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]

NCT07179120

/ Not yet recruiting临床2期IIT

Male Fertility Preservation: Efficacy Evaluation of GLP-1Receptor Agonist Therapy for Infertility in Obese Males - A Multicenter Clinical Randomized Controlled Trial

Why is this study being done? Obesity can harm men's fertility by lowering sperm quality and hormone levels, making it harder to have children. Weight loss through diet and exercise helps, but it's often hard to stick with. New medicines called GLP-1 receptor agonists, like semaglutide (Ozempic) and tirzepatide (Mounjaro), help people lose weight and improve health. Early studies suggest these drugs might also boost sperm health in obese men, but more proof is needed. This study tests if these drugs can safely improve fertility in obese men who are having trouble conceiving.
What will happen in this study?
This is a 48-week study at several hospitals in China. About 180 men will be randomly assigned to one of three groups:
Group 1: Standard lifestyle changes, like a healthy diet and exercise, guided by experts.
Group 2: Weekly injections of semaglutide, starting low and increasing as tolerated.
Group 3: Weekly injections of tirzepatide, starting low and increasing as tolerated.
All men will have regular check-ups, including blood tests, semen analysis, and weight measurements. We will track sperm quality, hormone levels, weight loss, and whether their partners get pregnant naturally. The study includes an 8-week adjustment period, 24 weeks of treatment, and 16 weeks of follow-up.
Who can join this study? Men aged 20-45 who are married, obese (BMI 28 or higher or waist size 90 cm or more), and have been trying to have a baby for at least a year without success due to low sperm count or poor sperm movement. Their female partners must be under 40 and have no major fertility issues. Men must be willing to attend visits and provide samples. People with serious health problems, recent use of similar drugs, or other causes of infertility (like genetic issues) cannot join.
How long will this study last? The full study lasts 48 weeks (about 11 months), with visits every 4-8 weeks, plus monthly phone check-ins for pregnancy updates.
What are the possible benefits and risks? Benefits: If the drugs work, men may lose weight, improve sperm quality, and have a better chance of their partners getting pregnant naturally. They might also feel healthier overall. Risks: Common side effects include nausea, vomiting, or diarrhea from the drugs, which usually improve over time. Rare risks include pancreas inflammation or gallbladder issues. Lifestyle changes might cause minor injuries from exercise. All side effects will be monitored closely, and participants can quit anytime. Insurance covers any study-related harm.

开始日期2026-05-01

申办/合作机构

温州医科大学附属第一医院

NCT07090343

/ Not yet recruiting临床3期IIT

Semaglutide for Reducing Cardiovascular Events in Patients Undergoing Transcatether Aortic Valve Replacement

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the safety and efficacy of once-weekly semaglutide 2.4 mg in adult patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) who meet current clinical criteria for semaglutide treatment. A total of 826 participants will be randomized 1:1 to receive semaglutide or placebo as an add-on to standard-of-care, starting 3 months before TAVR and continuing for 24 months post-procedure. The primary endpoint is time to first occurrence of a composite of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke or transient ischemic accident (TIA), and hospitalization for heart failure (HF). The study is event-driven and powered to detect a 20% relative risk reduction in primary outcome events. This trial aims to address the unmet need for medical therapies that improve outcomes in patients with severe AS following TAVR, with potential for direct clinical implementation.

开始日期2026-04-01

申办/合作机构

Leids Universitair Medisch Centrum

100 项与司美格鲁肽 (诺和诺德) 相关的临床结果

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100 项与司美格鲁肽 (诺和诺德) 相关的专利（医药）

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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

Impact of semaglutide 2.4 mg on healthcare resource utilization and medical costs in patients with atherosclerotic cardiovascular disease in the United States (SHINE-ASCVD)

Article

作者: Zhao, Zhenxiang ; Alvarez, Sara ; Michalak, Wojciech ; Faurby, Mads ; Fitch, Angela

BACKGROUND:

Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of morbidity and mortality. Semaglutide 2.4 mg (Wegovy) has demonstrated improved outcomes in patients with overweight or obesity (ov/ob) and ASCVD, but its impact on medical costs and healthcare resource utilization (HCRU) remains unknown.

AIMS:

To compare all-cause medical costs and HCRU among patients with ov/ob and ASCVD treated with semaglutide 2.4 mg versus semaglutide-untreated controls.

MATERIALS AND METHODS:

This observational cohort study utilized Komodo's Healthcare Map and included patients with ov/ob and ≥1 diagnosis of ASCVD during the baseline period with ≥12 months of insurance coverage before and after the index date. Patients in the semaglutide 2.4 mg cohort initiated treatment after 4 June 2021 and stayed adherent. Semaglutide-untreated controls were randomly selected and 1:4 propensity score matched based on baseline demographics, clinical characteristics, medical costs, and HCRU. Medical costs and HCRU were compared using generalized linear models.

RESULTS:

770 semaglutide 2.4 mg-treated patients and 3,080 controls were included. In the year following treatment initiation, semaglutide 2.4 mg was associated with 22% lower mean medical costs versus controls (-$4,639 per patient per year [PPPY]; cost ratio = 0.78, 95% confidence interval [CI] 0.67, 0.89). This difference is mainly due to lower inpatient costs with semaglutide 2.4 mg, which were 65% lower than controls (-$3,593; cost ratio = 0.35 [95% CI 0.21, 0.49]), along with a 48% lower inpatient visit rate (0.08 vs. 0.15; rate ratio = 0.52 [95% CI 0.34, 0.70]).

LIMITATIONS:

Limitations inherent to retrospective claims analyses apply to this study.

CONCLUSIONS:

This real-world analysis shows significantly lower annual medical costs and HCRU with semaglutide 2.4 mg versus no semaglutide 2.4 mg treatment in patients with ov/ob and ASCVD. Improving outcomes with semaglutide 2.4 mg combined with lower costs and HCRU may help slow the growing burden of ASCVD in this population.

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.

2025-12-01·SOCIAL SCIENCE & MEDICINE

Even with diet and exercise, Ozempic use reduces perceived effort and praiseworthiness of resulting weight loss

Article

作者: Savulescu, Julian ; Dranseika, Vilius ; Devolder, Katrien ; Hannikainen, Ivar ; Earp, Brian D ; Brown, Rebecca C H ; Bachmakova, Maria ; Ryan, Nanette ; Buyukbabani, Mey Bahar ; Everett, Jim A C

The injectable medication Ozempic (semaglutide) has demonstrated unprecedented effectiveness in promoting significant weight loss. However, its use has sparked moral debates, with critics dismissing it as a mere "shortcut" compared to traditional methods like diet and exercise. This study investigates how weight loss method-Ozempic, diet/exercise, or a combination of both-impacts perceptions of effort, praiseworthiness, and identity/value change. We used a contrastive vignette technique in two experiments (combined N = 1041, demographically representative for age, sex, and ethnicity) to study the attitudes of US participants toward a fictional character who lost 50 pounds through one of the three described methods. Weight loss through diet/exercise alone was deemed most effortful and most praiseworthy, whereas Ozempic use, even when combined with diet/exercise, was rated as both less effortful and less praiseworthy than diet/exercise alone. Ozempic use with no mention of diet/exercise was rated as least effortful and least praiseworthy. Compared to diet and exercise alone, Ozempic use also decreased perceptions that the individual had really changed as a person, or experienced a change in their underlying values. We discuss potential implications, address study limitations, and provide suggestions for further work.

6,624

项与司美格鲁肽 (诺和诺德) 相关的新闻（医药）

2025-11-13

·国际糖尿病idiabetes

从二级预防到一级预防：司美格鲁肽2.4 mg可为既往无心血管疾病的超重/肥胖人群提供心血管保护

点击“蓝字”关注我们编者按：近年来，GLP-1受体激动剂（GLP-1RA）在代谢与心血管领域的跨界价值日益凸显。SELECT[1]大型随机对照试验已证实司美格鲁肽2.4 mg在已确诊动脉粥样硬化性心血管疾病（ASCVD）患者中的心血管获益，但其在更广泛人群——仅具ASCVD风险因素但无既往心血管事件的超重/肥胖个体中的真实世界效果仍缺乏充分证据。近日，一项基于美国真实世界数据库、纳入逾14万人的研究首次系统评估了司美格鲁肽2.4 mg在此类“一级预防”人群中的心血管保护作用[2]。该研究结果于2025年11月5日在美国肥胖周（Obesity Week 2025）会议上进行了口头报告，为临床实践提供了重要参考。研究背景与设计 SELECT试验已证实，在已确诊心血管疾病（CVD，心肌梗死[MI]、卒中和/或外周动脉疾病[PAD]）且合并超重/肥胖不伴糖尿病的患者中，每周一次皮下注射司美格鲁肽2.4 mg可显著降低主要不良心血管事件（MACE）风险20%。真实世界研究SCORE[3]显示，司美格鲁肽2.4 mg可显著降低ASCVD合并超重/肥胖不伴糖尿病患者修订的5P-MACE（HR=0.55，P＜0.001）和修订的3P-MACE（HR=0.43，P＜0.001）风险；另一项真实世界研究STEER[5]比较了两种新型减重药（司美格鲁肽 vs. 替尔泊肽）的心血管结局，结果显示，对于确诊ASCVD且合并肥胖不伴糖尿病的患者，使用司美格鲁肽比替尔泊肽显著降低了3P-MACE风险达57%（HR=0.43，P=0.005）。然而，在真实世界中，对于存在多种危险因素、但尚未发生ASCVD的人群，司美格鲁肽的心血管获益证据仍有限。为此，研究团队开展了SCORE——一级预防人群研究（Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity in the Real World - Primary Prevention Population study），利用美国Komodo研究数据库中整合的临床、实验室及医保数据，对真实世界中使用司美格鲁肽2.4 mg的患者进行评估[2]。研究的纳入标准包括：年龄≥45岁、体重指数（BMI）≥27 kg/m2（定义为超重或肥胖）、具备≥3项ASCVD风险因素（包括吸烟、血脂异常、高血压、糖尿病前期、慢性肾脏病[CKD]或高敏C反应蛋白[hs-CRP]≥2 mg/L）。关键排除标准为：既往有ASCVD（如冠心病、缺血性卒中、短暂性脑缺血发作[TIA]、颈动脉狭窄、PAD等）、心力衰竭、出血性卒中或糖尿病病史。研究采用非简约（non-parsimonious）倾向性评分模型，基于50个协变量对司美格鲁肽2.4 mg使用者与非使用者进行1:2匹配，最终纳入48 184例司美格鲁肽2.4 mg使用者（女性69.2%，平均年龄55.0±6.5岁）与96 368例非使用者（女性68.7%，平均年龄55.2±6.7岁）。两组的基线特征均衡（标准化均数差[SMD]均<0.1）。核心研究结果在平均约9个月的随访期内，与非使用者相比，使用司美格鲁肽2.4 mg可使MACE风险降低，具体而言：修订的5P-MACE（MI、卒中、因心力衰竭住院、冠脉血运重建及全因死亡）风险降低35%（HR=0.65，95%CI：0.54~0.77；P<0.001）（图1、图3）；修订的3P-MACE（MI、卒中、全因死亡）风险降低41%（HR=0.59，95%CI：0.48~0.72；P<0.001）（图2、图3）；传统的5P-MACE（MI、卒中、因心力衰竭住院、冠脉血运重建及心血管死亡）风险降低25%（HR=0.75，95%CI：0.62~0.91；P<0.01）（图3）；传统的3P-MACE（MI、卒中、心血管死亡）风险降低27%（HR=0.73，95%CI：0.57~0.92；P<0.01）（图3）。图1. 司美格鲁肽2.4 mg使用者修订的5P-MACE风险降低图2. 司美格鲁肽2.4 mg使用者修订的3P-MACE风险降低图3. 研究的主要和次要心血管终点此外，司美格鲁肽2.4 mg还与因心力衰竭住院（HR=0.57，95% CI：0.38~0.85）、全因死亡（HR=0.25，95% CI：0.16~0.38）、心血管死亡（HR=0.19，95% CI：0.09~0.42）和3P-心力衰竭复合终点（因心力衰竭住院、心力衰竭急诊就诊、心血管死亡）（HR=0.44，95% CI：0.31~0.61）风险显著降低相关（图3）。 MACE发生率方面，修订的5P-MACE在使用司美格鲁肽2.4mg组为4.49/1000患者年，非使用组为6.93/1000患者年；修订的3P-MACE分别为3.05/1000患者年和5.17/1000患者年（图3）。临床意义两组人群基线ASCVD风险因素高度一致：血脂异常（93.0%）、高血压（~89%）和糖尿病前期（~83%）最为普遍。平均BMI约为37.2 kg/m2，提示研究人群具有显著的代谢负担。值得注意的是，超过三分之二为女性，且多数使用商业保险，反映了当前司美格鲁肽2.4 mg在美国的真实处方模式。该研究首次在真实世界一级预防人群中证实，司美格鲁肽2.4 mg不仅可减重，更可能带来实质性的心血管保护作用，修订的5P-MACE风险显著降低35%，修订的3P-MACE风险降低高达41%。这一发现拓展了该药的适用边界，从“二级预防”延伸至“高危一级预防”，为临床决策提供了新依据。研究优势与局限本研究优势在于样本量大、协变量调整充分、人群代表性较既往临床研究更广，且匹配后基线高度平衡。然而，作为观察性研究，仍存在未测量混杂、理赔数据潜在错分、随访时间相对较短等局限，且因果推断需谨慎。研究结果尚待其他真实世界数据库验证。结论在无糖尿病、无既往ASCVD但具多重风险因素的超重/肥胖美国成人中，真实世界使用司美格鲁肽2.4 mg与显著降低的MACE风险相关。这些“首项同类”（first-of-its-kind）数据支持其在心血管一级预防中的潜在价值，进一步巩固了GLP-1RA在代谢-心血管轴中的核心地位。参考文献： [1] Lincoff AM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023 Dec 14;389(24):2221-2232. [2] Lower Real-World Risk of Cardiovascular Events With Semaglutide 2.4 mg in People with Risk Factors for Atherosclerotic Cardiovascular Disease: Results from SCORE-Primary Prevention Population study(NCT07141914). Oral Presentation at Obesity Week 2025, November5, 2025. [3] Smolderen KG, et al. Lower risk of cardiovascular events in patients initiated on semaglutide 2.4?mg in the real-world: Results from the SCORE study (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity in the Real World). Diabetes Obes Metab. 2025 Nov;27(11):6691-6704. [4] Wilson L, et al. Presented at the European Society of Cardiology (ESC) Congress together with World Congress of Cardiology; Madrid, Spain; August 29 - September 1, 2025. 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。

临床结果临床研究

2025-11-13

·思齐俱乐部

前三季度销售额好的10款药物出炉！“药王”来自这家药企

随着三季度财报的揭晓，2025年前三季度，销售额好的10款药物也出炉，分别为：诺和诺德的司美格鲁肽、礼来的替尔泊肽、默沙东的帕博利珠单抗、赛诺菲的度普利尤单抗、艾伯维的利生奇珠单抗、强生的达雷妥尤单抗、百时美施贵宝的纳武利尤单抗、诺华的沙库巴曲缬沙坦、罗氏的奥瑞利珠单抗、艾伯维的乌帕替尼。其中诺和诺德的司美格鲁肽2025年前三季度销售额高达254.62亿美元，贡献总营收近74%，成为新的“药王”。其中，减肥版诺和盈(Wegovy)前三季度销售额达572.42亿丹麦克朗(约88.22亿美元)，同比激增54%；糖尿病注射版诺和泰(Ozempic)收入952.64亿丹麦克朗(约146.82亿美元)，同比增长 13%；口服版司美格鲁肽片诺和忻(Rybelsus)实现销售额167.90亿丹麦克朗(约25.88亿美元)，同比增长5%，成为口服剂型布局的关键支点。礼来的替尔泊肽2025年前三季度销售额为248.37亿美元，同比增长125%，成为礼来制药业务营收增长的主力。资料显示，替尔泊肽是一款GIP(葡萄糖依赖性促胰岛素多肽)和 GLP-1(胰高糖素样肽-1)双受体激动剂药物，其针对肥胖根源发挥作用，可以减少食欲和饮食摄入。此前，替尔泊肽已获NMPA批准适用于：在饮食控制和运动基础上，接受二甲双胍和/或磺脲类药物治疗血糖仍控制不佳的成人2型糖尿病患者；在控制饮食和增加运动基础上，初始体重指数(BMI)符合以下要求的成人的长期体重管理：≥28 kg/㎡(肥胖)，或≥24 kg/㎡(超重)并伴有至少一种体重相关合并症(例如高血压、血脂异常、高血糖、阻塞性睡眠呼吸暂停、心血管疾病等)。昔日“药王”默沙东的帕博利珠单抗2025年前三季度销售额为233.03亿美元，同比增长虽保持双位数，但已被GLP-1双雄远远超越。资料显示，帕博利珠单抗是由默沙东(MSD)公司研发的一款重磅抗PD-1抑制剂，可阻断PD-1与其配体PD-L1、PD-L2之间的相互作用，从而激活T淋巴细胞，其抗癌原理是通过增强人体免疫系统的能力，识别和对抗肿瘤细胞。除以上三个产品外，赛诺菲的度普利尤单抗、艾伯维的利生奇珠单抗、强生的达雷妥尤单抗、百时美施贵宝的纳武利尤单抗、诺华的沙库巴曲缬沙坦、罗氏的奥瑞利珠单抗、艾伯维的乌帕替尼销售额分别为132.35亿美元、125.56亿美元、104亿美元、73.56亿美元、64.95亿美元、62.10亿美元、59.30亿美元。从2025年前三季度营收来看，强生、罗氏、默沙东靠前，分别为696亿美元、549亿美元，486亿美元。其中强生核心增长动力来自创新药业务，第三季度创新药销售额达156亿美元，占总营收的65%；肿瘤板块表现尤为抢眼，在达雷妥尤单抗、西达基奥仑赛等产品带动下，第三季度营收65.29亿美元，同比增长21.3%。来源：制药网思齐圈公开课报名中！点击阅读原文了解更多

财报上市批准

2025-11-13

·恒瑞医药

重磅！恒瑞医药口服小分子GLP-1RA（HRS-7535）糖尿病肾病最新研究亮相ASN 2025

编者按糖尿病肾病（DKD）是2型糖尿病（T2DM）最常见的微血管并发症，也是全球终末期肾病（ESKD）的首要致病因素。当前，尽管已有肾素-血管紧张素系统抑制剂（RASi）、钠-葡萄糖共转运蛋白2抑制剂（SGLT2i）、非奈利酮作为DKD标准治疗方案中的推荐药物，但仍有大量已接受标准治疗的DKD患者面临蛋白尿进展与肾功能下降的高残留风险，临床对更有效治疗手段的需求极为迫切。GLP-1受体激动剂（GLP-1RA）虽在注射剂型中展现出肾脏保护作用，然而口服小分子GLP-1RA在DKD人群中的治疗证据长期处于空白状态。在此背景下，恒瑞医药自主研发的口服小分子GLP-1RA HRS-7535的Ⅱ期研究成果[1]，于2025年美国肾脏学会年会（ASN 2025）的“最新突破性研究口头报告（Late-Breaking Research Orals）”专场重磅发布。该研究首次填补了口服小分子GLP-1RA在DKD治疗领域的证据空白，为DKD患者带来了兼顾疗效、安全性与便利性的全新治疗选择。浙大附一院陈江华教授团队杜晓英医师现场汇报图一研究设计该研究由浙江大学医学院附属第一医院陈江华教授牵头，于全国80家研究中心开展，为多中心、随机、双盲、安慰剂对照的Ⅱ期临床试验，包括3周筛选期、16周双盲治疗期及2周安全随访期，共纳入281例DKD患者，其中280例至少接受1次试验药物治疗。研究分为三组：HRS-7535 30 mg组（n=93）、90 mg组（n=94）及安慰剂组（n=93）（图1）。图1. 研究设计受试者核心入选标准：糖化血红蛋白（HbA1c）为6.5%~10.0%、尿白蛋白肌酐比（UACR）300~3000 mg/g、估算的肾小球滤过率（eGFR）≥30 ml/（min·1.73m²）；同时，患者接受至少3个月标准肾脏保护治疗（RASi/SGLT2i /非奈利酮）且剂量稳定≥4周，并使用≥1种稳定降糖药物。主要终点为16周时UACR较基线变化的百分比；次要终点包括HbA1c、体重和eGFR变化及UACR达标率；同时，监测安全性指标。二基线特征三组患者基线特征均衡。人口学方面，患者平均年龄55.7岁，平均体重指数（BMI）26.7 kg/m²；患者平均T2DM病程13.1年、DKD病程3.1年；基线中位UACR 763.5 mg/g（远超大量白蛋白尿阈值）、平均HbA1c 7.61%。基线合并用药数据显示，肾脏保护药物中，85.7%患者使用RASi、64.6%使用SGLT2i、24.3%使用非奈利酮；降糖药物中，60.4%使用胰岛素、56.4%使用二甲双胍。该入组人群已接受高强度的DKD标准背景治疗，但仍处于大量白蛋白尿、血糖控制不佳的疾病高危状态，代表当前DKD治疗领域尚未满足的临床需求。三核心结果：多维度获益显著，安全性良好研究数据显示，HRS-7535在16周治疗期内，于肾脏保护、血糖控制、代谢改善及安全性方面均展现出色表现，且呈现明确的剂量依赖性。肾脏保护：突破残留风险，UACR显著降低治疗16周时，HRS-7535 30 mg组、90 mg组UACR较基线分别降低30%、46%，显著优于安慰剂组的-14%，且90 mg组降幅较30 mg组更大，呈明确的剂量依赖性（图2）。图2. 主要终点：UACR较基线的变化百分比根据2025年美国糖尿病协会（ADA）指南建议[2]，对于基线UACR≥300 mg/g的患者，推荐至少降低30%的UACR以延缓慢性肾病的进展。HRS-7535治疗显著增加了达到这一UACR降低目标的患者比例，具体来看：30 mg组达标率为45.2%，90 mg组达标率为56.4%，均显著高于安慰剂组的31.2%。亚组分析显示，无论患者使用1种、2种还是3种肾脏保护药物，HRS-7535均能带来额外获益：当患者同时使用较少的肾脏保护药物时，HRS-7535治疗后UACR降幅更为显著，在合并使用1种肾脏保护药物的患者中，90 mg组的UACR降幅高达52%（经安慰剂校正后）；在接受“RASi+SGLT2i +非奈利酮”三联治疗的患者中，90 mg组仍可使UACR额外降低25%（经安慰剂校正后）（图3）。图3. 亚组分析：合并使用不同数量的肾脏保护药物时UACR变化此外，治疗8周时，HRS-7535组出现轻微的eGFR下降，但16周时与安慰剂组无统计学差异，提示其对肾脏血流动力学的影响是温和且一过性的，导致急性肾衰竭的风险较低。血糖控制：强效降糖且达标率高治疗16周时，HRS-7535 30 mg组、90 mg组HbA1c较基线分别降低0.62%、1.01%，优于安慰剂组的0.08%，且剂量越高，降糖效果越显著（图4）。图4. HbA1c较基线的变化根据2024年改善全球肾脏病预后组织（KDIGO）和2025年ADA指南[2,3]，DKD患者HbA1c目标为<7.0%，高危患者需进一步控制在≤6.5%。该研究结果显示，HRS-7535 90 mg组中，74.5%的患者达到HbA1c<7.0%（指南推荐目标），50.0%达到≤6.5%（高危人群严格目标），高于安慰剂组的28.0%与10.8%（图5）。图5. HbA1c达标率代谢改善：体重持续下降，血压血脂协同获益治疗16周时，HRS-7535 90 mg组体重较基线降低3.50%，优于安慰剂组的0.55%，且未观察到下降平台期（图6），长期用药或可持续获益。图6. 体重较基线的变化研究同时观察到HRS-7535的额外代谢获益。HRS-7535 90 mg组收缩压较基线降低6.0 mmHg、舒张压降低2.5 mmHg，总胆固醇降低6.8%、甘油三酯降低4.8%，同时肝酶（ALT、AST）水平下降，为心血管与肝脏提供潜在保护。安全性：耐受性良好，无新增安全信号HRS-7535组治疗期间出现的不良事件（TEAE）发生率为78.5%（30 mg）、91.5%（90 mg），安慰剂组为64.5%，绝大多数为轻中度。HRS-7535组最常见的TEAE为胃肠道不良事件，发生率≥5%的胃肠道不良事件为恶心、呕吐、腹泻和腹胀。严重不良事件（SAE）发生率低（30 mg组5.4%、90 mg组4.3%、安慰剂组2.2%），未发生特别关注的不良事件（AESI），未出现新的安全性信号。四研究意义HRS-7535的Ⅱ期研究结果，对DKD诊疗实践具有多维度突破性意义，为临床提供了全新治疗方向，同时彰显了中国原研药物的创新实力。填补口服小分子GLP-1RA证据空白，引领DKD长期管理新范式此前，GLP-1RA的肾脏获益证据集中于多肽类注射剂型（如司美格鲁肽）[4]，口服小分子GLP-1RA在DKD人群中的数据缺乏。GLP-1RA的护肾作用源于对GLP-1受体的激活本身，还是依赖于GLP-1的多肽结构及其代谢产物，仍是悬而未决的科学问题。HRS-7535作为全球首个在DKD人群中完成概念性验证试验的口服小分子GLP-1RA，本次Ⅱ期研究结果为该科学问题提供了确凿的临床证据，与注射类多肽GLP-1RA形成了坚实的机制交叉验证，共同确立了GLP-1受体靶点在DKD治疗领域的重要地位。同时，小分子口服剂型突破了GLP-1RA注射制剂的多重局限。口服制剂通过避免注射疼痛与操作障碍，从根源上提升了患者长期用药的依从性，尤其惠及基层、老年及对注射存在顾虑的患者。另一方面，小分子药物提升了用药可及性，在生产成本、规模化产能及储存运输上具备显著优势，解决了多肽类药物潜在的产能瓶颈与高昂成本问题，有望为DKD的长期管理提供了更优解。突破标准治疗残留风险，多维度契合DKD管理需求从临床治疗困境来看，尽管RASi、SGLT2i、非奈利酮的联合治疗已成为DKD标准方案，但大量患者仍存在白蛋白尿进展、肾功能下降的残留风险[3,5]，临床对能进一步降低风险的治疗手段需求迫切。而HRS-7535在三重标准治疗基础上仍能实现25%的UACR额外降低，首次回答了“在DKD标准治疗的基础上使用GLP-1RA是否存在更多获益”的重要临床问题，为高风险DKD患者提供了“叠加治疗”新策略，有望成为DKD联合治疗的核心组成部分。从治疗策略上，当前糖尿病肾病治疗理念已经从传统的单一药物治疗，演进为“多重支柱”的协同管理模式，即将具有强效循证证据、覆盖不同靶点/机制的治疗手段早期联合启动。例如，一项正在开展中的GOLD-STANDARD试验，正聚焦于评估早期四药联合（SGLT2i、RASi、非奈利酮和GLP-1RA）治疗DKD的疗效[6]。而HRS-7535在低强度背景治疗人群中展现出UACR降低52%的优异疗效，支持其作为初治或早期DKD患者的优选方案，并具备成为一线标准治疗/起始用药的潜力。在治疗目标契合度上，DKD的治疗需兼顾“肾脏保护、血糖控制、代谢改善、心血管风险降低”四大目标，单一药物往往难以满足所有需求。而HRS-7535同时具备显著的UACR降低（肾脏保护）、HbA1c下降（血糖控制）、体重减轻（代谢改善）及血压/血脂降低（心血管保护）作用，完美契合DKD的综合管理目标，能从多维度切断疾病进展链条——既通过降低UACR减少肾小球损伤，又通过控制血糖、体重、血压和血脂减少肾脏代谢负担与心血管风险，而心血管疾病是DKD患者的首要死亡原因。这种“多靶点、跨系统”的获益能有效降低患者死亡风险，改善长期预后，为临床实现DKD全程管理提供了更高效的治疗工具。五总结与展望当前，尽管DKD患者接受多重肾脏保护治疗，仍面临较高的肾病进展风险。作为全球首个在DKD人群中完成概念性验证的口服小分子GLP-1RA，HRS-7535 Ⅱ期研究已充分证实其在DKD治疗中的价值，同时也为国内DKD精准治疗提供了重要的本土化循证依据，助力诊疗方案更贴合中国患者需求。展望未来，若后续在Ⅲ期研究中持续取得阳性结果，HRS-7535有望被纳入国内外DKD治疗指南，推动指南更新治疗推荐，重塑临床诊疗路径。这不仅为中国DKD患者带来更优质的治疗选择，更能作为中国原研创新药物的代表，为全球DKD治疗贡献中国方案，提升中国在代谢性疾病与肾脏病领域的药物研发影响力。参考文献1. Du XY, et al. Efficacy and Safety of the Oral Small-Molecule GLP-1 Receptor Agonist HRS-7535 in Patients with Diabetic Kidney Disease. FR-OR088, ASN 2025.2. ADA. Diabetes Care 2025;48(Suppl. 1):S239–S251.3. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. Kidney Int. 2024 Apr;105(4S):S117-S314.4. Perkovic V, et al. N Engl J Med. 2024 Jul 11;391(2):109-121.5. de Boer IH, et al. Diabetes Care. 2022 Dec 1;45(12):3075-3090. 6. https://www.healio.com/news/cardiology/20250618/goldstandard-trial-will-test-novel-combination-therapy-for-diabetic-kidney-disease.“肾医线”读者专属微信群建好了，快快加入吧。扫描“肾医线”小助手二维码（微信号：nephro-online），回复“肾医线读者”，ta会尽快拉您入群滴！（来源：《肾医线》编辑部）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。版权声明版权属《肾医线》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2期临床结果抗体药物偶联物

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
心血管疾病	美国	Novo Nordisk, Inc.	2025-08-15
代谢功能障碍相关脂肪性肝炎	美国	Novo Nordisk A/S	2025-08-15
代谢功能障碍相关脂肪性肝炎	美国	Novo Nordisk, Inc.	2025-08-15
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,

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适应症	最高研发状态	国家/地区	公司	日期
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
膝关节炎	临床3期	挪威	Novo Nordisk A/S	2021-10-01

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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	淵鑰襯顧鑰願窪遞壓淵(衊範願鬱艱糧遞憲願鏇) = 窪願醖鹹鏇襯餘襯糧蓋網獵鬱壓艱積鑰襯鬱鑰 (糧夢鹹醖觸鑰簾網艱膚 ) 更多	积极	2025-12-31
NCT04916470 (STEP-HFpEF DM, Pubmed \| JACC Heart Fail)	临床3期	-	1,145	Semaglutide	積夢餘製遞構衊夢憲膚(艱選製鬱鹹鹹夢鹽襯蓋): Difference (Semaglutide vs Placebo) = 14.6 (95.0% CI, 8.6 ~ 20.7), P-Value = < 0.0001 更多	积极	2025-11-01
				Placebo
NCT04019197 (Pubmed \| Clin Infect Dis)	临床2期	HIV感染	108	Semaglutide	築鏇築鏇膚艱願淵膚淵(醖衊糧遞構窪願遞膚鹹): P-Value = 0.04 更多	积极	2025-10-16
				Placebo
NCT06914141 \| NCT06914154 \| NCT06914102 (Pubmed \| JAMA)	N/A	射血分数保留型心力衰竭	97,790	Semaglutide	夢鹽齋築廠遞壓夢獵鹽(齋襯淵鹹製糧鏇顧觸積): HR = 0.58 (95.0% CI, 0.51 ~ 0.65) 更多	积极	2025-10-14
				Tirzepatide
NCT05435677 (Pubmed \| Diabetes Ther)	临床1期	2型糖尿病	20	IcoSema	夢壓觸顧壓齋糧窪製築(顧淵築築遞顧憲衊網鏇): ratio = 1.04 (90.0% CI, 0.99 ~ 1.08) 更多	积极	2025-10-06
				icodec
NCT02970942 \| NCT03548935 \| NCT03552757 (STEP 1, Pubmed \| JHEP Rep)	临床2期	代谢功能障碍相关脂肪性肝炎	-	Semaglutide 2.4 mg	選衊憲蓋鬱鏇夢構積顧(選鹹蓋鏇網壓網醖鬱構) = 廠製齋鹹積繭網鏇繭鬱壓鑰製構壓襯廠壓艱網 (顧積顧夢醖蓋襯鑰襯獵 ) 更多	积极	2025-10-01
				Semaglutide 1.0 mg	選衊憲蓋鬱鏇夢構積顧(選鹹蓋鏇網壓網醖鬱構) = 積願鏇齋積蓋網鏇醖醖壓鑰製構壓襯廠壓艱網 (顧積顧夢醖蓋襯鑰襯獵 ) 更多
NCT03914326 (SOUL, CTgov)	临床3期	2型糖尿病 \| 心肌梗塞 \| 心脏病 ... 更多	9,651	Semaglutide (Oral Semaglutide)	醖簾襯窪淵選遞衊繭顧 = 窪鹹襯簾遞範簾淵繭衊窪顧簾鹽鏇齋繭廠窪鑰 (繭醖淵製憲獵餘餘鹹製, 淵餘艱壓糧鹽觸襯衊膚 ~ 觸憲簾鹽獵鏇廠廠糧淵) 更多	-	2025-09-22
				Placebo (semaglutide) (Placebo)	醖簾襯窪淵選遞衊繭顧 = 顧膚齋觸淵獵憲憲網襯窪顧簾鹽鏇齋繭廠窪鑰 (繭醖淵製憲獵餘餘鹹製, 糧艱淵憲醖糧艱廠餘糧 ~ 積網廠蓋鏇鹽蓋繭選糧) 更多
NCT05564117 (OASIS 4, Pubmed \| N Engl J Med)	临床3期	-	307	Oral Semaglutide 25 mg	鏇衊淵衊夢艱鑰願顧獵(淵襯鹹淵衊網襯醖醖範) = 繭鬱壓積廠遞夢糧夢夢構範積襯選艱鬱簾製範 (鹹襯夢築窪築窪醖淵膚 )	积极	2025-09-18
				Placebo	鏇衊淵衊夢艱鑰願顧獵(淵襯鹹淵衊網襯醖醖範) = 選餘遞選築壓齋壓獵繭構範積襯選艱鬱簾製範 (鹹襯夢築窪築窪醖淵膚 )
NCT04126603 (CTgov)	临床4期	2型糖尿病	10	Placebos (Group A Placebo)	鹽鏇憲繭觸鏇鹹鏇觸襯(齋憲膚鑰憲構窪齋餘艱) = 齋醖餘鬱願獵範鑰願衊遞顧構衊壓鏇鬱鑰蓋製 (積鹹積鏇鑰願獵鏇鹹範, 0.06) 更多	-	2025-09-09
				Semaglutide (Group B Active)	鹽鏇憲繭觸鏇鹹鏇觸襯(齋憲膚鑰憲構窪齋餘艱) = 鏇蓋繭範構蓋範蓋獵鏇遞顧構衊壓鏇鬱鑰蓋製 (積鹹積鏇鑰願獵鏇鹹範, 0.16) 更多
NCT05193578 (Pubmed \| JAMA Psychiatry)	临床3期	精神分裂症	154	Semaglutide	膚膚築齋遞夢鏇艱齋觸(餘窪膚廠觸願遞淵鏇餘) = 醖蓋餘窪簾鬱製窪鑰憲選蓋廠夢窪艱選顧淵膚 (餘膚餘夢願築願願餘遞, 1.52 ~ 5.98) 更多	积极	2025-09-03