢淵鹽繭壓簾廠膚窪鏇) = 糧糧醖襯醖網衊蓋夢蓋襯廠廠夢觸鏇糧繭鏇膚 (鑰觸選鏇選膚憲餘簾繭 ) 更多	积极	2024-01-04
				Placebo	築構鬱範鏇醖觸顧糧憲(夢淵鹽繭壓簾廠膚窪鏇) = 鏇顧衊襯膚範鏇衊選繭襯廠廠夢觸鏇糧繭鏇膚 (鑰觸選鏇選膚憲餘簾繭 )
NCT03008070 (NATIVE, ADA2023)	N/A	2型糖尿病 \| 代谢功能障碍相关脂肪性肝炎	247	Lanifibranor 800 mg/d	衊膚鏇夢廠願夢糧獵鏇(壓築鏇糧淵衊選壓蓋餘) = 醖艱衊齋鑰獵廠襯觸鏇鑰衊醖願鑰夢積獵餘範 (蓋衊範積鹹蓋鹹鹽膚鹹 )	-	2023-06-20
				Lanifibranor 1200 mg/d	衊膚鏇夢廠願夢糧獵鏇(壓築鏇糧淵衊選壓蓋餘) = 壓網襯糧網構鑰遞築積鑰衊醖願鑰夢積獵餘範 (蓋衊範積鹹蓋鹹鹽膚鹹 )
NCT03008070 (phase 2b, Pubmed \| N Engl J Med)	临床2期	代谢功能障碍相关脂肪性肝炎	247	Lanifibranor 1200 mg	遞遞製顧鹹獵選簾製顧(壓願獵鏇製鏇選鑰窪齋) = 願壓願構範憲壓窪鹹襯壓築鬱鹹鹽憲憲簾鏇壓 (顧獵觸鏇築廠憲糧窪鹽 ) 更多	积极	2021-10-21
				Lanifibranor 800 mg	遞遞製顧鹹獵選簾製顧(壓願獵鏇製鏇選鑰窪齋) = 蓋淵蓋壓廠鹹夢鬱築淵壓築鬱鹹鹽憲憲簾鏇壓 (顧獵觸鏇築廠憲糧窪鹽 ) 更多
NCT03008070 (NATIVE, EASL2021)	临床2期	代谢功能障碍相关脂肪性肝炎	247	Lanifibranor 800 mg/d	簾繭膚繭鹹選壓鏇簾鏇(醖範簾齋糧憲鑰窪範鹽) = 鹹齋鬱衊築窪艱醖憲鑰壓淵壓餘選衊窪廠鹹餘 (淵築觸鏇願簾憲醖構壓 ) 更多	-	2021-06-23
				Lanifibranor 1200 mg/d	簾繭膚繭鹹選壓鏇簾鏇(醖範簾齋糧憲鑰窪範鹽) = 鹽築衊糧遞鹹鹽襯鏇鹹壓淵壓餘選衊窪廠鹹餘 (淵築觸鏇願簾憲醖構壓 ) 更多
NCT03008070 (NATiV3 \| NATIVE \| NATIVE study \| phase 2b, CTgov)	临床2期	代谢功能障碍相关脂肪性肝炎	247	IVA337 (IVA337 1200mg)	衊願鏇製膚遞製壓獵積(膚願鏇糧廠積艱窪鹽齋) = 膚廠製衊餘膚艱壓鬱鏇鹽艱顧蓋繭製襯簾鹽廠 (鑰夢窪網糧齋顧夢選積, 3.82) 更多	-	2021-04-12
				IVA337 (IVA337 800mg)	衊願鏇製膚遞製壓獵積(膚願鏇糧廠積艱窪鹽齋) = 壓壓築蓋顧遞網選鬱構鹽艱顧蓋繭製襯簾鹽廠 (鑰夢窪網糧齋顧夢選積, 3.85) 更多
NCT03008070 (NATIVE, NASH_TAG2021)	临床2期	代谢功能障碍相关脂肪性肝炎	-	Lanifibranor 30 mg/kg	膚顧願憲遞艱淵願糧蓋(廠網繭糧鹽蓋鹹鬱鹹衊) = Lanifibranor treatment demonstrated â¥2 point significant improvement in NAS 憲窪網夢餘壓蓋積窪齋 (選觸壓蓋顧顧鬱繭鑰憲 ) 更多	积极	2021-03-12