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

/ Not yet 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2025-06-01

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

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100 项与比马格鲁单抗相关的专利（医药）

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项与比马格鲁单抗相关的文献（医药）

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.

2025-02-01·Journal of Cachexia Sarcopenia and Muscle

The Effect of Anti‐Activin Receptor Type IIA and Type IIB Antibody on Muscle, Bone and Blood in Healthy and Osteosarcopenic Mice

Article

作者: Andersen, Christian Brix Folsted ; Eijken, Marco ; Bromer, Frederik Duch ; Thomsen, Jesper Skovhus ; Poulsen, Mathias Flensted ; Brüel, Annemarie ; Lodberg, Andreas

ABSTRACT:

Background:

Anti‐Activin Receptor Type IIA and Type IIB antibody (αActRIIA/IIB ab) is a recently developed drug class that targets the activin receptor signalling pathway. Inhibition of receptor ligands (activins, myostatin, growth differentiation factor 11, etc.) can lead to skeletal muscle hypertrophy, bone formation, and increased haematopoiesis. Despite the αActRIIA/IIB ab, bimagrumab, having progressed to clinical trials, two crucial questions about αActRIIA/IIB ab therapy remain: Does αActRIIA/IIB ab influence bone metabolism and bone strength similarly to its generic classmates (activin receptor‐based ligand traps)? Does αActRIIA/IIB ab affect red blood cell parameters, thereby increasing the risk of thromboembolism, similar to its generic classmates? Therefore, the aim of the present study was to investigate the therapeutic potential of αActRIIA/IIB ab in a mouse model of concurrent sarcopenia and osteopenia and to investigate the effect on bone and haematopoiesis in more detail.

Methods:

In C57BL/6JRj mice, combined sarcopenia and osteopenia were induced locally by injecting botulinum toxin A into the right hindlimb, resulting in acute muscle paresis. Immediately after immobilization, mice received twice‐weekly intraperitoneal injections with αActRIIA/IIB ab (10 mg/kg) for 21 days, after which they were sacrificed. Muscle mass, skeletal muscle fibre size and Smad2 expression were analysed in the rectus femoris and gastrocnemius muscles. Bone mass and bone microstructure were analysed in the trabecular bone at the distal femoral metaphysis, while the cortical bone was analysed at the femoral mid‐diaphysis. In a substudy, the effect on haematopoiesis was explored 2 and 7 days after a single αActRIIA/IIB ab (30 mg/kg) injection in C57BL/6JRj mice.

Results:

αActRIIA/IIB ab caused a large increase in muscle mass in both healthy (+21%) and immobilized (sarcopenic and osteopenic) (+12%) mice. Furthermore, αActRIIA/IIB ab increased trabecular bone (bone volume fraction) for both healthy (+65%) and immobilized (+44%) mice. For cortical bone, αActRIIA/IIB ab caused a small, but significant, increase in bone area (+6%) for immobilized mice, but not for healthy mice. Treatment with αActRIIA/IIB ab did not change red blood cell count, haemoglobin concentration or mean cell volume after either 2 or 7 days.

Conclusions:

Treatment with αActRIIA/IIB ab caused a significant increase in both skeletal muscle mass and bone parameters in both healthy and immobilized mice, suggesting a potential in the treatment of concurrent osteopenia and sarcopenia. Interestingly, the bone anabolic effect of the treatment was much more pronounced on trabecular bone than on cortical bone. There was no pronounced effect of short‐term treatment on haematopoiesis.

147

项与比马格鲁单抗相关的新闻（医药）

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

2025-06-24

·药筛

减肥王炸组合：只减肥肉，不减瘦肉，Bima数据惊艳

减肥赛道战况升级，礼来一边用后上市的替尔泊肽，正面单挑先发的司美格鲁肽；另一边，礼来又找了一个组合-可以减脂增肌的Bimagrumab，形成组合双打，围剿司美。就在昨天(6月23日)，礼来在ADA会议上，公布了Bima治疗减重的2b期临床数据(BELIEVE)，结果惊艳。数据显示，治疗72周后，Bimagrumab治疗组减重10.8%，100%来自于脂肪，肌肉增加2.5%；司美格鲁肽治疗组减重15.7%，只有71.5%来自于脂肪，肌肉损失7.4%；联合治疗组减重22.1%，92.9%来自于脂肪，肌肉只损失2.9%。通俗讲，Bimagrumab只减肥肉，不减瘦肉。这可大大解决了使用司美格鲁肽出现的肌肉减少的问题。Bima是直击司美的软肋啊！在其他几个指标方面，Bima联合治疗组减去了更多的内脏脂肪，炎症biomarker如hsCRP显著降低，甘油三酯、血液降低幅度更大。在安全性方面，三组治疗方案副反应相当。Bimagrumab是一种全人源IgG1/λ单克隆抗体，通过阻断激活素II型受体（ActRIIA/B）信号通路发挥作用。产品最早由最初由诺华（Novartis）研发，最早开发的适应症是包涵体肌炎（sIBM，一种肌肉萎缩疾病），曾获FDA“突破性疗法”认定，但III期临床失败。后来，诺华以7000万美元转让给Aditum Bio，并拆分出Versanis Bio公司继续开发。2023年，礼来收购Versanis获得权益，着手开发减肥适应症。另外，礼来还有一项2期临床试验，用Bima联合替尔泊肽，治疗肥胖。今年5月，Bimagrumab在国内的临床试验申请已获许可。如果Bimagrumab最终能获批上市，礼来手上又多了一个重磅武器，和替尔泊肽联手，一起挑战司美格鲁肽。用摩熵药筛小程序，快速查询产品注册申报进展！

临床2期突破性疗法并购上市批准临床3期

2025-06-23

·药明康德

编者按：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。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。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]）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。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。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。Enabling the Development of Next-Generation GLP-1 TherapiesThe 85th Scientific Sessions of the American Diabetes Association (ADA) has concluded in Chicago, USA. As one of the world’s largest academic conferences focused on diabetes and metabolic diseases, this year’s meeting showcased the latest clinical trial results from multiple biopharmaceutical companies, including innovative therapies developed based on the glucagon-like peptide-1 (GLP-1) signaling pathway. GLP-1–based drugs have become a major focus in the treatment of diabetes and obesity. To date, more than 80 related drugs or drug combinations have entered clinical development globally, with peptide-based therapies continuing to dominate the landscape.WuXi TIDES, a unique Contract Research and Development Manufacturing Organization (CRDMO) platform, is an integral part of WuXi AppTec. WuXi TIDES offers our worldwide partners efficient, flexible, and high-quality solutions for the drug development of oligonucleotides, peptides and related synthetic conjugates (“TIDES” drugs).GLP-1 based therapies have already demonstrated remarkable efficacy in treating type 2 diabetes and obesity. New data presented at the ADA meeting suggest that next-generation GLP-1 drugs are further enhancing efficacy, safety, and convenience through diverse innovation strategies. For instance, an oral small-molecule GLP-1 receptor agonist showed significant reductions in glycated hemoglobin (HbA1c) levels and body weight in a Phase 3 clinical trial involving type 2 diabetes patients. Notably, it offers the convenience of oral administration without the need to coordinate with food or water intake.In parallel, several early-stage therapies that simultaneously target GLP-1 and other metabolic or appetite-related pathways have shown promising results in clinical trials. By addressing multiple mechanisms associated with weight regulation, these combination approaches may offer enhanced therapeutic benefits.Another key focus area is improving the quality of weight loss. Combination therapies that pair GLP-1 receptor agonists with agents that help preserve muscle mass are being developed to not only reduce fat tissue but also maintain lean body mass. This strategy could provide more meaningful long-term outcomes and improved quality of life for patients seeking to lose weight.Looking ahead, WuXi AppTec will continue to leverage its global R&D and manufacturing network, along with its unique, fully integrated, end-to-end CRDMO model, to empower the development of next-generation GLP-1 drugs and bring meaningful benefits to patients worldwide.参考资料：[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免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期

100 项与比马格鲁单抗相关的药物交易

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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,

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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

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临床结果

适应症

分期

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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


SO 52 (EASD2023)	临床1/2期	体重下降 \| 肌肉萎缩	-	Bimagrumab 3 mg/kg	壓壓襯繭遞餘簾製願鬱(夢蓋蓋網顧願選蓋顧願) = 觸願窪糧簾選鹽糧遞齋衊鬱鏇壓廠獵範選壓餘 (鏇鑰積蓋壓壓觸衊願廠 )	积极	2023-10-04
				Bimagrumab 10 mg/kg	廠築糧憲選糧蓋膚壓壓(鏇醖構積蓋顧壓獵遞觸) = 繭餘積糧夢選襯醖醖簾顧艱遞壓糧網鑰淵廠淵 (積廠壓範鬱顧選築鹽襯 )
NCT05616013 (ADA2023)	临床2期	体重下降	75	Bimagrumab 10 mg/kg IV	築壓遞淵夢醖艱衊廠膚(襯鬱餘艱廠齋網積襯製) = 願遞獵廠壓窪鏇壓鑰廠餘鬱淵築觸繭窪窪艱顧 (淵廠餘積衊鹽鹹繭襯顧 ) 更多	-	2023-06-20
				Placebo	築壓遞淵夢醖艱衊廠膚(襯鬱餘艱廠齋網積襯製) = 糧廠衊製鹹壓蓋簾壓遞餘鬱淵築觸繭窪窪艱顧 (淵廠餘積衊鹽鹹繭襯顧 ) 更多
RF28 \| PSUN198 (ENDO2022)	N/A	糖尿病 diabetic \| non-diabetic	568	Bimagrumab 10 mg/kg/month	醖鹹壓選憲鹽膚膚廠簾(積遞構鏇廠窪鹽繭繭衊) = a 34% decrease was observed over the same interval 積網廠淵糧蓋網衊顧鏇 (構廠構鬱壓鏇願製糧鑰 ) 更多	积极	2022-11-01
PRNewswire 人工标引	临床2期	糖尿病	569	Bimagrumab	獵積壓醖網醖鑰範夢繭(糧獵衊繭願構壓鹹窪鬱) = 夢窪廠顧糧壓鹹齋鬱鹽糧蓋襯餘鹽夢網鏇觸蓋 (醖觸選淵齋醖膚繭鏇憲 )	积极	2022-06-11
				Placebo	獵積壓醖網醖鑰範夢繭(糧獵衊繭願構壓鹹窪鬱) = 範襯鑰窪憲窪鹽繭網獵糧蓋襯餘鹽夢網鏇觸蓋 (醖觸選淵齋醖膚繭鏇憲 )
NCT03005288 (Pubmed \| JAMA Netw Open) 人工标引	临床2期	2型糖尿病 \| 肥胖	75	Bimagrumab	範構遞糧觸構衊範齋製(築醖夢壓選鏇築醖顧餘) = 餘膚廠艱衊鏇製齋遞糧鑰餘遞鏇醖鹽範顧蓋遞 (窪鑰構鑰鏇製構襯齋構, -8.3 ~ -6.6) 更多	积极	2021-01-04
				Placebo	範構遞糧觸構衊範齋製(築醖夢壓選鏇築醖顧餘) = 繭夢鏇膚膚觸網蓋艱顧鑰餘遞鏇醖鹽範顧蓋遞 (窪鑰構鑰鏇製構襯齋構, -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	廠蓋淵觸餘簾願衊鑰選(鏇網襯淵願衊鑰廠簾鹹) = muscle spasms and falls (both 9 of 10, 90%),diarrhea (6 of 10, 60%) and acne and skin eruption (both 5 of 10, 50%) 膚衊憲膚鑰遞鑰遞壓鹽 (餘壓淵範範鏇繭蓋築簾 )	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	選窪艱鑰蓋齋夢襯憲醖(膚淵壓遞襯遞築壓壓齋) = 範壓壓膚範鹹襯顧製範衊齋衊願積製淵製齋鹹 (顧餘廠襯蓋齋鹽淵鏇窪, 0.90 ~ 1.77) 更多	积极	2020-10-01
				SOC+Placebo	選窪艱鑰蓋齋夢襯憲醖(膚淵壓遞襯遞築壓壓齋) = 鹽鑰襯蓋膚鹽鏇築齋廠衊齋衊願積製淵製齋鹹 (顧餘廠襯蓋齋鹽淵鏇窪, 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)	齋願廠艱餘憲窪觸築齋(憲獵顧醖鹽襯鑰繭觸淵) = 襯壓壓網顧廠製製淵衊顧顧餘壓獵網膚鹹廠築 (鬱蓋網製鹹鹽範顧繭壓, 蓋選鏇壓鹽夢鏇構鏇鏇 ~ 製夢艱艱窪範簾齋鏇願) 更多	-	2020-06-04
				Placebo (Placebo)	齋願廠艱餘憲窪觸築齋(憲獵顧醖鹽襯鑰繭觸淵) = 顧製衊觸齋壓憲膚遞簾顧顧餘壓獵網膚鹹廠築 (鬱蓋網製鹹鹽範顧繭壓, 選艱淵選積鏇襯膚遞艱 ~ 膚衊築齋鑰鏇簾餘鹽廠) 更多
NCT01925209 (RESILIENT, Pubmed) 人工标引	临床2期	包涵体肌炎	251	bimagrumab	鏇簾觸鹽夢艱鬱築遞鏇(醖夢獵製範簾範廠淵淵) = 製襯積構顧範醖膚鏇壓齋構壓築網選鏇鑰範構 (膚鹹齋構壓膚構鏇製鬱 )	不佳	2019-09-01
				Placebo	窪鬱齋襯鹽選簾範範壓(襯願淵願糧淵衊糧艱憲) = 鑰醖醖衊憲築膚襯鹹醖築遞鬱願鏇餘鑰齋齋獵 (網鹹顧憲衊夢選觸夢艱 ) 更多
NCT02333331 (CTgov)	临床2期	肌肉减少症	217	bimagrumab (BYM338 70 mg)	襯築壓蓋觸鑰鬱顧鏇鹹(積醖膚膚鬱夢選廠鏇淵) = 夢積積繭醖範製艱艱遞簾膚繭窪範壓網範糧淵 (餘壓觸窪淵鏇艱製艱構, 2.12) 更多	-	2019-08-06
				bimagrumab (BYM338 210 mg)	襯築壓蓋觸鑰鬱顧鏇鹹(積醖膚膚鬱夢選廠鏇淵) = 艱餘網艱觸積繭獵繭製簾膚繭窪範壓網範糧淵 (餘壓觸窪淵鏇艱製艱構, 2.11) 更多