In adults with obesity seeking treatment, weight loss would ideally be composed almost exclusively of fat mass. However, loss of muscle mass and bone are unintentional consequences of weight loss, which has detrimental effects on health by lessening improvements in glucose and insulin levels, contributing to weight regain by reducing basal metabolic rate, and increasing the risk of falls, and fractures. Data in animals and humans suggest that bimagrumab, an investigational new drug for obesity that inhibits the activin type II receptor (ActRII) inhibitor, may build muscle and bone while resulting in a loss of fat mass. Semaglutide, which is FDA-approved for the treatment of obesity, results in loss of fat mass, but its effects on muscle and bone are less clear. The investigators hypothesize that in a randomized, placebo-controlled trial of 65 adults with obesity randomized to IV bimagrumab, identical IV placebo plus semaglutide, or identical IV placebo alone, bimagrumab will result in improvements in muscle, fat, and bone compared to semaglutide or placebo when given in addition to a lifestyle intervention for weight loss over 52 weeks.

开始日期2025-08-01

申办/合作机构

The Schwartz Center for Compassionate Healthcare

NCT07030127

/ Not yet recruiting临床1期

A Phase 1, Participant- and Investigator-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Doses of LY3985863 in Healthy Chinese Participants

The purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

开始日期2025-08-01

申办/合作机构

Eli Lilly & Co.

NCT06901349

/ Active, not recruiting临床2期

A Phase 2b Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.

开始日期2025-05-23

申办/合作机构

Eli Lilly & Co.

100 项与比马格鲁单抗相关的临床结果

登录后查看更多信息

100 项与比马格鲁单抗相关的转化医学

登录后查看更多信息

100 项与比马格鲁单抗相关的专利（医药）

登录后查看更多信息

项与比马格鲁单抗相关的文献（医药）

2025-08-01·CLINICAL NUTRITION

Therapeutic advances in sarcopenia management: From traditional interventions to personalized medicine

Review

作者: Chen, Xinqiao ; Liu, Xiangliang ; Cui, Jiuwei

Sarcopenia, a progressive decline in skeletal muscle mass and function, has emerged as a critical geriatric syndrome affecting 10-40% of older adults, contributing to increased disability and mortality. This comprehensive review evaluates evidence-based strategies for sarcopenia management, from established interventions to emerging personalized approaches. Pathophysiological insights reveal multifactorial mechanisms involving anabolic resistance, chronic inflammation (elevated IL-6, TNF-α), hormonal imbalances (e.g., testosterone/IGF-1 decline), neuromuscular junction dysfunction, mitochondrial impairment, and novel mediators like GDF-15, which drive proteolysis and appetite suppression. Non-pharmacological interventions demonstrate robust efficacy: combined resistance-aerobic exercise regimens (2-3 sessions/week) improve muscle strength by 20-35%, while optimized protein intake (1.0-1.5 g/kg/day) with leucine or vitamin D supplementation enhances muscle synthesis and functional capacity. Pharmacological trials highlight selective androgen receptor modulators (SARMs) and myostatin inhibitors (e.g., bimagrumab) increasing lean mass by 3-5% in phase II studies, with GDF-15-neutralizing antibodies emerging as promising anti-catabolic agents. Advanced therapies, including stem cell transplantation and AAV-mediated gene editing targeting myostatin/IGF-1 pathways, show preclinical regenerative potential. However, clinical translation requires validation through large-scale trials. Personalized strategies integrating biomarkers, comorbidities, and digital monitoring tools optimize intervention efficacy, particularly in complex populations like diabetic or cachectic patients. This synthesis underscores the paradigm shift toward precision medicine but identifies critical knowledge gaps, including long-term safety of biologics and cost-effectiveness of regenerative approaches. Future research should prioritize multimodal therapies, validated biomarkers, and AI-driven algorithms to individualize sarcopenia management in aging populations.

2025-07-01·CURRENT OPINION IN CLINICAL NUTRITION AND METABOLIC CARE

Nutrition support whilst on glucagon-like peptide-1 based therapy. Is it necessary?

Review

作者: Chavez, Alvaro M ; León-Sanz, Miguel ; Carrasco Barria, Ruben

Aim of the review:

Weight loss is a primary goal in the treatment of obesity, but its effect on body composition – particularly fat-free mass (FFM) and skeletal muscle mass (SM) – is of increasing concern. This review examines the effects of antiobesity medications, particularly glucagon-like peptide-1 receptor analogs (GLP-1 RA), on body composition, the risk of sarcopenia, and strategies to preserve muscle mass during pharmacological weight loss.

Recent findings:

Studies have shown that while GLP-1 RA are effective in reducing fat mass, up to 40% of the total weight loss can come from FFM. However, it is important to distinguish between FFM and SM, as FFM includes nonmuscle components. Resistance training and adequate protein intake can mitigate muscle loss, but the evidence for their efficacy in the context of GLP-1 RA therapy is mixed. If these measures are insufficient to prevent and maintain muscle mass, the use of some nutrients, such as branched chain amino acids, creatine, leucine, omega-3 fatty acids and vitamin D, may be beneficial. Newer pharmacological approaches, such as bimagrumab, a human monoclonal antibody that acts by binding to the activin type II receptor II (ActRII), and other activin or myostatin inhibitors, show promise in preserving muscle mass while promoting fat loss.

Summary:

GLP-1 RA therapy for obesity should include resistance training, optimal protein intake and, if needed, specific nutrients and possibly pharmacological interventions to preserve muscle mass. Further research is needed to assess the long-term effects of GLP-1 RA on muscle health and to refine strategies to prevent sarcopenia in patients undergoing pharmacological weight loss.

2025-03-01·International journal of obesity (2005)

What is the pipeline for future medications for obesity?

Review

作者: Melson, Eka ; Papamargaritis, Dimitris ; Ashraf, Uzma ; Davies, Melanie J

Abstract:

Obesity is a chronic disease associated with increased risk of obesity-related complications and mortality. Our better understanding of the weight regulation mechanisms and the role of gut-brain axis on appetite has led to the development of safe and effective entero-pancreatic hormone-based treatments for obesity such as glucagon-like peptide-1 (GLP-1) receptor agonists (RA). Semaglutide 2.4 mg once weekly, a subcutaneously administered GLP-1 RA approved for obesity treatment in 2021, results in 15–17% mean weight loss (WL) with evidence of cardioprotection. Oral GLP-1 RA are also under development and early data shows similar WL efficacy to semaglutide 2.4 mg. Looking to the next generation of obesity treatments, combinations of GLP-1 with other entero-pancreatic hormones with complementary actions and/or synergistic potential (such as glucose-dependent insulinotropic polypeptide (GIP), glucagon, and amylin) are under investigation to enhance the WL and cardiometabolic benefits of GLP-1 RA. Tirzepatide, a dual GLP-1/GIP receptor agonist has been approved for glycaemic control in type 2 diabetes as well as for obesity management leading in up to 22.5% WL in phase 3 obesity trials. Other combinations of entero-pancreatic hormones including cagrisema (GLP-1/amylin RA) and the triple agonist retatrutide (GLP-1/GIP/glucagon RA) have also progressed to phase 3 trials as obesity treatments and early data suggests that may lead to even greater WL than tirzepatide. Additionally, agents with different mechanisms of action to entero-pancreatic hormones (e.g. bimagrumab) may improve the body composition during WL and are in early phase clinical trials. We are in a new era for obesity pharmacotherapy where combinations of entero-pancreatic hormones approach the WL achieved with bariatric surgery. In this review, we present the efficacy and safety data for the pipeline of obesity pharmacotherapies with a focus on entero-pancreatic hormone-based treatments and we consider the clinical implications and challenges that the new era in obesity management may bring.

149

项与比马格鲁单抗相关的新闻（医药）

2025-07-01

·BioPlus

诺和诺德vs.礼来：2大巨头，在ADA上都讲了什么？

作者：Medicina本文分享，2025年美国糖尿病协会（ADA）第85届科学年会上，诺和诺德与礼来，披露的一些管线进展和产品开发策略。AMYR vs. GLP-1R 从诺和诺德公司针对肥胖市场的产品组合策略中可以看出，减重深度排序为：Amylin类似物Cagrilintide＜GLP-1R激动剂Semaglutide＜Amylin类似物+GLP-1R激动剂CagriSema、AMYR/GLP-1R激动剂Amycretin＜三重激动剂，而安全性的排序与疗效相反。诺和诺德旨在通过针对不同患者特征、治疗目标以及安全性和耐受性来满足市场需求。诺和诺德的追赶诺和诺德公司在肥胖治疗领域的产品线正在不断扩展，其中Semaglutide已经成功上市。目前处于III期的产品为CagriSema（Amylin类似物+GLP-1R激动剂）、Amylin类似物Cagrilintide，以及GLP-1R/amylin receptor 激动剂Amycretin，可以看出诺和诺德的迭代产品选择了重点布局Amylin赛道。值得一提的是，今年3月份，诺和诺德从Lexicon Pharmaceuticals引进了临床前ACSL5抑制剂项目，以拓展减肥管线。诺和诺德（Novo Nordisk）公司由于礼来公司（Eli Lilly）在肥胖治疗领域的强势竞争，导致其市场份额被侵占，处于追赶状态。礼来的Tirzepatide（GLP-1R/GIPR激动剂，商品名为Mounjaro和Zepbound）在市场上表现出色，而诺和诺德一直未能推出能够超越该产品的资产，这在其三期临床资产Cagrisema（cagrilintide+semaglutide；amylin类似物+GLP-1R激动剂）的表现得到了体现。在糖尿病协会（ADA）会议上，诺和诺德公司分享了关于其两项关键资产的更多细节，这两项资产旨在帮助其在肥胖治疗领域重新站稳脚跟，分别是Cagrisema（cagrilintide+semaglutide）和amycretin（GLP-1R/AMYR激动剂），它们都是GLP-1/amylin receptor 激动剂。公司分享了来自Cagrisema的REDEFINE-1试验的进一步结果，分析师们认为该结果达到了礼来Tirzepatide所设定的标准，但并未击败其竞争对手。对于诺和诺德公司的另一个“关键产品”——Amycretin（GLP-1R/AMYR激动剂），分析师们希望找到证据来验证该公司将该资产推进至三期临床试验的决定，并进一步明确其与Tirzepatide的竞争优势。然而，Amycretin一期临床试验中采用的快速滴定方案让分析师们感到困惑，多位经纪人表示，该候选药物的安全性和有效性难以解读——这可能会将对其疗效特征的清晰理解推迟到2028年，届时公司预计将公布三期临床数据。诺和诺德公司在Amylin（胰淀素）领域进行了重点布局，胰淀素是一种多功能的激素，它在人体内具有多种作用，包括：①血糖调节，胰淀素能够增加对瘦素的响应性并减少胰高血糖素的分泌。②食欲调节，它可以减少食欲和能量摄入，同时增加饱腹感。③骨骼调节，胰淀素有助于抑制吸收和促进骨骼形成。④胃肠道作用，它能够减少胃酸分泌和胃排空。胰淀素类似物根据不同的分子骨架和受体选择性展现出不同的特性。诺和诺德的Amylin研发管线包括多个分子，它们处于不同的临床试验阶段：①Cagrilintide：Amylin类似物，已经进入III期临床试验。②Amycretin：GLP-1R/AMYR激动剂，即将开始III期临床试验。③Triple：这是一种三重激动剂，目前处于I期临床试验。④Amylin 355：也处于I期临床试验。⑥Amylin 1213：同样处于I期临床试验。礼来领跑新赛道礼来在基于肠促胰素的疗法并非一夜成功，从2005年上市的GLP-1R激动剂Byetta（艾塞那肽），到2014年获批上市的度拉糖肽（GLP-1-Fc融合蛋白）。2017年，GIPR/GLP-1R激动剂tirzepatide的首次人体数据显示出减重效果，2022年获批上市治疗T2D，并于2023年获批上市治疗肥胖，2024年获批治疗阻塞性睡眠呼吸暂停。与诺和诺德的下一代产品重点布局在Amylin不同，礼来的肥胖迭代产品分为三个创新主题：①在肠促胰素方面，开发口服和长效多功能肠促胰素，围绕GIPR、GCGR与GLP-1R进行单独或组合开发。②Amylin管线，布局了一个产品，具不同选择性特征的Eloralintide（AMYR激动剂）。③新靶点方面，包括Bimagrumab（抗ACVR2B/ACVR2A单抗）和Nisotriosamide（PYY类似物），以增加肌肉等方面的New benefits。虽然诺和诺德公司正在努力跟上替西帕肽（Tirzepatide）的步伐，但礼来公司一直处于攻势，为下一代肥胖产品造势，其中以口服小分子GLP-1激动剂orforglipron为主导。在ADA会议上，公司分享了orforglipron的ACHIEVE-1试验的详细结果，没有看到严重的肝脏毒性。此外，礼来公司旨在通过口服候选药物的便利性来抢占诺和诺德Semaglutide的市场份额——尽管如果其疗效过于显著，它也可能开始侵蚀其自身的Tirzepatide业务。礼来公司还分享了针对活化素受体阻断抗体bimagrumab（anti-ACVR2B/ACVR2A单抗）和胰淀素激动剂eloralintide（AMYR激动剂）的早期阶段数据，这两者都可能在肥胖市场中服务于相对较小的人群。在ADA会议上展示的这两种药物的结果都可能是 Best-in-class。将bimagrumab添加到司美格鲁肽中同时增加了减重和瘦体重的保持，研究结果表明，bimagrumab和司美格鲁肽联合疗法相比单独使用任一疗法，能更显著地减少体重、体脂、内脏脂肪和炎症标志物。联合疗法中，脂肪质量占总减重量的92.9%，而单独使用司美格鲁肽时这一比例为71.5%；单独使用司美格鲁肽时下降了15.7%。值得注意的是，单独使用bimagrumab时，100%的减重量都归因于脂肪质量，并且总瘦体重增加了2.5%。而Eloralintide（AMYR激动剂）则产生了迄今为止胰淀素单一疗法中最快的减重效果。然而，礼来公司到目前为止强调了每个候选药物相对较窄的市场，将bimagrumab的使用案例描述为可能超重且已经缺乏肌肉量的老年患者，而其胰淀素激动剂为那些难以忍受肠促胰素胃肠道副作用的患者。小结肥胖治疗领域正迎来新的发展阶段，其中产品创新的方向涵盖了给药途径、用药频率、额外代谢获益、耐受性、减重深度、减重质量以及血糖控制程度等多个方面。随着肥胖治疗市场逐渐细分，这些细分市场标准揭示了不同患者在选择治疗方案时的多样化需求和偏好。这不仅为制药公司提供了更精准的市场定位，也推动了企业开发更符合患者需求的治疗产品。欢迎大家加入BioPlus微信交流群，共同探讨。BioPlus微信交流群申请入群申请联系人：Lisa邮箱：lisa.li@bp-bioplus.com电话：18662346610（同微信）入群申请，请先添加Lisa微信，并分享名片入群画像：Biotech/药厂研发/BD、投资机构、临床医生等入群福利：不定时行业资料包分享参考文献：https://firstwordpharma.com/story/5976218https://investor.lilly.com/static-files/36604492-7d65-4649-bc20-f7b4372c2b2bhttps://www.novonordisk.com/content/dam/nncorp/global/en/investors/pdfs/ada/novo-nordisk-r-and-d-investor-event.pdf 拓展阅读 BioPlus-海外寻找资产系列：1.AACR复盘：9家CDH17-ADC数据对比2.自免小众靶点APRIL，正在悄悄火起来了！BioPlus国际大会跟踪系列：1. 2025 ASCO：ADC、双抗/多抗，有哪些看点？（附一览表）2. 2025 AACR 双抗与ADC有哪些看点？3. 小细胞肺癌领域，下一步将如何“破局”，ADC or TCE？4. ELCC 讨论：NSCLC的ADCs最新进展5. 未来ADC发展方向：新靶点，新载荷，双靶点/双表位...6. 2025 ASCO 重点项目临床数据：有哪些精彩看点？7. 2025 ASCO 重点项目临床数据（二）BioPlus靶点/管线研究系列：1. “待爆”：CDH17 ADC项目大比拼，谁将脱颖而出?2. PD-1激动剂在自免疾病项目数据盘点：失败项目的“坑”与启示3. 上临床就能卖？DLL3 ADC这么好卖？4. 胰腺癌三大热门靶点：CLDN18.2、EGFR、RAS5. TSLP/SCF双抗，下一个自免待爆靶点组合？6. GPC3靶点临床屡败，TCE能改写格局么？7. 亮相AACR，曾被临床终止的ADC靶点Ly6E，能否卷土重来？8. 最高18.45亿美元！赛诺菲为何重金买了两款TL1A双抗？9. 2025 Q1：BMS、Sanofi和Roche管线调整，哪些项目被砍？10. 现场！2025AACR：KRAS抑制剂的百花齐放11. IL-17小分子抑制剂，能否杀出重围？12.全球首款：华东医药申报MUC17 ADC药物13.荨麻疹 first-in-class双抗提交临床试验申请BioPlus技术平台深入剖析系列：1. TCE 免疫共刺激信号之选：CD2，一颗冉冉升起的新星2. BD爆发前夜！6家TCE Probody技术平台深度盘点3. TCE Probody：Amgen携重磅技术“破局“，改写行业格局？4. 有人放弃，有人前行！自免TCE全球管线大盘点5. Immunocore将TCR疗法照进现实，向自免疾病迈进6. B细胞清除免疫重置：SLE等疾病长效缓解终成现实！7. 国内50家CD3平台序列来源汇总8. CD28共刺激最终章？ZW209 DLL3/CD3/CD28 三抗剑指 Amgen9. TCE 结构之争落幕：行业用行动给出 “标准答案”10. CD3 VHH猴交叉：重要吗？11.Genentech创新前沿：口服VHH抗体，靶向IL-23R12.AbbVie专利公开：靶向PSMA/STEAP1 双抗ADCBioPlus人物专访：1. 专访肖亮：卖青苗不一定是坏事，这是中国Biotech长成参天大树的必经之路2. 专访王刚，恺佧生物这些年的“出海”之旅？

临床3期引进/卖出

2025-07-01

·EndPoints

Unnatural Products taps argenx's help for ringed molecules, expands internal work into obesity

Unnatural Products has signed on argenx as its latest partner to take forward its approach to ringed molecules. Argenx will deliver unspecified upfront money in the double-digit millions to the Santa Cruz, CA-based biotech. Unnatural Products can get up to $1.5 billion in biobucks if all goes well with their collaboration to create oral macrocyclic peptides, the duo disclosed Tuesday morning. The partners are staying mum on the scope of the partnership, other than saying it will revolve around “previously undruggable targets.” The collaboration will likely center on immunology, which has been the bread and butter of argenx’s strategy, including the multi-approved medicine Vyvgart. “They were interested in what modality comes next,” Unnatural Products CEO Cameron Pye said in an interview. “They’ve always had an innovative spirit in both what biologics can be and do, and then how to best commercialize those and really find these pipeline-in-a-product opportunities.” Unnatural Products is one of multiple biotech startups attempting to crack into the macrocyclic space. The goal in making the synthetic ringed molecules is to replace the complexity of biologics (but retain their precision) with the relative ease-of-use of oral small molecules. The 40-employee biotech originated out of the grad school work of Pye and his co-founder and scientific chief Joshua Schwochert nearly a decade ago. Other startups have come to the fore since then, including Orbis Medicines , Vilya and Boehringer Ingelheim -partnered Circle Pharma , among others. Unnatural Products had a successful partnership with BridgeBio , in which the fellow California drugmaker licensed some of its IP and molecules, Pye said. It’s also working on an up to $220 million pact with Merck in the cancer arena. Unnatural Products had initially been focused on hard-to-target areas in oncology like p53 and KRAS G12D, but the company is now focused on learning from validated targets being drugged by biologics. “The chilly markets of ’22 and ’23 just tempered on their enthusiasm for risky biology here. We know these things come in cycles. There’s going to be target consolidation on the validated targets and there already is, we know,” Pye said. Rather than choosing the “most obvious targets,” Unnatural Products is selecting “up-and-comers” with the goal to then “ride the wave up with the antibody and then provide a really desirable solution to the same problem that the antibody is solving.” The first target in the revamped pipeline will get it into one of the most lucrative and in vogue areas of drug R&D: obesity. Unnatural Products is working on an oral activin type 2 receptor antagonist. The startup seeks to follow the IV-administered program from Eli Lilly known as bimagrumab. The Indianapolis large pharma is in late-stage development of the asset via its $1.9 billion Versanis Bio buyout, to boost both fat loss and preserve muscle in patients on GLP-1s. Lilly presented Phase 2b data from the drug at last month’s American Diabetes Association’s annual meeting in Chicago. The drug helped many patients on Novo Nordisk’s Wegovy retain their lean tissue while also shedding fat. Pye was in the room for that data drop. “It’s pretty exciting times for that pathway,” he said. While it sifts through the vastness of the obesity and cardiovascular field, Unnatural Products could consider delving further into the more unknown world of undruggable targets in oncology. “I’m not opposed to going back to risk again. It’s just we have to earn it as a community and as a company as well,” Pye said. “In the meantime, finding partners that believe in that long-term vision bet, like the Merck partnership and BridgeBio, has been a way for us to do the science that we’re really passionate about and use this platform in all its multifaceted ways.” Merck’s Global Health Innovation Fund and Artis Ventures led the $32 million Series A for Unnatural Products in 2023. The biotech has yet to raise its Series B, and Pye declined to disclose timing of the upcoming round. The next round of funding will likely go toward the company’s evolving pipeline.

临床2期

2025-06-24

·同写意

下一代GLP-1疗法最新进展盘点：来自礼来、诺和诺德、安进……

同写意年度巨献！！大会特设“GLP-1全产业链创新发展”分会，7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！第85届美国糖尿病协会（ADA）科学年会已经在美国芝加哥落下帷幕。ADA年会是全球规模最大的糖尿病和代谢疾病学术会议之一，本届年会上，多家生物医药公司汇报了基于胰高血糖素样肽-1（GLP-1）信号通路开发的创新疗法的最新临床试验结果。GLP-1药物是治疗糖尿病和肥胖症的研发热点之一，目前全球已有超过80款相关药物或药物组合进入临床开发阶段，其中多肽疗法仍是主流。在GLP-1药物开发热潮到来之前，药明康德旗下的WuXi TIDES早已围绕多肽药物建立了一体化CRDMO平台，提供所有类型的多肽，包括线性、环状和高度修饰的多肽，以及非天然氨基酸、连接子、毒素和多肽偶联药物的合成服务，支持从药物发现、CMC开发到商业化生产的各个阶段，助力合作伙伴更高效地为患者提供新一代GLP-1疗法。本文将与读者分享在ADA年会上公布的GLP-1药物的最新研发进展。TONACEA01减掉的超过90%是脂肪！组合疗法2期临床结果公布研究人员公布了礼来公司（Eli Lilly and Company）开发的在研疗法bimagrumab与诺和诺德公司（Novo Nordisk）的GLP-1药物Wegovy（司美格鲁肽）联用，治疗肥胖症的2b期临床试验BELIEVE的最新结果。Bimagrumab是一款潜在“first-in-class"的单克隆抗体，靶向激活素2型受体（ActRII）。ActRII是在脂肪和肌肉细胞中都表达的激活素受体。ActRII受体激活可引发肌肉萎缩并促进脂肪组织中脂肪的堆积。通过阻断该通路，有望在减少脂肪的同时，改善患者的肌肉组成。试验数据显示，接受bimagrumab/Wegovy组合疗法治疗的受试者在72周后体重平均降低22.1%。值得注意的是，丢失的体重中92.8%源于脂肪组织减少。与单药治疗相比，该组合在减少腹部脂肪和炎症相关生物标志物方面也显示出更显著的疗效。TONACEA02体重减轻约20%，安进MariTide完整2期结果发布安进公司（Amgen）今日公布了其在研药物MariTide（maridebart cafraglutide，前称AMG 133）2期临床试验第一部分的完整结果。MariTide是一款潜在“first-in-class”的在研抗体多肽偶联药物，在靶向胃抑制肽受体（GIPR）的单克隆抗体的特定位点上偶联了两个GLP-1类似物，在激活GLP-1受体的同时抑制GIPR。它可通过皮下注射每月或更低频率给药。相关研究结果同时发表于《新英格兰医学杂志》。在2期研究中，MariTide在无2型糖尿病的肥胖人群中实现了最高约20%的平均体重减轻，而安慰剂组为2.6%；在患有糖尿病的肥胖人群中，MariTide组的体重平均减轻最高可达约17%，而安慰剂组仅为1.4%。在第52周时，体重减轻仍未出现平台期，显示出进一步减重的潜力。除了显著的减重效果外，MariTide还在患有糖尿病的肥胖人群中实现了最高达2.2个百分点的糖化血红蛋白（HbA1c）持续且显著下降。体重下降还伴随着一系列心血管代谢指标的改善，包括腰围、血压、高敏C反应蛋白（hs-CRP）及部分血脂参数的改善。▲MariTide的2期临床试验主要疗效结果（图片来源：参考资料[7]）TONACEA03礼来口服GLP-1激动剂3期结果，登《新英格兰医学杂志》礼来公司公布了ACHIEVE-1研究的详细结果。这项3期临床试验评估了orforglipron在仅通过饮食和锻炼控制血糖仍不理想的2型糖尿病成人患者中的安全性与有效性。新闻稿指出，orforglipron是首款完成3期临床试验的口服小分子（非肽类）GLP-1受体激动剂，在服用过程中不受进食与饮水的限制。在第40周时，orforglipron的3种剂量（3 mg、12 mg、36 mg）均达到主要终点，即在降低HbA1c方面优于安慰剂。此外，12 mg和36 mg剂量在体重减轻方面也表现出具有临床意义和统计学显著性的优势。研究显示，orforglipron的安全性特征与已有GLP-1药物相似，最常见的不良事件为胃肠道相关反应。相关结果已在ADA科学年会上公布，并同步发表于《新英格兰医学杂志》。在研究中，orforglipron在第40周达到主要终点，与安慰剂相比，其HbA1c下降幅度为1.3至1.6个百分点。在关键性次要终点方面，最多达76.2%的orforglipron受试者实现了ADA设定的治疗目标HbA1c＜7个百分点；66.0%的受试者达到HbA1c≤6.5个百分点；25.8%的受试者达到HbA1c＜5.7个百分点，即正常HbA1c范围。在另一项关键性次要终点中，接受最高剂量orforglipron治疗的受试者平均减重16.0磅（7.9%）。更长期的研究（如ATTAIN研究）将进一步全面评估orforglipron在肥胖治疗中的安全性与疗效。Orforglipron是一种每日一次的在研口服小分子GLP-1受体激动剂。它由Chugai Pharmaceutical发现，并于2018年授权给礼来公司。目前，礼来正开展orforglipron治疗2型糖尿病，以及治疗肥胖或超重成人患者的3期研究。TONACEA04诺和诺德amycretin早期临床结果登《柳叶刀》，直接进入3期临床试验诺和诺德公司宣布，在研创新肥胖治疗药物amycretin的两项早期临床试验结果在《柳叶刀》杂志上发布。Amycretin是诺和诺德正在研发的一种单分子长效GLP-1和胰淀素受体激动剂，拟用于治疗成人超重或肥胖人群，以及2型糖尿病患者。皮下注射amycretin的1b/2a期试验结果显示，治疗伴发不良事件（TEAEs）多数为轻度或中度，其发生频率呈剂量依赖性升高。最常见的不良事件为胃肠道相关症状。与安慰剂相比，接受amycretin治疗的受试者在研究的所有剂量范围内均观察到更显著的体重下降。接受最高剂量（60 mg）治疗的受试者在36周治疗后体重平均减轻幅度可达24.3%，而安慰剂组仅为1.1%。这一研究结果支持继续探索amycretin在减重方面的潜在疗效。已发表的口服amycretin的1期研究结果显示，最常见的不良事件为胃肠道症状以及食欲下降，且在较高剂量组中更为常见。接受治疗的受试者在所有剂量组中均显示出明显优于安慰剂组的体重减轻效果。探索性分析显示，每日口服100 mg amycretin的受试者在12周后平均体重减轻幅度为13.1%，而安慰剂组仅为1.2%。基于上述及其他已完成的临床研究结果，并结合监管机构的反馈意见，诺和诺德将推进口服与皮下注射两种剂型的amycretin进入3期临床开发，用于体重管理。TONACEA05体重减轻超13%，先为达生物偏向性GLP-1类似物3期临床结果发布先为达生物在ADA年会上发布了其在研cAMP偏向性GLP-1类似物埃诺格鲁肽（ecnoglutide）注射液的3期临床试验结果。该结果同时在The Lancet Diabetes and Endocrinology上发表。Ecnoglutide的cAMP偏向性可能通过降低GLP-1受体的内化和增强胰岛素的分泌来增强GLP-1受体激动剂的临床效果。在2023年4月5日至2024年6月20日期间，这项3期临床试验中，664人被随机分配接受不同剂量的ecnoglutide或安慰剂治疗。在第40周，体重的最小二乘均值百分比变化分别为：ecnoglutide 1.2毫克组为-9.1%，1.8毫克组为-10.9%，2.4毫克组为-13.2%，而安慰剂组为0.1%。与安慰剂相比，各剂量组的预估治疗差值分别为-9.2%、-11.1%和-13.3%，所有比较的p值均<0.0001。在第40周，体重减少≥5%的受试者比例为：ecnoglutide 1.2毫克组为77%，1.8毫克组为84%，2.4毫克组为87%，而安慰剂组仅为16%。GLP-1药物已在治疗2型糖尿病和肥胖方面展现出卓越疗效。ADA年会上公布的最新进展显示，新一代GLP-1药物正通过多种策略提升疗效、安全性和便捷性。药明康德很高兴能够为多款GLP-1药物赋能。今年摩根大通医疗健康大会的报告指出，2024年，公司赋能的临床阶段GLP-1管线从13个增加到20个。其中包括9个临床期多肽药物和11个临床期小分子药物，积极助力新一代GLP-1药物早日触达患者。展望未来，药明康德将继续秉持“让天下没有难做的药，难治的病”的愿景，依托全球研发基地与生产网络，凭借独特的一体化、端到端CRDMO模式，持续推动新一代GLP-1药物的开发进程，造福全球患者。参考资料：（上下滑动查看更多）[1] Novo Nordisk advances early-stage obesity medication, amycretin, to phase 3 clinical development based on early-phase clinical trial results in people with obesity or excess weight, published in The Lancet. Retrieved June 20, 2025, from https://www.prnewswire.com/news-releases/novo-nordisk-advances-early-stage-obesity-medication-amycretin-to-phase-3-clinical-development-based-on-early-phase-clinical-trial-results-in-people-with-obesity-or-excess-weight-published-in-the-lancet-302487500.html[2] Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medicine. Retrieved June 21, 2025, from https://www.prnewswire.com/news-releases/lillys-oral-glp-1-orforglipron-showed-compelling-efficacy-and-a-safety-profile-consistent-with-injectable-glp-1-medicines-in-complete-phase-3-results-published-in-the-new-england-journal-of-medicine-302487392.html[3] Verdiva Bio to Present New Data Highlighting Once-Weekly Potential of Its Investigational Oral Obesity Candidates at the ADA 85th Scientific Sessions. Retrieved June 21, 2025, from https://www.businesswire.com/news/home/20250620108098/en/Verdiva-Bio-to-Present-New-Data-Highlighting-Once-Weekly-Potential-of-Its-Investigational-Oral-Obesity-Candidates-at-the-ADA-85th-Scientific-Sessions[4] Lilly’s bimagrumab boosts weight and fat loss when added to Novo's Wegovy. Retrieved June 23, 2025, from https://endpoints.news/ada25-lillys-bimagrumab-boosts-weight-and-fat-loss-when-added-to-novos-wegovy/[5] Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine. Retrieved June 23, 2025, from https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916353[6] RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY OF MONTHLY MARITIDE PRESENTED AT THE AMERICAN DIABETES ASSOCIATION 85TH SCIENTIFIC SESSIONS. Retrieved June 23, 2025, from https://www.prnewswire.com/news-releases/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions-302487811.html[7] Jastreboff et al., (2025). Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial. NEJM, DOI: 10.1056/NEJMoa2504214

100 项与比马格鲁单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10620	比马格鲁单抗	-	DB12584

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
包涵体肌炎	临床3期	美国	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	日本	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	比利时	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	丹麦	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	法国	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	意大利	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	荷兰	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	瑞士	Novartis Pharmaceuticals Corp.	2015-11-02
包涵体肌炎	临床3期	英国	Novartis Pharmaceuticals Corp.	2015-11-02

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05616013 (OR10-03, CTgov)	临床2期	超重 \| 肥胖	507	Placebo (Placebo)	膚膚衊願範鬱淵襯糧衊(範窪襯餘觸鏇蓋鑰築憲) = 製憲壓簾齋觸鏇積觸獵積製憲廠構襯繭遞獵壓 (獵築鹽壓壓範襯網積鬱, 1.39) 更多	-	2025-07-18
				Bimagrumab (Bimagrumab 10 mg/kg)	膚膚衊願範鬱淵襯糧衊(範窪襯餘觸鏇蓋鑰築憲) = 鏇築鏇蓋築獵鹽遞醖觸積製憲廠構襯繭遞獵壓 (獵築鹽壓壓範襯網積鬱, 1.42) 更多
BELIEVE (NEWS) 人工标引	临床2期	超重 \| 肥胖	507	Bimagrumab/Semaglutide	網蓋製齋網憲鬱艱獵顧(廠襯築築蓋壓衊網築壓) = 製繭範觸壓積範願鬱衊願壓繭廠衊襯築築淵獵 (憲製齋膚鹽餘獵簾繭積 ) 更多	积极	2025-06-23
				Bimagrumab	網蓋製齋網憲鬱艱獵顧(廠襯築築蓋壓衊網築壓) = 網憲膚顧觸壓觸襯顧襯願壓繭廠衊襯築築淵獵 (憲製齋膚鹽餘獵簾繭積 ) 更多
SO 52 (EASD2023)	临床1/2期	体重下降 \| 肌肉萎缩	-	Bimagrumab 3 mg/kg	糧鑰齋繭餘獵夢廠範壓(鹽憲製積範壓鏇夢遞鹹) = 壓製醖餘鬱簾積獵齋鬱襯選艱鹽鏇鬱遞鹽範襯 (廠齋選蓋蓋夢遞壓網艱 )	积极	2023-10-04
				Bimagrumab 10 mg/kg	鏇願鹹蓋鹹鹹鏇鏇鏇糧(鏇顧憲製齋顧顧鑰壓壓) = 鹽衊衊糧鬱憲糧簾願觸衊獵願繭觸糧壓鏇廠齋 (範顧製餘鏇醖築餘鏇鹽 )
NCT05616013 (ADA2023)	临床2期	体重下降	75	Bimagrumab 10 mg/kg IV	蓋鏇鏇築範壓簾簾築選(襯鑰鬱簾蓋繭窪鹹願餘) = 艱構繭積積廠餘鬱夢構選艱網鑰網網簾廠鬱觸 (鹹構襯獵築積獵構構遞 ) 更多	-	2023-06-20
				Placebo	蓋鏇鏇築範壓簾簾築選(襯鑰鬱簾蓋繭窪鹹願餘) = 繭築蓋艱繭觸夢齋遞選選艱網鑰網網簾廠鬱觸 (鹹構襯獵築積獵構構遞 ) 更多
RF28 \| PSUN198 (ENDO2022)	N/A	糖尿病 diabetic \| non-diabetic	568	Bimagrumab 10 mg/kg/month	糧鹽衊襯積夢膚窪鹽製(選觸製網繭鑰選築壓憲) = a 34% decrease was observed over the same interval 淵廠獵範觸襯膚鹽觸願 (艱蓋膚鏇鏇繭襯願觸構 ) 更多	积极	2022-11-01
PRNewswire 人工标引	临床2期	糖尿病	569	Bimagrumab	鏇鬱壓齋遞鏇夢窪構簾(齋製艱網築夢窪製繭齋) = 製選艱襯獵鏇夢網構簾範繭遞壓廠顧顧糧鬱鏇 (築遞夢簾鏇築築製襯窪 )	积极	2022-06-11
				Placebo	鏇鬱壓齋遞鏇夢窪構簾(齋製艱網築夢窪製繭齋) = 繭廠積膚鏇範構壓齋簾範繭遞壓廠顧顧糧鬱鏇 (築遞夢簾鏇築築製襯窪 )
NCT03005288 (Pubmed \| JAMA Netw Open) 人工标引	临床2期	2型糖尿病 \| 肥胖	75	Bimagrumab	艱願淵顧憲窪蓋夢糧構(觸衊願鹹積選獵餘夢範) = 淵鏇選鏇齋齋鑰廠構製簾鑰艱襯夢鹽製願鑰憲 (膚網廠憲鬱壓艱糧艱鏇, -8.3 ~ -6.6) 更多	积极	2021-01-04
				Placebo	艱願淵顧憲窪蓋夢糧構(觸衊願鹹積選獵餘夢範) = 糧顧夢鹹積醖網獵鬱觸簾鑰艱襯夢鹽製願鑰憲 (膚網廠憲鬱壓艱糧艱鏇, -0.99 ~ 0.63) 更多
NCT02250443 (Pubmed \| Ann Neurol \| Neurology) 人工标引	临床2/3期	包涵体肌炎	10	Bimagrumab	衊夢築夢憲顧鬱艱鑰願(鏇鹽淵鹹製蓋願膚膚艱) = muscle spasms and falls (both 9 of 10, 90%),diarrhea (6 of 10, 60%) and acne and skin eruption (both 5 of 10, 50%) 鑰壓願獵艱夢壓淵壓獵 (衊積蓋淵鬱構糧襯獵鹽 )	不佳	2020-10-06
NCT02333331 (Pubmed \| JAMA Netw Open) 人工标引	临床2期	肌肉减少症	180	SOC+Bimagrumab	鹹遞淵膚糧製膚繭繭鏇(鹽糧鹽獵願齋觸夢襯鏇) = 鑰醖願鏇願蓋鹹積壓遞構夢簾網鏇蓋蓋繭壓觸 (範蓋積鑰範蓋鏇鑰蓋醖, 0.90 ~ 1.77) 更多	积极	2020-10-01
				SOC+Placebo	鹹遞淵膚糧製膚繭繭鏇(鹽糧鹽獵願齋觸夢襯鏇) = 淵淵淵願選繭獵糧獵獵構夢簾網鏇蓋蓋繭壓觸 (範蓋積鑰範蓋鏇鑰蓋醖, 0.53 ~ 1.52) 更多
NCT03005288 (CTgov)	临床2期	2型糖尿病 \| 肥胖	78	BYM338 10 mg/kg (BYM338 10 mg/kg)	積製選窪鹽繭獵選製鬱(壓鹹廠鹽齋醖鹽製壓遞) = 遞鹹齋衊蓋蓋願廠獵築糧簾淵繭遞膚膚積衊襯 (築築範獵鑰顧簾鏇範醖, 範蓋艱製蓋膚膚構選廠 ~ 繭鹹獵鹽憲廠網膚鏇願) 更多	-	2020-06-04
				Placebo (Placebo)	積製選窪鹽繭獵選製鬱(壓鹹廠鹽齋醖鹽製壓遞) = 鹽鏇鹽窪淵蓋壓鹽餘鏇糧簾淵繭遞膚膚積衊襯 (築築範獵鑰顧簾鏇範醖, 廠憲繭觸膚憲糧網遞網 ~ 膚築襯構衊選壓獵獵窪) 更多