To perform an observational analysis to emulate a target trial (i.e., a hypothetical pragmatic trial that would have answered the causal question of interest) comparing the effectiveness and safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in head-to-head comparisons in patients with type 2 diabetes (T2D).

开始日期2021-08-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+3]

NCT03015519 / Withdrawn临床3期

A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Albiglutide for the Treatment of Type 2 Diabetes Mellitus in Pediatric Patients

The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment options are limited in children and adolescents. Albiglutide, approved for the treatment of T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long half-life to permit once a week injection. The study will be conducted in 2 parts: Part A is a single dose pharmacokinetic (PK) study to confirm the dose and safety of albiglutide in pediatric subjects aged 10 to less than 18 years and Part B is a randomized double-blind placebo controlled study to evaluate the safety and efficacy (glycemic control) of albiglutide in the pediatric population. Treatment duration in Part B is 52 weeks (24 weeks double-blind placebo-controlled and 28 weeks open-label during which all subjects will receive albiglutide). Approximately 210 eligible male and female subjects will be included in the study.

开始日期2017-08-14

申办/合作机构

GSK Plc

NCT02750930 / Terminated临床4期

An Open-label Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Subjects With Type 2 Diabetes Mellitus

Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and has been approved by the United States (US) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single group, multicenter, extension study to Study 200952. This extension study will provide extended safety, tolerability and immunogenicity data for the albiglutide liquid drug product. This extension study will comprise 2 study periods: treatment (26 weeks) and post-treatment follow-up (8 weeks). A maximum of 300 subjects will be eligible to take part in this extension study.

开始日期2016-10-07

申办/合作机构

GSK Plc

100 项与阿必鲁肽相关的临床结果

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100 项与阿必鲁肽相关的转化医学

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100 项与阿必鲁肽相关的专利（医药）

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217

项与阿必鲁肽相关的文献（医药）

2023-11-29·Journal of agricultural and food chemistry

Optimization of Protein Folding for Improved Secretion of Human Serum Albumin Fusion Proteins in Saccharomyces cerevisiae

Article

作者: Li, Yanling ; Zheng, Lin ; Huang, Mingtao ; Xiao, Chufan ; Qin, Ling ; Pan, Yuyang ; Zhao, Mouming

The successful expression and secretion of recombinant proteins in cell factories significantly depend on the correct folding of nascent peptides, primarily achieved through disulfide bond formation. Thus, optimizing cellular protein folding is crucial, especially for proteins with complex spatial structures. In this study, protein disulfide isomerases (PDIs) from various species were introduced into Saccharomyces cerevisiae to facilitate proper disulfide bond formation and enhance recombinant protein secretion. The impacts of these PDIs on recombinant protein production and yeast growth metabolism were evaluated by substituting the endogenous PDI1. Heterologous PDIs cannot fully compensate the endogenous PDI. Furthermore, protein folding mediators, PDI and ER oxidoreductase 1 (Ero1), from different species were used to increase the production of complex human serum albumin (HSA) fusion proteins. The validated folding mediators were then introduced into unfolded protein response (UPR)-optimized strains, resulting in a 7.8-fold increase in amylase-HSA and an 18.2-fold increase in albiglutide compared with the control strain. These findings provide valuable insights for optimizing protein folding and expressing HSA-based drugs.

2023-08-08·Journal of the American College of Cardiology

GLP-1 Receptor Agonist Therapy With and Without SGLT2 Inhibitors in Patients With Type 2 Diabetes.

Article

作者: Vasques-Nóvoa, Francisco ; McMurray, John J V ; Leiter, Lawrence A ; Borges-Canha, Marta ; Carvalho, Davide ; Ferreira, João Pedro ; Granger, Christopher B ; Neves, João Sérgio ; Green, Jennifer B ; Leite-Moreira, Adelino ; Del Prato, Stefano ; Hernandez, Adrian F

BACKGROUND:

Sodium-glucose cotransporter-2 (SGLT2) inhibitors and GLP-1 receptor agonists (GLP-1 RAs) reduce adverse cardiovascular outcomes in type 2 diabetes (T2D). However, the efficacy of combination therapy is unclear.

OBJECTIVES:

The aim of this study was to evaluate the effects of GLP-1 RAs on cardiovascular outcomes in patients with T2D treated with or without SGLT2 inhibitors.

METHODS:

Post hoc analysis of Harmony Outcomes (Albiglutide and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Cardiovascular Disease) evaluating the effect of albiglutide in T2D with cardiovascular disease by background SGLT2 inhibitor use. Additionally, a trial-level meta-analysis of Harmony Outcomes and AMPLITUDE-O (Effect of Efpeglenatide on Cardiovascular Outcomes), which evaluated T2D with cardiovascular or renal disease, was performed, combining the treatment effect estimates according to SGLT2 inhibitor use.

RESULTS:

Of the 9,462 participants in Harmony Outcomes, 575 (6.1%) were treated with SGLT2 inhibitors at baseline. The effect of albiglutide on reducing the composite of cardiovascular death, myocardial infarction, or stroke (major adverse cardiovascular events) was consistent with or without SGLT2 inhibitors (P interaction = 0.70). The effect of albiglutide on secondary outcomes and adverse events was not modified by SGLT2 inhibitors. A meta-analysis of Harmony Outcomes and AMPLITUDE-O included 13,538 patients, of whom 1,193 (8.8%) used SGLT2 inhibitors. Compared to placebo, GLP1-RAs reduced major adverse cardiovascular events without effect modification by SGLT2 inhibitor use (HR: 0.77; 95% CI: 0.68-0.87 without SGLT2 inhibitors; and HR: 0.78; 95% CI: 0.49-1.24 with SGLT2 inhibitors) (P for interaction = 0.95) and reduced heart failure hospitalization (HR: 0.72; 95% CI: 0.55-0.92 vs HR: 0.34; 95% CI: 0.12-0.96) (P for interaction = 0.18).

CONCLUSIONS:

In patients with T2D and cardiovascular disease, GLP-1 RAs reduced cardiovascular events independently of SGLT2 inhibitor use. These findings suggest that the combination of GLP-1 RAs with SGLT2 inhibitors may further reduce cardiovascular risk. Clinical trials with combination therapy are needed.

2023-08-01·International journal of cardiology. Heart & vasculature

Effects of GLP-1 Agonists on mortality and arrhythmias in patients with Type II diabetes

Review

作者: Almasry, Ibrahim O ; Rashba, Eric J ; Aslam, Faisal M ; Tao, Michael ; Al-Sadawi, Mohammed A ; Alsaiqali, Mahmoud ; Singh, Abhijeet ; Fan, Roger

Background:

Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) are frequently used for the management of diabetes. The impact of GLP-1 RA on cardiovascular outcomes is unclear. We aim to assess the effect of GLP-1 RA on mortality, atrial and ventricular arrhythmias, and sudden cardiac death in patients with type II diabetes.

Methods:

We searched databases including Ovid MEDLINE, EMBASE, Scopus, Web of Science, Google Scholar and CINAHL, from inception to May 2022, for randomized controlled trials reporting the relationship between GLP-1 RA (including albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, and semaglutide) and mortality, atrial arrhythmias, and the combined incidence of ventricular arrhythmias and sudden cardiac death. The search was not restricted to time or publication status.

Results:

A total of 464 studies resulted from literature search, of which 44 studies, including 78,702 patients (41,800 GLP-1 agonists vs 36,902 control), were included. Follow up ranged from 52 to 208 weeks. GLP-1 RA were associated with lower risk of all-cause mortality (odds ratio 0.891, 95% confidence interval 0.837-0.949; P < 0.01) and reduced cardiovascular mortality (odds ratio 0.88, 95% confidence interval 0.881-0.954; P < 0.01). GLP-1 RA were not associated with increased risk of atrial (odds ratio 0.963, 95% confidence interval 0.869-1.066; P 0.46) or ventricular arrhythmias and sudden cardiac death (odds ratio 0.895, 95% confidence interval 0.706-1.135; P 0.36).

Conclusion:

GLP-1 RA are associated with decreased all-cause and cardiovascular mortality, and no increased risk of atrial and ventricular arrhythmias and sudden cardiac death.

109

项与阿必鲁肽相关的新闻（医药）

2024-06-27

·drugs

Exercise + GLP-1 RA Effective for Weight Loss While Preserving BMD

THURSDAY, June 27, 2024 -- For adults with obesity, without diabetes, combining exercise with the glucagon-like peptide-1 receptor agonist (GLP-1 RA), liraglutide , is effective for weight loss, while preserving bone health, according to a study published online June 25 in JAMA Network Open . Simon Birk Kjær Jensen, Ph.D., from the University of Copenhagen in Denmark, and colleagues examined bone health at clinically relevant sites after diet-induced weight loss followed by a one-year intervention with exercise, liraglutide, or both in a secondary analysis of a randomized trial involving adults aged 18 to 65 years with obesity, without diabetes. After an eight-week low-calorie diet, participants were randomly allocated to exercise alone, the GLP-1 RA liraglutide alone, the combination, or placebo for 52 weeks (48, 49, 49 and 49 participants, respectively). The researchers found that the total estimated mean change in weight losses during the study was 7.03 kg in the placebo group and 11.19, 13.74, and 16.88 kg in the exercise, liraglutide, and combination groups, respectively. Bone mineral density (BMD) was unchanged in the combination group versus the placebo group at the hip and lumbar spine. BMD decreased for the liraglutide versus the exercise group at the hip and spine (mean changes, −0.013 and −0.016 g/cm 2 , respectively). "Our findings highlight the importance of combining exercise with GLP-1 RA treatment for bone health," the authors write. Novo Nordisk supplied the liraglutide and placebo pens; Cambridge Weight Plan supplied low-calorie meal replacement products. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果

2024-06-26

·药时代

一年少打300多针！全球首款胰岛素周制剂在华获批

正文共：3692字 8图预计阅读时间：9分钟胰岛素周制剂，意味着什么？对患者而言，最直观的感受就是“可以少打针”。保守估计，胰岛素周制剂可将全年基础胰岛素注射次数从365次降低至52次，一年便可少打300多针，极大减轻了患者负担。 2024年6月24日，国家药品监督管理局（NMPA）正式批准了诺和诺德依柯胰岛素注射液（商品名：诺和期®）的上市申请，用于治疗成人2型糖尿病患者。（见图1）图1：诺和期®获批上市（图片来源：NMPA官网）诺和期®是截止目前全球首个且唯一获批的胰岛素周制剂，通过替换长链脂肪酸和氨基酸，使其能够高效可逆地结合白蛋白，从而将半衰期延长至196小时，实现一周仅需一针的给药频率。 “一针一周”，不仅标志着全球胰岛素周制剂治疗时代的开启，还意味着对当前胰岛素治疗困境的破冰。胰岛素治疗困境一直以来，胰岛素作为糖尿病治疗的基石性药物，其重要性不言而喻。尤其是在面对1型糖尿病及口服药物疗效不佳等复杂情况时，胰岛素治疗就是实现快速控制血糖的“最后一道防线”。即便近年来出现了SGLT-2抑制剂、GLP-1受体激动剂等新型降糖药物，胰岛素的地位依然稳固。然而，玉无完玉。胰岛素在实际运用中，患者常会因注射恐惧、临床惰性等因素，最终导致延迟治疗。一项纳入500例患者，200名内分泌医生，100名护士的横断面调查研究显示[1]，无论对于患者还是医务人员，注射相关问题都是起始胰岛素治疗的最常见临床负担。（见图2）图2：该试验评估了注射降糖疗法在患者关注、患者满意度、需要改进的地方及培训负担方面未满足的临床需求根据第十版IDF糖尿病地图显示，我国成人糖尿病患者人数已居世界各国之首，高达1.4亿[2]。然而血糖控制达标的患者仅占16.5%[3]，这一部分原因是由于对糖尿病和胰岛素的错误认知，另一部分原因则与胰岛素治疗下的低依从性密切相关。鉴于注射方式带来的不便，探寻新型给药路径自然而然便成为了科研前沿的焦点，即新型胰岛素主要研发方向之一。（见图3）图3：新型胰岛素的六大研发方向可遗憾的是，在新型胰岛素中，口服胰岛素面临极端pH条件下失活、酶促降解和渗透性不足的挑战，难以跨越胃酸、肠粘膜屏障，且生物利用度较低[4]。而吸入式胰岛素也显露出黏膜纤毛清除效应活跃、大分子穿透能力差等局限性[5]，新型给药途径目前仍需大量时间探索和临床积累。如此困境下，延长胰岛素作用时间，减少注射频率不失为另一条破解之道。而诺和期®的获批，恰是对这一思路的成功实践，为患者提供了更为高效、便捷的治疗选择。长效问题解决后，稳定性呢？针对诺和期®的开发，诺和诺德启动了6项3期ONWARDS系列研究，其中ONWARDS 1～5研究分别针对初治与既往使用胰岛素的2型糖尿病患者（见图4），ONWARDS 6研究则针对1型糖尿病患者。目前所有研究均已完成，且全部达到了主要临床终点[6]。图4：ONWARDS 1～5研究：HbA1c达标率和安全达标率在今年的ADA大会上，诺和诺德对ONWARDS 1～5研究进行了详尽的事后分析，探索了包括不同年龄段、体力活动（PA）相关低血糖的发生概率、不同族裔和种族、GLP-1RA使用情况、肾功能状态等不同层次的患者亚组在内的一系列复杂变量[7]。分析总结得出，诺和期®在对比每日给药的基础胰岛素（OD对照）时，其显著的治疗效果和较低的低血糖发生风险，具有高度的一致性和普遍适用性。总体而言，诺和期®的疗效与安全性不受患者年龄、种族背景、是否合用GLP-1RA治疗、或是肾功能状态的影响，有力证明了该药物在多样患者群体中的稳定性。而“稳定”，就是诺和期®最重要的“必杀技”。一是药物持续释放的稳定，二是面对患者多样性时的疗效稳定。首先是药物持续释放的稳定。一项开放标签、多剂量的1期药理学研究显示[8]，在药代动力学（PK）方面，诺和期®通过每周一次给药方案，患者在连续给药3至4周后可达到稳定的血药浓度平台期。值得一提的是，当首次剂量提升50%可加速稳态形成，患者只需2至3周便可达到稳态。（见图5）图5：诺和期®达到稳态的时间至于药效动力学（PD）方面，诺和期®在达稳态时降糖疗效日间分布接近平均（每日葡萄糖输注率曲线下面积占比为12.0%~16.1%），即血糖控制作用在全天分布均匀。（见图6）图6：诺和期®达到稳态时的降糖疗效分布诺和诺德大中国区医药质量部企业副总裁张克洲认为，胰岛素周制剂的意义并非简单的拉长周期，而是“模拟人体自身胰岛素的分泌状态”，持续且稳定的控糖恰好是诺和期®的特点之一。其次是面对患者多样性时的疗效稳定。在ONWARDS系列研究中，有一项研究尤为瞩目，它也是此次诺和期®在华获批的关键证据之一，ONWARDS 3。这项研究共入组588例T2DM患者，其中，来自中国（大陆13个研究中心和台湾5个研究中心）的患者共145例，构成了研究中最大的患者群体[9]。基于中国患者的高比例基数，诺和诺德对ONWARDS 3中国亚组进行了事后分析，旨在进一步确证在起始胰岛素治疗的中国2型糖尿病患者中，每周一次诺和期®相较于每日一次德谷胰岛素在控糖疗效与安全性的优势[10]。分析结果印证了主要终点的一贯性，即第26周时与德谷胰岛素相比，诺和期®促使HbA1c水平显著降低，差异值为-0.28%（95%置信区间-0.5至-0.05），统计学意义显著（P=0.0152）。（见图7）图7：主要终点（HbA1c自基线至26周的变化）在次要终点上，诺和期®与德谷胰岛素在降低空腹血糖（FPG）方面效果相当，差异微乎其微（ETD为-0.03mmol/L，95%CI-0.55至0.48），P值显示无显著差异（P=0.8965），且两组患者的空腹血糖随访期间的平均变化趋势相似。（见图8）图8：FPG和平均空腹SMPG自基线至第26周的变化在安全性终点上，诺和期®与德谷胰岛素的2级或3级低血糖事件发生率无显著差异，估计率比为1.34（95%CI 0.25,7.27），P值同样表明无统计学意义（P=0.7331），且两组均未报告严重低血糖事件。长期以来，基础胰岛素的研发导向始终围绕“更平缓、更持久、更安全”的目标前进，而诺和期®的上市，不仅是对该目标的显著提升，更是开启了糖尿病治疗的新篇章。获批背后的大“彩蛋” 在诺和期®获批的背后，还有一个“大彩蛋”。即，诺和期®是诺和诺德“中国同创”项目的首个落地成果。首次实现在中国、欧盟和美国同步开展临床试验，同步递交上市申请，欧盟获批仅1个月后就在中国获批，并提前于FDA获批，实现了全球同步获批。让中国患者更早获益于全球创新药。 “中国同创”计划启动于2020年，诺和诺德矢志在2025年后，实现90%以上的全球创新药在中国同步提交审批。这在以往，可是中国医药行业难以触及的梦想。在中国加入ICH之前的很长一段时间里，不说同步研发，仅是想要实现进口药物的同步引进，都是困难重重。受制于当时政策划定的红线，包括必须在海外进入二期临床后方能在中国开展国际多中心研究，海外批准后方可提交国内上市申请，以及国际多中心试验完成后还需重新申报临床，这一系列繁复的“三报三批”流程，导致了新药境内外上市的时间差，一度长达5年以上。面对“重重阻碍”，中国医药改革迅猛且高效，自2015年起逐步废除不合理审评程序，强化政策引导，特别是随着2023年《药审中心加快创新药上市许可申请审评工作规范（试行）》的发布，审批流程显著提速，为诺和期®实现全球同步研发与上市铺就了夯实的政策基石。此外，本土创新能力和丰富的临床资源也为“中国同创”计划的成功实施添砖加瓦。 ONWARDS 3研究的主要研究者母义明教授分享了研究过程中遭遇的艰辛，“尤其是研究的实施阶段，2021年3月至2022年6月，恰逢新冠疫情流行，中国研究者积极克服疫情所导致的各种难以想象的困难，使得试验能顺利推进。” 30多年前，潘长玉教授等糖尿病领域的前辈，开启了内分泌领域中国临床研究的新纪元。如今，接力棒已传递给了更多科研人员手中。诺和期®的获批，不仅仅是诺和诺德“中国同创”计划结出的首个硕果，标志着跨国药企与本土创新生态深度融合的里程碑；也是我国医疗改革深化进程中，推动医药创新与国际接轨、加速新药上市审批制度改革成效的集中体现；更是广大中国糖尿病患者迈向更加高效、便捷治疗新时代的象征。结语自1921年胰岛素被首次发现至今，已有百年历史。历经世纪更迭，胰岛素从最初的动物源形态，逐步演进至人胰岛素、合成胰岛素、胰岛素类似物，直至今日的新型胰岛素革命。可以说，每一次胰岛素的迭代，都深刻推动了糖尿病治疗理念与实践的飞跃。从单一的血糖控制目标，扩展至注重心血管健康与长期生存质量的综合考量，最终迈入以患者为中心，多维度综合管理的的新纪元，诺和诺德一直在为之努力。就在今年1月，诺和诺德公布了诺和期®联用司美格鲁肽周制剂（700U/2毫克/毫升）组合IcoSema的三期COMBINE研究结果。结果显示，在679名使用每日一次基础胰岛素控制不佳的2型糖尿病患者中，每周一次的IcoSema与每日注射一次的甘精胰岛素 U10和门冬胰岛素（每日餐时注射2～4次）相比，在降低HbA1c上显示具非劣效性[11]。此外，诺和诺德旗下亦有多款新一代胰岛素，包含Tresiba、Xultophy、Ryzodeg、Fiasp。 “驱动改变，为世代健康”，相信未来，会有更多慢病领域的患者从不断改变中获益。封面图来源：Pixabay 参考资料： [1]Chen T, et al. Clin Ther. 2020 Aug;42(8):1549-1563. [2]2021 IDF 糖尿病地图; IDF Diabetes Atlas 2021 [3]Wang L, et al. JAMA. 2021, 326(24):2498-2506. [4]Xiao Y,et al. Angew Chem Int Ed Engl. 2020 Nov 2;59(45):19787-19795. [5]Cernea S, Raz I.Am J Ther. 2020 JanFeb;27(1)e121-e132. [6]Q1-2023-investor-presentation.pdf. Retrieved May 4, 2023, From [7]【2024 ADA Abstracts】胰岛素最新研究进展（诺和诺德医学资讯） [8]Pieber TR, et al. Diabetes Obes Metab. 2023 Dec ; 25(12):3716-3723 [9]Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial [10]【胰岛素周制剂】胰岛素周制剂首个中国人群数据——ONWARDS 3研究事后分析亮相CSE 2023（诺和诺德医学资讯） [11]https://www.novonordisk.com.cn/content/dam/nncorp/cn/zh_cn/ir-materials/pdfs/2024/2024010901.pdf 点击了解更多诺和诺德！

上市批准临床结果

2024-06-26

·echemi

Novo Nordisk's Semaglutide - A Breakthrough in Obesity Management

Semaglutide, the active ingredient in Novo Nordisk's Wegovy®, is a GLP-1 receptor agonist that works by binding to and activating the GLP-1 receptor, thereby exerting its effects in the treatment of obesity. Given that the GLP-1 receptor is involved in the specific brain regions that regulate appetite, the application of Wegovy® in obese patients can significantly reduce hunger, enhance satiety, and decrease food cravings, thereby assisting patients in reducing caloric intake and achieving weight loss. Moreover, through genetic engineering, Wegovy® has been successful in extending its half-life to 7 days, allowing for a once-weekly dosing regimen, providing Chinese patients with a safe and convenient weight management solution. Zhangkezhou, the Corporate Vice President of Pharmaceutical Quality at Novo Nordisk Greater China, stated that Novo Nordisk's research in the field of obesity treatment has spanned over 25 years, and the company has established a solid scientific foundation based on GLP-1RA therapy. The company is committed to comprehensively addressing the overall health of obese patients and aims to provide them with an integrated treatment plan. Looking ahead, Novo Nordisk will continue to lead the innovative breakthroughs in the field of obesity treatment to meet the diverse medical needs of Chinese patients. Zhou Xiaping, the Global Senior Vice President and President of Novo Nordisk Greater China, emphasizes that as a global leader in the field of obesity treatment, Novo Nordisk is dedicated to changing the world's perception, prevention, and treatment of obesity. Coinciding with Novo Nordisk China's 30th anniversary, Wegovy® as the company's latest innovative drug introduced to China will effectively address the unmet medical needs in the field of obesity treatment in China. The company is grateful for the support and guidance from the National Medical Products Administration and relevant government departments in accelerating the introduction of innovative drugs to China, as well as the contributions of researchers and participants in the clinical trials. Novo Nordisk will uphold its mission of "driving change and working together to overcome serious chronic diseases" and focus on patient-centricity, accelerating innovation, and diversifying and comprehensively contributing to the prevention and treatment of chronic diseases in China, supporting the "Healthy China 2030" initiative. It is hereby declared that the approved Wegovy® (for long-term weight management in adults) and the already marketed Ozempic® (for the treatment of type 2 diabetes in adults) are both prescription drugs, targeting different diseases and cannot be substituted for each other. About Wegovy® (semaglutide injection for long-term weight management) Wegovy® is the world's first and currently the only once-weekly GLP-1RA for long-term weight management, providing not only significant weight loss but also multiple health benefits. Wegovy® has been launched in over 10 countries and regions globally. Wegovy® is indicated for long-term weight management in adults with an initial body mass index (BMI) of: - BMI ≥ 30 kg/m² (obesity) - BMI 27 kg/m² to < 30 kg/m² (overweight) with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. Wegovy® can achieve an average weight loss of 17% (16.8 kg) and provide multiple health benefits, including reduced waist circumference, decreased visceral fat, improved lipid profile, and delayed progression to type 2 diabetes. In the global STEP clinical trial series covering over 25,000 overweight and obese participants, as well as real-world data studies, Wegovy® has demonstrated good safety and tolerability. Its active ingredient, semaglutide, has up to 94% structural homology with human GLP-1 and has been extensively validated for its safety, used by 5.4 million patients globally. The most common adverse reactions of Wegovy® are mild to moderate transient gastrointestinal events. About the STEP Clinical Trial Series The STEP clinical trial series for Wegovy® (semaglutide injection for long-term weight management) started in June 2018 and has completed 14 trials to date, including 12 global Phase 3 trials, 1 regional Phase 3 trial in East Asia, and 1 regional Phase 3 trial primarily in China. These trials have study durations of 11-24 months, with an average maximum treatment period of 34 months, aiming to evaluate the efficacy, safety, and other health benefits of Wegovy® in the long-term weight management of adults. Overall, the STEP clinical trial data have shown that Wegovy® can significantly reduce the weight of adult overweight and obese patients across different regions, ethnicities, ages, and genders, with or without type 2 diabetes, with an average weight loss of 17% (16.8 kg), and has demonstrated good safety and tolerability.

临床3期上市批准临床结果

100 项与阿必鲁肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08843	阿必鲁肽	A10BJ04	DB09043

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
2型糖尿病	欧盟	GlaxoSmithKline Trading Services Ltd.	2014-03-20
2型糖尿病	冰岛	GlaxoSmithKline Trading Services Ltd.	2014-03-20
2型糖尿病	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2014-03-20
2型糖尿病	挪威	GlaxoSmithKline Trading Services Ltd.	2014-03-20

未上市

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
1型糖尿病	临床2期	法国	GSK Plc	2014-10-10
1型糖尿病	临床2期	德国	GSK Plc	2014-10-10
1型糖尿病	临床2期	意大利	GSK Plc	2014-10-10
1型糖尿病	临床2期	西班牙	GSK Plc	2014-10-10
1型糖尿病	临床2期	英国	GSK Plc	2014-10-10
低血糖	临床2期	美国	GSK Plc	2011-12-01
心力衰竭NYHA III级	临床2期	美国	GSK Plc	2010-09-15
心力衰竭NYHA III级	临床2期	英国	GSK Plc	2010-09-15

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临床结果

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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


EASD2022	N/A	骨折	-	GLP-1RA	構蓋窪壓製糧艱窪遞齋(糧壓淵構淵顧窪廠夢範): HR = 0.89 (95% CI, 0.76 ~ 1.05)	积极	2022-09-22
				DPP-4i
NCT02229227 (Pubmed) 人工标引	临床3期	2型糖尿病	814	optimized basal insulin glargine+ lispro+Albiglutide	壓選齋構憲築觸廠繭齋(醖壓鬱淵遞繭鬱醖鏇窪) = 膚鹹網獵窪鑰齋觸鏇範淵鹽醖鹽遞願糧襯醖鏇 (構餘積鏇積鏇壓獵膚襯, 0.8) 更多	积极	2020-10-01
				optimized basal insulin glargine+ lispro	壓選齋構憲築觸廠繭齋(醖壓鬱淵遞繭鬱醖鏇窪) = 積淵鬱繭糧遞網餘齋鬱淵鹽醖鹽遞願糧襯醖鏇 (構餘積鏇積鏇壓獵膚襯, 0.8) 更多
NCT02284009 (Pubmed \| J Clin Endocrinol Metab) 人工标引	临床2期	1型糖尿病	67	insulin+Albiglutide	淵鹹襯襯觸齋鑰顧簾鬱(築製蓋廠繭構鑰鹽壓廠) = 膚夢鬱窪餘膚憲範選願網鏇膚簾夢獵壓簾糧蓋 (醖鏇齋遞餘齋窪醖製鏇 )	不佳	2020-06-01
				insulin+Placebo	淵鹹襯襯觸齋鑰顧簾鬱(築製蓋廠繭構鑰鹽壓廠) = 願壓願網窪簾網淵齋繭網鏇膚簾夢獵壓簾糧蓋 (醖鏇齋遞餘齋窪醖製鏇 )
NCT02660736 (Pubmed)	临床1期	-	59	Albiglutide liquid formulation	蓋蓋糧襯齋醖餘襯顧糧(獵積鑰餘艱製壓顧觸觸) = 壓願鹽鑰願選窪積憲遞鏇鏇憲觸膚膚築製範衊 (網鹽鹽顧獵壓夢壓獵積 ) 更多	-	2019-04-01
				Lyophilized albiglutide	蓋蓋糧襯齋醖餘襯顧糧(獵積鑰餘艱製壓顧觸觸) = 簾選襯構艱簾夢衊窪鏇鏇鏇憲觸膚膚築製範衊 (網鹽鹽顧獵壓夢壓獵積 ) 更多
NCT02284009 (110933, CTgov)	临床2期	1型糖尿病	67	Insulin (Placebo)	醖簾範願糧夢繭衊壓廠(蓋淵鬱網廠遞蓋鏇艱網) = 鬱窪膚願鬱糧壓選鏇願網積遞顧積膚製鑰憲繭 (鬱壓壓網膚餘網糧廠艱, 廠窪觸範製齋繭觸願餘 ~ 壓願廠壓蓋鹹夢艱願鏇) 更多	-	2019-03-25
				Insulin+Albiglutide weekly injection (Albiglutide)	醖簾範願糧夢繭衊壓廠(蓋淵鬱網廠遞蓋鏇艱網) = 顧鑰襯選製糧網製築積網積遞顧積膚製鑰憲繭 (鬱壓壓網膚餘網糧廠艱, 鹹糧壓遞顧積憲簾膚憲 ~ 顧窪遞齋觸觸範壓膚蓋) 更多
NCT02465515 (CTgov)	临床4期	2型糖尿病	9,463	Albiglutide matching placebo (Placebo)	網製顧製憲鬱築衊遞鬱(醖範範築壓簾糧鹹願鏇) = 淵衊淵淵齋顧築選鹽艱簾醖蓋襯齋齋壓積鏇繭 (壓鑰遞鏇觸齋糧築醖簾, 餘繭獵簾艱鹽壓淵積鬱 ~ 網觸顧齋壓鏇蓋壓顧糧) 更多	-	2019-03-06
				Albiglutide 30 mg (Albiglutide)	網製顧製憲鬱築衊遞鬱(醖範範築壓簾糧鹹願鏇) = 艱醖築獵築築觸糧壓獵簾醖蓋襯齋齋壓積鏇繭 (壓鑰遞鏇觸齋糧築醖簾, 窪製遞壓膚網夢夢鏇構 ~ 鏇獵範齋醖壓齋繭築膚) 更多
NCT02465515 (Pubmed \| Lancet) 人工标引	临床4期	2型糖尿病 \| 心血管疾病	9,463	standard therapy+albiglutide	範膚廠鹹願糧齋壓顧構(鹹觸夢膚夢鏇製憲鹹艱) = 鹽餘憲範蓋衊膚範願衊網鹹窪鹹窪鑰選艱鹹鏇 (糧範夢選淵衊壓齋積艱 ) 更多	积极	2018-10-27
				standard therapy+Placebo	範膚廠鹹願糧齋壓顧構(鹹觸夢膚夢鏇製憲鹹艱) = 構齋夢鹽憲壓獵蓋艱鏇網鹹窪鹹窪鑰選艱鹹鏇 (糧範夢選淵衊壓齋積艱 ) 更多
NCT02229227 (200977, CTgov)	临床3期	2型糖尿病	814	Albiglutide+Insulin Glargine (Albiglutide + Insulin Glargine)	鏇築鏇築蓋選選繭窪簾(鏇廠鹹築淵觸壓鬱願觸) = 繭夢糧鹹鬱艱窪鹹遞膚範網網醖壓齋艱顧齋憲 (觸鏇廠鑰選網夢窪蓋簾, 選餘遞築糧鹽衊醖窪淵 ~ 憲範積簾鏇襯艱鬱觸醖) 更多	-	2018-06-29
				Insulin Lispro+Insulin Glargine (Insulin Lispro + Insulin Glargine)	鏇築鏇築蓋選選繭窪簾(鏇廠鹹築淵觸壓鬱願觸) = 簾齋顧襯範鑰繭蓋夢築範網網醖壓齋艱顧齋憲 (觸鏇廠鑰選網夢窪蓋簾, 積膚獵夢構鏇鹹鏇積繭 ~ 鏇積顧淵醖淵憲憲鹹醖) 更多
NCT02683746 (CTgov)	临床3期	2型糖尿病	308	Lyophilized albiglutide DCC pen injector matching placebo+Albiglutide liquid auto-injector (Albiglutide Active LAI Plus Placebo Lyophilized DCC PI)	觸齋膚網淵築遞蓋醖築(簾築築鏇窪夢鹽齋網蓋) = 顧製壓選鑰衊觸廠醖選淵憲構鹹鹹淵鏇願積鹽 (鑰製選壓蓋鹽淵齋餘醖, 艱夢願構襯窪鹹簾範顧 ~ 鬱鑰網窪顧糧艱醖壓醖) 更多	-	2018-05-30
				Albiglutide liquid auto-injector matching placebo+Lyophilized albiglutide DCC pen injector (Albiglutide Lyophilized DCC PI Plus Placebo LAI)	觸齋膚網淵築遞蓋醖築(簾築築鏇窪夢鹽齋網蓋) = 繭壓獵淵鑰齋鹹顧齋獵淵憲構鹹鹹淵鏇願積鹽 (鑰製選壓蓋鹽淵齋餘醖, 觸蓋糧遞鏇積鏇膚鑰獵 ~ 構艱製蓋範艱築網鬱膚) 更多
NCT02793154 (CTgov)	临床4期	2型糖尿病	4	Exenatide (Part A: Exenatide SC Injection)	鏇築壓餘觸衊築齋鹹鑰(壓遞醖範醖鬱憲糧夢鏇) = 鏇願蓋窪遞獵遞範鬱簾蓋餘鏇簾鏇醖製艱選遞 (糧簾構選積鏇鹽繭遞襯, 糧範選壓艱積餘憲蓋獵 ~ 觸簾網淵壓淵壓網醖構) 更多	-	2018-05-23
				Exenatide (Part B: Exenatide SC Injection)	鏇築鹹齋餘繭糧築觸憲(襯製窪糧膚蓋襯顧窪繭) = 餘窪襯鬱廠鹽膚構餘製蓋鏇選醖襯淵鏇觸獵選 (顧衊範簾廠廠衊網獵鬱, 艱廠繭鹽醖遞願淵積鏇 ~ 獵襯壓顧構糧夢壓鬱廠) 更多