Efficacy, Safety, and Tolerability of a GLP-1/GCG Dual Receptor Agonist in Type 2 Diabetes Patients With Cognitive Dysfunction: A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Trial

The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 432 type 2 diabetes patients with early dementia are randomized 1:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential disease-modifying effects of mazdutide on cognitive dysfunction in type 2 diabetes.

开始日期2025-08-01

申办/合作机构

上海市第一人民医院

[+1]

NCT06937749

/ Recruiting临床2期

A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.

开始日期2025-07-01

申办/合作机构

信达生物制药（苏州）有限公司

NCT07000955

/ Recruiting临床1/2期

Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg Administered Multiple Times in Chinese Patients With Moderate to Severe Obesity

This study is a multicenter, randomized, partially double-blind (double-blind in both the IBI362 group and the placebo group, with the tirbopeptide group open), placebo and active drug controlled design study

开始日期2025-06-17

申办/合作机构

信达生物制药（苏州）有限公司

100 项与玛仕度肽相关的临床结果

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100 项与玛仕度肽相关的转化医学

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100 项与玛仕度肽相关的专利（医药）

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项与玛仕度肽相关的文献（医药）

2025-07-01·EBioMedicine

Mazdutide, a dual agonist targeting GLP-1R and GCGR, mitigates diabetes-associated cognitive dysfunction: mechanistic insights from multi-omics analysis

Article

作者: Yang, Maoxing ; Zhao, Ziyue ; Dong, Wanqing ; Zhang, Yongjiang ; Zhang, Ziyue ; Jiang, Hongwei ; Bai, Jie ; Yuan, Qibin ; Zhang, Yingyu ; Li, Hanxiao

BACKGROUND:

Cognitive impairment and dementia are highly associated with obesity and type 2 diabetes mellitus (T2DM). Recent studies have demonstrated that GLP-1 receptor agonists can improve cognitive function through brain activation in patients with T2DM, compared to other oral glucose-lowering drugs. Mazdutide, a dual agonist of the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR), has been shown to simultaneously reduce body weight, blood glucose levels, and other comorbidities associated with obesity in patients with T2DM. While its insulinotropic and glucose-lowering effects through the GLP-1 pathway are well-established, mazdutide may also enhance energy expenditure via activation of the GCGR pathway. However, its potential impact on cognitive function remains to be elucidated.

METHODS:

This study aimed to investigate the effects of mazdutide on cognitive behaviour and cerebral pathology in male db/db mice, a model of T2DM, in comparison to dulaglutide, a GLP-1 receptor agonist. All animal findings are applicable to male mice only. Behavioural tests were conducted to evaluate cognitive function, and pathological analyses were performed to assess neurodegenerative markers in the brain. Furthermore, transcriptomic, proteomic, and metabolomics analyses were employed to explore the underlying molecular mechanisms of mazdutide's effects.

FINDINGS:

Compared to dulaglutide, mazdutide significantly improved cognitive performance in db/db mice, as evidenced by comprehensive behavioural tests. Pathological assessments revealed improvements in neuronal structure and brain tissue integrity in the mazdutide-treated group. Multi-omics analyses further identified distinct molecular pathways involved in neuroprotection, energy metabolism, and synaptic plasticity, suggesting that dual GLP-1/GCGR activation contributes to enhanced cognitive resilience.

INTERPRETATION:

Our findings indicate that mazdutide, via its dual GLP-1/GCGR activation effects, exerts multifactorial improvements in cognitive function in the context of obesity and T2DM. These results suggest that mazdutide is a promising therapeutic option for mitigating cognitive deficits associated with metabolic disorders.

FUNDING:

Medical Science and Technology Research and Development Plan Major Project Jointly Constructed by the Henan Province and Ministerial Departments in China (No. SBGJ202301010).

2025-06-12·NEW ENGLAND JOURNAL OF MEDICINE

Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight

Article

作者: Wang, Yanqi ; Tian, Junhang ; Deng, Huan ; Liu, Zihan ; Lv, Lingchun ; Ji, Linong ; Liu, Dexue ; Li, Li ; Gu, Jieyu ; Qian, Lei ; Lian, Qiufang ; Yang, Ping ; Chen, Lei ; Huang, Chongbing ; Zhong, Shao ; Qiu, Wei ; Li, Hua ; Bi, Yan ; Jiang, Hongwei ; Han, Jie ; Pei, Lijuan ; Zhao, Yuzhu ; Zhang, Yawei

BACKGROUND:

Evidence suggests that incretin-based dual agonist pharmacotherapy is helpful in persons with obesity. Mazdutide, a glucagon-like peptide-1 and glucagon receptor dual agonist, may have efficacy in persons with overweight or obesity.

METHODS:

In a phase 3, double-blind, placebo-controlled trial in China, we randomly assigned, in a 1:1:1 ratio, adults 18 to 75 years of age who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 28 or had a BMI of 24 to less than 28 plus at least one weight-related coexisting condition to receive 4 mg of mazdutide, 6 mg of mazdutide, or placebo for 48 weeks. The two primary end points were the percentage change in body weight from baseline and a weight reduction of at least 5% at week 32, as assessed in a treatment-policy estimand analysis (which assessed effects regardless of early discontinuation of mazdutide or placebo and the initiation of new antiobesity therapies).

RESULTS:

Among 610 participants, the mean body weight was 87.2 kg and the mean BMI was 31.1 at baseline. At week 32, the mean percentage change in body weight from baseline was -10.09% (95% confidence interval [CI], -11.15 to -9.04) in the 4-mg mazdutide group, -12.55% (95% CI, -13.64 to -11.45) in the 6-mg mazdutide group, and 0.45% (95% CI, -0.61 to 1.52) in the placebo group, and 73.9%, 82.0%, and 10.5% of the participants, respectively, had a weight reduction of at least 5% (P<0.001 for all comparisons with placebo). At week 48, the mean percentage change in body weight from baseline was -11.00% (95% CI, -12.27 to -9.73) in the 4-mg mazdutide group, -14.01% (95% CI, -15.36 to -12.66) in the 6-mg mazdutide group, and 0.30% (95% CI, -0.98 to 1.58) in the placebo group, and 35.7%, 49.5%, and 2.0% of the participants, respectively, had a weight reduction of at least 15% (P<0.001 for all comparisons with placebo). Beneficial effects on all prespecified cardiometabolic measures were seen with mazdutide. The most frequently reported adverse events were gastrointestinal and mostly mild to moderate in severity. The incidence of adverse events leading to discontinuation of the trial regimen was 1.5% with the 4-mg mazdutide dose, 0.5% with the 6-mg mazdutide dose, and 1.0% with placebo.

CONCLUSIONS:

In Chinese adults with overweight or obesity, once-weekly mazdutide at a dose of 4 mg or 6 mg for 32 weeks led to clinically relevant reductions in body weight. (Funded by Innovent Biologics; GLORY-1 ClinicalTrials.gov number, NCT05607680.).

2025-05-01·PEPTIDES

Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities

Review

作者: Flatt, Peter R ; Bailey, Clifford J ; Conlon, J Michael

Recent studies with peptide-based incretin therapies have focussed mainly on the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and the dual agonist tirzepatide that engages receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). Randomised clinical trials and 'real-world' studies have confirmed the marked glucose-lowering and weight-lowering efficacy of these agents across diverse populations. These include different ethnic groups, young and elderly individuals with and without diabetes and/or overweight or obesity. Recent studies have also confirmed protections against the development and progression of cardiovascular and renal diseases that are additive to the benefits conferred by improved control of blood glucose and body weight. Emerging evidence suggests that incretin therapies could additionally ameliorate fatty liver disease, chronic inflammation, sleep apnea and possibly degenerative bone disorders and cognitive decline. New incretin-based peptide therapies in development include a long-acting glucagon receptor agonist (LY3324954), dual GLP-1/glucagon receptor agonists (survodutide, pemvidutide, mazdutide, G49), triple GLP-1/GIP/glucagon receptor agonists (retatrutide, efocipegtrutide), a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), a unimolecular GLP-1/amylin receptor dual agonist (amycretin), and a GIP receptor antibody with GLP-1 receptor agonism (MariTide). The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities. The aim of the review is to acquaint the reader with developments in the field from 2023 to the present (February 2025).

641

项与玛仕度肽相关的新闻（医药）

2025-07-28

·米内网

糖尿病“药王”跌超10%，扬子江、甘李……国产品牌突围！东阳光药、华东重磅新药火热来袭

精彩内容近期，糖尿病用药市场波澜再起。河南立诺制药|天津汉瑞药业的达格列净二甲双胍缓释片(Ⅰ)、达格列净二甲双胍缓释片(Ⅱ)、达格列净二甲双胍缓释片(Ⅲ)同日报产获CDE受理，诺和诺德的司美格鲁肽注射液新适应症获批。米内网数据显示，糖尿病用药（化+生）在2025年一季度中国零售药店终端销售额同比增长近9.00%。从品牌TOP20来看，“药王”跌超10%，扬子江药业、甘李药业等国产品牌突围。今年以来，糖尿病用药已有超过40个品种报产在审，其中，6个品种为新药，涉及东阳光药、华东医药、恒瑞医药等企业。重磅新品获批不断，奥萨、鲁南贝特发起冲击日前，诺和诺德的司美格鲁肽注射液新适应症获批，福安药业烟台只楚药业的硫辛酸片、湖南及正医药科技的二甲双胍恩格列净片(Ⅰ)、深圳奥萨制药的恩格列净片、鲁南贝特制药的利格列汀片等均以新分类报产先后获批上市。今年以来糖尿病用药（化+生）新药获批情况来源：米内网中国申报进度（MED）数据库今年以来，糖尿病用药（化+生）已有超过90个受理号获批上市，涉及品种超过30个。其中，信达生物制药(苏州)的玛仕度肽注射液、山东盛迪医药的瑞格列汀二甲双胍片(Ⅰ)和瑞格列汀二甲双胍片(Ⅱ)、上海银诺医药的依苏帕格鲁肽α注射液、石药欧意药业的普卢格列汀片为1类新药。糖尿病“药王”跌超10%，扬子江、甘李……国产品牌突围米内网数据显示，糖尿病用药（化+生）在近年中国零售药店（城市实体药店+网上药店）终端市场规模持续扩容，2024年销售额突破130亿元，2025年一季度同比增长近9%。其中，城市实体药店是主力销售渠道，网上药店则保持快速增长。从一级集团TOP20来看，跨国药企占据前列位置，诺和诺德、阿斯利康、默克、默沙东、礼来排前五位。值得一提的是，国内药企仅远大健康和扬子江药业在前十之列，而甘李药业、华领医药、正大制药等均有双位数增速。2025年一季度中国零售药店终端糖尿病用药（化+生）小类格局来源：米内网格局数据库GLP-1受体激动剂、胰岛素及其类似药、SGLT2抑制剂是TOP3治疗小类，口服降糖药复方增速最快，同比增长超过35%。从剂型来看，片剂一枝独秀，注射剂位居第二，合计市场份额占比超过90%。从在销品种数量来看，涉及产品超过140个，超过600个品牌。2025年一季度中国零售药店终端糖尿病用药（化+生）品牌TOP20来源：米内网格局数据库注：增长率不足10%用*表示品牌TOP20中，4个销售额超过1亿元，诺和诺德的司美格鲁肽注射液和阿斯利康的达格列净片超过4亿元，默克的盐酸二甲双胍片超过2亿元，默沙东的磷酸西格列汀片超过1亿元。从增速来看，礼来的替尔泊肽注射液暴涨1036.37%，诺和诺德的德谷胰岛素注射液和德谷胰岛素利拉鲁肽注射液增速均超过50%。4个上榜的国产品牌均为正增长，甘李药业的甘精胰岛素注射液增速最快，达28.97%；华领医药(上海)的多格列艾汀片和杭州中美华东制药的吡格列酮二甲双胍片(15mg/500mg)增速均超过10%。此外，诺和诺德的司美格鲁肽注射液则是TOP20中跌幅最大的品牌。从集团层面来看，诺和诺德最多，有司美格鲁肽注射液、门冬胰岛素30注射液、德谷门冬双胰岛素注射液等7个品种上榜；默沙东和赛诺菲各有2个品种上榜。近年中国零售药店终端司美格鲁肽注射液销售情况（单位：万元）来源：米内网格局数据库司美格鲁肽注射液是诺和诺德研发的一款新型长效胰高糖素样肽-1（GLP-1）类似物，2021年中国获批进口上市。该产品在2024年中国零售药店终端突破20亿元的销售规模，2025年一季度下滑超过10%，是糖尿病用药（化+生）TOP1产品。目前，司美格鲁肽注射液仅有诺和诺德拥有生产批文，多家国内药企则纷纷出手布局。杭州九源基因、丽珠集团新北江制药、齐鲁制药、珠海联邦生物医药等国内药企报产在审，海南中和药业、山东新时代药业、浙江普洛康裕制药等超过20家企业获批临床。新药大爆发，东阳光药、华东、恒瑞火热来袭7月28日，CDE官网显示，河南立诺制药|天津汉瑞药业的达格列净二甲双胍缓释片(Ⅰ)、达格列净二甲双胍缓释片(Ⅱ)、达格列净二甲双胍缓释片(Ⅲ)同日报产获受理。在此之前，河北智恒医药科技的达格列净二甲双胍缓释片(Ⅰ)、河南大新药业的吡格列酮二甲双胍片、天津力生制药的达格列净片、湖南千金湘江药业的达格列净二甲双胍缓释片(Ⅰ)和达格列净二甲双胍缓释片(Ⅲ)等产品先后提交上市申请。今年以来糖尿病用药（化+生）新药报产在审情况来源：米内网中国申报进度（MED）数据库今年以来，糖尿病用药（化+生）已有超过160个受理号报产在审，涉及品种超过40个，其中，6个品种为新药，东阳光药（德谷门冬双胰岛素注射液、德谷胰岛素注射液）和华东医药（司美格鲁肽注射液、德谷胰岛素注射液）各有2个产品报产在审，舒地胰岛素注射液则是恒瑞医药首个胰岛素制剂。2022年至今，糖尿病用药（化+生）新药共有16个品种报产在审。资料来源：米内网数据库、公司公告等注：米内网《中国城市实体药店药品终端竞争格局》，统计范围是：全国地级及以上城市实体药店，不含县乡村药店；《中国网上药店药品终端竞争格局》，统计范围是：全国网上药店所有药品数据，包括天猫、京东等第三方平台及私域平台上所有网上药店药品数据；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准生物类似药

2025-07-28

·药时代

GCG直击肝脏靶点，双管齐下“燃烧”肝脏脂肪

胰高血糖素（glucagon，GCG）作为一种经典的“分解代谢”激素，其发现至今已有100年的历史。GCG协同胰高糖素样肽-1（GLP-1）开发的双靶点、多靶点激动剂现已成为针对糖尿病、肥胖等代谢疾病治疗的重要方向。GCG受体激动在GLP-1受体激动抑制食欲的基础上，促进脂肪代谢、增加能量消耗，达到减重、降糖的双重获益。同时，GCG受体主要在肝脏表达，激活GCG受体能够抑制肝脏脂肪合成、促进脂肪酸β氧化从而燃烧肝脏脂肪，带来肝脏保护的多重受益。GCG如何调节肝脏代谢？GCG燃烧肝脏脂肪的具体机制是什么？除了燃烧肝脏脂肪以外，GCG受体激活还有哪些肝脏获益？GCG/GLP-1双受体激动剂玛仕度肽降低肝脏脂肪的具体疗效如何？带着这些问题，我们采访华中科技大学同济医学院附属同济医院余学锋教授，请他为我们解读GCG“燃烧肝脏脂肪”的具体作用机制以及GCG/GLP-1双受体激动剂改善肝脏脂肪的具体疗效。生理条件下肝脏中的脂肪是如何代谢的?余学锋教授：肝脏是机体脂质代谢的核心器官，承担了脂质的摄取与处理功能。肝脏中的脂质有2个来源3个去路。来源：肝脏中脂质的第一个来源是游离脂肪酸的摄入，摄入食物后肠道产生的乳糜微粒以及储存在脂肪组织中甘油三酯（Triglyceride，TG）分解形成的游离脂肪酸释放到血液中输送到肝脏。脂质的第二个主要来源从头脂肪生成（De novo lipogenesis，DNL）是肝细胞将食物中的碳水化合物分解产生的葡萄糖和果糖转化为脂肪酸的过程。去路：进入肝脏的脂质一部分被运输到线粒体中进行脂肪酸的β氧化，为机体提供能量，这是肝脏脂肪消耗的主要形式。肝脏脂质还可以再酯化形成甘油三酯，以脂滴的形式储存在肝细胞中。这些再酯化形成的甘油三酯少量被组装形成极低密度脂蛋白（VLDL）运输到肝脏外的血液中，剩余的脂质还累积在肝脏中。当肝脏对脂质的氧化与输出不足以消耗掉肝脏中累积的脂质就会导致肝脏脂肪变性，从而引起脂肪肝，腹型肥胖等一些列的代谢性疾病（图1）。图1 肝脏脂肪代谢示意图[1]GCG与肝脏之间有什么关系?GCG如何调节肝脏代谢呢?余学锋教授：GCG由胰腺中的胰岛α细胞分泌，在体内主要与胰岛素共同作用起到稳定血糖的作用。GCG受体主要在肝脏表达，在肝脏中发挥重要作用调节三大营养物质代谢，减少肝脏脂肪，提高肝细胞存活率。当血糖下降时，胰高血糖素会从胰腺α细胞释放到肝门静脉，从而迅速到达肝细胞与GCG受体结合、刺激腺苷酸环化酶-cAMP系统以及随后激活蛋白激酶A通路来刺激糖原分解和糖异生并刺激内源性葡萄糖生成[2]。此外，GCG受体的激活能够通过多重机制协同作用燃烧肝脏脂肪，包括抑制脏脂肪生成，促进脂肪酸氧化，增加糖异生，改善炎症、纤维化等多个方面减少肝脏脂肪含量。激动GCG受体能够直接燃烧肝脏脂肪的具体机制是什么?余学锋教授：刚刚我们也提到GCG受体激动带来的燃脂作用是多方面的，它既能够抑制脂肪合成，又能够促进脂肪分解，双管齐下，调节脂肪代谢，具体来讲：（1）GCG受体激活抑制脂肪从头合成，增强脂质耐受性。GCG受体激活介导PKA和AMPK信号，使得脂质合成途径中的关键酶乙酰辅酶a羧化酶-1和2（ACC1和ACC2）被磷酸化从而抑制其活性，能直接抑制肝内从头脂肪合成。GCG受体激活还能够抑制二甘油酯酰基转移酶DGAT和HMG-CoA还原酶，抑制甘油三酯合成并降低循环中的胆固醇水平[3]。有研究表明，静脉输注GCG可通过增加脂蛋白脂肪酶（LPL）活性加速TG从血浆中清除从而在数分钟内降低血浆TG浓度[4]。（2）GCG受体激活通过刺激脂肪分解和脂肪酸β-氧化来减少肝脏内脂质的累积。研究表明，GCG受体激活后，磷脂酶A和酰基转移酶1（Plaat1）的表达增加，非酰化脂肪酸输出显著增加，这些都表明GCG受体激活导致肝脏脂质分解代谢增加[5]。线粒体是肝细胞重要的细胞器，是肝脏中脂肪酸β氧化的场所。GCG受体激活能促进脂肪酸进入线粒体，促进脂肪β-氧化功能。同时，GCG能够增强线粒体功能从而刺激肝线粒体脂肪酸β-氧化，逆转肝脏脂肪变性。此外，GCG激活上调线粒体生物合成调节剂PGC-1α基因表达，能够加快线粒体合成，增强线粒体氧化呼吸功能[5]。综上，GCG受体激活通过多种作用机制协同作用，减少肝脏脂肪。（3）GCG激活影响多种代谢途径，减少肝脏脂肪。肝细胞中GCG受体激活刺激成纤维细胞生长因子21（FGF21）的表达和分泌增加，FGF21能够通过多种途径包括抑制脂肪生成基因的表达，增加脂肪酸的线粒体β氧化减少肝脏脂肪。此外，FGF21显著降低肝星形细胞（HSC）活化和增殖，减少Kupffer细胞和损伤肝细胞促纤维化因子的表达和分泌[6]。GCG受体激活还能够通过肝脏法尼醇X受体（FXR）路径增加能量消耗。在肝细胞中，FXR激活会抑制固醇调节元件因子结合蛋白-1c（SREBP-1c）的表达，抑制从头脂肪生成外，FXR激活还会诱导过氧化物酶体增殖激活受体（PPARα）及其靶基因的表达以促进游离脂肪酸（FFA）氧化，故FXR激活通过抑制从头脂肪生成和促进脂质氧化和清除来减少肝脏脂肪变性[7]。除了燃烧肝脏脂肪以外，GCG受体激活还有哪些肝脏获益呢?余学锋教授：GCG受体激活还能减少肝脏炎症和纤维化，提高肝细胞存活率。研究表明，在非酒精性脂肪性肝炎（NASH）的肥胖（ob）/ob小鼠模型中，与GLP-1受体激动剂相比，GCG/GLP-1双受体激动剂进一步减轻了肝纤维化和炎症。GCG/GLP-1双受体激动剂降低了血浆丙氨酸氨基转移酶（ALT）、肝脏α-平滑肌肌动蛋白、肝脏羟脯氨酸含量，免疫细胞浸润标志物CD68及纤维化评分，使用GCG/GLP-1双受体激动剂后，肝脏纤维化和炎症相关基因的转录水平显著下降，且下降幅度优于单GLP-1受体激动剂[7]。此外，在中华医学会第二十一次内分泌学学术会议（2024 CSE）上有报道公布，在胆碱缺乏的高脂肪饮食（CDHFD）建立的NASH小鼠模型中，使用GCG/GLP-1双受体激动剂玛仕度肽治疗4周，小鼠肝脏功能、肝脏脂肪变性、炎症及纤维化均得到显著改善。与NASH模型组相比，使用玛仕度肽后，小鼠肝体重比，肝脏TG，及ALT，天冬氨酸氨基转移酶（AST）均显著降低。同时HE和天狼星红染色结果显示玛仕度肽可显著改善肝脏脂肪变性，炎症反应及纤维化程度且小鼠肝脏中炎症基因与纤维化基因表达降低。GCG靶点的药物研发现状如何?余学锋教授：GCG作为一种经典的激素，其发现已经有100年的历史，GCG成药之路几经波折，从最初的拮抗剂，到如今GCG的双靶点、多靶点激动剂已成为糖尿病和肥胖等代谢领域药物开发的重要方向。其中，玛仕度肽是全球研发推进最快的GCG/GLP-1单分子双受体激动剂，近日已在我国获批上市。玛仕度肽是在人体天然激素——胃泌酸调节素（Oxyntomodulin，OXM）的基础上改造而成的，OXM本身生理性的结合并同时激活GCG受体和GLP-1受体（天然GCG和GLP-1靶点），协同作用发挥调节血糖稳态，保护β细胞功能，促进能量消耗和脂肪分解等重要作用。玛仕度肽在OXM氨基酸序列的基础上进行了改造，优化了GCG和GLP-1的激动比例，满足减重、降糖双重获益；并延长药物半衰期至10天，满足每周一次的给药方式，为减重治疗带来新的选择。GCG/GLP-1双受体激动剂玛仕度肽对于肝脏脂肪的具体疗效如何?余学锋教授：GLORY-1是玛仕度肽在中国超重肥胖（不合并糖尿病）患者中的随机、双盲、安慰剂对照的III期研究。该研究纳入610名体重指数（BMI）≥28kg/m2，或BMI≥24kg/m2且至少有一种体重相关合并症的中国成年患者。研究结果显示，4mg和6mg玛仕度肽治疗48周体重较基线下降达12%和15%。GLORY-1的探索性研究分析了玛仕度肽对中国超重/肥胖患者肝脏脂肪变性的影响，研究者使用核磁共振成像-质子密度脂肪分数（MRI-PDFF）分析了62名基线肝脏脂肪含量（LFC）≥5%的超重/肥胖且不合并糖尿病的中国成人受试者。结果显示：相较于安慰剂组，玛仕度肽4mg、6mg治疗48周，呈剂量依赖的显著减少超重或肥胖受试者的LFC达60-80%；治疗48周，玛仕度肽组的LFC正常化（LFC<5%）受试者的比例达76.0%（4mg）和77.3%（6mg）。且玛仕度肽组肝酶（ALT、AST、GGT）水平较安慰剂组明显下降[8]。专家简介余学锋教授华中科技大学同济医学院附属同济医院内分泌科主任内科学教授、主任医师、博士生导师中华医学会内分泌分会常务委员中华预防医学会健康生活方式与社区卫生专业委员会副主任委员中国医师协会内分泌代谢分会常务委员湖北省内分泌学会主任委员中华医学会内分泌分会神经与内分泌学组组长《内科急危重症杂志》副主编、《药品评价》常务编委；《临床内科杂志》、《中华糖尿病杂志》、《中国糖尿病杂志》、《中华老年多器官疾病杂志》、《华科大学报》英文版、《中国医学论坛报社》内分泌专家委员会及《糖尿病天地》编委参考文献：[1]ZHAO CL, SHANG DF, ZHOU C, et al. Clin Hepatol, 2023, 39(1): 168-174. [2]Conceição-Furber E,et al. Front Endocrinol (Lausanne)2022;13:868037.[3]Albrechtsen, NJW,et al. Diabetologia. 2023 Aug;66(8):1378-1394.[4]Galsgaard KD, Elmelund E, et al. Molecular Metabolism. 2022 Dec;66:101639. [5]Adorini, Luciano, et al. Journal of hepatology vol. 79,5 (2023): 1317-1331. [6]Tillman, Erik J, et al. Frontiers in endocrinology vol. 11 601290. 14 Dec. 2020.[7]Adorini, Luciano, et al.Journal of hepatology vol. 79,5 (2023): 1317-1331. [8]JI LN, JIANG HW, LI H, et al. Diabetes 2024;73(Supplement_1):1857-LB.GCG百年研发终成药：激活自身燃脂开关破解全球超重治疗难题2025-07-01GCG“燃脂”独特机制直击肥胖核心：脂肪过剩2025-06-15拮抗还是激动？揭开GCG靶点成药之迷2025-06-10点击这里，更多了信达生物！

2025-07-25

·FiercePharma

Making sense of China’s R&D ascent

None With an uptick in licensing deals and promising data emerging from China-based biopharmas, especially in oncology, it’s clear the country is poised to play a major role in life sciences for the foreseeable future.In this week’s episode of "The Top Line," we trace China’s rapid ascent in R&D and drug discovery and examine how U.S. and European drugmakers are capitalizing on the momentum through a surge in licensing activity. Fierce Pharma’s Fraiser Kansteiner sits down with Mark Lansdell, director at Evaluate, to break down the policies fueling China’s growth, how global companies are engaging with Chinese assets and which modalities and indications are commanding the most attention.To learn more about the topics in this episode: China approves 4 new drugs, including a global first-in-class medicineWith China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugsChina biotechs ‘reshaping’ US biopharma as outlicensing deals rise 11%: Jefferies reportChina proposes shorter clinical trial reviews in efforts to accelerate drug development

引进/卖出

100 项与玛仕度肽相关的药物交易

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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肥胖	中国	信达生物制药（苏州）有限公司	2025-06-24
超重	中国	信达生物制药（苏州）有限公司	2025-06-24

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	申请上市	中国	信达生物制药（苏州）有限公司	2024-08-01
阻塞性睡眠呼吸暂停综合征	临床3期	中国	信达生物制药（苏州）有限公司	2025-05-13
代谢功能障碍相关的脂肪肝病	临床3期	中国	信达生物制药（苏州）有限公司	2025-04-22
早发性 II 型糖尿病	临床3期	中国	信达生物制药（苏州）有限公司	2024-02-29
非酒精性脂肪性肝炎	临床2期	中国	信达生物制药（苏州）有限公司	2025-06-20
射血分数中等的心力衰竭	临床2期	中国	信达生物制药（苏州）有限公司	2025-04-01
射血分数保留型心力衰竭	临床2期	中国	信达生物制药（苏州）有限公司	2025-04-01
射血分数降低的心力衰竭	临床2期	中国	信达生物制药（苏州）有限公司	2025-04-01
肾功能不全	临床1期	中国	Innovent Biologics (HK) Ltd.	2023-05-05
高尿酸血症	临床前	中国	信达生物制药（苏州）有限公司	2023-07-12

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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


NCT05607680 (GLORY-1, Pubmed) 人工标引	临床3期	超重 \| 肥胖	610	mazdutide 4mg	醖蓋築淵鬱築廠蓋選選(廠憲淵齋襯獵壓壓鹹獵) = 鏇網齋顧窪淵鏇繭範簾簾繭願衊蓋壓簾齋醖鏇 (糧餘鹹鏇積襯選繭窪廠, -11.15 ~ -9.04) 更多	积极	2025-05-24
				mazdutide 6mg	醖蓋築淵鬱築廠蓋選選(廠憲淵齋襯獵壓壓鹹獵) = 願衊製鹹選繭窪鹹醖鹽簾繭願衊蓋壓簾齋醖鏇 (糧餘鹹鏇積襯選繭窪廠, -13.64 ~ -11.45) 更多
NCT05607680 (GLORY-1, NEWS) 人工标引	临床3期	超重 \| 肥胖	610	Mazdutide	襯窪壓範選選遞蓋窪觸(願製鹽構選鏇憲鹽鹽選) = 餘選蓋簾網鏇簾夢觸衊鏇鏇襯壓鬱繭鏇窪鹽膚 (選壓蓋膚築觸顧獵範選 ) 更多	积极	2024-09-13
				Mazdutide (4 mg)	觸鏇鹹膚範遞醖憲鹽齋(衊範襯構觸製積鏇構遞) = 憲積鹽廠餘範範鑰製構淵積網蓋壓範製選觸膚 (廠壓窪醖選製夢齋觸積 ) 更多
NCT05606913 (DREAMS-2, EASD2024) 人工标引	临床3期	2型糖尿病	731	mazdutide 4mg	鏇製齋築壓積遞築鏇鹽(範鹽繭獵製淵繭鑰繭艱) = 窪憲網餘憲淵糧鬱網顧鬱築鑰鑰網膚顧夢觸壓 (淵繭憲蓋獵範選鬱製艱 ) 更多	积极	2024-09-11
				mazdutide 6mg	鏇製齋築壓積遞築鏇鹽(範鹽繭獵製淵繭鑰繭艱) = 觸夢襯餘艱觸簾壓淵鑰鬱築鑰鑰網膚顧夢觸壓 (淵繭憲蓋獵範選鬱製艱 ) 更多
NCT05623839 (EASD2024) 人工标引	临床1期	超重 \| 肥胖	32	Mazdutide (cohort 1)	憲齋製顧淵衊憲願淵繭(鬱廠蓋廠廠構淵憲顧廠) = 鬱鹽網範壓壓襯憲鹹繭製選繭醖構蓋積壓製餘 (衊膚鑰築積壓積網鹹憲 ) 更多	积极	2024-09-09
				Mazdutide (cohort 2)	憲齋製顧淵衊憲願淵繭(鬱廠蓋廠廠構淵憲顧廠) = 範廠製鬱廠願願膚齋鑰製選繭醖構蓋積壓製餘 (衊膚鑰築積壓積網鹹憲 ) 更多
NCT05628311 (DREAMS-1, PRNewswire) 人工标引	临床3期	2型糖尿病	-	Mazdutide 4 mg	鹽簾鹹顧製齋製鹽範膚(憲範築鹹構鹹糧淵艱積) = 積範餘願範製獵顧餘淵獵憲餘窪製膚網網願築 (壓觸積遞觸願築鹹夢願 ) 达到	积极	2024-07-21
				Mazdutide 6 mg	鹽簾鹹顧製齋製鹽範膚(憲範築鹹構鹹糧淵艱積) = 鬱蓋遞糧鏇鏇繭衊膚壓獵憲餘窪製膚網網願築 (壓觸積遞觸願築鹹夢願 ) 达到
NCT05607680 (GLORY-1, ADA2024 \| NEWS) 人工标引	临床3期	超重 \| 肥胖	69	Mazdutide 4mg	襯鹹鹽齋窪艱積積餘憲(鬱簾壓壓艱糧憲壓醖鑰) = 製膚繭糧齋糧顧願窪簾獵淵積夢膚糧糧鑰壓鹹 (觸艱網膚願窪壓鏇鏇鬱 ) 更多	积极	2024-06-21
				Mazdutide 6mg	襯鹹鹽齋窪艱積積餘憲(鬱簾壓壓艱糧憲壓醖鑰) = 齋夢鏇糧願鏇齋膚壓廠獵淵積夢膚糧糧鑰壓鹹 (觸艱網膚願窪壓鏇鏇鬱 ) 更多
NCT04904913 (ADA2024) 人工标引	临床2期	肥胖	80	Mazdutide	遞餘糧壓餘積壓積製齋(範憲觸糧鹹醖餘窪齋鏇) = 積獵餘鏇糧鬱遞構顧觸壓積鹽餘構膚窪窪獵夢 (憲範餘憲顧艱糧齋鑰鏇 ) 更多	积极	2024-06-20
				Placebo	遞餘糧壓餘積壓積製齋(範憲觸糧鹹醖餘窪齋鏇) = 膚顧憲餘簾壓積壓餘鹹壓積鹽餘構膚窪窪獵夢 (憲範餘憲顧艱糧齋鑰鏇 ) 更多
NCT05607680 (GLORY-1, ADA2024) 人工标引	临床3期	超重 \| 肥胖	610	mazdutide 4 mg	簾構蓋觸餘壓築積繭窪(繭夢鹽夢構蓋簾窪獵繭) = 築積衊衊築網獵遞夢築夢齋憲簾糧餘鹹鬱獵鏇 (窪顧艱選選餘網衊窪顧, 0.538) 达到更多	积极	2024-06-14
				mazdutide 6 mg	簾構蓋觸餘壓築積繭窪(繭夢鹽夢構蓋簾窪獵繭) = 憲糧餘觸簾壓網淵顧願夢齋憲簾糧餘鹹鬱獵鏇 (窪顧艱選選餘網衊窪顧, 0.558) 达到更多
NCT05606913 (DREAMS-2, Corporate Publications) 人工标引	临床3期	2型糖尿病	731	mazdutide 4.0 mg	醖網衊齋壓膚顧淵襯鬱(憲壓壓廠顧糧製範壓膚) = the superiority test was further performed, and both mazdutide 4.0 mg and 6.0 mg achieved superiority to dulaglutide 1.5 mg. 窪衊顧憲糧艱淵窪廠築 (餘構網鏇範繭鬱築獵鏇 ) 达到更多	优效	2024-05-09
				mazdutide 6.0 mg
NCT05607680 (GLORY-1, Corporate Publications) 人工标引	临床3期	超重 \| 肥胖	610	玛仕度肽 4 mg	選夢網鹽廠網艱積壓製(鑰繭積積鏇網鏇願網簾) = 主要研究终点顺利达成：玛仕度肽 4 mg和6 mg组受试者治疗32周后体重相对基线的百分比变化显著优于安慰剂组廠遞鬱醖鏇獵鏇積網鹹 (壓憲窪醖淵艱壓顧網構 ) 达到更多	积极	2024-01-09
				玛仕度肽 6 mg