Glucagon-like peptide 1 receptor agonists (GLP-1RA), such as Ozempic and Wegovy, have been rapidly adopted for the treatment of obesity in both youth and adults. However, despite this rapid adoption and the known GLP-1RA mechanism of action for weight loss, which targets brain circuits responsible for appetite and eating behaviors, almost nothing is known about how these drugs affect the brain in youth who are treated for obesity, or how these drugs affect the brain of youth differently from adults. The goal of the current study is to compare youth and adults with obesity who are treated a GLP-1RA and measure potential difference in GLP-1RA associated change in brain function, appetite, and eating behaviors.

开始日期2026-05-01

申办/合作机构

University of Colorado Denver

[+1]

NCT06913023

/ Not yet recruiting临床2/3期IIT

Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus

The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of placebo and semaglutide therapy in 74 KTR at risk of post-transplant diabetes mellitus (PTDM).

开始日期2026-01-05

申办/合作机构

University Health Network

NCT06977438

/ Not yet recruiting临床4期IIT

Promoting Healthy Children and Youth

The rapid emergence of new and highly effective obesity medications has turned the field of pediatric weight management on its head. Adolescents living with obesity, their caregivers, healthcare providers, healthcare systems, policymakers, and payors are now wondering what role health behavior and lifestyle treatment (HBLT) has in terms of body mass index (BMI) reduction, improvements in quality of life and cardiometabolic health, and mitigating nutritional concerns when medications are used. Is intensive (26+ hours) of HBLT needed or could low intensity HBLT be an equally effective alternative; and if so, for whom? Our proposed project will answer these important questions that arise daily in the clinical setting and will generate critical new insights to guide decision-making for teens with obesity and the stakeholders who care deeply about them.

开始日期2026-01-01

申办/合作机构

University of Minnesota

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项与司美格鲁肽 (诺和诺德) 相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of semaglutide in people with obesity and cardiovascular disease without diabetes

Article

作者: Lübker, Christopher ; Lincoff, A. Michael ; Bøg, Martin ; Lingvay, Ildiko ; McEwan, Phil ; Toliver, Joshua C. ; Yeates, Florian ; Faurby, Mads ; Miller, Ryan ; Foos, Volker

AIMS:

The cardioprotective effects of semaglutide 2.4 mg reported in the SELECT cardiovascular (CV) outcomes trial (ClinicalTrials.gov NCT03574597) provide clinical benefit for subjects with overweight or obesity and established CV disease without type 2 diabetes (T2D). We assessed cost-effectiveness of semaglutide 2.4 mg in this population against the American College of Cardiology/American Heart Association value framework.

MATERIALS AND METHODS:

A cohort-level Markov-state cost-effectiveness model using trial-derived data with outcomes from a healthcare sector perspective measured over a lifetime horizon was developed. Treatment costs were based on US list prices; scenario analyses used literature-reported estimated rebates. Healthcare costs and benefits were discounted at 3.0%. A simulated cohort of 100,000 subjects was aligned to the SELECT trial population baseline characteristics and time-on-treatment. Subjects received either semaglutide 2.4 mg or placebo in addition to standard of care (SoC). Modelled outcomes included clinical events (CV events, progression to T2D, chronic kidney disease [CKD]) and health economic measures, including direct costs and quality-adjusted life years (QALYs).

RESULTS:

Mean semaglutide 2.4 mg treatment duration was 2.79 years. Per 100,000 subjects, treatment avoided 2,791 non-fatal myocardial infarctions, 3,000 coronary revascularizations, 487 non-fatal strokes, and 115 CV deaths over the modeled lifetime horizon. Average per-subject lifetime treatment costs were $47,353; savings arose from avoided T2D ($14,431), CKD ($2,074), and CV events ($1,512). Semaglutide 2.4 mg was associated with increased lifetime costs ($29,767), additional QALYs gained (0.218) and an incremental cost-effectiveness ratio of $136,271/QALY at list price; a scenario using an empirically estimated 48% rebate predicted $32,219/QALY.

LIMITATIONS:

The generalizability of observations from SELECT to a broader US population is unknown. Our model does not capture all outcomes nor costs that may be affected by weight loss. Modeling assumptions may present limitations.

CONCLUSIONS:

Semaglutide 2.4 mg use as in SELECT is cost-effective at list price, using a $150,000/QALY willingness-to-pay threshold.

2025-09-01·Obesity Pillars

Antiemetic effect of acupressure wristbands for GLP-1 medication associated nausea

Article

作者: Reyes, Anita ; Belarj, Soufiane ; Ziemke, Florencia ; Istfan, Nawfal ; Esguerra, Jem

Background:

Nausea is one of the most reported side effect of GLP-1 receptor agonists (GLP-1a). Current recommendations fall short in taming the symptoms, include antiemetic medication, behavior changes, GLP-1a dose adjustment, and often cause a disruption to treatment. Sea-Band® is a drug-free, class II FDA-cleared medical device for relief of nausea in motion sickness, morning sickness, chemotherapy and anesthesia induced nausea. The device is a set of soft, elastic, reusable acupressure wristbands (ACW) with a skin-facing plastic button worn below the wrist crease applying pressure at acupoint pericardium 6. We hypothesized that ACW was an effective tool for GLP-1a associated nausea.

Methods:

This was a one-arm, open-label, non-randomized, prospective interventional study evaluating the antiemetic effect of ACW in non-pregnant adults on GLP-1as with nausea. GLP-1a were semaglutide or tirzepatide. Exclusion criteria were patients on GLP-1a without nausea, recent use of antiemetic medications, other nausea-related conditions, history of gastroparesis, and uncontrolled gastroesophageal reflux disease. Patients were shown how to properly place and use ACW at the onset of nausea and were followed weekly for 4 weeks. Follow-ups assessed frequency of nausea, ACW use frequency and duration, and change in nausea.

Results:

359 episodes of nausea were recorded amongst 31 adult participants over 4 weeks. Adults, mean age 55, mean BMI 34, mean HbA1c 5.9 %, reported nausea over 80 % of the time on a weekly basis. ACW were used in all recorded episodes of nausea. Medication doses were kept stable throughout the duration of this study. Nausea relief was achieved within 5 min in one third of episodes, and in over 5 min but under 20 min in the remainder of the episodes. A logistic regression model was used to evaluate the likelihood of nausea relief. A consistent rate of nausea relief over 80 % was observed during the study period, adjusting for the correlation between reduced nausea episodes and reduced episodes.

Conclusion:

Although not a controlled trial, this pilot, proof of concept, pragmatic study suggests that ACW may offer a safe, self-administered, reusable, and drug-free option for managing GLP-1a associated nausea.ACW's nausea reducing effect was seen in over 80 % of episodes, and remained consistent throughout the study period. One third of participants experienced relief within 5 min of wearing ACW in the first three weeks. Given the relatively small sample size of the population, further large-scale investigations are justified. Nausea is common in day-to-day real-world use of GLP-1as, and our results suggest that using ACW may provide a first-line therapeutic intervention used ad libitum to tame a disruptive symptom, improve day-to-day well-being, and positively impact a person's treatment journey on GLP-1a.

2025-07-01·JOURNAL OF THE AMERICAN PHARMACISTS ASSOCIATION

TikTok’s Take on Adverse Effects for Glucagon-Like Peptide-1 and Gastric Inhibitory Polypeptide Receptor Agonists

Article

作者: Wantuch, Gwendolyn A ; Singleton, Jerica

BACKGROUND:

TikTok's MedTok is an interconnected network of patients, providers, and producers sharing knowledge and experiences of health-related topics. Awareness of popular content on weight loss medications can benefit healthcare professionals, especially regarding side effects and management.

OBJECTIVES:

Describe content in popular TikTok videos using side effect hashtags for gastric inhibitory peptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists. Compare content between healthcare and non-healthcare creators and reported side effects versus medication package inserts.

METHODS:

This observational study evaluated videos for popular GLP-1 and GIP receptor agonist side-effect hashtags on TikTok, in June 2023. Video metadata collected included content creator demographics, and content of video including side effects discussed and recommendations to address these. Side effects were compared to package insert data. Qualitative data was evaluated through descriptive coding, quantitative data through descriptive statistics and Pearson chi-square for comparisons.

RESULTS:

A total of 165 videos were analyzed. Content creators were mostly medication users (89%) and non-healthcare professionals (90%). Medication indications included weight loss (82%), PCOS (20%), and diabetes (6%). Diet, exercise, or weight loss were discussed in 34%, 16%, and 38% of videos, respectively. Non-healthcare professionals mentioned specific products to address side effects more frequently than healthcare professionals, 24% versus 13% (p = 0.292). All side effects mentioned in at least five videos aligned with medication package inserts, most commonly gastrointestinal disturbances, except for insomnia.

CONCLUSION:

Most content creators were non-healthcare professionals and medication users. Despite Ozempic and Mounjaro lacking FDA approval for weight loss at the time, it was the most identified indication. The alignment of most reported side effects with medication package inserts underscores the reliability of user-shared experiences, though discrepancies like insomnia were noted. Given TikTok's significant reach and influence, awareness of patient-reported experiences and recommendations is essential for healthcare providers to enhance care and dispel misconceptions.

5,290

项与司美格鲁肽 (诺和诺德) 相关的新闻（医药）

2025-07-01

·国际糖尿病idiabetes

大咖谈 | 乔洁教授：聚焦肥胖病理生理机制——司美格鲁肽的靶向干预策略

点击“蓝字”关注我们编者按：肥胖的病理生理机制复杂，其中脑-肠轴对食欲与能量代谢的调控至关重要。胰高糖素样肽-1受体激动剂（GLP-1RA）通过模拟内源性GLP-1，作用于大脑增强饱腹感、抑制食欲，同时在外周调节血糖、减缓胃排空及可能影响能量消耗，从而靶向干预肥胖核心环节。作为长效GLP-1RA周制剂，司美格鲁肽因其显著的减重疗效而备受瞩目。本期大咖谈，上海交通大学医学院附属第九人民医院乔洁教授从脑-肠轴调控食欲与能量代谢角度，结合关键临床证据，解析司美格鲁肽在肥胖治疗中的有效性和安全性，为理解其靶向干预策略提供科学视角。乔洁教授上海交通大学医学院附属第九人民医院主任医师，教授，博士生导师上海交通大学医学院附属第九人民医院内分泌科主任上海市医学会内分泌分会委员上海医学会内分泌分会性腺学组副组长中国生物物理学会临床罕见代谢病分会委员上海医师协会罕见病专委会委员美国内分泌学会（Endocrine Society）成员美国加州大学旧金山分校和美国密歇根大学访问学者长期从事内分泌与代谢病的临床工作和基础研究，在糖尿病、甲状腺疾病诊疗中积累了丰富的临床经验，专长于疑难性腺疾病的诊疗。发表SCI论文50余篇，以项目负责人承担国家自然基金5项，入选上海交通大学医学院新百人计划。《国际糖尿病》近年来，脑-肠轴受到广泛关注，请您从生理角度分享其调控食欲与能量代谢的机制是什么？乔洁教授：在激素信号通路层面，肠道分泌的肠促胰素，包括胰高糖素样肽-1（GLP-1）和胰多肽家族的肽YY（PYY），可经血液循环或迷走神经传入信号，作用于下丘脑弓状核的GLP-1受体。该作用可抑制食欲相关神经元（如NPY/AgRP神经元）的活性，同时激活饱腹感相关神经元（如POMC/CART神经元），从而减少摄食并增加能量消耗[1,2]。另外，胃分泌的胃饥饿素通过激活下丘脑的生长激素促分泌素受体（GHSR），刺激食欲并促进脂肪储存[3]。在神经通路介导方面，肠道的机械扩张或营养信号可经迷走神经传入孤束核，经整合后投射至下丘脑，调控摄食终止[4]。下丘脑弓状核还负责整合外周激素信号（如胰岛素、瘦素）及肠道信号，以维持能量摄入与消耗的动态平衡[5]。此外，传统观点认为肠道脂质吸收主要依赖于小肠的自主活动，如微绒毛表面积及肠腔-血液浓度梯度。然而，去年9月份王卫庆教授团队在Nature上发表的研究[6]揭示了大脑通过迷走神经运动背核（DMV）神经元直接调控小肠脂质吸收的机制：当DMV-迷走神经-空肠轴受到抑制时，小肠上皮细胞微绒毛长度缩短，导致吸收表面积减少，脂质吸收效率下降，未被吸收的脂质随粪便排出量相应增加。因此，脑-肠轴对于食欲与能量代谢的调控作用主要通过上述激素信号通路与神经通路实现。《国际糖尿病》食欲与能量代谢失衡的表现之一为肥胖，而这也是目前一大全球性公共卫生问题。在肥胖发生过程中，脑-肠轴的作用是什么？乔洁教授：肥胖的发生涉及复杂的病理生理机制。在肥胖患者中，多种激素分泌存在异常，例如餐后GLP-1和PYY的释放受损，导致饱腹感延迟及食欲抑制功能减弱[7,8]，这与患者的过度进食行为相关。同时，神经信号敏感性下降是重要因素。中枢神经系统对瘦素和胰岛素的敏感性降低，抑制下丘脑POMC神经元的活性，加剧能量正平衡[9]。肥胖还导致迷走神经对肠道传入信号的响应减弱，延缓饱腹信号向中枢的传递[10]。此外，肠道菌群-脑轴功能紊乱参与其中。肠道菌群失调，如厚壁菌门与拟杆菌门比例异常，通过短链脂肪酸（SCFA）代谢途径影响肠促胰素GLP-1的分泌，并干扰中枢食欲调控，从而促进肥胖的发生发展[11,12]。《国际糖尿病》肠道激素作用被深入探索，且作为干预靶点研发了诸多药物。其中，GLP-1RA是如何通过脑-肠轴发挥减重作用的？乔洁教授：GLP-1RA的作用由GLP-1受体介导，而GLP-1受体在体内广泛表达，除了外周的胰岛β细胞、心脏、肺、胃肠道、肾脏等，中枢神经系统摄食调节区域如下丘脑、孤束核、后脑区及纹状体的神经元亦存在GLP-1受体表达[13]。近年来，随着多种GLP-1RA的研发与临床应用，基础与临床研究证实，其作用不仅限于调节胰岛α和β细胞功能，而是广泛影响外周靶组织及下丘脑食欲中枢。GLP-1RA通过脑-肠轴介导减重作用的机制主要包括以下方面：其一，作用于中枢神经系统调控食欲。该类药物可透过血脑屏障或经由迷走神经传入信号，激活下丘脑弓状核、室旁核及脑干孤束核的GLP-1受体，抑制食欲相关神经元（如NPY/AgRP神经元）活性，同时增强饱腹感信号神经元（如POMC神经元）功能，从而减少摄食行为[14]。其二，发挥外周作用，延缓胃排空。GLP-1RA作用于胃肠道GLP-1受体，延缓胃排空速度，延长食物在胃肠道的滞留时间。食物滞留产生的机械性扩张刺激迷走神经传入纤维，向中枢传递饱腹信号[15,16]，临床观察中看到该效应可显著增强患者的饱腹感并降低进食欲望。其三，迷走神经介导脑-肠轴信号传递。肠道GLP-1受体激活后，通过迷走神经传入通路将信号传递至脑干孤束核，经整合后投射至下丘脑，最终产生食欲抑制作用[17]。Laurie L Baggio和Daniel J Drucker曾在一篇述评中对GLP-1RA如何作用于大脑来控制食欲和体重进行了总结（图1）[18]。图1. GLP-1RA通过下丘脑弓状核中功能性GLP-1受体的信号传导机制来减少摄食和体重《国际糖尿病》以GLP-1RA周制剂司美格鲁肽为例，现有临床证据如何支持其用于超重/肥胖患者的疗效与安全性？乔洁教授：司美格鲁肽在超重或肥胖患者中的疗效与安全性证据主要来源于STEP系列临床研究。该系列研究纳入体重指数（BMI）≥30 kg/m2，或BMI≥27 kg/m2且伴有≥1种体重相关合并症的患者。其中，STEP 1~4研究[19-22]共纳入近5000例受试者，随访期均为68周。研究结果一致证实司美格鲁肽2.4 mg具有显著的减重效果。具体而言：STEP 1研究：在不合并糖尿病的超重或肥胖患者中，司美格鲁肽2.4 mg治疗68周后，受试者平均体重较基线下降14.9%，显著优于安慰剂组的2.4%[19]；STEP 2研究：在合并2型糖尿病的超重或肥胖患者中，司美格鲁肽2.4 mg组体重降低9.6%，安慰剂组为3.4%[20]；STEP 3研究：在强化生活方式干预基础上联用司美格鲁肽2.4 mg，进一步提升减重效果，体重降低16.0%，显著高于安慰剂组的5.7%[21]；STEP 4研究：受试者在整个试验期间持续使用司美格鲁肽2.4 mg，治疗组平均体重降幅达17.4%，安慰剂组为5.0%[22]。关于体重的稳定和维持，STEP 5研究长达104周的随访结果显示，司美格鲁肽2.4 mg可使患者平均体重较基线减轻15.2%，且在2年随访期内未观察到显著反弹[23]。除减重外，司美格鲁肽2.4 mg治疗还显著改善了多项代谢指标，包括腰围、收缩压、舒张压、糖化血红蛋白（HbA1c）、空腹血糖以及低密度脂蛋白胆固醇（LDL-C）等。STEP系列研究对安全性进行了全面评估，最常见的不良事件为轻至中度的短暂性胃肠道反应。此类反应多发生于剂量递增期，通常可耐受，并随治疗时间的延长在多数患者中得到缓解。结语基于脑-肠轴在食欲与能量代谢调控中的核心作用，肥胖的发生发展与相关激素信号异常、神经敏感性下降及肠道菌群紊乱密切相关。GLP-1RA通过模拟内源性GLP-1，靶向作用于中枢神经系统和外周组织，实现对肥胖的多环节干预。长效GLP-1RA周制剂司美格鲁肽在大型临床研究中展现出显著且持久的减重疗效，同时可改善多项代谢指标，且安全性良好。这为肥胖的病理生理机制理解和靶向治疗提供了重要科学依据。参考文献（上下滑动可查看）1. Müller TD, et al. Glucagon-like peptide 1 (GLP-1). Mol Metab. 2019; 30: 72-130.2. Drucker DJ. Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1. Cell Metab. 2018; 27(4): 740-756.3. Cummings DE, et al. Plasma ghrelin levels after diet-induced weight loss or gastric bypass surgery. N Engl J Med. 2002; 346(21): 1623-1630.4. Berthoud HR. The vagus nerve, food intake and obesity. Regul Pept. 2008; 149(1-3): 15-25. https://conference.idf.org/cmportal/searchable/idf23/config/normal#!abstractdetails/00002446905. Schwartz MW, et al. Central nervous system control of food intake. Nature. 2000; 404(6778): 661-671.6. Lyu Q, et al. A brain-to-gut signal controls intestinal fat absorption. Nature. 2024; 634(8035): 936-943.7. Batterham RL, et al. Inhibition of food intake in obese subjects by peptide YY3-36. N Engl J Med. 2003; 349(10): 941-948.8. Lean ME, Malkova D. Altered gut and adipose tissue hormones in overweight and obese individuals: cause or consequence? Int J Obes (Lond). 2016; 40(4): 622-632.9. Friedman JM. Leptin and the regulation of body weight. Keio J Med. 2011; 60(1): 1-9.10. de Lartigue G. Role of the vagus nerve in the development and treatment of diet-induced obesity. J Physiol. 2016; 594(20): 5791-5815.11. Turnbaugh PJ, et al. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006; 444(7122): 1027-1031.12. Byrne CS, et al. The role of short chain fatty acids in appetite regulation and energy homeostasis. Int J Obes (Lond). 2015; 39(9): 1331-1338.13. Jastreboff AM, Kushner RF. New Frontiers in Obesity Treatment: GLP-1 and Nascent Nutrient-Stimulated Hormone-Based Therapeutics. Annu Rev Med. 2023; 74: 125-139.14. Secher A, et al. The arcuate nucleus mediates GLP-1 receptor agonist liraglutide-dependent weight loss. J Clin Invest. 2014; 124(10): 4473-4488.15. Maselli DB, Camilleri M. Effects of GLP-1 and Its Analogs on Gastric Physiology in Diabetes Mellitus and Obesity. Adv Exp Med Biol. 2021; 1307: 171-192.16. Williams EK, et al. Sensory Neurons that Detect Stretch and Nutrients in the Digestive System. Cell. 2016; 166(1): 209-221.17. Berthoud HR. Vagal and hormonal gut-brain communication: from satiation to satisfaction. Neurogastroenterol Motil. 2008; 20 Suppl 1(0 1): 64-72.18. Baggio LL, Drucker DJ. Glucagon-like peptide-1 receptors in the brain: controlling food intake and body weight. J Clin Invest. 2014; 124(10): 4223-4226.19. Wilding JPH, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021; 384(11): 989-1002.20. Davies M, et al. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021; 397(10278): 971-984.21. Wadden TA, et al. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults with Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021; 325(14): 1403-1413.22. Rubino D, et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults with Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021; 325(14): 1414-1425.23. Garvey WT, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022; 28(10): 2083-2091.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。

细胞疗法

2025-07-01

·PRNewswire

Levi & Korsinsky Reminds Shareholders of a Lead Plaintiff Deadline of August 25, 2025 in Hims & Hers Health, Inc. Lawsuit - HIMS

NEW YORK, July 1, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Hims & Hers Health, Inc. ("Hims & Hers Health, Inc." or the "Company") (NYSE: HIMS) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Hims & Hers Health, Inc. investors who were adversely affected by alleged securities fraud between April 29, 2025 and June 23, 2025. Follow the link below to get more information and be contacted by a member of our team: HIMS investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: The filed complaint alleges that defendants made false statements and/or concealed that: (1) Hims was engaged in the "deceptive promotion and selling of illegitimate, knockoff versions of Wegovy® that put patient safety at risk;" (2) as a result, there was a substantial risk that the Company's collaboration with Novo Nordisk would be terminated; and (3) as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. WHAT'S NEXT? If you suffered a loss in Hims & Hers Health, Inc. during the relevant time frame, you have until August 25, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT: Levi & Korsinsky, LLP Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 17th Floor New York, NY 10004 [email protected] Tel: (212) 363-7500 Fax: (212) 363-7171 SOURCE Levi & Korsinsky, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

专利侵权

2025-07-01

·BioPlus

诺和诺德vs.礼来：2大巨头，在ADA上都讲了什么？

作者：Medicina本文分享，2025年美国糖尿病协会（ADA）第85届科学年会上，诺和诺德与礼来，披露的一些管线进展和产品开发策略。AMYR vs. GLP-1R 从诺和诺德公司针对肥胖市场的产品组合策略中可以看出，减重深度排序为：Amylin类似物Cagrilintide＜GLP-1R激动剂Semaglutide＜Amylin类似物+GLP-1R激动剂CagriSema、AMYR/GLP-1R激动剂Amycretin＜三重激动剂，而安全性的排序与疗效相反。诺和诺德旨在通过针对不同患者特征、治疗目标以及安全性和耐受性来满足市场需求。诺和诺德的追赶诺和诺德公司在肥胖治疗领域的产品线正在不断扩展，其中Semaglutide已经成功上市。目前处于III期的产品为CagriSema（Amylin类似物+GLP-1R激动剂）、Amylin类似物Cagrilintide，以及GLP-1R/amylin receptor 激动剂Amycretin，可以看出诺和诺德的迭代产品选择了重点布局Amylin赛道。值得一提的是，今年3月份，诺和诺德从Lexicon Pharmaceuticals引进了临床前ACSL5抑制剂项目，以拓展减肥管线。诺和诺德（Novo Nordisk）公司由于礼来公司（Eli Lilly）在肥胖治疗领域的强势竞争，导致其市场份额被侵占，处于追赶状态。礼来的Tirzepatide（GLP-1R/GIPR激动剂，商品名为Mounjaro和Zepbound）在市场上表现出色，而诺和诺德一直未能推出能够超越该产品的资产，这在其三期临床资产Cagrisema（cagrilintide+semaglutide；amylin类似物+GLP-1R激动剂）的表现得到了体现。在糖尿病协会（ADA）会议上，诺和诺德公司分享了关于其两项关键资产的更多细节，这两项资产旨在帮助其在肥胖治疗领域重新站稳脚跟，分别是Cagrisema（cagrilintide+semaglutide）和amycretin（GLP-1R/AMYR激动剂），它们都是GLP-1/amylin receptor 激动剂。公司分享了来自Cagrisema的REDEFINE-1试验的进一步结果，分析师们认为该结果达到了礼来Tirzepatide所设定的标准，但并未击败其竞争对手。对于诺和诺德公司的另一个“关键产品”——Amycretin（GLP-1R/AMYR激动剂），分析师们希望找到证据来验证该公司将该资产推进至三期临床试验的决定，并进一步明确其与Tirzepatide的竞争优势。然而，Amycretin一期临床试验中采用的快速滴定方案让分析师们感到困惑，多位经纪人表示，该候选药物的安全性和有效性难以解读——这可能会将对其疗效特征的清晰理解推迟到2028年，届时公司预计将公布三期临床数据。诺和诺德公司在Amylin（胰淀素）领域进行了重点布局，胰淀素是一种多功能的激素，它在人体内具有多种作用，包括：①血糖调节，胰淀素能够增加对瘦素的响应性并减少胰高血糖素的分泌。②食欲调节，它可以减少食欲和能量摄入，同时增加饱腹感。③骨骼调节，胰淀素有助于抑制吸收和促进骨骼形成。④胃肠道作用，它能够减少胃酸分泌和胃排空。胰淀素类似物根据不同的分子骨架和受体选择性展现出不同的特性。诺和诺德的Amylin研发管线包括多个分子，它们处于不同的临床试验阶段：①Cagrilintide：Amylin类似物，已经进入III期临床试验。②Amycretin：GLP-1R/AMYR激动剂，即将开始III期临床试验。③Triple：这是一种三重激动剂，目前处于I期临床试验。④Amylin 355：也处于I期临床试验。⑥Amylin 1213：同样处于I期临床试验。礼来领跑新赛道礼来在基于肠促胰素的疗法并非一夜成功，从2005年上市的GLP-1R激动剂Byetta（艾塞那肽），到2014年获批上市的度拉糖肽（GLP-1-Fc融合蛋白）。2017年，GIPR/GLP-1R激动剂tirzepatide的首次人体数据显示出减重效果，2022年获批上市治疗T2D，并于2023年获批上市治疗肥胖，2024年获批治疗阻塞性睡眠呼吸暂停。与诺和诺德的下一代产品重点布局在Amylin不同，礼来的肥胖迭代产品分为三个创新主题：①在肠促胰素方面，开发口服和长效多功能肠促胰素，围绕GIPR、GCGR与GLP-1R进行单独或组合开发。②Amylin管线，布局了一个产品，具不同选择性特征的Eloralintide（AMYR激动剂）。③新靶点方面，包括Bimagrumab（抗ACVR2B/ACVR2A单抗）和Nisotriosamide（PYY类似物），以增加肌肉等方面的New benefits。虽然诺和诺德公司正在努力跟上替西帕肽（Tirzepatide）的步伐，但礼来公司一直处于攻势，为下一代肥胖产品造势，其中以口服小分子GLP-1激动剂orforglipron为主导。在ADA会议上，公司分享了orforglipron的ACHIEVE-1试验的详细结果，没有看到严重的肝脏毒性。此外，礼来公司旨在通过口服候选药物的便利性来抢占诺和诺德Semaglutide的市场份额——尽管如果其疗效过于显著，它也可能开始侵蚀其自身的Tirzepatide业务。礼来公司还分享了针对活化素受体阻断抗体bimagrumab（anti-ACVR2B/ACVR2A单抗）和胰淀素激动剂eloralintide（AMYR激动剂）的早期阶段数据，这两者都可能在肥胖市场中服务于相对较小的人群。在ADA会议上展示的这两种药物的结果都可能是 Best-in-class。将bimagrumab添加到司美格鲁肽中同时增加了减重和瘦体重的保持，研究结果表明，bimagrumab和司美格鲁肽联合疗法相比单独使用任一疗法，能更显著地减少体重、体脂、内脏脂肪和炎症标志物。联合疗法中，脂肪质量占总减重量的92.9%，而单独使用司美格鲁肽时这一比例为71.5%；单独使用司美格鲁肽时下降了15.7%。值得注意的是，单独使用bimagrumab时，100%的减重量都归因于脂肪质量，并且总瘦体重增加了2.5%。而Eloralintide（AMYR激动剂）则产生了迄今为止胰淀素单一疗法中最快的减重效果。然而，礼来公司到目前为止强调了每个候选药物相对较窄的市场，将bimagrumab的使用案例描述为可能超重且已经缺乏肌肉量的老年患者，而其胰淀素激动剂为那些难以忍受肠促胰素胃肠道副作用的患者。小结肥胖治疗领域正迎来新的发展阶段，其中产品创新的方向涵盖了给药途径、用药频率、额外代谢获益、耐受性、减重深度、减重质量以及血糖控制程度等多个方面。随着肥胖治疗市场逐渐细分，这些细分市场标准揭示了不同患者在选择治疗方案时的多样化需求和偏好。这不仅为制药公司提供了更精准的市场定位，也推动了企业开发更符合患者需求的治疗产品。欢迎大家加入BioPlus微信交流群，共同探讨。BioPlus微信交流群申请入群申请联系人：Lisa邮箱：lisa.li@bp-bioplus.com电话：18662346610（同微信）入群申请，请先添加Lisa微信，并分享名片入群画像：Biotech/药厂研发/BD、投资机构、临床医生等入群福利：不定时行业资料包分享参考文献：https://firstwordpharma.com/story/5976218https://investor.lilly.com/static-files/36604492-7d65-4649-bc20-f7b4372c2b2bhttps://www.novonordisk.com/content/dam/nncorp/global/en/investors/pdfs/ada/novo-nordisk-r-and-d-investor-event.pdf 拓展阅读 BioPlus-海外寻找资产系列：1.AACR复盘：9家CDH17-ADC数据对比2.自免小众靶点APRIL，正在悄悄火起来了！BioPlus国际大会跟踪系列：1. 2025 ASCO：ADC、双抗/多抗，有哪些看点？（附一览表）2. 2025 AACR 双抗与ADC有哪些看点？3. 小细胞肺癌领域，下一步将如何“破局”，ADC or TCE？4. ELCC 讨论：NSCLC的ADCs最新进展5. 未来ADC发展方向：新靶点，新载荷，双靶点/双表位...6. 2025 ASCO 重点项目临床数据：有哪些精彩看点？7. 2025 ASCO 重点项目临床数据（二）BioPlus靶点/管线研究系列：1. “待爆”：CDH17 ADC项目大比拼，谁将脱颖而出?2. PD-1激动剂在自免疾病项目数据盘点：失败项目的“坑”与启示3. 上临床就能卖？DLL3 ADC这么好卖？4. 胰腺癌三大热门靶点：CLDN18.2、EGFR、RAS5. TSLP/SCF双抗，下一个自免待爆靶点组合？6. GPC3靶点临床屡败，TCE能改写格局么？7. 亮相AACR，曾被临床终止的ADC靶点Ly6E，能否卷土重来？8. 最高18.45亿美元！赛诺菲为何重金买了两款TL1A双抗？9. 2025 Q1：BMS、Sanofi和Roche管线调整，哪些项目被砍？10. 现场！2025AACR：KRAS抑制剂的百花齐放11. IL-17小分子抑制剂，能否杀出重围？12.全球首款：华东医药申报MUC17 ADC药物13.荨麻疹 first-in-class双抗提交临床试验申请BioPlus技术平台深入剖析系列：1. TCE 免疫共刺激信号之选：CD2，一颗冉冉升起的新星2. BD爆发前夜！6家TCE Probody技术平台深度盘点3. TCE Probody：Amgen携重磅技术“破局“，改写行业格局？4. 有人放弃，有人前行！自免TCE全球管线大盘点5. Immunocore将TCR疗法照进现实，向自免疾病迈进6. B细胞清除免疫重置：SLE等疾病长效缓解终成现实！7. 国内50家CD3平台序列来源汇总8. CD28共刺激最终章？ZW209 DLL3/CD3/CD28 三抗剑指 Amgen9. TCE 结构之争落幕：行业用行动给出 “标准答案”10. CD3 VHH猴交叉：重要吗？11.Genentech创新前沿：口服VHH抗体，靶向IL-23R12.AbbVie专利公开：靶向PSMA/STEAP1 双抗ADCBioPlus人物专访：1. 专访肖亮：卖青苗不一定是坏事，这是中国Biotech长成参天大树的必经之路2. 专访王刚，恺佧生物这些年的“出海”之旅？

临床3期引进/卖出

100 项与司美格鲁肽 (诺和诺德) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10025	司美格鲁肽 (诺和诺德)	A10BJ06	DB13928

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
慢性肾病	美国	Novo Nordisk A/S	2025-01-28
慢性肾病	美国	Novo Nordisk, Inc.	2025-01-28
脑卒中	澳大利亚	Novo Nordisk Pharmaceuticals Pty Ltd.	2024-12-16
心肌梗塞	加拿大	Novo Nordisk Canada, Inc.	2024-11-27
肥胖	美国	Novo Nordisk, Inc.	2021-06-04
超重	美国	Novo Nordisk, Inc.	2021-06-04
2型糖尿病	美国	Novo Nordisk, Inc.	2017-12-05

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
非酒精性脂肪性肝炎	申请上市	美国	Novo Nordisk A/S	2025-04-30
白蛋白尿	临床3期	加拿大	Novo Nordisk A/S	2022-03-14
白蛋白尿	临床3期	德国	Novo Nordisk A/S	2022-03-14
白蛋白尿	临床3期	荷兰	Novo Nordisk A/S	2022-03-14
白蛋白尿	临床3期	西班牙	Novo Nordisk A/S	2022-03-14
膝关节炎	临床3期	美国	Novo Nordisk A/S	2021-10-01
膝关节炎	临床3期	加拿大	Novo Nordisk A/S	2021-10-01
膝关节炎	临床3期	哥伦比亚	Novo Nordisk A/S	2021-10-01
膝关节炎	临床3期	丹麦	Novo Nordisk A/S	2021-10-01
膝关节炎	临床3期	法国	Novo Nordisk A/S	2021-10-01

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临床结果

适应症

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


NCT03574597 (SELECT, Pubmed \| J Med Econ)	临床3期	心血管疾病 \| 肥胖	-	Semaglutide 2.4 mg	衊範鑰鹹願鹹憲膚蓋齋(鏇蓋憲築遞壓網製願襯) = 廠遞壓醖壓鬱窪餘鏇夢鑰築選選窪齋製鹹襯觸 (糧鬱顧網獵網簾醖襯襯 ) 更多	积极	2025-12-31
NCT06282458 (QUALITY, GlobeNewswire) 人工标引	临床2期	肌肉萎缩 \| 肥胖	148	Placebosemaglutide (after discontinuation of semaglutide; Day 112 to Day 196, ITT population)	廠選積鹹鹹膚壓衊鑰獵(鏇糧窪窪遞壓艱艱選獵) = 鑰膚糧鏇壓網構遞顧衊網蓋膚鏇衊簾鑰築艱夢 (觸齋夢衊夢衊範繭積鹽, 0.40) 更多	积极	2025-06-24
				Enobosarm 3mgsemaglutide (after discontinuation of semaglutide; Day 112 to Day 196, ITT population)	廠選積鹹鹹膚壓衊鑰獵(鏇糧窪窪遞壓艱艱選獵) = 網廠鑰鬱繭廠衊獵餘襯網蓋膚鏇衊簾鑰築艱夢 (觸齋夢衊夢衊範繭積鹽, 0.40) 更多
NEWS 人工标引	N/A	肥胖	-	Semaglutide/Tirzepatide	選繭窪鬱構憲鏇鑰遞構(廠衊網鬱網顧製窪鹹積) = 獵蓋選觸選築遞築鬱餘鹽網鬱製夢鹽鏇襯構積 (夢遞憲齋壓繭獵鬱衊簾 ) 更多	-	2025-06-10
NCT04822181 (Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis, Pubmed \| N Engl J Med)	临床3期	非酒精性脂肪性肝炎	1,197	Semaglutide 2.4 mg	壓築壓遞願壓淵積艱獵(淵窪鬱顧繭膚齋遞膚淵) = 積鏇鏇窪顧鹹選淵醖鑰網顧醖獵膚鏇願膚壓鹽 (鏇衊廠廠獵願築鑰顧蓋, 7.5 ~ 21.3) 更多	积极	2025-06-05
				Placebo	壓築壓遞願壓淵積艱獵(淵窪鬱顧繭膚齋遞膚淵) = 鏇憲壓衊築蓋糧淵憲淵網顧醖獵膚鏇願膚壓鹽 (鏇衊廠廠獵願築鑰顧蓋 ) 更多
NCT03914326 (SOUL, Pubmed \| N Engl J Med \| NEWS) 人工标引	临床3期	2型糖尿病	9,650	Oral Semaglutide	選夢獵醖窪鏇醖範淵蓋(糧蓋醖簾鹽齋淵鏇艱鏇) = 構鑰鹽窪襯窪廠艱醖築製顧選膚壓鹹廠艱範積 (齋壓夢糧構積鹽鏇簾繭 ) 更多	积极	2025-05-29
				Placebo	選夢獵醖窪鏇醖範淵蓋(糧蓋醖簾鹽齋淵鏇艱鏇) = 顧廠製廠獵醖衊積鹹壓製顧選膚壓鹹廠艱範積 (齋壓夢糧構積鹽鏇簾繭 ) 更多
NCT04822181 (ESSENCE, NEWS) 人工标引	临床3期	非酒精性脂肪性肝炎	-	司美格鲁肽（Wegovy）2.4 mg	鑰餘鬱積糧壓遞鑰簾獵(鑰蓋鑰選壓壓鹽襯膚淵) = 襯廠鹽壓製鹽壓鑰顧壓願壓構鹽鑰齋窪願壓繭 (築築築積淵顧鹹構齋選 ) 更多	积极	2025-05-21
				Placebo	鑰餘鬱積糧壓遞鑰簾獵(鑰蓋鑰選壓壓鹽襯膚淵) = 蓋窪鏇壓襯選鹽醖淵願願壓構鹽鑰齋窪願壓繭 (築築築積淵顧鹹構齋選 ) 更多
ATS2025	N/A	特发性肺纤维化	-	GLP-1 agonists	積憲鑰選蓋積鏇網蓋觸(製憲壓選顧艱壓製窪範): HR = 0.62 (95% CI, 0.53 ~ 0.74), P-Value = <0.01	积极	2025-05-16
				Glucagon-Like Peptide-1 Agonists (No GLP-1 agonists)
NCT03574597 (SELECT, PRNewswire) 人工标引	临床3期	心血管疾病	17,604	Wegovy® 2.4 mg	顧窪鹽糧鹽憲廠糧鹽憲(構艱襯餘夢淵鏇積淵範): HR = 0.63 (95% CI, 0.41 ~ 0.95) 更多	积极	2025-05-13
				Placebo
NEWS 人工标引	N/A	肥胖	-	司美格鲁肽 (2.4mg)	齋觸窪齋糧蓋鹽淵鏇簾(簾淵蓋鑰積遞夢艱鑰鏇) = 鑰遞醖範選淵膚網艱餘醖簾壓醖積壓範壓夢鑰 (觸壓獵繭壓糧壓範鹹範 ) 更多	积极	2025-05-07
NCT05786521 (CTgov)	临床4期	2型糖尿病 \| 胰岛素抵抗 \| 糖尿病前期 ... 更多	20	Semaglutide Injectable Product+Lifestyle Counseling (Semaglutide and Lifestyle Intervention)	憲網鏇獵廠選範製襯構(窪積艱淵壓壓遞淵壓鬱) = 糧鏇糧膚蓋遞遞鏇製範衊糧選廠壓遞壓鏇醖獵 (觸願壓鹹憲範鹽網餘積, 醖遞鹽製鏇範鏇餘衊壓 ~ 網選憲築築繭網鏇糧鏇) 更多	-	2025-05-04
				Lifestyle Counseling (Lifestyle Intervention)	憲網鏇獵廠選範製襯構(窪積艱淵壓壓遞淵壓鬱) = 艱製鹽築鹹獵夢衊鬱鬱衊糧選廠壓遞壓鏇醖獵 (觸願壓鹹憲範鹽網餘積, 觸遞淵範積獵獵襯願願 ~ 鬱窪夢鑰襯觸鏇顧構遞) 更多