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

NCT07021937

/ Not yet recruiting临床3期IIT

Investigating Brain PLASTICity and GLP-1 Receptor Agonists in the Treatment of Obesity: The PLASTIC Trial

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]

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

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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 ; Faurby, Mads ; Michalak, Wojciech ; 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.

6,538

项与司美格鲁肽 (诺和诺德) 相关的新闻（医药）

15 小时之前

·PRNewswire

Parker Waichman LLP Files Lawsuit on behalf of Florida Resident Alleging Development of Irreversible Eye Condition, NAION, after taking Ozempic

Parker Waichman, a national law firm, has now filed multiple lawsuits where each Plaintiff alleged that he or she developed NAION after taking Novo Nordisk's Ozempic or Wegovy. PORT WASHINGTON, N.Y., Nov. 10, 2025 /PRNewswire/ -- Parker Waichman has now filed multiple lawsuits in New Jersey state court on behalf of victims who were prescribed Ozempic or Wegovy and developed NAION, an irreversible eye condition that causes partial or complete permanent vision loss in one or both eyes. Most recently, on November 6, 2025, the Firm filed a lawsuit on behalf of a Florida resident who developed NAION after taking Ozempic. See Martin v. Novo Nordisk Inc., Docket No: MID-L-007920-25. Parker Waichman continues to file additional cases and urges individuals who have suffered serious eye injuries after taking these widely prescribed GLP-1 receptor agonist medications to contact them for a free case review. These medications, originally developed to treat Type 2 diabetes, have surged in popularity for weight loss. However, recent studies have uncovered a disturbing link between semaglutide (Ozempic/Wegovy) and NAION, a condition that causes permanent vision loss by cutting off blood flow to the optic nerve. Patients who took these drugs have reported sudden blindness, optic nerve damage, and other irreversible complications, raising concerns about the failure of drug manufacturers to warn consumers and medical professionals about these risks. A 2025 study published in JAMA Ophthalmology examined nine patients who developed optic nerve disorders after using GLP-1 medications, with the majority suffering from NAION-like symptoms. Additional research from Harvard's Mass Eye and Ear Institute found that diabetic users of semaglutide were four times more likely to develop NAION, while non-diabetic users taking the drug for weight loss faced a sevenfold increased risk. Despite growing scientific evidence, Novo Nordisk continues to downplay the dangers associated with these medications, failing to include adequate warnings about the risk of permanent blindness. Parker Waichman LLP Fights for Victims Nationwide "NAION is a devastating, and permanent, eye injury diagnosis. Studies from multiple, reputable institutions, have shown a statistically significant relationship between semaglutide (the active ingredient in Ozempic and Wegovy) and NAION. Despite this evidence, Novo Nordisk continues to deny reality by failing to warn consumers and medical professionals about this horrific injury and must be held accountable," said Jason S. Goldstein, Senior Litigation Counsel at Parker Waichman LLP. Parker Waichman LLP is currently accepting cases nationwide for individuals who have suffered vision loss, blindness, or serious optic nerve damage after taking Ozempic or Wegovy. Victims may be entitled to compensation for medical expenses, lost wages, pain and suffering, and other damages. Free Case Review for Affected Individuals If you or a loved one experienced sudden vision loss, blindness, or optic nerve damage after using Ozempic or Wegovy, you may have a legal claim against the drug manufacturers. Parker Waichman LLP is offering free, no-obligation case evaluations to help victims understand their rights and pursue justice. Contact Parker Waichman LLP Today For a free consultation, call 1-800-YOUR-LAWYER (1-800-968-7529) or visit YourLawyer.com to learn more about your legal options and how to protect your rights. About Parker Waichman LLP Parker Waichman LLP is a nationally recognized law firm dedicated to fighting for victims of defective drugs, dangerous products, accidents, and corporate negligence. Specifically, the Firm is quite experienced in representing eye injury victims due to the negligence of pharmaceutical companies. Representative cases include In Re Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation and Bausch & Lomb Contact Lens Solutions Prod. Liab. Litig. With a proven track record of holding pharmaceutical companies accountable, the firm has secured billions in settlements and verdicts for injured clients. Media Contact: Jason Goldstein Phone: 516-466-6500 Email: [email protected] SOURCE Parker Waichman LLP 21% more press release views with Request a Demo

专利侵权

15 小时之前

·E药经理人

礼来霸榜、辉瑞再降，默沙东、BMS承压！全球制药营收TOP10再洗牌

撰文| 张烨静随着Q3财报季走入尾声，全球制药巨头再次迎来“大洗牌”。礼来凭借超过50%的营收增速强势登顶，成为本季度最亮眼的存在；同在GLP-1赛道的诺和诺德，曾于今年H1财报季进入跨国药企营收TOP10榜单，与礼来此刻的霸榜相呼应。相比之下，“昔日霸主”辉瑞却成为TOP10中唯一接连“双降”的企业。强生、默沙东、BMS同样增长乏力，整体呈现疲软态势。尽管几家欢喜几家愁，但一个共同的焦虑摆在多数MNC面前：明星药物专利悬崖、核心产品增长见顶后，该如何寻找“下一个重磅炸弹”？生物制药的竞赛强度正不断升级，一个财报季就是一次洗牌。但不变的是，在这个竞技场上，没有永恒的王者，只有持续的创新者。数据来源：公司财报几家欢喜几家愁整体来看，MNC三季度业绩呈现出几家欢喜几家愁的局面。礼来以超高增速“一骑绝尘”，AZ上半年和Q3均实现双位数增长，艾伯维、诺华和赛诺菲也保持在高个位数的增长，展现出一定的业务韧性。与此同时，辉瑞、BMS是榜单中唯二出现营收下滑的MNC，尤其是辉瑞未能守住2024年的榜首位置，延续业绩下滑趋势。此外，默沙东和强生虽然排名基本保持在原先的水平，但持续面临着增长乏力；罗氏Q3增速有所放缓。先看礼来。回顾近两年TOP10榜单，礼来在2024年仅排第9名，到2025年H1升至第6名，如今的Q3已跃居营收榜首，可谓是一路“超车”。今年前三季度，礼来总营收458.87亿美元，同比增长46%，其中Q3营收176.01亿美元，增速达到54%。尤为亮眼的是，Q3净利润为55.83亿，同比增长475.34%，成长势头极为强劲。 “明星产品”替尔泊肽是礼来的绝对增长引擎。前三季度，替尔泊肽创收248.37亿美元，占总营收的半壁江山，增速更是达到了125%。事实上，早在今年上半年，替尔泊肽就以121.3%的增速实现收入147.34亿美元，与司美格鲁肽的差距缩小到约20亿美元。截至前三季度，双方差距已不到10亿美元。此外，礼来和诺和诺德在GLP-1类药物美国处方量上的占比也进一步拉开：上半年分别为57.0%和42.5%，第三季度变为57.9%和41.7%。值得一提的是，今年最后一个季度，礼来在GLP-1领域仍有进展值得期待。其口服小分子GLP-1药物orforglipron计划于年内递交肥胖适应症相关申请，有望在2026年上市后迅速抢占市场份额，而CGR/GIPR/GLP-1R三靶点药物Retatrutide也将完成首个III期研究。总体来看，礼来将2025全年收入预期从600亿-620亿美元再次上调至630亿-635亿美元。业界预计，替尔泊肽全年营收有望在年底反超司美格鲁肽。阿斯利康在前三季度都实现了双位数增长，总收入432.36亿美元，同比增长11%；Q3总营收151.91 亿美元，同比增长10%。前三季度，阿斯利康五大核心业务版块均实现增长，肿瘤、心血管-肾脏-代谢疾病、呼吸与免疫、疫苗与免疫疗法以及罕见病，分别贡献了185.91亿美元（+16%）、98.09亿美元（+5%）、64.93亿美元（+13%）、8.26亿美元（+2%）、67.52亿美元（+6%）的收入。其中，肿瘤药是AZ的第一大业务板块，占了产品总收入的43%。尤其ADC药物表现突出，其HER2 ADC药物Enhertu (DS-8201)，前三个季度销售额达到35.75亿美元，同比增长31%。另一款靶向TROP2的ADC药物Datroway，于2025年1月获得美国FDA批准上市，8月份也首次在中国获批，前九个月销售达到3800万美元。此外，艾伯维、诺华和赛诺菲都保持在高个位数的增长，整体增速稳健。艾伯维目前位列营收TOP10第四，其前三季度总营收445.42亿美元，同比增长8%，其中Q3收入157.76亿美元，同比增长9.1%。按板块来看，其艾伯维自免、神经科学、肿瘤三大领域均正向增长，前三季度分别收入217.80亿美元（+12.3%）、78.06亿美元（+20.3%）和49.91亿美元（+2.6%）。两款重磅自免药物是艾伯维的增长动力，IL-23单抗Skyrizi（利生奇珠单抗）和JAK1抑制剂Rinvoq（乌帕替尼）前三季度分别创收125.56亿美元（+58.1%）和59.30亿美元（+43.3%）。而曾经的“药王”Humira（阿达木单抗）自2023年失去关键专利保护后，业绩持续下滑。2024年，其销售额为89.93 亿美元，同比下降37.6%。今年前三季度，其销售额为32.94亿美元，同比下降55.0%。诺华排在第七名，公司前九个月净销售额达411.96亿美元，同比增长11%，其中Q3净销售额为139.09亿美元，同比增长7%，净利润39.3亿美元，同比增长25%。值得一提的是，公司前三季度已有10个重磅产品的销售额累计超过10亿美元。诺华的业绩“顶梁柱”是降压药Entresto，该药前三季度创收64.9亿美元，同比增长15%。然而，随着关键专利在2025年7月到期，销售额也逐渐承压，Q3营收为18.7亿美元，同比下降1%。推荐阅读 * AZ超罗氏，礼来追赛诺菲，诺华掉出前五，全球制药营收TOP10洗牌 * 礼来狂飙，诺华爆发，百济首进，全球畅销药TOP50变天！专利悬崖潮来袭尽管礼来、AZ均增长亮眼，但从整体来看，MNC的日子普遍不太好过，辉瑞、BMS、默沙东、强生和罗氏均有不同程度的承压。辉瑞格外受到关注。近期，辉瑞出现了多方面的变动——Q3业绩下滑、砍掉11条管线、百亿美元竞价收购。一边是豪赌、一边是撤退，昔日霸主的短期阵痛和长久焦虑，集中地呈现出来。从业绩上看，辉瑞的困境已经不是“新鲜事”。2025年第一季度，辉瑞总营收已经同比下跌8%。前三季度，辉瑞总营收450.22亿美元，同比下降2%，Q3的营收更是由去年同期的177亿美元降至166.5亿美元，同比下降6%；Q3净利润为35.41亿美元，同比下降21%。凭借新冠疫苗Comirnaty和新冠口服药Paxlovid，辉瑞曾成为全球首个年收入超千亿美元的制药企业。但随着市场消退，这两款产品持续下滑。今年第三季度，Paxlovid收入同比暴跌55%，Comirnaty也下降了20%，辉瑞正面临最陡峭的收入断崖。更深的焦虑在于，辉瑞的多款王牌产品即将迎来专利到期。未来五年内，Eliquis、Prevnar13、lbrance、Xtandi将相继面临仿制药冲击。其中，Eliquis今年Q3贡献了20.03亿美元收入，占辉瑞总收入的13.7%，该药将于2026年率先专利到期。因此，无论是砍掉11条管线，还是百亿竞价收购Metsera，都是辉瑞为应对危机采取的腾挪之举。尤其是对Metsera的收购，被视为辉瑞在GLP-1赛道的“放手一搏”。Metsera处于2b期的GLP-1受体激动剂MET-097i支持每月一次注射，在12周的Ⅱ期试验中，受试者体重减少了11.3%，且副作用有限，极具竞争优势。事实上，辉瑞曾早早布局炙手可热的GLP-1赛道，并且多次表示“肥胖产品是公司应对80亿美元的专利危机的潜力增长点”。但随着管线推进不断受挫，辉瑞三款GLP-1激动剂的研发全部终止，业内一度认为辉瑞全面退出该赛道。直到今年9月22日，辉瑞与Metsera达成初步协议，以每股70美元、总价约73亿美元的价格收购该公司，重新落子GLP-1。然而，同样焦虑与迫切的不只辉瑞。曾在今年9月裁员9000人的诺和诺德，也正在积极寻求解法——10月30日，诺和诺德突然提出每股77.75美元，总价约90亿美元的收购要约，要从辉瑞手里抢下Metsera。诺和诺德同样处于专利悬崖的梦魇之下，司美格鲁肽的核心专利将于2026年3月到期，已有多家仿制药虎视眈眈，替尔泊肽的亮眼表现更是带来一重压力。在“前有标兵、后有追兵”的窘境下，诺和诺德正试图通过收购，巩固自身在代谢领域的优势。诺和诺德入局后，一场颇有火药味的竞价就此开启。两家制药巨头展开多轮竞价，辉瑞将报价提升至每股70美元（总价81亿美元），而诺和诺德则报出每股86.2美元（总价100亿美元）。直到在最后阶段，辉瑞将报价提升至与诺和诺德持平的水平，均为每股86.20美元，总价最高达100亿美元，从而达成交易。事实上，不只辉瑞与诺和诺德：未来五年，全球制药业将迎来最恐怖的专利到期潮，默沙东的Keytruda、强生的Darzalex、罗氏的Ocrevus和Vabysmo、BMS的Eliquis和Opdivo等“重磅药”将陆续走入“悬崖”。其中，默沙东K药（Keytruda）的专利将于2028年到期，Evaluate预测其2030年的销售额将比2024年（295亿美元）下滑近一半。今年前三季度，默沙东制药业务收入432.99亿美元，与去年同期基本持平，而K药的销售额达233.03亿美元，同比增长8%，增势已明显趋缓。 O药（Opdivo）则是BMS最突出的资产。为了延长专利保护期，BMS通过推出新剂型和新适应症开发，成功将O药的专利保护期延长至2028年。此外，BMS的Revlimid将在2026年专利到期。今年前三季度，BMS收入356.92亿美元，同比下降1%，Q3营收122.22亿美元，同比增长3%。其中，Opdivo在2025年前三季度保持稳定增长，收入73.56亿美元，同比增长8%。而Revlimid前三季度收入下滑至23.49亿美元，同比下降47%。行业已再次站在关键的转折点——未来五年，前所未有的专利到期潮将席卷大多数MNC。无论是向内“战略收缩”，还是向外“开拓增量”，站在最真实的焦虑面前，穿越周期、寻找下一个增长极，已成为所有MNC的共识。谁才能在下一次“排位赛”里，继续留在高段位？11月24-26日，2025’第十七届中国医药企业家科学家投资家大会（启思会）将在北京海淀盛大召开。启思会将以“结构性拐点”为价值锚点，与行业精英一起，共探中国医药产业高质量发展的路径。扫码报名获得【2025启思会】参会名额扫码进群了解【2025启思会】更多详情大会咨询参会咨询联系人：Mily 联系电话：15801338547 商务合作联系人：Chen 联系电话：18611165131 媒体咨询联系人：Yuvia 联系电话：18811130861 参展咨询为落实国务院和党中央关于生物医药全产业链创新发展的精神，推动我国生物医药产业迈向全球价值链中高端、实现高水平科技自立自强的重要举措。2025第十七届中国医药企业家科学家投资家大会特别组织“十四五”中国医药产业优质供应商系列活动，邀请相关企业【免费参与】联系人：Wenbo 联系电话：13716707405 一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

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15 小时之前

·PRNewswire

Novo Nordisk's Wegovy® (semaglutide 2.4 mg) was associated with liver health-related benefits not solely based on weight loss in adult patients with MASH with liver scarring, according to a new post hoc analysis

Secondary analyses of the ESSENCE trial were presented at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting® 2025 Across a spectrum of weight loss thresholds, a post hoc analysis showed Wegovy® (semaglutide 2.4 mg) injection was associated with resolution in liver injury, while improvements in liver scarring trended to favor semaglutide 2.4 mg1 An additional secondary analysis found that semaglutide 2.4 mg, when compared to placebo, showed improvements in both liver injury and in liver scarring across various ages, genders, races, and ethnicities2 BAGSVÆRD, Denmark & PLAINSBORO, N.J., Nov. 10, 2025 /PRNewswire/ -- Novo Nordisk today presented data at the 76th annual American Association for the Study of Liver Diseases (AASLD) meeting, The Liver Meeting® 2025, in Washington, D.C., evaluating the effects of semaglutide 2.4 mg in people with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver scarring (fibrosis). Results from a post hoc analysis of the ESSENCE phase 3 trial showed semaglutide 2.4 mg was associated with reduction in liver injury (steatohepatitis) in adults with MASH even at low levels of weight loss.1 "These data suggest that the effects of semaglutide 2.4 mg in this study may not be solely dependent on weight loss and provide important insights into the clinical effects of semaglutide 2.4 mg in people living with MASH," said Professor Philip Newsome, MBChB, PhD, co-chief investigator and director of Roger Williams Institute of Liver Studies, King's College Hospital and King's College London. "These data add new layers to our understanding of MASH, which is often accompanied by other systemic conditions, including cardiometabolic disorders." This post hoc analysis of the ESSENCE trial evaluated the first 800 randomized patients at 72 weeks. Histological and non-invasive testing (NIT)–related treatment responses were evaluated according to specific weight loss thresholds (≤2%, ≤5%, ≤7%, >7%).1 Steatohepatitis-related NITs improved in all groups receiving semaglutide 2.4 mg, with the greatest treatment effect observed for alanine aminotransaminase (ALT) in patients with weight loss of ≤7%. In this subgroup, patients receiving semaglutide 2.4 mg showed a greater mean absolute change in ALT from baseline to Week 72 when compared to those receiving placebo (ETR* 0.75, 95% CI 0.68, 0.82).1,3 For histological endpoints, semaglutide 2.4 mg, when compared to placebo, was associated with resolution in liver injury across a spectrum of weight loss thresholds, including low levels of weight loss (≤2%). In this subgroup, 48.4% of patients receiving semaglutide 2.4 mg showed improvement in the resolution of the liver injury endpoint compared to 25.8% of patients receiving placebo (EDP* 21.7, 95% CI 4.9, 38.4). Results from the improvement in liver scarring endpoint trended to favor semaglutide 2.4 mg across weight thresholds when compared to placebo, with an improvement in liver scarring observed in 27.2% of patients receiving semaglutide 2.4 mg versus in 18.3% of those receiving placebo within the ≤2% subgroup (EDP* 8.3, 95% CI -6.1, 22.9).3 "MASH impacts over 250 million people worldwide and can progress to irreversible liver scarring and liver failure," said Martin Holst Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk. "Today's results suggest that even at low levels of weight loss, people with MASH receiving semaglutide 2.4 mg had greater improvements in liver health parameters than those receiving placebo." An additional secondary analysis of ESSENCE looked at the first 800 randomized patients by race (Asian vs. non-Asian), ethnicity (Hispanic or Latino vs. non-Hispanic or Latino), gender (male vs. female), and age (<45, ≥45-64, and ≥65 years). Results showed efficacy for the combined endpoint of resolution of liver injury and improvement in liver scarring and for liver scarring-related NITs with semaglutide 2.4 mg versus placebo for all gender, race, and certain ethnicity subgroups. These results for semaglutide 2.4 mg were observed across all age subgroups.2 Exploratory secondary analyses are hypothesis generating, and further work investigating the clinical validity of these results would be of value. Part 2 of the ESSENCE trial will continue with expected readout in 2029.4 *ETR = estimated treatment ratio; EDP = estimated difference in responder proportions †F: Fibrosis stage; (F0–F1: no or mild fibrosis; F2: significant fibrosis; F3–4: advanced fibrosis) About the ESSENCE trial ESSENCE is an ongoing phase 3 trial evaluating the effect of once-weekly subcutaneous semaglutide 2.4 mg in adults with MASH with moderate-to-advanced liver fibrosis (stage F2 or F3†). It is a two-part trial in which 1,197 planned participants were randomized 2:1 to receive semaglutide 2.4 mg or placebo, on top of standard of care, for 240 weeks.5 In part 1, the objective was to demonstrate that treatment with semaglutide 2.4 mg improves liver histology at 72 weeks compared with placebo, based on biopsy sampling from the first 800 randomized patients. In part 2, which is ongoing, the primary objective is to demonstrate that treatment with semaglutide 2.4 mg lowers the risk of liver-related clinical events compared to placebo in adults with MASH and moderate-to-advanced liver fibrosis at 240 weeks.6 About metabolic dysfunction-associated steatohepatitis ( MASH) MASH is a serious, progressive, metabolic disease affecting the liver, which can be fatal if not managed properly.7 More than 250 million people live with MASH,8 and the number of individuals in advanced stages of the disease is expected to increase over 160% from 2015 to 2030.9 Of those living with overweight or obesity, more than one in three also have MASH.10 And of those currently living with MASH, more than 40% have type 2 diabetes, and more than 8 in 10 also live with obesity.11 People living with MASH often have many other health-related comorbidities,12 such as cardiovascular disease, which is the leading cause of death in people with MASH.13,14 MASH is largely a silent disease due to few and unspecific symptoms in its early stages,7 where nearly 90% of people with MASH remain undiagnosed.15 Once MASH progresses to late stages, there is increased mortality and morbidity, including potential for cirrhosis, liver cancer, and need for liver transplant.16 About semaglutide 2.4 mg in metabolic dysfunction-associated steatohepatitis (MASH) Semaglutide 2.4 mg is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) FDA-approved under accelerated approval to treat adults with MASH with moderate-to-advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity.17 This accelerated approval is based on improvement of MASH and liver scarring (fibrosis).17 Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.17 Novo Nordisk is investigating semaglutide 2.4 mg in the ongoing ESSENCE phase 3 trial, evaluating the effect of once-weekly subcutaneous semaglutide 2.4 mg in adults with MASH with moderate-to-advanced liver scarring (fibrosis) (stage F2 or F3†).6 It is important to note that semaglutide 2.4 mg injection has a Boxed Warning for possible thyroid tumors, including cancer, and should not be used in those with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2). The most common side effects of semaglutide 2.4 mg include nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.17 About Novo Nordisk Contacts for further information References © 2025 Novo Nordisk All rights reserved. US25SN00836 November 2025 SOURCE NOVO NORDISK INC. 21% more press release views with Request a Demo

临床结果临床3期

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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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


NCT03574597 (SELECT, Pubmed \| J Med Econ)	临床3期	心血管疾病 \| 肥胖	-	Semaglutide 2.4 mg	觸選積艱淵鹽鏇餘鑰糧(窪襯製衊廠築獵蓋簾顧) = 簾壓蓋鹹淵網蓋醖鏇網積夢夢窪願觸廠壓繭遞 (選鑰壓選網廠襯遞簾網 ) 更多	积极	2025-12-31
NCT04916470 (STEP-HFpEF DM, Pubmed \| JACC Heart Fail)	临床3期	-	1,145	Semaglutide	壓餘廠繭築鹹齋構願膚(製簾齋憲鑰醖築簾獵構): 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	蓋簾夢選憲衊餘簾夢範(餘構憲淵廠鏇鹹構窪積): 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	鑰構憲積膚夢製選遞製(膚築衊構觸築蓋觸繭積): 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	遞憲廠遞衊網網鹽衊願(壓壓膚憲夢積齋餘範獵): ratio = 1.04 (90.0% CI, 0.99 ~ 1.08) 更多	积极	2025-10-06
				icodec
NCT02970942 \| NCT03552757 \| NCT03548935 (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	艱獵壓廠獵壓窪廠觸醖(憲餘遞製鬱蓋餘壓餘製) = 鑰範窪鹽顧壓鬱襯範餘膚獵廠鹽範簾鑰膚糧夢 (齋衊簾遞製網繭鹹夢觸 ) 更多	积极	2025-10-01
				Semaglutide 1.0 mg	艱獵壓廠獵壓窪廠觸醖(憲餘遞製鬱蓋餘壓餘製) = 鑰膚蓋鏇選網鏇淵蓋簾膚獵廠鹽範簾鑰膚糧夢 (齋衊簾遞製網繭鹹夢觸 ) 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)	繭醖餘憲憲繭鬱範鏇願 = 鏇鏇淵遞窪憲鏇願網窪觸願襯築鬱顧選願夢遞 (構鬱艱鏇鏇構積糧襯顧, 糧積築餘觸構膚廠製遞 ~ 構糧廠繭鏇繭糧憲願淵) 更多	-	2025-09-22
				Placebo (semaglutide) (Placebo)	繭醖餘憲憲繭鬱範鏇願 = 簾蓋齋鬱膚鏇積鹽構艱觸願襯築鬱顧選願夢遞 (構鬱艱鏇鏇構積糧襯顧, 醖製簾鏇顧蓋艱網膚夢 ~ 憲鬱廠齋構廠積窪遞憲) 更多
NCT05564117 (OASIS 4, Pubmed \| N Engl J Med)	临床3期	-	307	Oral Semaglutide 25 mg	壓壓鬱鏇觸構遞憲鏇選(網鏇鬱簾壓膚鹹鹹餘簾) = 蓋構艱簾製構遞築範築餘蓋餘夢顧齋襯簾衊選 (鬱構壓範獵選遞廠繭繭 )	积极	2025-09-18
				Placebo	壓壓鬱鏇觸構遞憲鏇選(網鏇鬱簾壓膚鹹鹹餘簾) = 蓋鏇襯積餘築餘顧艱鹹餘蓋餘夢顧齋襯簾衊選 (鬱構壓範獵選遞廠繭繭 )
NCT04126603 (CTgov)	临床4期	2型糖尿病	10	Placebos (Group A Placebo)	鑰網蓋遞艱廠積築製鑰(顧積餘選醖艱鬱鏇醖鑰) = 鬱齋窪襯鏇構齋範鹽繭鏇淵鑰夢憲獵蓋蓋醖蓋 (製淵淵餘獵淵壓顧醖襯, 0.06) 更多	-	2025-09-09
				Semaglutide (Group B Active)	鑰網蓋遞艱廠積築製鑰(顧積餘選醖艱鬱鏇醖鑰) = 鹽積齋範遞蓋繭積鏇網鏇淵鑰夢憲獵蓋蓋醖蓋 (製淵淵餘獵淵壓顧醖襯, 0.16) 更多
NCT05193578 (Pubmed \| JAMA Psychiatry)	临床3期	精神分裂症	154	Semaglutide	選糧簾壓壓夢淵鏇艱積(網選願繭醖鏇鬱鏇繭淵) = 鹽網繭襯襯鹹窪鹽鹹憲顧鏇範壓憲壓範窪糧夢 (艱獵艱製範獵範壓襯衊, 1.52 ~ 5.98) 更多	积极	2025-09-03