A Pilot, Safety and Feasibility Trial of Anti-Thymocyte Globulin (ATG), Low Dose Interleukin-2 (IL-2), Adalimumab and Exenatide in the Treatment of New-Onset Type 1 Diabetes

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

开始日期2025-01-01

申办/合作机构

University of Miami

[+1]

NCT05663515

/ RecruitingN/A

EXCEED - A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs

EXCEED is a non-interventional post-authorisation safety study aiming to assess the risk of developing pancreatic cancer among type 2 diabetes mellitus (T2DM) patients who initiated exenatide compared to those who initiated other non-glucagon like peptide 1 receptor agonists (GLP-1 RA) based glucose lowering drugs (GLDs). Study data will be collected from secondary data sources across 7 European countries. The study will be conducted as a multi-country, long-term, retrospective, observational database study. Initiators of exenatide will be matched to initiators of non-GLP-1 RA based GLDs (comparator group) based on propensity score and calendar period of study entry. All analyses for pancreatic cancer will be conducted in the matched study population using an "intention-to-treat" approach. The study will use information from 8 data sources in 7 European countries (France, Spain, The United Kingdom, Finland, Denmark, Norway, and Sweden). Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of prescriptions or insurance claims registrations as available in the different data sources. The outcome of pancreatic cancer will be defined as a primary diagnosis of pancreatic cancer during follow-up.

开始日期2024-09-30

申办/合作机构

AstraZeneca PLC

[+1]

NCT06252623

/ Recruiting临床1期IIT

A Human Laboratory Study of Exenatide for Reducing the Reinforcing Effects of Cocaine

This study will determine the safety and tolerability of exenatide (Bydureon®) as a pharmacotherapy for cocaine use disorder. An inpatient human laboratory study will be conducted in which the self-administration of cocaine, as well as the subjective and physiological effects of cocaine, are evaluated during maintenance on placebo and exenatide.
Although exenatide (Bydureon) is approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, it has not been approved by the FDA to treat cocaine use; therefore, it is called an investigational drug.

开始日期2024-08-01

申办/合作机构

Baylor College of Medicine

100 项与艾塞那肽相关的临床结果

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100 项与艾塞那肽相关的转化医学

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100 项与艾塞那肽相关的专利（医药）

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4,138

项与艾塞那肽相关的文献（医药）

2025-03-01·JOURNAL OF CONTROLLED RELEASE

Design, evaluation, and in vitro–in vivo correlation of self-nanoemulsifying drug delivery systems to improve the oral absorption of exenatide

Article

作者: Al-Maghrabi, Passant M ; Müllertz, Anette ; Lind, Tania ; Rades, Thomas ; Mota-Santiago, Pablo ; Alavi, Oscar ; Sassene, Philip Jonas ; Venkatasubramanian, Ramakrishnan ; Kirkensgaard, Jacob J K

The ability to predict the absorption of exenatide (Ex), a GLP-1 analogue, after oral dosing to rats in self-nanoemulsifying drug delivery systems (SNEDDS), using in vitro methods, was assessed. Ex was complexed with soybean phosphatidylcholine (SPC) prior to loading into SNEDDS. A design of experiments (DoE) approach was employed to develop SNEDDS incorporating medium-chain triglycerides (MCT), medium-chain mono- and diglycerides (MGDG), Kolliphor® RH40, and monoacyl phosphatidylcholine. SNEDDS with higher proportions of MGDG and Kolliphor® RH40 demonstrated a 9-fold reduction in droplet size (230 to 26 nm), a 1.5-fold decrease in lipolysis (0.23 to 0.34 mmol of FFA), and a 2-fold enhancement in exenatide protection against proteolysis (73 % to 38 %) compared to those with higher MCT content. Permeability studies in Caco-2 cells showed that SNEDDS with higher proportion of MGDG displayed a 40-fold increase in apparent permeability of FD4, when compared to SNEDDS with higher proportion of MCT. An oral gavage study in rats revealed a 1.8-fold higher absorption of Ex in SNEDDS with a higher proportion of MGDG and Kolliphor®RH40 compared to SNEDDS with higher MCT. These results establish a clear in vitro-in vivo correlation, demonstrating that the selected in vitro methods effectively differentiated formulations with high and low absorption of exenatide after oral dosing in rats.

2025-02-01·DIABETES CARE

Osteoprotegerin, Osteopontin, and Osteocalcin Are Associated With Cardiovascular Events in Type 2 Diabetes: Insights From EXSCEL

Article

作者: Maddaloni, Ernesto ; Shah, Svati H. ; Holman, Rury R. ; Nguyen, Maggie

OBJECTIVE:

To evaluate the association of four bone metabolism biomarkers (osteoprotegerin, osteopontin, sclerostin, and osteocalcin) with cardiovascular events in people with type 2 diabetes (T2D).

RESEARCH DESIGN AND METHODS:

The Exenatide Study of Cardiovascular Event Lowering (EXSCEL) was a randomized clinical trial evaluating the cardiovascular (CV) safety and efficacy of once-weekly exenatide for patients with T2D. Candidate biomarker data were selected from proteomic profiling performed at baseline and 12 months after randomization samples by SomaScan assay in 5,473 trial participants. The primary composite outcome was the first occurrence of CV death, nonfatal myocardial infarction, or nonfatal stroke (major cardiovascular events [MACE]). Cox proportional hazards models controlling for confounders were used for time-to-event analyses to calculate hazard ratios (HRs) with 95% CI for a 1 SD increase in the biomarker concentrations.

RESULTS:

The primary outcome occurred in 813 participants (14.9%). Higher levels of osteoprotegerin (HR 1.11; 95% CI 1.03–1.20; P = 0.0047) and osteopontin (HR 1.10; 95% CI 1.02–1.18; P = 0.0095) were associated with an increased risk of MACE. The addition of osteoprotegerin and osteopontin to a clinical predictive model containing traditional CV risk factors provided minimal incremental value for MACE prediction (C-index 0.629 vs. 0.638; likelihood ratio test P < 0.001). Osteocalcin and sclerostin were not associated with MACE. Osteocalcin had a nonlinear association with all-cause death and with CV death.

CONCLUSIONS:

Higher levels of osteoprotegerin and osteopontin are associated with an increased risk of CV events in people with T2D, supporting the hypothesis that pathways involved in bone metabolism play a role in CV disease.

2025-02-01·CLINICAL THERAPEUTICS

Recent Advances in Individualized Clinical Strategies for Polycystic Ovary Syndrome: Evidence From Clinical Trials and Emerging Pharmacotherapies

Review

作者: Moka, Murali Krishna ; George, Melvin ; Sriram, Damal Kandadai

PURPOSE:

Clinical trials are advancing the treatment of polycystic ovary syndrome (PCOS), an endocrine disorder affecting 8-13% of women. Lifestyle interventions, including nutritional plans, physical activity, and stress management, can improve reproductive hormones and metabolic health. Novel pharmacotherapies targeting hormonal, metabolic, and reproductive abnormalities are being explored for individualized treatment. Combination therapies and lifestyle interventions like acupuncture, high-intensity interval training, and vitamin D3 supplementation are also being explored.

METHODS:

We conducted a narrative review by searching English-language studies across electronic databases such as PubMed, Science direct, and Google Scholar for articles related to the topics of PCOS and novel drug therapies such as metformin, LIK-066, elagolix, saxenda, exenatide, clomiphene, letrozole, and other diagnostic interventions. Our review excluded preclinical studies and articles not in english.

FINDINGS:

In addition to pharmacological treatments, lifestyle interventions such as Tung's acupuncture, high-intensity interval training (HIIT), and vitamin D3 supplementation have proven effective in managing symptoms of PCOS and enhancing overall health outcomes. These interventions offer a complementary approach to traditional medical therapies, emphasizing the importance of integrating lifestyle modifications into the treatment plan for women with PCOS.

IMPLICATIONS:

This comprehensive approach underscores the importance of tailored treatments in optimizing clinical outcomes and quality of life for women with PCOS. The aim of this review is to highlight recent advancements in the treatment of PCOS through clinical trials and emerging pharmacotherapies, emphasizing the need for individualized and multifaceted treatment approaches.

342

项与艾塞那肽相关的新闻（医药）

2025-02-17

·国际糖尿病idiabetes

太全面了！GLP-1RA一路开挂，下一站将到哪儿？

点击“蓝字”关注我们胰高糖素样肽-1受体激动剂（GLP-1RA）更多技能不断解锁中！除心肾获益外，司美格鲁肽还可降低2型糖尿病（T2DM）患者脑卒中风险，并在代谢相关脂肪性肝病（MASLD）中展现出治疗潜力。GLP-1RA临床获益呈剂量依赖性，临床如何优化剂量以使其治疗获益更佳？继上期内容之后，复旦大学附属中山医院李晓牧教授与丹麦哥本哈根Steno糖尿病中心Tina Vilsbøll教授还对以上问题进行了深入探讨。要点一览降低卒中风险：国内外指南/共识一致推荐GLP-1RA用于降低糖尿病患者卒中风险。司美格鲁肽降低非致死性卒中风险达39%。优化治疗剂量：司美格鲁肽滴定到1.0 mg，改善心肾代谢效果更佳。为使患者获益最大化，如可耐受，应尽量滴定至足量1.0 mg维持治疗。肝脏获益：GLP-1RA治疗代谢相关脂肪性肝病展现良好潜力，被中外指南推荐用于T2DM伴MASLD患者。一、关注卒中获益：GLP-1RA被纳入国内外指南/共识，用于降低糖尿病患者卒中风险在糖尿病大血管并发症中，人们更多关注冠心病，但卒中同样不容忽视。在心血管结局研究（CVOT）中，部分GLP-1RA展现出对卒中的治疗获益，并推动指南更新。2024年《AHA/ASA卒中一级预防指南》推荐：对于心血管高危或已确诊心血管疾病且HbA1c≥7%的糖尿病患者，使用GLP-1RA治疗可有效降低卒中风险（1类推荐，A级证据）[1]。 Tina Vilsbøll教授指出，卒中是糖尿病的严重并发症，可带来毁灭性后果。应尽量避免T2DM患者发生卒中，包括首次卒中及复发。SUSTAIN 6研究显示，司美格鲁肽显著降低非致死性卒中风险达39%（图1）[2]。图1. 司美格鲁肽显著降低非致死性卒中风险达39% Tina Vilsbøll教授：作为SUSTAIN 6研究作者之一，我非常高兴看到司美格鲁肽注射液可显著降低卒中风险。这很有趣，并非所有GLP-1RA都有预防卒中作用。我也很期待SOUL研究最终结果发布，从目前披露数据来看，口服司美格鲁肽同样可显著降低MACE风险，且获益由三个组分（心血管死亡、非致死性心梗或非致死性卒中）共同驱动[3]。她进一步解释，司美格鲁之所以有如此全面的心脑血管获益，可能是由降糖、减重、抗炎、抗动脉硬化等综合作用所致，具体机制有待进一步阐明。而在中国，卒中问题显得更为严重。李晓牧教授提到，无论对整体人群还是T2DM患者，卒中都是导致死亡的重要病因。糖尿病患者合并高血压是卒中高发的主要原因，我国这一情况尤为严重。为了降低卒中风险，需要采取降糖、降压、调脂等综合措施。2024年7月，中国发布《2型糖尿病患者卒中预防及血糖管理专家共识》，推荐GLP-1RA用于卒中的一级和二级预防（图2）[4]：无卒中病史的T2DM患者预防卒中发生：选择证实可减少卒中风险的GLP-1RA。有卒中病史的T2DM患者预防卒中复发：可考虑联用经证实减少卒中风险的GLP-1RA。图2. T2DM患者卒中预防中的高血糖管理路径 2025年1月，《中国糖尿病防治指南（2024版）》（以下简称“2024CDS指南”）正式发布，对合并动脉粥样硬化性心血管疾病（ASCVD）或其高风险的T2DM患者，在保持对GLP-1RA一线优选推荐的基础上，特别强调卒中是主要心血管不良事件（MACE）的重要组分，并新增推荐：“有缺血性卒中史的T2DM患者，降糖药首选有获益证据的GLP‑1RA” [5]。李晓牧教授：无论对于卒中高风险还是已诊断卒中的T2DM患者，GLP-1RA均有助于控制多种危险因素，从而降低卒中新发和再发风险。二、优化治疗剂量：司美格鲁肽剂量可调节，1.0 mg心肾代谢获益更佳司美格鲁肽维持剂量包括0.5 mg和1.0 mg两种，目前证据支持其临床获益呈剂量依赖性。SUSTAIN系列研究证实，司美格鲁肽剂量滴定到1.0 mg，可降低HbA1c最高达1.8%，且可更有效改善多重心血管代谢危险因素，包括显著减轻体重最高达6.5 kg，66%的患者减重幅度≥5%，27%的患者减重幅度≥10%；显著缩小腰围最高达6.0 cm；显著降低收缩压最高达7.3 mmHg，并显著全面改善血脂水平（图3）[6-15]。图3. SUSTAIN系列研究：司美格鲁肽从0.5 mg滴定到1.0 mg，显著改善T2DM患者多种心血管代谢危险因素已有多项证据支持，司美格鲁肽1.0 mg心肾获益更佳。一项研究评估肠促胰素类药物与MACE风险之间的暴露-反应关系，回归分析结果显示，GLP-1RA药物暴露水平与MACE风险比之间呈线性关系，提示GLP-1RA剂量较高和暴露量增加的情况下，心血管获益可能更明显[16]。FLOW研究中，T2DM合并慢性肾脏病（CKD）患者应用司美格鲁肽1.0 mg，观察到显著的肾脏获益[17]。因此，在临床实践中，若T2DM患者能够耐受，应尽量将司美格鲁肽维持剂量滴定至1.0 mg。两位教授分别分享了自己的临床用药经验。Tina Vilsbøll教授认为，GLP-1RA的作用存在明显的剂量依赖性，之所以在治疗T2DM时司美格鲁肽会有两种维持剂量，主要是受胃肠道不良反应的限制，患者的耐受情况存在较大的个体化差异。 Tina Vilsbøll教授：我在临床使用司美格鲁肽的剂量因人而异，一般而言，如果患者能够耐受，为更好地实现血糖控制和体重管理，我会尽量滴定至1.0 mg或最大耐受剂量。李晓牧教授强调，对每一例T2DM患者，均应平衡治疗获益和安全性。司美格鲁肽经典的剂量调整方案是从0.25 mg起始，4周后剂量递增至0.5 mg维持，4周后如有进一步需要可提升至1.0 mg维持治疗。李晓牧教授：对于大多数合并心肾疾病的T2DM患者，司美格鲁肽可以滴定至1.0 mg作为维持剂量。在我们医院，至少有半数患者可维持1.0 mg。研究表明，司美格鲁肽1.0 mg和0.5 mg的安全性相当。为使患者获益最大化，积极调整司美格鲁肽剂量是有必要的。三、肝脏获益：GLP-1RA治疗代谢相关脂肪性肝病展现良好潜力 T2DM与MASLD互为因果，相互影响。在2024CDS指南的T2DM治疗路径图中，首次将MASLD纳入作为降糖用药依据之一，对于无ASCVD或其高风险、心衰或CKD的T2DM患者，如果伴有MASLD，推荐选择有肝脏和心血管获益证据的GLP-1RA或双受体激动剂[5]。研究表明，对于MASLD高风险的T2DM和/或肥胖人群，司美格鲁肽显著降低丙氨酸转氨酶（ALT）和超敏C反应蛋白（hs-CRP）水平[18]。司美格鲁肽还可缓解代谢相关脂肪性肝炎（MASH）并延缓纤维化进展[19]。2024CDS指南指出，GLP-1RA可显著降低伴MASLD的T2DM患者全因死亡风险，并减少新发心衰和脑血管事件[5]。李晓牧教授：脂肪性肝病首次出现在我国T2DM治疗流程图中，这一更新虽小，但非常重要。此外，2024年发表的中国MAFLD防治指南也明确指出，司美格鲁肽等GLP-1RA具有肝脏获益[20]。与此高度吻合的是，2025美国糖尿病协会（ADA）指南也对MASLD相关内容进行了重磅更新，新增MASLD治疗流程图（图4），以强调对MASLD患者的综合管理，并针对不同纤维化阶段患者糖尿病、肥胖和MASH的药物治疗作出了推荐。对于T2DM合并MASLD/MASH患者，具有肝脏获益的GLP-1RA或GIP/GLP-1双激动剂和吡格列酮是优选[21]。图4. 2025ADA指南：MASLD治疗流程图 Tina Vilsbøll教授介绍，ESSENCE研究是一项3期临床研究，旨在评估每周一次皮下注射司美格鲁肽2.4 mg对患有MASH和中度至重度肝纤维化（2期或3期）成人的影响。基于ESSENCE研究第一部分主要结果，司美格鲁肽不仅可缓解脂肪性肝炎，还能显著改善肝纤维化[22,23]。关于GLP-1RA对肝脏的作用及其对MASH的影响，期待将来的更多结果和证据。四、结语两位专家全面探讨了GLP-1RA的心脑肾及代谢获益，并就如何在临床实践中优化应用分享了宝贵经验。专家一致认为，对于T2DM合并ASCVD或其高危患者，内分泌医生应高度关注并及早识别，优选GLP-1RA进行治疗，同时注意优化治疗剂量，司美格鲁肽滴定至最大剂量1.0 mg可带来更佳临床获益，建议根据个体化需求足量应用。除心血管获益外，司美格鲁肽在改善多重代谢危险因素的同时，兼具明确的肾脏获益、卒中获益，并展现出肝脏获益潜力，在内分泌代谢及心血管、肾病、神经科等领域齐头并进，临床前景可期！参考文献（上下滑动可查看） 1. Bushnell C, et al. Stroke. 2024; 55(12): e344-e424. 2. Marso SP, et al. N Engl J Med. 2016; 375(19): 1834-1844. 3.https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=171480 4.《2型糖尿病患者卒中预防及血糖管理专家共识》编写委员会. 中华内科杂志. 2024; 63(7): 649-659. 5. 中华医学会糖尿病学分会. 中国糖尿病防治指南(2024版). 中华糖尿病杂志. 2025; 17(1): 16-139. 6. Sorli C, et al. Lancet Diabetes Endocrinol. 2017; 5(4): 251-260. 7. Ji L, et al. Diabetes Obes Metab. 2021; 23(2): 404-414. 8. Ahrén B, et al. Lancet Diabetes Endocrinol. 2017; 5(5): 341-354. 9. Ahmann AJ, et al. Diabetes Care. 2018; 41(2): 258-266. 10. Pratley RE, et al. Lancet Diabetes Endocrinol. 2018; 6(4): 275-286. 11. Lingvay I, et al. Lancet Diabetes Endocrinol. 2019; 7(11): 834-844. 12. Zinman B, et al. Lancet Diabetes Endocrinol. 2019; 7(5): 356-367. 13. Capehorn MS, et al. Diabetes Metab. 2020; 46(2): 100-109. 14. Aroda VR, et al. Lancet Diabetes Endocrinol. 2017; 5(5): 355-366. 15. Rodbard HW, et al. J Clin Endocrinol Metab. 2018; 103(6): 2291-2301. 16. Pan Q, et al. Front Endocrinol (Lausanne). 2022; 13: 893971. 17. Perkovic V, et al. N Engl J Med. 2024; 391(2): 109-121. 18. Newsome P, et al. Aliment Pharmacol Ther. 2019; 50(2): 193-203. 19. Newsome PN, et al. N Engl J Med. 2021; 384(12): 1113-1124. 20. 中华医学会肝病学分会. 中华肝脏病杂志. 2024; 32(5): 418-434. 21. ADA. Diabetes Care. 2025; 48(Suppl 1): S59-S85. 22. Newsome PN, et al. Aliment Pharmacol Ther. 2024; 60(11-12): 1525-1533. 23. Newsome PN, et al. Phase 3 ESSENCE trial: Semaglutide in metabolic dysfunction-associated steatohepatitis. Presented at: The Liver Meeting; Nov. 15-19, 2024; San Diego (hybrid meeting). 往/期/回/顾上海与哥本哈根的对话：2型糖尿病管理的“全局观” 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际糖尿病》编辑部）版权声明版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。

临床结果AHA会议

2025-02-12

·EndPoints

Novo's weight loss drug helps curb some drinking habits, small study shows

New research from the University of North Carolina-Chapel Hill found that Novo Nordisk’s weight loss drug may help people curb their alcohol consumption. Results from the small Phase 2 study released Wednesday found that the most significant effects of semaglutide were a decrease in alcohol cravings and the number of drinks consumed on drinking days. There was a non-significant impact on the number of drinks each person consumed on a daily basis. The study, published in JAMA Psychiatry , randomized 48 non-treatment-seeking patients with alcohol use disorder to receive either once-weekly semaglutide or placebo over nine weeks. Those who received Novo’s drug got the lowest dose during the first four weeks and then increased to 0.5 mg per week for weeks five through eight. Some of the treated patients received a final, 1 mg dose during the ninth week. One of the researchers on the study, Klara Klein, has previously consulted for Novo Nordisk. Researchers found that the proportion of patients who were given semaglutide and reported zero heavy drink days “increased significantly” over the two dose phases. But the drug did not appear to alter the proportion of abstinence and drinking days. An even smaller subset of patients that were smoking cigarettes before the study found medication-by-time reductions in cigarettes smoked per day. The findings are a small but substantive step forward for the GLP-1 drugs as treatments for substance abuse disorders. The companies themselves have come around to the prospect after earlier batches of data seemed to suggest their potential. Eli Lilly CEO David Ricks said in December that large studies in patients who suffer from alcohol and drug abuse would begin this year. “I think that’s really the next frontier to make a big difference,” he told the Economic Club of Washington, DC. A medical advisor for the company’s diabetes therapeutic area said the company was strongly considering testing the drugs as treatments for cognitive disorders as well. So far, the hypothesis surrounding the drugs’ potential in the brain has lacked rigorous investigation, with the researchers noting that much of the data come from observational or anecdotal data. The new results advance the potential of GLP-1 therapies beyond their first-generation peers, like exenatide, which wasn’t found to reduce alcohol consumption in a previous randomized study. “Although differences in sample characteristics or study design could contribute to differential evidence for efficacy across these 2 trials, the superior efficacy of semaglutide vs exenatide is likely the simplest interpretation,” the authors wrote.

临床结果临床2期

2025-02-08

·生物世界

柳叶刀：GLP-1类药物遇挫，对帕金森病患者没有任何治疗益处

撰文丨王聪编辑丨王多鱼排版丨水成文近年来，GLP-1 受体激动剂类药物，例如司美格鲁肽，越来越受欢迎，其除了用于治疗 2 型糖尿病和减肥，人们对其潜在的健康益处产生了极大的兴趣。艾塞那肽（exenatide）是第一款上市的 GLP-1 受体激动剂类药物，此前的流行病学研究和小型随机试验的结果表明，艾塞那肽等 GLP-1 受体激动剂可能对帕金森病患者具有潜在益处。 2025年2月4日，国际顶尖医学期刊《柳叶刀》（The Lancet）发表了题为：Exenatide once a week versus placebo as a potential disease-modifying treatment for people with Parkinson's disease in the UK: a phase 3, multicentre, double-blind, parallel-group, randomised, placebo-controlled trial 的临床研究论文。这项 3 期、多中心、双盲、平行组、随机、安慰剂对照临床试验显示，每周 1 次，持续 96 周的艾塞那肽治疗帕金森病患者，没有显示出任何治疗益处。艾塞那肽（exenatide）是第一款上市的 GLP-1 受体激动剂药物，相比于近年来广为流行的司美格鲁肽，艾塞那肽属于短效 GLP-1 受体激动剂。在这项研究中，研究团队在英国的 6 家医院进行了一项 3期、多中心、双盲、平行组、随机、安慰剂对照临床试验。旨在确定 GLP-1 受体激动剂艾塞那肽是否可以减缓帕金森病的进展速度。该研究共有 194 名帕金森病患者参与，他们的年龄在 25-80 岁，在接受多巴胺能治疗时的 Hoehn-Yahr 分期≤2.5期，并且在纳入研究前接受多巴胺能治疗至少 4 周。这些参与者被随机分为两组，一组接受艾塞那肽缓释剂治疗，每周一次，每次 2毫克，另一组接受外观相同的安慰剂治疗。所有参与者和研究人员均不知晓随机分配情况。该临床试验的主要结局是在治疗第 96 周时使用线性混合模型方法分析统一帕金森病评定量表（MDS-UPDRS）第三部分评分，结果显示，在第 96 周时，艾塞那肽治疗组的评分平均增加了 5.7 分，安慰剂组平均增加 4.5 分，评分增加代表病情恶化。在安全性方面，艾塞那肽治疗有 9 例（9%）参与者发生了至少 1 次严重不良事件，而安慰剂组为 11 例（11%）。总的来说，这项迄今最大规模、最长时间的艾塞那肽治疗帕金森病的临床试验显示，在为期 96 周的治疗中，艾塞那肽治疗组相比于安慰剂组并未显示出任何治疗益处，对帕金森病患者运动的客观检查、患者自己报告的症状严重程度或影像学检查结果均未显示出获益。研究团队表示，这项临床试验的结果受到了热切期待，然而，阴性结果让帕金森病患者和帕金森病研究者感到非常失望。论文链接： https://www-thelancet-com.libproxy1.nus.edu.sg/journals/lancet/article/PIIS0140-6736(24)02808-3/fulltext 设置星标，不错过精彩推文开放转载欢迎转发到朋友圈和微信群微信加群为促进前沿研究的传播和交流，我们组建了多个专业交流群，长按下方二维码，即可添加小编微信进群，由于申请人数较多，添加微信时请备注：学校/专业/姓名，如果是PI/教授，还请注明。点在看，传递你的品味

临床3期临床结果临床2期临床成功临床失败

100 项与艾塞那肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04121	艾塞那肽	A10BJ01	DB01276

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	美国	AstraZeneca AB	2005-04-28

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
假性脑肿瘤	临床3期	美国	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	澳大利亚	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	德国	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	以色列	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	新西兰	Invex Therapeutics Ltd.	2022-11-18
假性脑肿瘤	临床3期	英国	Invex Therapeutics Ltd.	2022-11-18
1型糖尿病	临床3期	荷兰	AstraZeneca PLC	2017-02-21
肥胖	临床3期	美国	AstraZeneca PLC	2016-03-22
多囊卵巢综合征	临床3期	美国	AstraZeneca PLC	2016-03-22
心脏衰竭	临床3期	法国	AstraZeneca PLC	2015-05-01

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临床结果

适应症

分期

评价

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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


NCT04232969 (Pubmed) 人工标引	临床3期	帕金森病	194	exenatide	襯選廠廠廠憲鏇壓衊觸(繭簾遞糧網製憲獵鹽齋) = 遞窪淵獵構積遞製淵衊製構鑰繭網襯淵簾蓋衊 (築廠衊鏇範網鏇遞夢壓, 11.2) 更多	不佳	2025-02-04
				placebo	襯選廠廠廠憲鏇壓衊觸(繭簾遞糧網製憲獵鹽齋) = 鹹獵壓選鹽鹹遞顧構窪製構鑰繭網襯淵簾蓋衊 (築廠衊鏇範網鏇遞夢壓, 11.4) 更多
NCT01107717 (EDICT, CTgov)	临床4期	2型糖尿病	318	exenatide+pioglitazone+metformin (Triple Therapy)	糧網糧艱繭壓餘顧鑰衊(網夢醖鹽壓選淵範範壓) = 淵繭選遞選築齋構鑰積鏇鏇製鹽艱觸壓膚鬱壓 (艱鬱構廠製顧簾觸壓顧, 蓋窪襯鬱窪壓衊糧艱鑰 ~ 衊膚淵憲鏇蓋膚憲夢鹹) 更多	-	2024-09-05
				glargine+metformin+glyburide (Conventional Therapy)	糧網糧艱繭壓餘顧鑰衊(網夢醖鹽壓選淵範範壓) = 構鬱製獵鏇膚願範窪顧鏇鏇製鹽艱觸壓膚鬱壓 (艱鬱構廠製顧簾觸壓顧, 窪衊衊襯鹽顧簾積窪憲 ~ 製簾蓋衊憲範鏇壓醖獵) 更多
T1D Exchange Online Registry (ADA2024)	N/A	1型糖尿病	-	GLP-1	夢憲襯糧觸簾顧製簾膚(壓觸衊憲製遞簾簾餘齋) = 齋選遞顧窪齋醖獵憲獵糧齋淵齋製觸膚鹽範積 (積餘築願淵憲網鹽願鬱 )	积极	2024-06-14
NCT03029351 (1981, CTgov)	临床4期	肾脏疾病 \| 2型糖尿病 \| 蛋白尿	15	Exenatide Extended Release for Inj Susp 2 MG (Exenatide Extended Release)	簾遞鏇齋窪鏇繭夢鏇積(餘糧醖觸繭艱壓鹽顧願) = 夢觸夢繭積廠鹽製鏇餘齋積夢製築構範憲製鏇 (獵製製鹽廠鬱淵糧糧觸, 醖積構選製顧蓋觸繭鹽 ~ 醖襯範壓襯積窪選鬱網) 更多	-	2024-04-16
				Placebo (Placebo)	簾遞鏇齋窪鏇繭夢鏇積(餘糧醖觸繭艱壓鹽顧願) = 蓋願膚餘糧醖糧淵膚積齋積夢製築構範憲製鏇 (獵製製鹽廠鬱淵糧糧觸, 醖襯積壓築齋鏇襯觸鏇 ~ 顧膚範選窪繭鬱壓築襯) 更多
NCT02962492 (CTgov)	N/A	1型糖尿病	70	Placebo (Placebo Arm:)	遞衊鬱壓糧觸積觸製鏇(遞網鏇願願簾膚鏇鑰獵) = 壓繭夢鏇壓壓糧夢築選膚艱選鏇鬱廠遞積簾願 (獵簾選壓襯積壓繭鏇製, 顧鹽範衊壓簾蓋觸淵餘 ~ 獵獵鬱糧廠夢衊簾觸鹽) 更多	-	2024-02-29
				Dapagliflozin (Dapagliflozin Arm:)	遞衊鬱壓糧觸積觸製鏇(遞網鏇願願簾膚鏇鑰獵) = 衊醖鹹艱夢願鏇鹽繭衊膚艱選鏇鬱廠遞積簾願 (獵簾選壓襯積壓繭鏇製, 衊衊窪壓憲鹹夢襯廠製 ~ 醖顧積淵觸鹹衊齋壓淵) 更多
NCT01524705 (FLAT-SUGAR, CTgov)	临床4期	2型糖尿病	102	Insulin Glargine+Metformin+Exenatide	襯網鬱鹽鹽願築簾鬱繭(醖選簾鑰構遞蓋構壓鏇) = 壓廠蓋壓築鬱築蓋遞壓觸醖鹽糧窪鏇鑰鹹壓簾 (築鑰艱願壓願選顧範壓, 繭憲窪獵鑰憲膚膚糧艱 ~ 廠醖製醖糧築齋壓獵選) 更多	-	2023-12-29
ACTRN12619000497101 (ACTRN, EASD2023)	临床2期	2型糖尿病	32	Exenatide once-weekly (QW)	網襯蓋艱鏇膚膚餘艱壓(積網壓齋醖窪積鹽窪築) = 願壓選夢糧鹹選願壓餘遞糧製鬱襯鹽襯繭願顧 (構製廠醖顧簾築顧築遞, 1.7)	积极	2023-10-04
				Placebo	網襯蓋艱鏇膚膚餘艱壓(積網壓齋醖窪積鹽窪築) = 襯襯壓壓製構繭築獵繭遞糧製鬱襯鹽襯繭願顧 (構製廠醖顧簾築顧築遞, 2.1)
NCT04307797 (EASD2023)	临床4期	2型糖尿病	8	Saline	選糧鏇遞製鑰鹽窪淵鏇(顧遞衊繭壓觸糧簾鬱膚) = There were no adverse events 選鏇鏇憲鹹簾範衊獵糧 (醖夢憲襯觸鏇顧鏇鹽繭 ) 更多	不佳	2023-10-04
				Glucagon
NCT02621489 (Rebuild study, ESC2023)	临床4期	非胰岛素依赖型糖尿病2	38	Bydureon	鹹衊餘襯製膚餘顧膚繭(積鹹廠遞鹹夢築衊繭遞) = 蓋繭夢壓製淵蓋簾築願糧願齋鏇餘鬱憲糧襯遞 (膚鏇衊鹽夢廠齋顧鹹網 ) 更多	-	2023-08-25
				Standard treatment	鹹衊餘襯製膚餘顧膚繭(積鹹廠遞鹹夢築衊繭遞) = 簾觸淵範壓願範艱觸齋糧願齋鏇餘鬱憲糧襯遞 (膚鏇衊鹽夢廠齋顧鹹網 ) 更多
NCT03331289 (CTgov)	临床4期	2型糖尿病	107	Placebo (Placebo)	鏇衊積窪衊築糧範鬱淵(窪選網鬱觸積淵顧醖壓) = 糧廠選簾齋醖製築網窪選艱網鏇鏇鏇廠醖鏇構 (製願選餘構醖鹽遞簾遞, 淵夢獵構餘襯繭鬱積廠 ~ 憲糧齋淵簾蓋壓鏇齋築) 更多	-	2023-07-24
				Exenatide (Exenatide)	鏇衊積窪衊築糧範鬱淵(窪選網鬱觸積淵顧醖壓) = 窪夢鏇構鬱遞糧築鹽憲選艱網鏇鏇鏇廠醖鏇構 (製願選餘構醖鹽遞簾遞, 廠範壓蓋糧鏇壓獵鹹齋 ~ 鹽廠壓範鑰鑰願壓簾鹹) 更多