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

NCT06934655

/ Not yet recruiting临床3期IIT

Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth

This is a Phase 3a, randomized, parallel-controlled trial designed to compare the early re-initiation of semaglutide, starting two weeks after sleeve gastrectomy, to standard care (no pharmacotherapy following surgery). The trial will involve 150 youth with severe obesity who have been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery. Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months. Primary, secondary, and tertiary outcomes will be assessed at multiple time points: 1-month, day of surgery, and 1-, 3-, 6-, 9-, 12-, 18-, and 24-months postoperatively. We hypothesize that early re-initiation of semaglutide will be safe, well-tolerated, and lead to greater improvements in obesity, cardiometabolic risk, and eating behaviors.

开始日期2025-11-01

申办/合作机构

Children's Hospital Los Angeles

NCT06909006

/ Not yet recruiting临床3期IIT

Obesity and Semaglutide in Type 1 Diabetes Therapy: a Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial

The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.

开始日期2025-10-01

申办/合作机构

Zealand University Hospital

[+1]

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项与司美格鲁肽 (诺和诺德) 相关的文献（医药）

2025-07-01·Current Neuropharmacology

In Silico Pharmacogenomic Assessment of Glucagon-like Peptide-1 (GLP1) Agonists and the Genetic Addiction Risk Score (GARS) Related Pathways: Implications for Suicidal Ideation and Substance Use Disorder

Article

作者: Pollack, Aryeh R ; Badgaiyan, Rajendra D ; Ashford, J Wes ; Khalsa, Jag H ; Blum, Kenneth ; Bowirrat, Abdalla ; Baron, David ; Schmidt, Sergio ; Gardner, Eliot L ; Elman, Igor ; Carney, Paul R ; Lewandrowski, Kai-Uwe ; Hanna, Colin ; Fuehrlein, Brian ; Sharafshah, Alireza ; Wang, Gene Jack ; Gold, Mark S ; Dennen, Catherine A ; Braverman, Eric R ; Pinhasov, Albert ; Modestino, Edward J ; Cadet, Jean Lud ; Fiorelli, Rossano Kepler Alvim ; Cortese, Rene ; Thanos, Panayotis K

Introduction::

Glucagon-Like Peptide-1 Receptor (GLP1R) agonists have become widespread anti-obesity/diabetes pharmaceuticals in the United States.

Aim::

This article aimed to provide our current knowledge on the plausible mechanisms linked to the role of Ozempic (Semaglutide), which is generalized as one of the anti-addiction compounds.

Methods::

The effects of GLP1R agonists in Alcohol Use Disorder (AUD) and substance use disorder (SUD) are mediated, in part, through the downregulation of dopamine signaling. We posit that while GLP1R agonism could offer therapeutic advantages in hyperdopaminergia, it may be detrimental in patients with hypodopaminergia, potentially leading to long-term induction of Suicidal Ideation (SI). The alleged posit of GLP1 agonists to induce dopamine homeostasis is incorrect. This study refined 31 genes based on the targets of Ozempic, GLP1R, and related enzymes for SI and 10 genes of the Genetic Addiction Risk Score (GARS) test. STRING-MODEL refined 29 genes, and further primary analyses indicated associations of GLP1R with DRD3, BDNF, CREB1, CRH, IL6, and DPP4.

Results::

In-depth silico enrichment analysis revealed an association between candidate genes and depressive phenotypes linked with dopaminergic signaling. Finally, through primary and in-depth silico analyses, we demonstrated multiple findings supporting that GLP1R agonists can induce depression phenotypes.

Conclusion::

Our findings suggest that associated polymorphisms seem to have overlapping effects with addictive behaviors of Reward Deficiency Syndrome (RDS) and dopamine regulation. Consequently, GLP1R agonists may represent a double-edged sword, potentially triggering both antiaddictive effects and SI by exacerbating depressive phenotypes. Thus, we encourage the scientific community to perform further empirical clinical studies to confirm this proposed pathway. Keywords: GLP1, Ozempic, suicide ideation, substance use disorder, dopamine homeostasis, in-depth in silico.

2025-05-01·LANCET

Semaglutide and walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes (STRIDE): a phase 3b, double-blind, randomised, placebo-controlled trial

Article

作者: Rasouli, Neda ; Catarig, Andrei-Mircea ; Bonaca, Marc P ; Verma, Subodh ; Ramesh, Chethana Kalmady ; Houlind, Kim ; Videmark, Alex ; Ludvik, Bernhard ; Nordanstig, Joakim ; Sourij, Harald

BACKGROUND:

Peripheral artery disease is a highly morbid type of atherosclerotic vascular disease involving the legs and is estimated to affect over 230 million individuals globally. Few therapies improve functional capacity and health-related quality of life in people with lower limb peripheral artery disease. We aimed to evaluate whether semaglutide improves function as measured by walking ability as well as symptoms, quality of life, and outcomes in people with peripheral artery disease and type 2 diabetes.

METHODS:

STRIDE was a double-blind, randomised, placebo-controlled trial done at 112 outpatient clinical trial sites in 20 countries in North America, Asia, and Europe. Participants were aged 18 years and older, with type 2 diabetes and peripheral artery disease with intermittent claudication (Fontaine stage IIa, able to walk >200 m) and an ankle-brachial index of less than or equal to 0·90 or toe-brachial index of less than or equal to 0·70. Participants were randomly assigned (1:1) using an interactive web response system to receive subcutaneous semaglutide 1·0 mg once per week for 52 weeks or placebo. The primary endpoint was the ratio to baseline of the maximum walking distance at week 52 measured on a constant load treadmill in the full analysis set. Safety was evaluated in the safety analysis set. This trial is registered with ClinicalTrials.gov, NCT04560998 and is now completed.

FINDINGS:

From Oct 1, 2020, to July 12, 2024, 1363 patients were screened for eligibility, of whom 792 were randomly assigned to semaglutide (n=396) or placebo (n=396). 195 (25%) participants were female and 597 (75%) were male. Median age was 68·0 years (IQR 61·0-73·0). The estimated median ratio to baseline in maximum walking distance at week 52 was significantly greater in the semaglutide group than the placebo group (1·21 [IQR 0·95-1·55] vs 1·08 [0·86-1·36]; estimated treatment ratio 1·13 [95% CI 1·06-1·21]; p=0·0004). Six serious adverse events in five (1%) participants in the semaglutide group and nine serious adverse events in six (2%) participants in the placebo group were possibly or probably treatment related, with the most frequent being serious gastrointestinal events (two events reports by two [1%] in the semaglutide group and five events reported by three [1%] in the placebo group). There were no treatment-related deaths.

INTERPRETATION:

Semaglutide increased walking distance in patients with symptomatic peripheral artery disease and type 2 diabetes. Research implications include the need for future studies to further elucidate mechanisms of benefit and to assess the efficacy and safety in patients with peripheral artery disease who do not have type 2 diabetes.

FUNDING:

Novo Nordisk.

2025-05-01·Diabetes Therapy

PIONEER REAL Italy: Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes

Article

作者: Deinega, Alisa ; Giordano, Carla ; Desenzani, Paolo ; Memoli, Pasqualina ; Faldetta, Maria Cassone ; Gioia, Daniela ; Ventura, Claudio ; Serra, Rosalia ; Gallo, Marco ; Berra, Cesare ; Braae, Uffe Christian ; Memoli, Giuseppe ; Manetti, Francesco ; Bisio, Alessandro ; Paccagnella, Agostino ; Strazzabosco, Marco ; Mirani, Marco ; Marangoni, Alberto ; Anzaldi, Massimiliano ; De Cata, Pasquale ; Girelli, Angela ; Di Loreto, Chiara ; De Cosmo, Salvatore ; Scatena, Alessia ; Manti, Roberta ; Ferrara, Lidia

INTRODUCTION:

The PIONEER REAL Italy study examined the clinical outcomes associated with oral semaglutide in real-world settings.

METHODS:

This was a multicenter, prospective, non-interventional, single-arm study in adults with type 2 diabetes (T2D) who were treatment-naive to injectable glucose-lowering medications. Participants initiated oral semaglutide at doses of 3, 7, or 14 mg, and were followed for 34-44 weeks. The primary endpoint was the change in glycated hemoglobin (HbA_1c) from baseline to the end of study (EoS). Secondary endpoints were the change in body weight (BW), the percentage of participants attaining HbA_1c < 7%, composite endpoints of HbA_1c reduction ≥ 1%-point plus BW reduction (≥ 3%/ ≥ 5%), and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.

RESULTS:

Of 445 eligible participants, 398 completed the study; 351 (78.9%) remained on oral semaglutide at EoS. The median time of treatment follow-up was 40 weeks for each participant. At baseline, participants had a mean (standard deviation [SD]) age of 62.9 (10.2) years, HbA_1c of 7.8% (1.3), T2D duration of 8.0 (6.9) years, and BW of 87.8 (19.0) kg. The estimated changes (95% confidence interval) from baseline to EoS in HbA_1c and BW were - 0.9%-points (- 1.01 to - 0.82; p < 0.0001) and - 3.8 kg (- 4.45 to - 3.24; p < 0.0001), respectively. At EoS, 65.1% achieved HbA_1c < 7%; 25.5% and 19.1% reached HbA_1c reduction ≥ 1%-point plus ≥ 3% and ≥ 5% reduction in BW, respectively. DTSQ status improved significantly at EoS (estimated change + 5.24; 95% CI, 5.24 to 6.61, p < 0.0001). Of participants who remained on oral semaglutide at EoS, 72.6% received a 7-mg dose. No new safety signals were observed.

CONCLUSIONS:

In Italy, the real-world clinical outcomes associated with oral semaglutide in adults with T2D complemented the findings from clinical trials. This reassures oral semaglutide usage in routine clinical practice.

TRIAL REGISTRATION:

NCT05230615.

4,985

项与司美格鲁肽 (诺和诺德) 相关的新闻（医药）

2025-05-16

·PRNewswire

Weekly Recap: 14 Health Press Releases You Need to See

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including the 2025-2026 Best OTC Medicine & Health Products, Lilly's collaboration expansion with Purdue University, and a breakthrough in gene editing. NEW YORK, May 16, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, May 12-16, 2025. World's First Patient Treated with Personalized CRISPR Gene Editing Therapy at Children's Hospital of Philadelphia "We want each and every patient to have the potential to experience the same results we saw in this first patient, and we hope that other academic investigators will replicate this method for many rare diseases and give many patients a fair shot at living a healthy life," said Kiran Musunuru, MD, PhD, the Barry J. Gertz Professor for Translational Research in Penn's Perelman School of Medicine. $101M XPRIZE Healthspan Awards First Milestone Winners Driving Toward Revolutionary Healthy Aging Advances Launched in November 2023, the $101M XPRIZE Healthspan is the first health-focused competition of its kind, incentivizing teams to develop proactive, accessible therapeutic solutions that restore muscle, cognition, and immune function by a minimum of 10 years, with a goal of 20 years, in persons aged 50-80 years, in one year or less. U.S. News Announces the 2025-2026 Best OTC Medicine & Health Products The brands with the most No. 1 products among the 2025-2026 rankings are Nature Made (7), followed by CeraVe (6) and Neutrogena (5); the companies with the most No. 1 products are Haleon plc, followed by Kenvue Inc., Prestige Consumer Healthcare Inc., The Procter & Gamble Company and L'Oreal Usa, Inc. FDA Approves Teal Health's Teal Wand™--The First and Only At-Home Self-Collection Device for Cervical Cancer Screening, Introducing a Comfortable Alternative to In-Person Screening Women can now collect their own sample from the privacy of home, no speculum required, and mail it to a certified lab to be tested on the same test as the doctor's office, with the same accuracy. Pager Health and Protera Health Team Up to Expand Access to Value-Based, Virtual-First MSK Care Pager Health's omnichannel care navigation solution will rapidly identify members with potential MSK-related issues and connect them seamlessly to Protera Health's virtual MSK program. From there, members will be directed to in-home care, in-network physical therapy or orthopedic surgical consults as appropriate. Sanofi to invest at least $20 billion in the US through 2030, growing investments in science and expanding domestic manufacturing "Sanofi's 13,000 US-based employees are pioneering the research and development of first- and best-in-class medicines across numerous therapeutic areas. Our expected investments in the US will be substantial and will help ensure the production of key medicines in the US," said Paul Hudson, Sanofi Chief Executive Officer. In new SELECT trial analysis, early reduction in cardiovascular events was observed with Wegovy®, before clinically meaningful changes in body weight "For people with obesity and existing cardiovascular disease, preventing another heart attack or stroke is vitally important. Seeing this SELECT secondary data demonstrate that patients experienced MACE risk reduction within three months is remarkable," said Dr. Jason Brett, MD, Principal Medical Head at Novo Nordisk Inc. Lilly plans to expand Purdue University collaboration with up to a $250 million investment to accelerate pharmaceutical innovation The Lilly-Purdue 360 Initiative aims to achieve several key goals, including discovering and accelerating the delivery of medicines to patients; bridging the gap between laboratory discoveries and clinical applications; creating more resilient, efficient and sustainable supply chains; and deploying innovative, scalable approaches to workforce development. Guardian adds over 20 new and innovative benefits to its hospital indemnity insurance policy, designed to inspire well-being® Guardian's enhanced hospital indemnity insurance policy becomes one of the industry's most comprehensive offerings, going further to support workers' mental, physical, and financial well-being needs. As part of these additions, Guardian becomes the first carrier to include fertility health, family-building, and caregiving wellness solutions directly in hospital indemnity insurance. U.S. Drug Spending Up 10.2% in 2024, with Weight Loss Drugs Remaining Top Driver Clinic drug spending rose sharply — up 14.4% to $158.2 billion — while nonfederal hospitals saw a more modest 4.9% increase to $39.0 billion. With GLP-1 shortages largely resolved, continued growth in this category is expected, though direct-to-consumer channels may complicate efforts to track usage trends. American College of Lifestyle Medicine Announces Integration of First Set of Lifestyle Behavior Assessment Tools Into Epic Electronic Health Records The new tools include ACLM's lifestyle medicine short form assessment tool, a clinical survey to capture patient lifestyle behaviors and readiness for change; ACLM's Diet Screener, which helps clinicians quickly capture a picture of a patient's diet during routine medical appointments; the Physical Activity Vital Sign (PAVS) tool for assessing physical activity in adults; as well as additional tools to capture lifestyle behaviors and opportunities for change. Hearing Wellness Pioneer Eargo Launches Eargo 8 As Its Newest Flagship Hearing Aid Eargo 8 was thoughtfully engineered with premium features, technology, and design while delivering essential post-purchase assistance for a seamless integration into users' lives. Eargo 8 is FDA cleared and its MSRP is $2,699. AbbVie and ADARx Pharmaceuticals Announce Collaboration and License Option Agreement to Develop Next-Generation siRNA Therapies Across Multiple Therapeutic Areas The strategic collaboration will leverage ADARx's RNA discovery expertise and proprietary siRNA technology, which has the potential to enable sustained and precise mRNA silencing. AbbVie will contribute its expertise in antibody engineering, antibody drug conjugates (ADCs) and tissue delivery approaches as appropriate, to augment ADARx's discovery efforts. MavriX Bio Announces FDA Clearance of IND Application to Initiate First-in-Human Study of Gene Therapy for Angelman Syndrome "We are thrilled to achieve this critical milestone and move one step closer to delivering the first gene therapy to individuals living with Angelman syndrome," said Allyson Berent, DVM, DACVIM, Chief Development Officer of MavriX Bio. "The clearance of our IND signals a key transition point for our development program and our unwavering commitment to advance novel therapeutic options and a potential single treatment therapy for the Angelman community." For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出

2025-05-16

·医药观澜

速递丨信达生物玛仕度肽3期临床完成首例受试者给药，针对超重或肥胖合并脂肪肝

5月16日，信达生物宣布：胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂玛仕度肽在中国超重或肥胖合并代谢相关脂肪性肝病（MAFLD）受试者中的一项3期临床研究（GLORY-3）完成首例受试者给药。本研究是一项在中国超重或肥胖合并MAFLD受试者中比较玛仕度肽与一款GLP-1单受体激动剂有效性和安全性的多中心、随机、开放标签的3期临床研究（NCT06884293）。本研究计划入组约470例超重或肥胖（BMI≥27 kg/m2）合并代谢功能障碍相关性脂肪性肝病（MAFLD）受试者，按1:1的比例随机分配至玛仕度肽9 mg组或对照组。研究的主要终点是第48周时磁共振质子密度脂肪分数（MRI-PDFF）评估肝脏脂肪含量较基线百分比变化及第48周时体重较基线的百分比变化。在一项中国肥胖受试者（BMI≥30 kg/m2）中开展的2期研究（NCT04904913）结果显示，在给药48周后，玛仕度肽9 mg组体重降幅相较安慰剂组的差值达−18.6%，平均变化值与安慰剂组的差值达−17.8 kg；玛仕度肽 9 mg组中51.2%的受试者体重较基线下降15%以上，34.9%的受试者体重较基线下降20%以上。在基线肝脏脂肪含量（由MRI-PDFF测量）超过5%的受试者中，玛仕度肽9 mg组治疗24周后肝脏脂肪含量较基线平均百分比下降73.3%，该降幅在48周延长治疗期得以维持。提示玛仕度肽可有效降低超重或肥胖受试者的体重及肝脏脂肪，为超重或肥胖合并MAFLD的患者带来获益。代谢功能障碍相关性脂肪性肝病（MAFLD）是常见的慢性肝病。肥胖是MAFLD的危险因素之一。信达生物新闻稿表示，作为GCG/GLP-1双受体激动剂，玛仕度肽9mg在超重或肥胖人群中减重疗效强劲，且因其对GCG受体的额外激动作用，可使肝脏脂肪含量和肝酶水平大幅降低，可为受试者带来更显著的肝脏获益。玛仕度肽作为GCG/GLP-1双受体激动剂，相较于GLP-1单受体激动剂药物，激动GCG受体可促进脂肪分解和脂肪酸氧化，并带来一系列代谢综合获益。在中国肥胖受试者中开展的2期研究中，基线肝脏脂肪含量超过5%的受试者接受玛仕度肽9 mg组治疗24周后其肝脏脂肪含量即可较基线平均百分比下降73.3%，初步证明了玛仕度肽降低肝脏脂肪含量的疗效。参考资料：[1]信达生物玛仕度肽第二项头对头司美格鲁肽临床研究：在中国超重或肥胖合并脂肪肝受试者中的III期临床研究GLORY-3完成首例受试者给药. Retrieved May 16,2025, from https://www.prnasia.com/story/489211-1.shtml免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床结果临床2期临床3期

2025-05-16

·信达生物

玛仕度肽第二项头对头司美格鲁肽临床研究：在中国超重或肥胖合并脂肪肝受试者中的III期临床研究GLORY-3完成首例受试者给药

2025年5月16日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售用于治疗肿瘤、自免、代谢、眼科等重大疾病领域创新药物的生物制药公司，宣布：胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂玛仕度肽在中国超重或肥胖合并代谢相关脂肪性肝病（MAFLD）的受试者中的一项III期临床研究（GLORY-3）完成首例受试者给药。本研究是一项在中国超重或肥胖合并MAFLD受试者中比较玛仕度肽与司美格鲁肽有效性和安全性的多中心、随机、开放标签的III期临床研究（NCT06884293）。本研究计划入组约470例超重或肥胖（BMI≥27 kg/m2）合并代谢功能障碍相关性脂肪性肝病（MAFLD）受试者，按1:1的比例随机分配至玛仕度肽9 mg组或司美格鲁肽2.4 mg组。研究的主要终点是第48周时磁共振质子密度脂肪分数（MRI-PDFF）评估肝脏脂肪含量较基线百分比变化及第48周时体重较基线的百分比变化。在一项中国肥胖受试者（BMI≥30 kg/m2）中开展的II期研究(NCT04904913)结果显示，在给药48周后，玛仕度肽9 mg组体重降幅相较安慰剂组的差值达−18.6%，平均变化值与安慰剂组的差值达−17.8 kg；玛仕度肽 9 mg组中51.2%的受试者体重较基线下降15%以上，34.9%的受试者体重较基线下降20%以上。在基线肝脏脂肪含量（由MRI-PDFF测量）超过5%的受试者中，玛仕度肽9 mg组治疗24周后肝脏脂肪含量较基线平均百分比下降73.3%，该降幅在48周延长治疗期得以维持。提示玛仕度肽可有效降低超重或肥胖受试者的体重及肝脏脂肪，为超重或肥胖合并MAFLD的患者带来获益。本项研究的主要研究者、北京医院郭立新教授表示：“代谢功能障碍相关性脂肪性肝病（MAFLD）是全球最常见的慢性肝病，且已经取代病毒性肝炎成为中国第一大慢性肝病。肥胖是MAFLD的危险因素之一，中国肥胖人群MAFLD患病率为81.8%1。GLP-1类药物如司美格鲁肽已被最新的《中国肥胖患者长期体重管理和药物临床应用指南》推荐可用于肥胖合并MAFLD的治疗。作为GCG/GLP-1双受体激动剂，玛仕度肽9mg在超重或肥胖人群中减重疗效强劲，且因其对GCG受体的额外激动作用，可使肝脏脂肪含量和肝酶水平大幅降低，可为受试者带来更显著的肝脏获益。GLORY-3将在超重或肥胖合并MAFLD的受试者中比较玛仕度肽9mg和司美格鲁肽2.4mg的疗效和安全性，这也是第一个在这类患者人群对比GCG/GLP-1双受体激动剂和GLP-1单靶点药物的临床研究。我将与GLORY-3的研究者们一起同心协力推进和高质量完成此项研究，在获得高质量的临床证据的同时，为中国超重或肥胖合并MAFLD的人群提供更优的治疗选择。”信达生物制药集团临床开发高级副总裁钱镭博士表示：“玛仕度肽作为GCG/ GLP-1双受体激动剂，相较于GLP-1单受体激动剂药物，激动GCG受体可促进脂肪分解和脂肪酸氧化，并带来一系列代谢综合获益。在中国肥胖受试者中开展的II期研究中，基线肝脏脂肪含量超过5%的受试者接受玛仕度肽9 mg组治疗24周后其肝脏脂肪含量即可较基线平均百分比下降73.3%，初步证明了玛仕度肽降低肝脏脂肪含量的疗效。我非常有信心玛仕度肽在GLORY-3研究中会继续在前期研究中的强大减重及改善肝脏代谢等临床指标，为超重或肥胖且合并MAFLD的患者带来全面的代谢获益和更优的治疗选择。”关于肥胖- 滑动查看更多介绍 -我国是全球超重和肥胖人口最多的国家，且呈现逐渐上升趋势2。肥胖可以导致一系列并发症或者相关疾病，进而影响预期寿命或者导致生活质量下降。在较为严重的肥胖患者中，心血管疾病、糖尿病和某些肿瘤的发生率及死亡率明显上升。2019年超重和肥胖导致的死亡在慢性非传染性疾病相关死亡中占比11.1%，相比1990年的5.7%显著增加3。肥胖症是需要长期治疗的慢性疾病，目前缺乏长期有效且安全的治疗手段。生活方式干预是超重或肥胖者的首选和基础治疗手段，但是仍有相当一部分患者由于种种原因不能达到期望的减重目标，需用药物辅助减重。传统减肥药减重效果有限，且存在安全性问题，对疗效更好且安全的减肥疗法的需求尚未得到满足。关于代谢相关脂肪肝病（MAFLD）- 滑动查看更多介绍 -MAFLD是全球最常见的慢性肝病，全球MAFLD总体患病率估计为32.4%，且患病率逐年升高。肥胖作为MAFLD的危险因素之一，全球肥胖人群中的MAFLD患病率达到75.3%。在中国，MAFLD且已经取代病毒性肝炎成为中国第一大慢性肝病。中国肥胖人群MAFLD患病率为81.8%1。同时，中国MAFLD年发病率在正常人群或肥胖人群中均为全球最高。MAFLD治疗目标包括减少体质量和腰围、改善胰岛素抵抗、防治代谢相关综合征、逆转纤维化等等，与肥胖患者的治疗原则存在相似之处。对于超重或肥胖合并MAFLD的患者，在生活方式干预的基础上辅以药物治疗是实现有效减重、改善合并症以及提高生活质量的优选方案。关于玛仕度肽（IBI362）- 滑动查看更多介绍 -玛仕度肽（IBI362）是信达生物与礼来制药共同推进的一款胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂。作为一种哺乳动物胃泌酸调节素（OXM）类似物，玛仕度肽除了通过激动GLP-1R促进胰岛素分泌、降低血糖和减轻体重外，还可通过激动GCGR增加能量消耗增强减重疗效，同时改善肝脏脂肪代谢。玛仕度肽已在多项临床研究中展现出优秀的减重和降糖疗效，以及降低腰围、血脂、血压、血尿酸、肝酶及肝脏脂肪含量，以及改善胰岛素敏感性，带来多重代谢获益。玛仕度肽当前共有两项NDA获NMPA受理审评，包括：用于成人肥胖或超重患者的长期体重控制；用于成人2型糖尿病患者的血糖控制。玛仕度肽当前共开展了六项III期临床研究，包括：在中国超重或肥胖受试者中开展的III期临床研究（GLORY-1）；在中国中重度肥胖受试者中开展的III期临床研究（GLORY-2）；在中国超重或肥胖合并MAFLD受试者中开展的对比玛仕度肽和司美格鲁肽的III期临床研究（GLORY-3）;在初治的中国2型糖尿病受试者中开展的III期临床研究（DREAMS-1）；在口服药物治疗血糖控制不佳的中国2型糖尿病受试者中开展的对比玛仕度肽和度拉糖肽的III期临床研究（DREAMS-2）；在中国2型糖尿病合并肥胖的受试者中开展的对比玛仕度肽和司美格鲁肽的III期临床研究（DREAMS-3）。其中，GLORY-1、DREAMS-1和DREAMS-2研究均已达成终点。此外，玛仕度肽的多项新临床研究计划启动，其中包括治疗青少年肥胖和阻塞性睡眠呼吸暂停（OSA）的两项III期临床研究，以及治疗代谢相关脂肪性肝炎（MASH）、射血分数保留心力衰竭（HFpEF）等新临床研究。关于信达生物- 滑动查看更多介绍 -“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。声明：1.信达不推荐任何未获批的药品/适应症使用。2.雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®）和匹妥布替尼片（捷帕力®）由礼来公司研发。参考文献：[1]Chen K, Shen Z, Gu W, Lyu Z, Qi X, Mu Y, Ning Y; Meinian Investigator Group. Prevalence of obesity and associated complications in China: A cross-sectional, real-world study in 15.8 million adults. Diabetes Obes Metab. 2023 Nov;25(11):3390-3399.[2] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373–92.[3]Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool.http://ghdx.healthdata.org/gbd-resultstool (accessed Jan 10, 2021).前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

临床结果临床3期临床2期临床成功

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,

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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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


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)	鹽糧鬱網壓窪鬱構鬱淵(壓遞鏇鑰鏇襯築積醖鏇) = 網淵壓範遞繭鬱獵憲遞網醖製膚蓋壓鏇鏇觸鏇 (獵簾餘艱顧夢網製願觸, 窪壓顧顧遞顧憲獵餘憲 ~ 鑰積築選壓齋鑰簾鹽蓋) 更多	-	2025-05-04
				Lifestyle Counseling (Lifestyle Intervention)	鹽糧鬱網壓窪鬱構鬱淵(壓遞鏇鑰鏇襯築積醖鏇) = 艱觸築鑰顧製觸膚餘壓網醖製膚蓋壓鏇鏇觸鏇 (獵簾餘艱顧夢網製願觸, 糧衊顧艱鏇淵餘醖繭醖 ~ 製製襯遞鏇糧積簾範淵) 更多
NCT04822181 (ESSENCE, PRNewswire \| Pubmed) 人工标引	临床3期	非酒精性脂肪性肝炎	800	Semaglutide 2.4 mg	簾艱鏇糧繭鏇獵廠憲廠(構醖網艱糧鬱簾鹹鹹廠) = 遞壓憲鏇廠簾築夢膚廠壓鹽觸艱鑰願糧憲鹹壓 (簾蓋憲糧廠鏇獵艱鬱廠 ) 更多	积极	2025-04-30
				Placebo	簾艱鏇糧繭鏇獵廠憲廠(構醖網艱糧鬱簾鹹鹹廠) = 餘膚獵窪鹽獵壓積選觸壓鹽觸艱鑰願糧憲鹹壓 (簾蓋憲糧廠鏇獵艱鬱廠 ) 更多
NCT03574597 (SELECT, PRNewswire) 人工标引	临床3期	超重 \| 肥胖	17,604	司美格鲁肽2.4mg	齋積淵鹽鏇簾鹹艱壓糧(窪鬱衊繭膚蓋憲觸膚構) = 繭膚鏇鏇餘憲選繭壓齋壓獵選鑰餘餘餘鑰繭鹽 (選醖範憲壓鬱選製艱壓 ) 更多	积极	2025-04-03
				Placebo	-
NCT04998136 (CTgov)	临床3期	肥胖	150	Placebo (semaglutide 2.4 mg)	齋鏇願鹽積膚艱蓋選鏇(鹽憲鬱鬱壓製淵範窪鏇) = 壓衊願膚觸顧壓鹽蓋淵鹹窪製顧積觸選廠鑰鹽 (壓範膚鑰築憲夢夢顧觸, 5.8) 更多	-	2025-04-03
NCT03914326 (SOUL, Pubmed \| N Engl J Med) 人工标引	临床3期	2型糖尿病	9,650	Oral Semaglutide	夢壓觸鏇築顧簾壓願餘(壓獵淵糧鹹製鑰選窪鬱) = 鬱鏇窪壓餘廠築願鏇蓋顧窪簾範製鹹壓選糧醖 (膚構繭壓選蓋觸夢簾顧 ) 更多	积极	2025-03-29
				Placebo	夢壓觸鏇築顧簾壓願餘(壓獵淵糧鹹製鑰選窪鬱) = 繭醖鬱遞遞網襯憲繭蓋顧窪簾範製鹹壓選糧醖 (膚構繭壓選蓋觸夢簾顧 ) 更多
NCT05230615 (PIONEER REAL Italy, Pubmed \| Diabetes Ther)	N/A	2型糖尿病	445	Oral Semaglutide 3 mg	糧築淵構範鹹遞鏇鏇範(鏇顧構鏇蓋網積餘遞構) = 簾鏇廠選餘鑰簾鏇鹽願淵網簾壓壓廠鏇築積衊 (鹽憲窪願積獵構憲壓積 )	积极	2025-03-25
				Oral Semaglutide 7 mg	糧築淵構範鹹遞鏇鏇範(鏇顧構鏇蓋網積餘遞構) = 壓積製範襯遞顧網蓋鹹淵網簾壓壓廠鏇築積衊 (鹽憲窪願積獵構憲壓積 )
NCT05520775 (CTgov)	临床2期	酒精使用障碍 \| 吸烟	48	Semaglutide (Semaglutide)	選鹽艱鹽製鏇艱鬱鑰築(築選鑰遞觸觸積遞襯簾) = 遞餘繭繭淵艱蓋網齋鑰廠夢廠築糧鏇醖遞糧醖 (糧鹽醖築製築鹹壓製襯, 27.98) 更多	-	2025-03-25
				Sham/placebo (Sham/Placebo)	選鹽艱鹽製鏇艱鬱鑰築(築選鑰遞觸觸積遞襯簾) = 鏇鬱鏇鹽壓淵簾醖淵餘廠夢廠築糧鏇醖遞糧醖 (糧鹽醖築製築鹹壓製襯, 24.49) 更多
NCT03819153 (FLOW, CTgov)	临床3期	2型糖尿病 \| 慢性肾病	3,533	semaglutide (Semaglutide)	鹽遞繭範鏇鹹構觸蓋窪 = 鹹鹹鹹醖選糧顧壓選範衊餘積鑰廠艱顧憲夢餘 (艱夢鑰鬱觸衊網憲齋範, 窪壓選膚蓋糧壓鹹顧鏇 ~ 窪鹹衊齋夢鑰願膚鬱醖) 更多	-	2025-03-20
				Placebo (semaglutide) (Placebo)	鹽遞繭範鏇鹹構觸蓋窪 = 獵糧選齋獵艱淵餘選築衊餘積鑰廠艱顧憲夢餘 (艱夢鑰鬱觸衊網憲齋範, 夢鹽鹽簾鹽壓淵鹹艱廠 ~ 齋簾夢鑰醖願襯繭衊觸) 更多
Drugs 人工标引	N/A	肥胖	364	Semaglutide	膚鬱簾憲廠鬱構顧鏇願(蓋鑰獵鹹襯鬱獵網膚網) = 鏇積窪鹽蓋獵範餘憲獵積積壓夢顧夢觸遞獵製 (積壓鹹鏇艱願鑰獵觸構 )	不佳	2025-03-12
				Control (No Semaglutide)	膚鬱簾憲廠鬱構顧鏇願(蓋鑰獵鹹襯鬱獵網膚網) = 鹽獵獵醖蓋窪製鑰艱糧積積壓夢顧夢觸遞獵製 (積壓鹹鏇艱願鑰獵觸構 )
NCT04560998 (STRIDE, Pubmed \| Lancet) 人工标引	临床3期	2型糖尿病 \| 外周动脉疾病	792	Semaglutide	窪鑰餘選鏇艱餘鏇淵願(襯餘顧壓淵夢繭鏇壓簾) = 願壓簾衊築夢鹽積簾齋構網遞膚觸餘夢醖顧餘 (鹹醖蓋簾糧簾鏇襯製鏇, 0.95 ~ 1.55) 更多	积极	2025-03-01
				Placebo	窪鑰餘選鏇艱餘鏇淵願(襯餘顧壓淵夢繭鏇壓簾) = 鑰醖衊齋顧壓齋淵窪顧構網遞膚觸餘夢醖顧餘 (鹹醖蓋簾糧簾鏇襯製鏇, 0.86 ~ 1.36) 更多