EFFICACY and SAFETY of GZR18 INJECTED EVERY 2 WEEKS (Q2W) in PARTICIPANTS WITHOUT TYPE 2 DIABETES, WHO HAVE OBESITY or ARE OVERWEIGHT: a RANDOMIZED, TIRZEPATIDE- and PLACEBO-CONTROLLED STUDY

This is a Phase 2 study to evaluate the safety and efficacy of 24, 36, and 48 mg GZR18 (Q2W) compared with placebo and 15 mg tirzepatide (QW). The study will evaluate weight management in participants with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with weight-related comorbidities (excluding type 2 diabetes mellitus).

开始日期2025-02-12

申办/合作机构

甘李药业股份有限公司

NCT06777238

/ Not yet recruiting临床3期

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise

The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise

开始日期2025-01-17

申办/合作机构

甘李药业股份有限公司

NCT06778967

/ Not yet recruiting临床3期

A Multicenter, Randomized, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas

The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas

开始日期2025-01-07

申办/合作机构

甘李药业股份有限公司

100 项与博凡格鲁肽相关的临床结果

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100 项与博凡格鲁肽相关的转化医学

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100 项与博凡格鲁肽相关的专利（医药）

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项与博凡格鲁肽相关的文献（医药）

2025-05-01·DIABETES OBESITY & METABOLISM

The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects

Article

作者: Hunt, Allen ; Chen, Wei ; Liu, Yue ; Zhao, Liyuan ; Li, Yue ; Gan, Zhong‐Ru ; Xie, Tian ; Shi, Aixin ; He, Xuemei ; He, Anshun ; Zhao, Jing

Abstract:

Aims:

GZR18, a novel long‐acting GLP‐1 receptor agonist, has demonstrated substantial metabolic improvements in diabetic and obese animal models. The present studies aimed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the ascending dose of GZR18 in healthy American and Chinese subjects.

Materials and Methods:

In these phases 1, randomized, double‐blind, placebo‐controlled, sequential, dose‐escalation US and Chinese studies, healthy American and Chinese adults with similar age were enrolled to once‐weekly subcutaneous injection of GZR18 or placebo. The studies included three cohorts of male American subjects (cohorts US‐1–3) and six cohorts of Chinese subjects (cohorts CN‐1–6, male and female), each with a specified target dose of GZR18 ranging from 1 to 50 μg/kg (1–10 μg/kg for US study and 5–50 μg/kg for Chinese study). The primary endpoints were the safety and tolerability of GZR18. Blood samples were collected for PK and PD analysis of GZR18 before and after dosing. A population PK analysis of GZR18 was conducted to ascertain whether there are ethnic PK differences between American and Chinese adults.

Results:

The exposure of GZR18 was comparable between healthy American and Chinese subjects, with the geometric mean ratio between the two populations for AUC0‐t and Cmax close to 1. A dose‐dependent increase in AUC0–t and Cmax occurred in both populations. The median time to maximum plasma concentrations (Tmax) in American subjects ranged from 72 to 96 h, and the mean Tmax ranged from 60 to 72 h in Chinese subjects. The half‐life of GZR18 was approximately 7 days in both American and Chinese subjects. Evident body weight reduction was observed in GZR18 treatment groups in Chinese subjects (cohorts CN‐3–6 on Day 15, −1.25 to −1.86 kg; −1.88% to −3.11%). No deaths, serious adverse events or hypoglycaemia were reported. Decreased appetite and nausea were the most frequently reported treatment‐emergent adverse events, observed in Chinese study and mild in severity. The safety profile of GZR18 was generally consistent with the same class of drugs.

Conclusions:

GZR18 demonstrates good tolerability in healthy American and Chinese subjects. No ethnic differences were observed between healthy American and Chinese subjects. The safety, PK and PD profiles of GZR18 support its further clinical evaluation for glycaemic and body weight control.

2022-08-01·European journal of pharmacology

GZR18, a novel long-acting GLP-1 analog, demonstrated positive in vitro and in vivo pharmacokinetic and pharmacodynamic characteristics in animal models

Article

作者: Deng, Ying ; Chen, Wei ; Mazuranic, Michelle ; Wang, Yue ; Qian, Yuzhen ; He, Anshun ; Xue, Fangkai ; Peng, Xiaohong ; Zhang, Yining ; Wei, Bing ; Cui, Cheng ; Zhang, Man ; Xing, Wancai

GZR18 is a novel analog of glucagon-like peptide-1 (GLP-1). This study evaluates the pharmacology, pharmacokinetics, and efficacy of GZR18, and its potential for the treatment of Type 2 diabetes mellitus (T2DM). In vitro pharmacology and activity of GZR18 were characterized by a binding assay of GZR18 using human serum albumin (HSA), an activation assay in human GLP-1 receptor-expressing cell lines, and its effect on glucose-stimulated insulin secretion (GSIS) in primary mice islets. Pharmacokinetic profiling was performed in Sprague Dawley rats and cynomolgus monkeys, and efficacy evaluated using GZR18 single or repeated doses in db/db mice. GZR18 showed similar binding affinity for HSA and GLP-1 receptor compared with semaglutide and liraglutide. GZR18 increased GSIS, which was confirmed by dynamic islet perifusion and fluorescence imaging using PKZnR-5 for real-time detection. In cynomolgus monkeys, the average GZR18 maximal concentration was 527 nmol L^-1, the terminal half-life (T_1/2) was 61.3 h, and the time to maximum concentration was 14 h. Single-dose GZR18 lowered blood glucose levels and reduced body weight over 72 h in db/db mice. GZR18 successive administration (every three days for 33 days, i.e. 11 doses) lowered nonfasting and fasting blood glucose levels (p < 0.05 versus control) and glycated hemoglobin, following the 11th dose. Food and water consumption in db/db mice was lowered following repeated doses of GZR18 (p < 0.05 versus control), without a reduction in body weight. These results demonstrate the potential of GZR18 as a long-acting GLP-1 analog for the treatment of T2DM.

项与博凡格鲁肽相关的新闻（医药）

2025-03-11

·Pharma CMC

投入近3亿！甘李药业披露「博凡格鲁肽」临床进展

3月10日，甘李药业发布公告，其自主研发的博凡格鲁肽（研发代号：GZR18）注射液正在美国开展Ⅱ期临床试验，于近日成功完成首例受试者给药。博凡格鲁肽（研发代号：GZR18）注射液是一种每两周给药一次的GLP-1RA，旨在治疗成人2型糖尿病及肥胖/超重个体的体重管理。目前正在美国开展适应症为肥胖/超重的Ⅱ期临床试验，这也是全球首款与替尔泊肽头对头评估药物减重疗效的单靶点GLP-1RA。博凡格鲁肽注射液作为GLP-1受体激动剂，能够通过激活胃肠道GLP-1受体使胃排空减慢，并激活下丘脑等部位的GLP-1受体增强饱腹感并抑制食欲、减少食物的摄入量，进而减轻患者体重。作为潜在的全球首个GLP-1双周制剂，目前博凡格鲁肽注射液的临床数据显示出相较已上市同类产品可比甚至更优的减重效果，且安全性和耐受性符合GLP-1类药物的特征。双周制剂博凡格鲁肽注射液将有望进一步提高患者的治疗依从性，并为肥胖症患者提供更灵活的治疗选择，从而改善长期体重管理的效果。博凡格鲁肽在2021年10月获得了中国国家药品监督管理局开展临床试验的批准。2022年7月在中国完成Ⅱ期首例受试者给药，2024年10月中国Ⅱ期临床试验完成。2024年12月在中国完成Ⅲ期首例受试者给药并在美国获批开展Ⅱ期临床试验。临床研究数据表明GZR18注射液每周和每两周给药一次均能实现良好的降糖或减重效果。全球市场用于2型糖尿病患者血糖控制及肥胖/超重患者体重控制的GLP-1受体激动剂周制剂主要有诺和诺德的司美格鲁肽（Semaglutide），其2024年全球销售额为1785.48亿丹麦克朗（250.46亿美元），其中用于体重控制的Wegovy®销售额为582.06亿丹麦克朗（81.65亿美元）据公告披露，甘李药业在GZR18注射液项目中累计投入研发费用2.84亿元人民币。

临床2期临床3期

2025-03-11

·PipelineReview

Gan & Lee Pharmaceuticals Announced First Participant Dosed in the US Phase 2 Clinical Study of Bofanglutide (GZR18) Injection for Overweight or Obesity

BEIJING, China and BRIDGEWATER, NJ, USA I March 10, 2025 I Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced that the first participant has been successfully dosed in a Phase 2 clinical trial of bofanglutide (research code: GZR18) injection, a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) independently developed by Gan & Lee, in the US participants with overweight or obesity. Notably, bofanglutide is the first GLP-1 receptor mono-agonist to undergo a head-to-head comparison with tirzepatide for evaluating the efficacy in body weight management globally. This Phase 2 clinical trial (ClinicalTrials.gov registration number: NCT06737042) was designed to evaluate the efficacy and safety of bofanglutide injection in US adults with overweight or obesity. The study plans to enroll 285 subjects, who will be randomized to receive either 24 mg, 36 mg, or 48 mg of bofanglutide bi-weekly, 15 mg of tirzepatide once-weekly, or placebo. The primary endpoint is the percentage change in body weight from baseline at the end of the treatment. Previously, a Phase 1 study (NCT06548997) of bofanglutide injection demonstrated good safety and tolerability in US subjects, along with promising glucose-lowering and weight-loss potential [1] . The initiation of head-to-head clinical study for bofanglutide versus tirzepatide, marking a new phase in Gan & Lee’s GLP-1 innovation. This milestone underscores the company’s ambition to challenge the leading GLP-1 therapy in the global market for weight management, aiming to provide a better treatment option for patients with overweight or obesity worldwide. Reference: [1].Liu Y, Chen W, He X, He A, Zhao L, Xie T, Li Y, Zhao J, Hunt A, Shi A, Gan ZR. The safety, tolerability, pharmacokinetics and pharmacodynamics of GZR18 in healthy American and Chinese adult subjects. Diabetes Obes Metab. 2025 Mar 3. doi: 10.1111/dom.16285. Epub ahead of print. PMID: 40028667. About Bofanglutide (GZR18) Bofanglutide (R&D Code: GZR18) injection, developed by Gan & Lee Pharmaceuticals, is a bi-weekly GLP-1 receptor agonist (RA) indicated for glycemic control in adults with type 2 diabetes and body weight management in overweight/obese individuals. As the potential first bi-weekly GLP-1 RA in the world, early clinical trials have demonstrated its efficacy in weight reduction comparable to or superior to marketed counterparts, with a safety and tolerability profile consistent with the established class of GLP-1 RAs, and significant reductions in both blood glucose levels and body weight. About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin), fast-acting lispro injection (Prandilin ® ™), fast-acting aspart injection (Rapilin), mixed protamine zinc lispro injection (25R) (Prandilin ® ™25), aspart 30 injection (Rapilin30), and one human insulin injection – mixed protamine human insulin injection (30R) (Similin30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine) ® . In China’s 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets ® . In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas. SOURCE: Gan & Lee Pharmaceuticals

临床1期临床2期上市批准

2025-02-14

·药智网

DeepSeek眼中最具价值的国产新药研发项目TOP10

近日，国产人工智能大型语言模型DeepSeek在全球走红。其拥有强大的自然语言处理能力，能够理解并回答问题，“深度思考”“走心的回答”特点在一众AI大模型中脱颖而出。小编也试问了DeepSeek几个问题来看看这位顶流AI对中国新药研发项目的看法。图片来源：DeepSeek网站截图 1 如何评价新药的价值？新药的价值可从以下几个维度评价：临床需求：适应症的未满足程度（如罕见病、难治性疾病）；技术突破：靶点创新性、药物类型（如双抗、ADC、小分子等）的差异化优势；市场潜力：适应症患者规模、全球竞争格局及商业化前景；研发进度：临床阶段（优先Ⅲ期及突破性疗法项目）；数据表现：临床试验疗效与安全性数据优于现有疗法或同类竞品。 2 Deepseek眼中最具价值的国产新药研发项目TOP10 基于上述标准，Deepseek筛选了10个国产新药研发项目： 1.SHR-1918（ANGPTL3单抗）研发企业：恒瑞医药适应症：纯合子型家族性高胆固醇血症（HoFH）研发阶段：Ⅲ期（2024年9月获CDE突破性疗法认定）项目亮点：靶向ANGPTL3，通过抑制脂质代谢关键蛋白降低LDL-C和甘油三酯，疗效显著（LDL-C降低49.1%，TG降低82.8%）；全球仅再生元Evinacumab获批同类靶点，SHR-1918为首个国产ANGPTL3单抗，半衰期长达53.5天，每月一次给药；针对罕见病HoFH，填补国内治疗空白。上榜理由：突破性疗法资格、罕见病领域高临床价值、全球竞争格局宽松。 2.博凡格鲁肽（GZR18）研发企业：甘李药业适应症：肥胖、2型糖尿病研发阶段：Ⅲ期项目亮点：双周或每周一次注射的GLP-1R激动剂，Ⅱ期数据显示48mg Q2W组减重17.29%，优于司美格鲁肽27；开发口服片剂（每日一次），已完成I期减重试验（体重降低4.16%）；全球GLP-1赛道竞争激烈，但口服剂型有望差异化竞争。上榜理由：口服剂型技术突破、减肥适应症市场潜力巨大。 3.VDJ-001（IL-6R单抗）研发企业：伟德杰生物适应症：类风湿性关节炎（RA）研发阶段：Ⅲ期项目亮点：疗效显著优于托珠单抗（ACR70达33.3%，对照组为25%）2；可阻断IL-6三种信号通路，安全性更优；国内RA患者超500万，现有药物ACR 70达标率不足，需求迫切。上榜理由：疗效数据全球领先、自免领域高临床价值。 4.SHR-A2102(Nectin-4 ADC) 研发企业：恒瑞医药适应症：尿路上皮癌研发阶段：Ⅲ期项目亮点：全球仅维恩妥尤单抗（辉瑞）获批同类靶点，SHR-A2102为进度最快的国产Nectin-4 ADC； I期数据显示ORR达23.3%，DCR达76.7%2；针对PD-(L)1治疗失败的晚期患者，填补治疗空白。上榜理由：高未满足临床需求、ADC技术平台优势。 5.瑞康曲妥珠单抗（HER2 ADC）研发企业：恒瑞医药适应症：HER2突变非小细胞肺癌（NSCLC）研发阶段：注册申请（2024年9月提交上市申请，优先审评中）项目亮点：结构采用曲妥珠单抗+Exatecan衍生物，通过靶向HER2精准释放毒素，抑制肿瘤细胞DNA修复； Ⅱ期试验中ORR显著优于历史数据，且安全性可控；首个针对HER2突变NSCLC的国产ADC药物，恒瑞有望抢占先机。上榜理由：差异化适应症布局、填补临床空白、技术平台优势。 6.HRS-7535（口服GLP-1R小分子激动剂）研发企业：恒瑞医药适应症：2型糖尿病、肥胖研发阶段：Ⅲ期项目亮点：全球尚无口服小分子GLP-1R激动剂上市，I期数据减重6.63%10；半衰期长（8.42小时），每日一次给药；突破注射剂型限制，患者依从性显著提升。上榜理由：剂型创新、糖尿病与减重双适应症潜力。 7.MRG003(EGFR ADC) 研发企业：美雅珂生物适应症：实体瘤（鼻咽癌等）研发阶段：注册申请（2024年9月申报上市）项目亮点：国内首个申报上市的EGFR ADC，结构含微管抑制剂ED04，DAR值87；获FDA孤儿药、突破性疗法等资格，I期鼻咽癌ORR达45.8%10； EGFR在亚洲高发癌种中过表达率高，市场空间广阔。上榜理由：首个国产EGFR ADC、FDA认可的国际潜力。 8.TQB2102(HER2双抗ADC) 研发企业：正大天晴适应症：HER2低表达乳腺癌研发阶段：Ⅲ期项目亮点：靶向HER2双表位，覆盖高、中、低表达人群，潜在疗效优于德曲妥珠单抗4；国内首个进入Ⅲ期的HER2双抗ADC； HER2低表达乳腺癌占乳腺癌患者50%，现有疗法匮乏。上榜理由：差异化覆盖人群、双抗ADC技术优势。 9.ICP-332（TYK2抑制剂）研发企业：诺诚健华适应症：特应性皮炎研发阶段：Ⅲ期项目亮点： Ⅱ期数据显示湿疹面积减少78.5%，显著优于安慰剂4；全球仅氘可来昔替尼（BMS）获批同类靶点，ICP-332为首个国产TYK2抑制剂；特应性皮炎患者超3000万，现有生物制剂价格高昂。上榜理由：自免领域创新靶点、疗效数据突出。 10.MY008211A（CFB抑制剂）研发企业：朗来科技适应症：阵发性睡眠性血红蛋白尿症（PNH）研发阶段：Ⅲ期项目亮点：国内首个进入Ⅲ期的CFB抑制剂，安全性优于C5单抗10； PNH为罕见溶血性疾病，国内尚无CFB靶向药；全球仅伊普可泮（诺华）获批，市场独占性强。上榜理由：罕见病领域突破、替代疗法潜力。 3 核心亮点总结靶点创新：ANGPTL3（恒瑞）、TYK2（诺诚健华）等全新靶点布局；技术平台突破：ADC（恒瑞、美雅珂）、双抗ADC（正大天晴）、口服小分子（恒瑞、甘李）；临床需求覆盖：罕见病（HoFH、PNH）、肿瘤耐药（尿路上皮癌、NSCLC）、慢性病（糖尿病、自免疾病）；国际化潜力：MRG003获FDA突破性疗法认定，SHR-1918对标全球唯一竞品。 DeepSeek眼中的最具价值的新药研发项目你认可吗？欢迎探讨~ 注：以上内容仅为AI结合大数据分析推测，不作为任何决策使用。声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

突破性疗法抗体药物偶联物临床3期临床2期

100 项与博凡格鲁肽相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
低血糖	临床3期	-	甘李药业股份有限公司	2025-01-17
2型糖尿病	临床3期	中国	甘李药业股份有限公司	2024-12-26
肥胖	临床3期	-	甘李药业股份有限公司	2024-12-01

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临床结果

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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


CTR20232069 (NEWS) 人工标引	临床2期	2型糖尿病	264	GZR18 (每两周给药一次)	膚鏇蓋糧構襯製鏇衊鹽(構遞衊壓壓築衊繭顧觸) = 積鬱襯齋顧網淵齋鬱鬱鑰範鹹鹽鹹蓋製獵壓積 (糧網鑰範艱鑰遞憲淵築 ) 更多	积极	2024-10-15
				GZR18 (12 mg)	膚鏇蓋糧構襯製鏇衊鹽(蓋壓齋窪選壓鑰積鏇鹽) = 艱襯網範積鑰顧願壓遞夢壓廠遞蓋壓鏇膚鹽選 (糧齋鹽淵淵壓艱選鏇夢 )
CTR20231695 (PRNewswire) 人工标引	临床2期	超重 \| 肥胖	-	GZR18 12 mg Q2W	選範淵積齋餘鹽餘齋餘(鏇鬱範淵遞遞醖鑰蓋構) = 顧網鹽簾艱襯壓選蓋夢獵糧壓餘鏇獵構遞鹹鏇 (願淵鬱願鹹構淵齋糧築 )	积极	2024-07-22
				GZR18 18 mg Q2W	選範淵積齋餘鹽餘齋餘(鏇鬱範淵遞遞醖鑰蓋構) = 夢鑰製鹹鏇夢鬱淵糧遞獵糧壓餘鏇獵構遞鹹鏇 (願淵鬱願鹹構淵齋糧築 )
NCT06256536 (ADA2024) 人工标引	临床1/2期	肥胖	35	GZR18 30 mg QW	製簾衊製衊鏇醖網膚構(選製鬱鬱醖窪築糧選鑰) = 鬱製艱夢艱遞鹹鏇築憲廠壓築淵獵鏇鏇廠遞選 (襯蓋膚淵艱齋餘衊築製, -21.8 ~ -13.9) 更多	积极	2024-06-21
				GZR18 30 mg Q2W	製簾衊製衊鏇醖網膚構(選製鬱鬱醖窪築糧選鑰) = 構壓選鏇窪鬱膚襯襯鏇廠壓築淵獵鏇鏇廠遞選 (襯蓋膚淵艱齋餘衊築製, -17.5 ~ -8.0) 更多