Bioequivalence of Survodutide (BI 456906) When Administered Via Pre-filled Syringe (Formulation A) and Pre Filled Pen (Formulation B2) in Male and Female Trial Participants Who Are Healthy or Otherwise Healthy With Overweight/Obesity (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)

The goal of this study is to find out whether different formulations of survodutide given by different delivery methods is taken up in the body in a similar way.
Participants visit the study site regularly. During study visits, the doctors collect information about participants' health. To assess the study endpoints, participants regularly have blood samples taken.

开始日期2026-03-03

申办/合作机构

Boehringer Ingelheim GmbH

NCT07206290

/ Not yet recruiting临床2期

Albuminuria Reduction Trial and Investigation With Survodutide Treatment in CKD

The ARTIST-CKD trial is a clinical study evaluating the effect of weekly subcutaneous administration of survodutide (3.6 mg) on kidney function in patients with chronic kidney disease (CKD) and elevated albuminuria. The primary objective is to determine whether survodutide leads to early, sustained, and clinically meaningful reductions in albuminuria, regardless of diabetes status.

开始日期2026-03-02

申办/合作机构

Universitair Medisch Centrum Groningen

NCT07221591

/ Active, not recruiting临床1期

Relative Bioavailability of Two Survodutide (BI 456906) Formulations When Administered Subcutaneously Via Pre-filled Syringe Over 28 Weeks (an Open-label, Randomised, Multiple Dose, Parallel Group Trial)

This study is open to healthy people between 18 and 65 years of age. People can join the study if they have a body mass index between 27 and 39.9 kg/m2.
The purpose of this study is to test a new formulation of a medicine called survodutide. Survodutide is being developed to help people with obesity and people with liver conditions. When a new formulation is developed, it is important to understand how it is taken up by the body.
Participants are divided into 2 groups by chance. One group gets the reference formulation of survodutide (formulation A). The other group gets the new formulation of survodutide (formulation B2). Participants in both groups inject survodutide under their skin once a week for about 6 and a half months.
Participants are in the study for about 7 months. During this time, they visit the study site 15 times. For one of the visits, participants stay overnight for 3 nights at the study site. The site staff takes blood samples to measure how much survodutide is in the blood. They also check participants' health and take note of any unwanted effects.

开始日期2025-11-05

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 Survodutide 相关的临床结果

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100 项与 Survodutide 相关的转化医学

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100 项与 Survodutide 相关的专利（医药）

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项与 Survodutide 相关的文献（医药）

2026-03-01·Molecular Metabolism

Survodutide acts through circumventricular organs in the brain and activates neuronal regions associated with appetite regulation

Article

作者: Klein, Holger ; Doerr, Jonas ; Augustin, Robert ; Jarosch, Sebastian ; Hecksher-Sørensen, Jacob ; Zimmermann, Tina ; Chehimi, Samar N ; Lam, Daniel ; Roostalu, Urmas ; Hayes, Matthew R ; Pekcec, Anton ; Perens, Johanna ; Crist, Richard C ; Bleymehl, Katherin ; Reiner, Benjamin C ; Haebel, Peter

Survodutide is a novel GCG/GLP-1 receptor (GCGR/GLP-1R) dual agonist in clinical development for people with obesity and people with metabolic dysfunction-associated steatohepatitis (MASH). Preclinically, survodutide demonstrated body weight lowering efficacy through decreased energy intake and increased energy expenditure. Here, we investigated the central site of action of survodutide and provide further insights into its mechanism of action in reducing body weight. We assessed GCGR and GLP1R expression in human and mouse circumventricular organs (CVOS) and showed for the first time that GCGR is barely detectable in area postrema (AP) and arcuate nucleus of the hypothalamus (ARH) at the single cell level. In contrast, GLP1R is expressed in these tissues. Using a fluorophore labeled survodutide to visualize sites of action in the mouse brain, survodutide was observed to directly access the CVOs and adjacent hypothalamic and hindbrain nuclei, without evidence of uniformly crossing the blood-brain-barrier. In addition, c-Fos labeling showed that multiple nuclei associated with the control of food intake were activated by survodutide. Consistent with the hypothesis that the intake suppressive effects of survodutide are GLP-1R dependent, a long-acting GCGR agonist did not induce neuronal activation in satiety-mediating regions, nor reduced food intake but showed reduction in body weight. These data further support the dual mode of action of survodutide and its potential to provide clinical benefit for people with obesity and/or MASH.

2026-02-01·DIABETES OBESITY & METABOLISM

Baseline characteristics in the SYNCHRONIZE ™‐2 randomized phase 3 trial of survodutide, a glucagon receptor/ GLP ‐1 receptor dual agonist, for obesity in people with type 2 diabetes

Article

作者: Bleckert, Gabriele ; le Roux, Carel W. ; Platz, Elke ; Startseva, Elena ; Brueckmann, Martina ; Wharton, Sean ; Kaplan, Lee M. ; Bozkurt, Biykem ; Ajaz Hussain, Samina ; Kloer, Isabel M.

Abstract:

Aims:

Survodutide is an investigational glucagon receptor/glucagon‐like peptide‐1 receptor dual agonist that has shown promise for treating obesity and its complications in Phase 2 trials. Two double‐blind, randomized, global Phase 3 trials are designed to assess the efficacy and safety of survodutide for treatment of obesity—SYNCHRONIZE™‐1 in people with obesity without type 2 diabetes (T2D) and SYNCHRONIZE™‐2 in people with obesity and T2D. This paper describes the baseline characteristics of participants in SYNCHRONIZE‐2 ( ClinicalTrials.gov identifier NCT06066528).

Materials and Methods:

Participants aged ≥18 years with a body mass index (BMI) ≥27 kg/m 2 and T2D were randomized 1:1:1 to weekly subcutaneous survodutide (up‐titrated to 3.6 or 6.0 mg) or placebo with recommendations for modified diet and physical activity. The primary endpoints are the percentage change in body weight (BW) and achievement of BW reduction of ≥5% from baseline to Week 76.

Results:

SYNCHRONIZE‐2 includes 752 treated participants from 133 sites across 19 countries. At baseline, participants had a mean age of 55.7 years, BMI 36.5 kg/m 2 , BW 104.1 kg, waist circumference 115.5 cm and haemoglobin A1c 7.4%; 50.7% were female. Overall, 36.2% are from Europe, 32.8% from North America and 22.3% from East Asia. The most common obesity complications included hypertension (69.0%), dyslipidaemia (67.6%), obstructive sleep apnoea (17.3%) and arteriosclerotic cardiovascular disease (10.9%); 78.7% were treated with metformin, 34.2% with sodium‐glucose co‐transporter‐2 inhibitors and 58.6% with lipid‐lowering medications.

Conclusions:

SYNCHRONIZE‐2 will determine the efficacy, safety and tolerability of survodutide for BW reduction in people with obesity and T2D, whose baseline characteristics suggest a representative, diverse cohort.

2026-02-01·Contemporary Clinical Trials Communications

Optimization of patient and site engagement in the SYNCHRONIZE™ phase 3 clinical trial program for survodutide in obesity through clinical trial simulation

Article

作者: Recaldin, Christopher ; Daniëls, Wouter ; Baanstra, David ; Mooney, Vicki ; van de Walle, Viviënne ; Rubino, Domenica M ; Nadglowski, Joe

Introduction:

Clinical trial simulations (CTSs) are an increasingly common way to incorporate site staff and participant feedback into clinical trial design. CTSs can help overcome the unique challenges presented in obesity trials. Here, a CTS was conducted for three trials from the SYNCHRONIZE™ phase 3 program of survodutide in obesity.

Methods:

Individuals meeting the inclusion criteria of the SYNCHRONIZE trials (referred to as "participants"), and clinical trial professionals with experience in conducting obesity trials ("site staff"), were recruited. Trial designs were reviewed by participants and site staff, and participant-facing materials by participants. Both groups were interviewed about these aspects of the trials.

Results:

Overall responses to the clinical trial designs were positive. Site staff were comfortable with the inclusion/exclusion criteria and thought recruitment would not be difficult. However, they indicated that pre-screening could help ensure participants' appropriateness for the trial. Additionally, they felt steps should be taken to encourage participant engagement throughout the trial. Participants' concerns focused on optimizing training and educational materials, time commitments for the trial, and burden of data collection. Recommendations from the CTS led to changes in visit interval, increased virtual visit options, and changes in participant materials. Psychological support was identified as potentially helpful by both site staff and participants. However, understanding how to implement this in clinical trials remains to be elucidated.

Conclusions:

These results suggest participant and site staff input from a CTS could help improve obesity clinical trial design, which may ultimately lead to more robust data and reliable clinical findings.

306

项与 Survodutide 相关的新闻（医药）

2026-02-27

·抗体圈

肥胖领域实力排名：谁能撼动礼来与诺和诺德的霸主地位？

2034 年全球肥胖治疗市场规模将突破 1300 亿美元，这一赛道也成为制药行业中最具活力的黄金赛道。各大制药巨头正加速推进研发管线布局，全力抢占这一高潜力市场。为筛选出该领域最具增长潜力的企业，菲尼克斯集团（Fenix Group）重磅发布《肥胖领域企业实力排名》，遴选出全球十强玩家。本次排名对 20 余家制药企业展开综合评估，围绕管线研发深度、临床差异化优势、商业基础设施等 15 项核心指标进行加权评分，最终得出满分为 5 分的综合评分结果。若欲深入了解完整的评估体系框架，可直接与菲尼克斯团队取得联系。下文将为业内解读本次排名的核心依据，并深度分析影响各企业市场地位的核心机遇与挑战。礼来（评分 4.9/5）：稳坐行业头把交椅，口服新药成增长核心引擎礼来仍是肥胖领域当之无愧的全球领导者，这一地位在 2025 年得到极致印证 —— 其替尔泊肽系列产品超越默沙东的可瑞达，以超 360 亿美元的年营收登顶全球最畅销药物宝座。目前，礼来拥有布局完善、实力强劲的后期研发管线，这将成为其稳固行业领导地位的核心支撑。而短期内，企业的增长动能将高度聚焦于 2026 年第二季度即将上市的奥福鲁肽（orforglipron）。值得关注的是，诺和诺德的口服版司美格鲁肽（Wegovy）在疗效方面略占微弱优势，这也意味着礼来的商业团队此次或将迎来一场需要 “逆风翻盘” 的市场硬仗。诺和诺德（评分 4.8/5）：开创者遇发展瓶颈，创新乏力成核心痛点作为凭借司美格鲁肽开创现代肥胖治疗市场的先驱者，诺和诺德迈入 2026 年却遭遇多重发展困境：执行层面的接连挑战叠加创新能力的明显下滑，最终导致公司自司美格鲁肽崛起以来，首次发布负面年度销售预期。当前，诺和诺德正寄望于 7.2mg 高剂量 Wegovy 注射剂、Wegovy 口服药以及 CagriSema 的顺利上市，以此稳定其美国市场份额，并重振投资者信心。尽管这几款产品的上市或能缓解短期市场压力，但市场对于诺和诺德是否真正找到司美格鲁肽的长期继任产品，仍持高度怀疑态度。辉瑞（评分 4.1/5）：大手笔布局补齐短板，排名实现跨越式跃升 2025 年，辉瑞完成两项重磅动作 —— 以 100 亿美元收购 Metsera，同时与药企达成口服 GLP-1 新药许可协议，这两大布局直接推动其在肥胖领域的竞争力排名大幅跃升。回顾此前，辉瑞在肥胖赛道曾屡遭挫折，丹鲁肽（danuglipron）、洛替格列酮（lotiglipron）等多个核心研发项目相继终止。而如今，辉瑞终于构建起一条极具差异化的研发管线，且能充分依托自身成熟的商业渠道与生产基础设施，实现管线价值的最大化发挥。罗氏（评分 4.0/5）：跨界布局肥胖赛道，二期临床结果成战略关键尽管罗氏在心脏代谢领域的历史布局相对有限，但该公司已明确对外释放雄心 —— 立志成为肥胖市场前三强玩家。近期，其 GLP-1/GIP 双重受体激动剂 CT-388 的二期临床试验取得令人鼓舞的顶线数据，为其在肥胖赛道的布局打响头炮。当下，市场目光全部聚焦于 2026 年上半年即将公布的 petrelintide 二期临床试验结果，这一数据将成为影响罗氏与 Zealand Pharma 合作走向的核心关键，更将决定罗氏肥胖领域整体战略的最终落地。阿斯利康（评分 3.6/5）：管线深度构筑优势，成市场最大黑马候选凭借深厚的研发管线储备，阿斯利康被业内视作本次实力排名中最具潜力的 “黑马”，有望冲击前三强席位。2025 年，阿斯利康低调推进其中期研发管线的多项布局，而 2026 年多款产品的二期临床试验结果将密集公布，为其市场竞争力再添筹码。此外，阿斯利康与石药集团达成的许可协议，新增一款每月给药一次的双重激动剂产品，这一动作进一步巩固了其在肥胖领域作为核心竞争者的市场地位。安进（评分 3.3/5）：押注长效给药差异化，耐受性问题成待解难题安进正将核心筹码押注于 MariTide 的延长给药间隔设计，试图以此打造其在肥胖市场的关键差异化优势 —— 该产品实现按季度给药，与现有主流产品形成明显区别。但值得警惕的是，在 2025 年美国糖尿病协会（ADA）年会上，MariTide 二期临床试验暴露的耐受性问题让投资者倍感担忧。安进能否顺利解决这一临床痛点，将直接决定其在肥胖赛道的未来发展。勃林格殷格翰（评分 3.0/5）：三期数据成破局关键，管线拓展刻不容缓勃林格殷格翰的 GLP-1R/GCGR 双激动剂 survodutide 三期临床试验数据预计将于 2026 年上半年公布，该公司也借此成为首个直面礼来、诺和诺德双寡头格局的挑战者。即便 survodutide 能交出亮眼的三期临床数据，勃林格殷格翰仍需加快管线拓展步伐，将研发布局从目前处于二期临床的三重激动剂向外延伸，才能真正成为肥胖领域的长期竞争者。再生元（评分 2.9/5）：打破外围布局策略，产品多元化成必答题此前，业内普遍认为再生元在肥胖市场采取 “外围布局” 策略，聚焦于开发能维持瘦体重的相关药物。而 2025 年 6 月，再生元引进奥洛替肽（olarotepide）的许可协议，首次向市场展露其在肥胖领域的更大野心。但与勃林格殷格翰、安进类似，再生元若想跻身肥胖市场领导者阵营，必须进一步丰富产品组合，实现管线多元化布局，这已是其发展的必答题。Zealand Pharma（评分 2.4/5）：押注胰淀素赛道，二期临床迎关键验证在首席执行官 Adam Steenburg 的带领下，Zealand Pharma 怀揣着终结其口中 “减肥奥林匹克竞赛” 的雄心，正将战略核心押注于胰淀素 —— 将其视作下一代核心抗肥胖药物品类。继与罗氏达成 petrelintide 合作后，Zealand Pharma 即将公布 ZUPREME-1 二期临床试验结果，这一数据将首次为 petrelintide 是否能达到其预设的产品特性目标，提供具有实际意义的临床验证。Kailera Therapeutics（评分 2.2/5）：引进中国创新药，商业化模式成未知变量 Kailera Therapeutics 从中国恒瑞医药引进 GLP-1/GIP 双靶点激动剂瑞波肽（ribupatide），该药物已在中国人群的临床试验中展现出强劲的后期减重疗效。在此基础上，Kailera Therapeutics 已启动自研三期临床项目，评估该药物更高剂量（＞6 毫克）、更长治疗周期下的临床效果。目前，市场对该公司的最大关注集中于其商业化模式选择：是将遵循行业传统，与大型制药企业展开合作？还是将采用全新的美国商业化模式，直接面向患者进行销售？这一选择将成为决定其市场发展的关键未知变量。原文链接：https://www.fiercepharma.com/sponsored/obesity-power-rankings-who-will-challenge-lilly-and-novo 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

2026-02-26

·减重时讯

MASH治疗新视角：29项RCT网络Meta分析揭晓药物疗效排序

点击“蓝字”关注我们编者按：代谢功能障碍相关脂肪性肝炎（MASH）药物研发正步入新纪元，多种靶向不同机制的药物在临床试验中展现出潜力。然而，由于缺乏直接的头对头比较研究，如何评估这些药物的相对疗效已成为临床决策的难点。近期发表于Hepatology的一项系统综述和网络Meta分析，通过对现有随机对照试验（RCT）的综合评估，为不同药物在关键组织学终点上的疗效提供了清晰的排序证据，这对指导临床实践及未来研究具有重要价值。研究背景：MASH治疗的挑战与机遇 MASH是与全球肥胖和糖尿病流行密切相关的慢性肝病，影响着全球近三分之一的人口。该病是驱动肝纤维化、肝硬化、肝功能失代偿乃至肝细胞癌的关键因素，构成了严峻的公共卫生挑战。MASH的病理生理机制极为复杂，涉及胰岛素抵抗、脂毒性、氧化应激、炎症反应和纤维化信号通路等多环节的相互作用。其中，肝纤维化是决定MASH患者长期临床预后的核心病理特征——纤维化分期越高，肝脏相关并发症及死亡风险越呈急剧上升趋势。因此，逆转或延缓肝纤维化进程已成为MASH药物研发的首要目标。在生活方式干预之外，MASH领域长期面临无有效获批药物的治疗空白期，临床管理主要依赖生活方式干预，但患者依从性及疗效持久性均面临严峻挑战。近年来，随着对MASH发病机制认知的深入，针对成纤维细胞生长因子21（FGF21）通路、胰高糖素样肽-1（GLP-1）受体、甲状腺激素受体-β（THR-β）等多个靶点的药物研发已取得突破性进展。多项II期和III期临床试验显示，这些新药在改善肝脏组织学方面展现出令人鼓舞的疗效。然而，这些试验大多采用安慰剂对照设计，缺乏药物间的直接比较数据，使得临床医生难以在众多选择中为特定患者做出最优决策。研究设计：网络Meta分析与主要终点为破解缺乏头对头研究证据的困境，本研究采用严谨的系统综述与网络Meta分析（NMA）方法。研究团队严格遵循PRISMA声明规范，系统检索了PubMed及Embase数据库，纳入2020年1月1日至2024年12月1日期间发表的、针对活检证实MASH患者的Ⅱ-Ⅳ期随机对照试验（RCTs）。分析采用贝叶斯统计框架，通过间接比较评估缺乏直接对照证据的多种药物疗效差异，并运用累积排名概率曲线下面积（SUCRA）对各种药物的疗效排序——SUCRA值越高表明疗效越优。研究设定了两个协同主要终点，均基于肝脏组织学评估：（1）肝纤维化改善≥1期且MASH未恶化；（2）MASH缓解且肝纤维化未恶化。这两个终点指标是当前MASH新药临床试验中普遍采用的关键疗效指标。研究结果：MASH药物疗效的全面图景经过严格筛选，该研究最终纳入29项独立的RCTs、9324例经活检证实的MASH患者。其中，9项于北美开展，3项在亚洲，1项在欧洲，其余16项为跨国研究，且绝大多数（93.1%）为多中心试验。受试者基线特征显示其代表典型MASH人群，多数伴有显著肝纤维化。为清晰呈现药物间比较关系，研究构建了网络关系图（图1）。该图通过节点大小直观反映患者分配数量，边粗细则对应的数量，从而系统体现各药物间的证据连接强度。图1. 纳入研究的网络关系图（A）肝纤维化改善≥1期且MASH未恶化、（B）MASH缓解且肝纤维化未恶化协同主要终点一：肝纤维化逆转在“肝纤维化改善≥1期且MASH未恶化”这一主要终点评估中，共纳入24项RCTs、共8708例患者，结果揭示了不同药物在逆转肝纤维化方面的疗效差异（图1）。单药治疗中，FGF21类似物Pegozafermin疗效最优，其SUCRA值高达79.92，相对风险（RR）为3.46（95%置信区间[CI]：1.54~11.15）；脂肪酸合酶（FASN）抑制剂Denifanstat的SUCRA值60.64；葡萄糖依赖性促胰岛素多肽和胰高糖素样肽-1（GIP/GLP-1）双受体激动剂Survodutide的SUCRA值59.89；FXR激动剂奥贝胆酸（Obeticholic acid）的SUCRA值58.86；GIP/GLP-1双受体激动剂替尔泊肽（Tirzepatide）的SUCRA值57.37；THR-β激动剂Resmetirom的SUCRA值50.14，均显示出较好的纤维化改善潜力。联合疗法表现亮眼：法尼醇X受体（FXR）激动剂Cilofexor联合乙酰辅酶A羧化酶（ACC）抑制剂Firsocostat的SUCRA为71.38，紧随单药FGF21类似物Pegozafermin之后；Cilofexor联合凋亡信号调节激酶1（ASK1）抑制剂Selonsertib的SUCRA值达69.11，位列第三。图1：不同药物在“纤维化改善≥1期且MASH不恶化”终点的治疗效果森林图协同主要终点二：MASH缓解在“MASH缓解且肝纤维化未恶化”这一主要终点评估中，纳入28项RCTs、9277例患者，结果揭示了不同药物的疗效差异（图2）。 FGF21类似物Pegozafermin以最高SUCRA值（94.32）位居榜首，其相对风险（RR）达8.65（95%CI：2.63~59.42）；GIP/GLP-1双受体激动剂Survodutide、替尔泊肽紧随其后，SUCRA分别为90.87、84.70，RR值分别为6.62（95%CI：3.13~17.97）、4.65（95% CI：2.31~10.66）。其次，FGF21类似物Efruxifermin的SUCRA为76.22、GLP-1受体激动剂利拉鲁肽的SUCRA为71.58，THR-β激动剂Resmetirom的SUCRA为63.95。这些数据进一步验证了靶向代谢通路——特别是FGF21信号通路与多重肠促胰素受体激动剂——在实现MASH病理学缓解中的核心作用，为临床治疗策略的选择提供了高水平的循证医学证据。图2：不同药物在“MASH缓解且纤维化不恶化”终点的治疗效果森林图此外，在2个共同主要终点的SUCRAs二维分布中，Pegozafermin、Cilofexor+Firsocostat、Survodutide等均处于较高水平，综合疗效表现突出（图3）。图3. 各药物在两大协同主要终点上的SUCRA二维图亚组分析：治疗时长与作用机制的影响为验证疗效排序的稳健性，研究者开展了基于治疗时长的敏感性分析，揭示了治疗周期对药物疗效评估的关键影响。结果显示，当治疗时长≥52周时，在“肝纤维化改善≥1期且MASH未恶化”的终点中，FASN抑制剂Denifanstat以SUCRA值66.49跃居首位，FXR激动剂奥贝胆酸以65.90紧随其后，GIP/GLP-1受体激动剂替尔泊肽则以62.98位列第三，提示这些药物在长期治疗中可能具有更持久的纤维化逆转效果。在“MASH缓解且肝纤维化未恶化”终点中，替尔泊肽以87.03的SUCRA值展现绝对优势，进一步验证了其作为长效治疗方案的潜力。而在治疗周期＜52周的试验中，Pegozafermin在纤维化改善（SUCRA：65.92）和MASH缓解（SUCRA：84.09）两个终点上均排名第一，显示出其快速起效的特性。本项敏感性分析强调了临床试验设计中治疗时长选择的重要性，表明不同药物可能具有不同的起效速度和作用模式，为临床根据患者情况选择短期或长期治疗方案提供了线索。从作用机制上看，FGF21类似物和GLP-1受体相关激动剂在两个终点上均表现出强大的竞争力，而THR-β激动剂瑞则展现了均衡且稳健的疗效。这些发现为理解不同药物的作用特点及未来探索联合用药提供了重要洞见。研究局限性本研究亦需谨慎考量以下局限性：首先，药物间疗效比较主要基于间接证据网络，缺乏头对头直接对照试验的验证，可能存在选择偏倚或混杂因素干扰；其次，纳入研究在试验设计（如随机方法、盲法实施）、基线人群特征（如肝纤维化分期分布、代谢合并症比例）及终点判定标准等方面存在显著异质性，可能影响结果的外推性；最后，部分药物仍处于早期研发阶段（如Ⅰ/Ⅱ期临床试验），其长期安全性数据尚未完全明确，且最终能否通过监管审批存在不确定性。因此，对结果的解读需保持谨慎。结语本项网络Meta分析为MASH药物治疗领域提供了迄今最全面的疗效排序证据，对临床实践和未来研究具有重要的指导意义。研究结果清晰地揭示了Pegozafermin、Survodutide和替尔泊肽为代表的新型药物在改善肝脏组织学方面的巨大潜力。这些数据不仅有助于指导未来临床试验的设计，特别是在联合治疗方案的探索上，也为临床医生在多种治疗选择并存时进行个体化决策提供了参考。未来，亟需开展更多头对头的RCT来直接验证这些发现，并推动非侵入性诊断工具的开发，以期为MASH患者带来更有效、更安全的治疗策略。参考文献： Souza M, et al. Comparison of pharmacological therapies in metabolic dysfunction–associated steatohepatitis for fibrosis regression and MASH resolution: Systematic review and network meta-analysis. Hepatology. 2025;82:1523-1533. 点击左下角“阅读原文”查看原文声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息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，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。（来源：《减重时讯》编辑部）版权声明版权属《减重时讯》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

临床2期临床结果

2026-02-23

·FiercePharma

Obesity Power Rankings: Who will challenge Lilly and Novo?

None With the obesity market projected to exceed $130 billion by 2034, many major pharmaceutical players are rapidly advancing pipelines to capitalize on what is arguably the most dynamic space in the industry. To identify the companies positioned to outperform, FENIX has created the Obesity Power Rankings of the Top 10 players. For context, >20 companies were assessed across more than 15 weighted criteria, including pipeline depth, clinical differentiation, and commercial infrastructure, to derive a composite score out of five. If you’re interested in a deeper look at the full assessment framework, please contact the FENIX team. Below, FENIX outlines the rationale for all rankings and highlights key headwinds and tailwinds that shape each company’s position: Lilly (4.9/5): Lilly remains the undisputed market leader in obesity, as evidenced by its tirzepatide franchise becoming the world’s top-selling drug in 2025, surpassing Merck’s Keytruda to generate >$36 billion in annual revenue. While Lilly possesses a robust late-stage pipeline which is anticipated to help defend its leadership position, near-term momentum is expected to center on the orforglipron launch in Q2 2026. Considering Novo’s Wegovy Pill appears to hold a marginal edge in terms of efficacy, Lilly’s commercial team may need, for once, to come from behind. Novo Nordisk (4.8/5): Having effectively pioneered the modern obesity market with semaglutide, Novo entered 2026 confronting a convergence of executional challenges and a visible decline in innovation, factors that culminated in the company issuing its first negative annual sales outlook since semaglutide’s ascent. Novo now relies on strong launches of injectable 7.2mg Wegovy, Wegovy Pill, and CagriSema to stabilize its US market share and rebuild investor confidence. While these launches may alleviate near-term pressures, it remains uncertain whether Novo has truly identified a long-term successor to semaglutide. Pfizer (4.1/5): Following its $10 billion Metsera acquisition and licensing agreement with YaoPharma in 2025, Pfizer has significantly vaulted up the competitive rankings. While the company previously faced multiple setbacks in obesity (e.g., danuglipron and lotiglipron discontinuations), Pfizer finally appears to have assembled a differentiated pipeline that can fully leverage its established commercial and manufacturing infrastructure. Roche (4.0/5): Despite its historically limited presence in the cardiometabolic space, Roche has publicly emphasized its ambition to become a Top 3 player in the obesity market. Following the recent encouraging topline CT‑388 Phase 2 results, attention now turns to the upcoming Phase 2 petrelintide readout in H1 2026, a pivotal catalyst that will likely shape the trajectory of its partnership with Zealand and, ultimately, Roche’s broader obesity aspirations. AstraZeneca (3.6/5): A compelling case can be made that AZ has the pipeline depth to emerge as a dark horse contender for the third-place position in the power rankings. The company quietly advanced a broad mid-stage pipeline throughout 2025; and with multiple Phase 2 readouts expected in 2026, it's licensing agreement with CSPC Pharmaceuticals, which added a monthly dual agonist to its arsenal, further strengthens it as a serious contender. Amgen (3.3/5): Amgen is effectively placing a concentrated bet that MariTide’s extended dosing will be its key differentiator in the future obesity market. While quarterly maintenance dosing is differentiated, it remains to be seen whether the company can overcome the Phase 2 tolerability issues that unsettled investors at ADA 2025. Boehringer Ingelheim (3.0/5): With data from the Phase 3 survodutide program anticipated to begin reading out in H1 2026, BI is set to become the first challenger to the current Lilly+Novo duopoly. Even with positive Phase 3 survodutide data, BI likely needs to expand its pipeline beyond its Phase 2 triple agonist to become a long-term competitive player in the space. Regeneron (2.9/5): While it was previously believed Regeneron was taking a tangential approach in the obesity market, looking to develop lean mass-sparing assets, its in-licensing deal for olatorepatide in June 2025 revealed the company’s broader obesity ambitions. However, similar to both BI and Amgen, it is believed Regeneron also needs to further diversify its portfolio to be considered a future leader in obesity. Zealand Pharma (2.4/5): Zealand, guided by CEO Adam Steenburg’s ambition to end what he describes as the “Weight Loss Olympics,” is making a strategic bet that amylin will become the next foundational anti-obesity class. Following Zealand’s partnership with Roche for petrelintide, the upcoming Phase 2 ZUPREME-1 readout will offer the first meaningful look into whether petrelintide lives up to the TPP promise. Kailera Therapeutics (2.2/5): Having licensed China-based Hengrui’s GLP-1/GIP dual agonist (ribupatide), which has already demonstrated strong late-stage weight loss efficacy in a Chinese population, Kailera initiated its own Phase 3 program evaluating higher doses (>6 mg) over longer treatment durations. It will be interesting to see if Kailera follows the traditional path of partnering with Big Pharma or if it goes alone with a new US commercial model (i.e., solely direct-to-patient).

临床3期临床2期引进/卖出

100 项与 Survodutide 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
肝纤维化	临床3期	美国	Boehringer Ingelheim GmbH	2024-10-14
肝纤维化	临床3期	中国	Boehringer Ingelheim GmbH	2024-10-14
肝纤维化	临床3期	日本	Boehringer Ingelheim GmbH	2024-10-14
肝纤维化	临床3期	阿根廷	勃林格殷格翰（中国）投资有限公司	2024-10-14
肝纤维化	临床3期	阿根廷	Boehringer Ingelheim GmbH	2024-10-14
肝纤维化	临床3期	澳大利亚	Boehringer Ingelheim GmbH	2024-10-14
肝纤维化	临床3期	奥地利	Boehringer Ingelheim GmbH	2024-10-14
肝纤维化	临床3期	比利时	Boehringer Ingelheim GmbH	2024-10-14
肝纤维化	临床3期	巴西	Boehringer Ingelheim GmbH	2024-10-14
肝纤维化	临床3期	保加利亚	Boehringer Ingelheim GmbH	2024-10-14

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临床结果

适应症

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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


NCT04771273 (1404-0043, CTgov)	临床2期	代谢功能障碍相关脂肪性肝炎	295	Survodutide (Survodutide 2.4 mg - Planned Maintenance Treatment)	餘鹹築壓鑰範觸觸製製 = 構壓構網艱醖構繭範餘鑰壓鹹鹽淵製廠齋窪選 (鬱膚憲鬱鹽製窪膚憲製, 醖襯鏇廠鏇壓鹹構鬱醖 ~ 鬱製鹽淵憲鏇夢膚夢窪) 更多	-	2024-12-03
				Survodutide (Survodutide 4.8 mg - Planned Maintenance Treatment)	餘鹹築壓鑰範觸觸製製 = 網繭蓋廠蓋願窪鬱鑰簾鑰壓鹹鹽淵製廠齋窪選 (鬱膚憲鬱鹽製窪膚憲製, 獵蓋獵鏇糧艱糧獵襯襯 ~ 蓋願築築遞憲積鏇觸繭) 更多
ESC2024	临床2期	肥胖	387	Survodutide 4.8 mg	餘鹽鹹繭選糧糧製遞蓋(壓廠鹹顧觸鏇齋蓋築獵) = 願膚衊憲鹽鹽獵範鑰鏇觸選繭鑰繭餘壓艱衊鬱 (衊餘衊糧糧鏇遞襯選襯 )	积极	2024-09-01
NCT04153929 \| NCT04667377 \| NCT03591718 (1665-P, ADA2024)	临床1/2期	2型糖尿病 \| 肥胖 HbA1c \| insulin sensitivity \| glucose biomarkers ... 更多	-	Survodutide	壓積網憲獵鹹夢鏇淵積(衊衊鑰鬱構窪蓋壓糧壓) = 0.4 vs 0.0 願築選網壓廠醖積觸繭 (願鹹齋獵窪鹽範網築蓋 ) 更多	积极	2024-06-14
				Placebo
NCT04771273 (1404-0043, Pubmed)	临床2期	代谢功能障碍相关脂肪性肝炎	293	Survodutide 2.4 mg	膚鏇窪鹽觸夢壓淵遞淵(顧淵醖觸顧淵壓醖蓋衊) = 艱選艱襯願繭窪選壓鑰廠鏇膚壓網廠構淵廠衊 (淵積顧範鏇願淵齋憲齋 ) 更多	积极	2024-06-07
				Survodutide 4.8 mg	膚鏇窪鹽觸夢壓淵遞淵(顧淵醖觸顧淵壓醖蓋衊) = 選糧憲製壓糧築鹽憲糧廠鏇膚壓網廠構淵廠衊 (淵積顧範鏇願淵齋憲齋 ) 更多
NCT04667377 (Phase II Trial, ENDO2024)	临床2期	超重 \| 肥胖	384	Survodutide 4.8 mg	衊製積鹹製衊構製艱糧(觸簾遞繭繭築蓋壓艱願) = 願鹹觸鏇繭積蓋壓餘鬱鹽糧簾蓋艱廠糧選製觸 (願膚獵夢網壓鏇顧齋醖 )	积极	2024-06-01
				Placebo	衊製積鹹製衊構製艱糧(觸簾遞繭繭築蓋壓艱願) = 製簾憲鬱簾鏇夢襯鏇艱鹽糧簾蓋艱廠糧選製觸 (願膚獵夢網壓鏇顧齋醖 )
NCT04771273 (GlobeNewswire) 人工标引	临床3期	代谢功能障碍相关脂肪性肝炎	-	survodutide	構齋蓋鹹獵觸衊鬱窪構(築構夢遞壓鹽憲築鏇顧) = 憲膚網鬱窪鹹獵選蓋鹹鹹夢醖鬱壓衊窪製觸鹽 (築遞壓鏇襯觸鬱積壓齋 ) 达到	积极	2024-02-26
				Placebo	構齋蓋鹹獵觸衊鬱窪構(築構夢遞壓鹽憲築鏇顧) = 獵觸淵遞願構窪網蓋窪鹹夢醖鬱壓衊窪製觸鹽 (築遞壓鏇襯觸鬱積壓齋 ) 达到
NCT04771273 (Corporate Publications) 人工标引	临床2期	代谢功能障碍相关的脂肪肝病	295	Survodutide	觸衊選糧窪醖齋觸觸鑰(鑰鹹憲積觸窪鹽範簾簾) = 蓋鬱淵築齋蓋顧願襯醖積襯艱憲範構獵選構餘 (觸簾廠鬱窪憲觸蓋糧艱 ) 达到	积极	2024-02-26
				placebo	觸衊選糧窪醖齋觸觸鑰(鑰鹹憲積觸窪鹽範簾簾) = 觸鏇鑰繭壓選壓獵窪蓋積襯艱憲範構獵選構餘 (觸簾廠鬱窪憲觸蓋糧艱 ) 达到
NCT04667377 (Phase II Trial, CTgov)	临床2期	肥胖	387	BI 456906 (0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation))	蓋鑰膚顧淵壓築糧願築(壓鬱網願網憲鏇壓膚糧) = 膚鏇淵艱選築艱蓋鬱衊繭窪齋網築構壓選願構 (製選繭廠鏇夢選繭築窪, 1.07) 更多	-	2023-11-02
				BI 456906 (2.4 mg BI 456906 - Planned Maintenance Treatment)	蓋鑰膚顧淵壓築糧願築(壓鬱網願網憲鏇壓膚糧) = 繭糧範鹽簾憲淵遞鹹範繭窪齋網築構壓選願構 (製選繭廠鏇夢選繭築窪, 1.01) 更多
NCT04667377 (ADA2023) 人工标引	临床2期	超重 \| 肥胖	387	BI 456906 0.6 mg	選鹹選夢繭糧淵鬱鹽壓(鬱網醖範願壓鏇遞構憲) = 鏇觸壓壓繭憲鹹艱獵衊獵憲鹽窪淵鏇窪糧齋範 (糧網醖獵醖選遞積廠糧 ) 更多	积极	2023-06-23
				BI 456906 2.4 mg	選鹹選夢繭糧淵鬱鹽壓(鬱網醖範願壓鏇遞構憲) = 淵艱願齋遞憲繭齋淵鹽獵憲鹽窪淵鏇窪糧齋範 (糧網醖獵醖選遞積廠糧 ) 更多
NCT04153929 (Phase II, CTgov)	临床2期	2型糖尿病	413	Placebo (Placebo)	網餘鹽鑰廠夢壓鹹衊廠(製積夢網鹽鑰廠夢憲選) = 憲鹽獵製選鏇廠繭繭齋構鏇鑰衊窪構築醖觸築 (蓋願顧窪鏇構範鏇遞襯, 0.81) 更多	-	2022-11-29
				BI 456906 (BI 456906 0.3 mg)	網餘鹽鑰廠夢壓鹹衊廠(製積夢網鹽鑰廠夢憲選) = 積鏇壓憲網憲遞衊襯範構鏇鑰衊窪構築醖觸築 (蓋願顧窪鏇構範鏇遞襯, 0.71) 更多