Core Viewpoint - The combination of Bimagrumab and Semaglutide shows significant efficacy in weight management, with an average weight loss of 22.1% over 48 weeks, primarily from fat reduction, indicating a comprehensive strategy for obesity treatment [2][4]. Group 1: Clinical Trial Results - In a 48-week trial, participants receiving the combination treatment lost an average of 22.1% of their body weight, with 92.8% of this loss attributed to fat reduction, compared to a 15.7% weight loss with Semaglutide alone, where 71.8% was fat loss [2]. - The combination therapy not only resulted in greater weight loss but also preserved more lean body mass, which is particularly important for populations at risk of sarcopenia [4]. Group 2: Significance of the Research - The study addresses a major public health issue, as obesity is linked to various complications such as diabetes, heart disease, and certain cancers, and the combination therapy may improve the quality of life for many patients [4]. - Bimagrumab's development is part of Eli Lilly's ongoing innovation strategy in obesity treatment, focusing on the often-overlooked issue of muscle preservation during weight loss [4]. Group 3: Future Directions - Eli Lilly is also advancing clinical trials for Bimagrumab in combination with Zepbound, a dual-target GLP-1/GIP agonist, expanding treatment options for patients and healthcare providers [5]. - The acquisition of Versanis Bio for approximately $2 billion highlights the company's commitment to exploring new avenues in weight management, particularly targeting ActRII [6]. Group 4: Mechanism of Action - Bimagrumab targets the activin receptor type II (ActRII), which plays a crucial role in muscle growth regulation, and its inhibition may provide a more effective approach to preserving muscle mass during weight loss [12][13]. - The signaling pathway involving ActRII has implications for muscle diseases, and targeting this receptor could lead to advancements in treating conditions like sarcopenia and cachexia [9][13].

Core Viewpoint - Wave Life Sciences Ltd. presents promising preclinical data for its candidate drug WVE-007, which targets INHBE mRNA to reduce fat mass without compromising muscle quality, potentially lowering the risk of metabolic diseases such as type 2 diabetes and coronary artery disease [1][7]. Group 1: Mechanism and Efficacy - WVE-007 is a GalNAc-modified siRNA that significantly downregulates INHBE mRNA and its product Activin E protein, which inhibits fat breakdown in obesity [2]. - A single administration of WVE-007 results in weight loss comparable to the widely used GLP-1 receptor agonist semaglutide [3]. - The drug effectively reduces visceral fat, decreases adipocyte size, and preserves muscle mass, supporting weight loss through the restoration of adipose tissue function [4]. Group 2: Inflammatory Response - WVE-007 significantly inhibits the recruitment of pro-inflammatory M1 macrophages while maintaining levels of anti-inflammatory M2 macrophages, demonstrating strong anti-inflammatory potential [5]. Group 3: Combination and Maintenance Therapy - When used in conjunction with semaglutide, INHBE-siRNA can double the weight loss effect, indicating a synergistic therapeutic potential [6]. - After discontinuation of semaglutide, INHBE-siRNA significantly slows weight regain, suggesting it could serve as a maintenance or transitional therapy for GLP-1 treatments [7]. Group 4: Genetic Insights and Future Prospects - Individuals carrying INHBE gene loss-of-function variants often exhibit healthier metabolic profiles, including reduced abdominal fat, lower triglyceride levels, and decreased risks of type 2 diabetes and cardiovascular diseases [7]. - The Chief Scientific Officer of Wave emphasizes that if clinical trials confirm these mechanisms, WVE-007 could revolutionize obesity treatment by offering a new pathway that requires only one to two injections per year for healthy weight loss while preserving muscle mass [7].

6 月 25 日，CDE 官网显示，阿斯利康的 AZD6234 与 AZD9550 注射液已获批在中国开展临床试验，拟联合应用于患有至少一种肥胖 相关合并症的超重或肥胖成年人，进行长期体重管理。 整理 | GLP1减重宝典内容团队 版权声明：所有「GLP1减重宝典」的原创文章，转载须联系授权，并在文首/文末注明来源、作者、微信ID，否则减重宝典将向其追究法律责 任。部分文章推送时未能与原作者或公众号平台取得联系。若涉及版权问题，敬请原作者联系我们。合作事宜，请添加微信：andyxu365 | | 国家药品监督管理局药品审评中心 | | | | | 0 网站地图 | C 联系我们 | ▽ CDE邮箱 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | CENTER FOR DRUG EVALUATION. NMPA | | | | | ○ 请输入关键词 | | 搜索 | | 首页 | 机构职能 新闻中心 | 政策法规 | 党建工作 | 信息公开 | 申请人之窗 | 办事服务 监督与反馈 | | | | 信息公开 | ○ 当前位置:信息公开 ...

整理 | GLP1减重宝典内容团队 礼来公司近日公布的一项Ⅱ期临床试验数据显示，将Bimagrumab与司美格鲁肽（商品名Wegovy）联合使用，在体重管理方面取得了显著疗 效。在为期48周的试验中，接受联合治疗的受试者体重平均下降22.1%，其中92.8%的减重来自脂肪减少。相比之下，单独使用司美格鲁肽的受 试者体重减少15.7%，其中71.8%为脂肪减少。这表明Bimagrumab在促进脂肪代谢的同时有助于保留肌肉组织，为肥胖治疗提供了一种更全面 的策略。 这一组合疗法标志着肥胖治疗领域的重要进展。司美格鲁肽是一种由诺和诺德开发的GLP-1受体激动剂，已被广泛用于减重治疗。但GLP-1类 药物一个常见问题是减重过程中可能导致肌肉流失。礼来研发的Bimagrumab是一种靶向活化素II型受体的抗体，该受体在调节肌肉生长和维持 中发挥关键作用。通过抑制该受体，Bimagrumab能够在减重过程中保护肌肉质量，与司美格鲁肽形成互补。 临床数据显示，两药联合使用具有协同效应。接受组合治疗的受试者不仅减重幅度更大，还保留了更多的瘦体重，相较于单用司美格鲁肽者表 现更优。这对于存在肌少症风险的人群尤为重要。肌少症是指 ...

整理 | GLP1减重宝典内容团队 今年，Mounjaro 在寻求有效解决方案以实现可持续减肥的人群中获得了前所未有的关注。Mounjaro 是一种最初用于治疗 2 型糖尿病的药物， 它迅速成为对抗肥胖的有力工具。这种注射药物模仿人体的天然激素来调节血糖和食欲，已被证明对控制血糖和减肥非常有效。 ▍颠覆认知：临床试验数据惊艳全球 Mounjaro 成为肥胖治疗领域游戏规则改变者的关键原因之一是它能够带来切实的效果。 SURMOUNT-5的3b期临床试验头对头研究，旨在评估 减重版替尔泊肽与Wegovy在肥胖或超重成年人中的疗效和安全性，这些成年人至少有一种合并症：高血压、血脂异常、阻塞性睡眠呼吸暂停 （OSA）或心血管疾病，且没有糖尿病。 在72周时，其参与者减掉了50.3磅（22.8公斤）。 肥胖医学领域的顶尖专家Michael Harris博士指出："我们掌握的有关 Mounjaro 减肥的数据具有开创性意义。它是首批有效结合减肥和改善代 谢健康的药物之一，是现代肥胖治疗的基石。" 点击关注，追踪最新GLP-1资讯 ▍双靶点机制：科学揭秘"神奇"之源 Mounjaro 在减肥领域的崛起并非偶然。正如体重管 ...

撰文丨王聪 编辑丨王多鱼 排版丨水成文 全世界范围内，肥胖的发病率激增。《 柳叶刀 》2025 年 3 月发布的最新数据显示，在 2021 年，全球有 21.1 亿成年人和 4.93 亿儿童和青少年受到超重或肥胖的影响，照此趋势，到 2050 年，将有 60% 的成 年人 （约38亿） 以及 31% 的儿童和青少年 （约7.5亿） 面临超重和肥胖问题。 这些数据凸显了立即采 取行动以防止人类面临的前所未有的超重和肥胖问题的必要性。 近年来，司美格鲁肽、替尔泊肽等 GLP-1 类减肥药的流行，为控制肥胖流行带来了强大武器。而一项最新 研究显示， 大脑神经元中的一个微小天线状结构中有着一条此前未知的信号通路，其在控制食欲方面发挥 着关键作用，从而为 抗肥胖治疗开辟了新途径。 2025 年 6 月 5 日，德克萨斯大学西南医学中心 张召 团队 （ 寻禹 、 蒋怡翱 为共同第一作者） 在国际顶 尖学术期刊 Science 上发表了题为： GPR45 modulates Gα S at primary cilia of the paraventricular hypothalamus to control food i ...

Core Viewpoint - Eli Lilly (LLY) is positioned as a strong long-term investment opportunity in the obesity treatment market, particularly with its GLP-1 drugs, despite potential competition and earnings growth slowdown risks. Group 1: Market Performance and Resilience - Eli Lilly's stock has shown relative resilience compared to the broader market, with a 19% decline during the 2022 inflation shock and a 23% decline during the 2020 COVID-19 pandemic, while the S&P 500 experienced declines of 25% and 34% respectively [2] - LLY stock has already absorbed significant impacts, falling over 20% from its 52-week high of over $970 to below $750 [3] Group 2: Market Potential and Competitive Position - The market for GLP-1 drugs is projected to grow to $150 billion by 2030, with Eli Lilly and Novo Nordisk currently dominating, having generated over $40 billion in sales last year [3] - Eli Lilly is a leader in the obesity treatment race, with superior efficacy and multiple product offerings, including injectable Zepbound and promising oral GLP-1 formulations showing nearly 8% weight loss in trials [3] Group 3: Financial Performance and Stability - Eli Lilly's growth rate is accelerating at over 30%, significantly higher than AbbVie's under 5%, with a three-year average growth rate of 17% compared to AbbVie's less than 1% [6] - Eli Lilly's three-year average margins stand at 34%, superior to AbbVie's 26%, indicating better profitability [6] - Eli Lilly's balance sheet is stronger, with debt making up only 4% of equity compared to AbbVie's 20%, signaling a healthier financial standing [6]

整理 | GLP1减重宝典内容团队 再生元制药公司（NASDAQ: REGN）宣布与翰森制药集团有限公司（"翰森制药"）达成许可协议，再生元获得GLP-1/GIP双重受体激动剂 （HS-20094）在中国大陆、香港和澳门以外地区的独家临床开发和商业化权利。 该候选药物目前正处于三期临床试验阶段，作为每周一次的皮下注射方案，已在超过1,000名患者中进行测试，显示出良好的安全性和疗效，其 表现与目前美国FDA唯一批准的GLP-1/GIP双重受体激动剂相似。目前，该药正在中国进行一项治疗肥胖的三期临床试验以及一项糖尿病二期b 试验。 根据协议条款，再生元将向翰森制药支付8000万美元的预付款，并在开发、监管及销售里程碑达成时，可能额外支付最高19.3亿美元。此外，在 协议指定地区以外的全球销售收入中，翰森制药还将获得低双位数百分比的销售提成。 再生元内科临床开发高级副总裁Boaz Hirshberg医学博士补充道："获得这一处于后期开发阶段的药物，使我们有机会将其与自有在研药物进行 联合探索，进一步解决肌肉流失以及心血管疾病、肝脏疾病和糖尿病等肥胖并发症。这也与我们在肥胖治疗领域的整体战略相一致，例如我们正 在进 ...

近日，国内GLP-1类创新减重药物玛仕度肽在中国超重或肥胖受试者中的Ⅲ期临床研究（GLORY-1）登上国际知名期刊《新英格兰医学杂志》，这是全球首 个且唯一申报上市的胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂减重降糖药物的临床研究首次登上医学权威学术期刊。而玛仕度肽并非 全球首个开展临床研究的双靶点GLP-1激动剂药物，GLORY-1为何能登上国际顶刊？ 玛仕度肽（IBI362）是信达生物与礼来制药共同推进的一款胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂。去年1月，信达生物公司曾宣 布，玛仕度肽在中国超重或肥胖成人受试者中的首个Ⅲ期临床研究（GLORY-1）达成主要终点和所有关键次要终点。此次入选《新英格兰医学杂志》的研 究，正是GLORY-1。 值得一提的是，玛仕度肽并不是全球首个开展临床研究的双靶点GLP-1激动剂药物。全球首个获批的双靶点GLP-1药物是礼来制药的另一款产品替尔泊肽， 该药物分别于去年5月和7月在国内获批了降糖和体重管理的适应证，今年1月正式在国内上市，目前有4种规格。 在此背景下，GLORY-1研究为何还能得到《新英格兰医学杂志》的青睐？ ...

在肥胖治疗领域，GLP-1（胰高血糖素样肽-1）靶点的价值已被广泛认可。作为重要的肠促胰素，GLP- 1通过激活GLP-1受体，既能调节血糖，又能作用于中枢抑制食欲、延缓胃排空以减少能量摄入。而 GCG（胰高血糖素）靶点的研究则为肥胖治疗打开了新视野。GCG由胰岛α细胞分泌，其受体 （GCGR）的激活可增强脂肪氧化、促进能量消耗，尤其在改善肝脏脂肪代谢方面具有独特潜力。GCG 与GLP-1靶点联用，可以通过"抑制食欲+加速代谢"的双重机制，更全面地解决肥胖患者内脏脂肪堆 积、胰岛素抵抗等复杂代谢问题，突破单一靶点的治疗局限。 "玛仕度肽（1BI362）是一种每周一次给药的GCG/GLP-1双受体激动剂。"纪立农介绍，在Ⅱ期临床试验 中，玛仕度肽6mg在中国超重或肥胖受试者和2型糖尿病受试者中均显示出显著的体重减轻效果，且其 耐受性和安全性与GLP-1受体激动剂及其联合激动剂相似。纪立农表示，此次入选《新英格兰医学杂 志》的研究，是首个在中国超重或肥胖受试者中评估玛仕度肽疗效和安全性的Ⅲ期临床试验（GLORY- 1）。该研究共入组610名受试者，结果显示各剂量玛仕度肽相较安慰剂均可显著降低体重。同时，患者 在血 ...