Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

开始日期2024-11-05

申办/合作机构

Novo Nordisk A/S

NCT06388187 / Recruiting临床3期

Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c.(CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) Once-weekly in Participants With Overweight or Obesity

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.

开始日期2024-06-24

申办/合作机构

Novo Nordisk A/S

NCT06409130 / Recruiting临床2期

Effects of NNC0194-0499 Alone and in Combination With Semaglutide, of Semaglutide Alone, and of Cagrilintide Alone and in Combination With Semaglutide on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease

The study will look at the effects of NNC0194-0499, cagrilintide and semaglutide, on liver damage and alcohol use in participants with alcoholic liver disease. Participants will get NNC0194-0499, semaglutide, cagrilintide or ''dummy" medicine in different treatment combinations. Which treatment participants get is decided by chance. The study will last for about 39 weeks.

开始日期2024-05-20

申办/合作机构

Novo Nordisk A/S

100 项与 Cagrilintide 相关的临床结果

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100 项与 Cagrilintide 相关的转化医学

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100 项与 Cagrilintide 相关的专利（医药）

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项与 Cagrilintide 相关的文献（医药）

2024-03-01·Peptides

Recent advances in peptide-based therapies for obesity and type 2 diabetes

Article

作者: Flatt, Peter R ; Conlon, J Michael ; Bailey, Clifford J

Options for the treatment of type 2 diabetes mellitus (T2DM) and obesity have recently been expanded by the results of several large clinical trials with incretin-based peptide therapies. Most of these studies have been conducted with the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, which is available as a once weekly subcutaneous injection and once daily tablet, and the once weekly injected dual agonist tirzepatide, which interacts with receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). In individuals with T2DM these therapies have achieved reductions of glycated haemoglobin (HbA1c) by > 2% and lowered body weight by > 10%. In some studies, these agents tested in non-diabetic, obese individuals at much higher doses have lowered body weight by > 15%. Emerging evidence suggests these agents can also offer cardio-protective and potentially reno-protective effects. Other incretin-based peptide therapies in early clinical development, notably a triple GLP-1/GIP/glucagon receptor agonist (retatrutide) and a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), have shown strong efficacy. Although incretin therapies can incur adverse gastrointestinal effects these are for most patients mild-to-moderate and transient but result in cessation of treatment in some cases. Thus, the efficacy of new incretin-based peptide therapies is enhancing the opportunity to control body weight and blood glucose and improve the treatment of T2DM and obesity.

2024-02-01·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Efficacy and safety of GLP-1RAs for people with obesity: A systematic review based on RCT and Bayesian network meta-analysis

Review

作者: Nie, Juan ; Li, Hong ; Yu, Guanzheng ; Liu, Yinbei ; Huang, Qi ; Yang, Bao ; Tu, Xing

BACKGROUND:

GLP-1 receptor agonists (GLP-1RAs) reduce glucagon and glycogen secretion, inhibit appetite and slow gastric empties and have recently been approved to treat obesity.

OBJECTIVE:

To explore the safety and efficacy of GLP-1RAs in the treatment of obesity and clarify the optimal GLP-1RAs treatment regimen.

METHODS:

PubMed, Embase, Web of Science, and Cochrane Library databases were searched for English randomized controlled trials (RCTs) on GLP-1RAs in the treatment and management of obesity published before July 18, 2023. Literature screening and data extraction were performed independently by three researchers. Bayesian random effect model was used to compare the effects of interventions. Continuous variables were expressed as mean difference with 95% CI, and dichotomous variables were reported as RR with 95% CI.

RESULTS:

A total of 29 studies with 10,333 participants were included in the present study. The combination of cagrilintide and semaglutide (short for cagrANDsema) was an optimal strategy for weight loss and glycosylated hemoglobin (HbA1c) reduction. Compared to placebo, cagrANDsema reduced weight by - 14.13 kg (95% CI: -16.49, -11.73) and HbA1c by - 0.33% (95% CI: -0.41, -0.25). Moreover, this study indicated that orforglipron and semaglutide also had relatively good effects on weight loss. Meta-regression results indicated that higher dose levels might have better effects on weight loss.

CONCLUSIONS:

CagrANDsema exerts the best effect for weight loss. In terms of current dose levels, a higher dose gets better weight-loss effects without increasing the risk of adverse events.

2024-01-01·Cardiology in review

Cagrilintide: A Long-Acting Amylin Analog for the Treatment of Obesity

Article

作者: D'Ascanio, Antonella M ; Frishman, William H ; Mullally, Jamie A

Despite the worldwide epidemic of obesity, there remain few approved pharmacological treatment options to bridge the gap between lifestyle therapy and bariatric surgery. Cagrilintide is an amylin-analog, now being developed in combination with the GLP-1 agonist semaglutide to achieve sustained weight loss in persons with overweight and obesity. Amylin, released with insulin from beta cells in the pancreas, induces its satiating effect via both the homoeostatic and hedonic regions of the brain. Semaglutide, a GLP-1 receptor agonist, reduces appetite via GLP-1 receptors in the hypothalamus and increases the production of insulin, and reduces glucagon secretion, delaying gastric emptying. These separate, but related mechanisms of action of an amylin-analog and a GLP-1 receptor agonist appear to have an additive effect on appetite reduction. Given the heterogeneity and complex pathogenesis of obesity, combination therapy with multiple pathophysiological targets is a logical approach to increasing weight loss response with pharmacotherapy. Cagrilintide alone, as well as cagrilintide in combination with semaglutide have shown promising weight loss in clinical trials that supports the further development of this therapy for sustained weight management.

103

项与 Cagrilintide 相关的新闻（医药）

2024-09-14

·药智网

诺和诺德的新锚点

2024上半年，诺和诺德实现营收1334亿丹麦克朗，同比增长24%，业绩保持增长。司美格鲁肽的放量是业绩增长的关键因素。司美格鲁肽降糖注射剂Ozempic实现营收567亿丹麦克朗，司美格鲁肽降糖口服剂Rybelsus营收109亿丹麦克朗，司美格鲁肽减重注射剂Wegovy营收210亿丹麦克朗，司美格鲁肽合计销售额887亿丹麦克朗，同比增长43%，占诺和诺德总营收的2/3。在司美格鲁肽全球热卖的同时，诺和诺德也正在不断调整优化自身的研发策略和业务布局，通过丰富产品组合，进一步加强降糖减脂领域的霸主地位，同时，也在逐渐延伸慢病治疗边界。关注新生力量根据诺和诺德2024年中报显示，诺和诺德在企业战略发展方面，将糖尿病和肥胖业务作为关键优先研发领域，主要的战略举措则是进一步丰富相关治疗领域的产品组合，布局将更加广泛和深入。在减重领域，凭借Wegovy打开了肥胖症的市场。未来，诺和诺德将通过重点建立差异化的产品组合，从单纯的减重拓展到针对肥胖症患者的健康状况管理。除Wegovy外，复方制剂CagriSema已启动全球III期临床试验，两款全新的减重药物GLP-1R/胰淀素受体双靶点激动剂Amycretin、口服小分子CB1R反向激动剂Monlunabant的减重疗效也备受期待。 CagriSema是一款复方制剂，它包含2.4mg长效胰淀素受体类似物卡格列肽（Cagrilintide）和2.4mg长效GLP-1RA司美格鲁肽。CagriSema的II期临床数据显示，在治疗的32周，CagriSema治疗组体重下降15.6%，减重效果优于单独使用卡格列肽和司美格鲁肽。53.6%的CagriSema组受试者体重降幅超过15%。目前，CagriSema已启动全球III期临床，主要针对超重/肥胖症适应症。另外，针对伴有超重/肥胖的2型糖尿病适应症的全球III期临床、伴有心血管疾病的肥胖人群的全球III期临床也正在进行。诺和诺德Amycretin共开发了口服和皮下注射两种剂型。诺和诺德在今年的CMD会议上公布了口服Amycretin的初步I期临床数据：接受每日口服1次Amycretin治疗的患者，在治疗的第12周，体重较基线下降13.1%，对比安慰剂组受试者的体重降幅仅1.1%。目前，口服Amycretin已完成I期临床试验，皮下注射剂型Amycretin的I期临床试验数据预计将在2025年读出。另一款新药Monlunabant（INV-202）是一种CB1反向激动剂，CB1是一种大麻素受体，在调节食欲和心脏代谢中发挥重要作用。2023年8月，诺和诺德以10.57亿美元收购加拿大公司Inversago Pharma，由此，诺和诺德获得该公司的主要资产Monlunabant。 Monlunabant的I期临床数据显示，在治疗的第28天，Monlunabant组平均体重下降3.3%（即3.5KG），安慰剂组体重增长0.5%（即0.6KG）。Monlunabant治疗肥胖症和糖尿病肾病的II期临床试验正在进行。在降糖领域，目前诺和诺德的产品组合已覆盖胰岛素、注射型和口服型GLP-1药物。未来，诺和诺德将通过持续推进在研管线，将糖尿病的创新疗法扩展至糖尿病共患病中，例如糖尿病肾病等，以解决糖尿病管理中的尚未满足需求。延伸慢病治疗边界借助GLP-1产品的开发，诺和诺德的研发布局正在不断拓宽边界，朝着更广阔的慢病领域进发。根据券商研究资料显示，截至2023年底，司美格鲁肽全球共涉及148项临床试验，除了糖尿病和肥胖症适应症以外，在NASH、疼痛、慢性肾病、卒中等方面均有布局。其中，司美格鲁肽治疗NASH的Ⅱ期临床试验已取得积极疗效数据，目前正在进行全球III期临床试验。另外，司美格鲁肽在治疗射血分数保留型心力衰竭肥胖成人患者的III期临床试验中同样取得了积极的疗效结果。值得一提的是，GLP-1的另一巨头礼来，同样在扩展替尔泊肽的应用领域。根据礼来2024年中报资料，礼来已向FDA和EMA提交替尔泊肽用于治疗中度至重度阻塞性睡眠呼吸暂停的上市申请，预计FDA方面最早于2024年底给出相关回复。此外，礼来正在就替尔泊肽用于治疗代谢功能障碍相关的脂肪性肝炎的III期临床试验注册策略与有关监管机构进行洽谈。进军更广阔的心血管领域相较于其他跨国药企通过积极投资并购拓展业务领域，诺和诺德的并购活动则更为谨慎。2010年—2023年，诺和诺德仅进行过14项并购，在研发出GLP-1减重，心衰等适应症前，糖尿病是诺和诺德的核心，研发管线的高度专注是诺和诺德谨慎并购的核心原因。但是，自2020年开始，诺和诺德的并购步伐不断加快。尤其是2023年，6月-10月期间相继宣布5项并购项目，交易金额合计高达35亿美元。其中，收购Inversago Pharma公司和Embark Biotech是为了进一步强化肥胖领域的布局，在加码减重领域外，KBP Biosciences（2023）、Prothena（2021）、Corvidia Therapeutics（2020）的三项并购则强化了心血管疾病领域的研发能力。 2023年10月，诺和诺德以13亿美元从KBP Biosciences公司获得用于治疗心血管和肾脏疾病的高血压控制药物Ocedurenone，以加强自身心血管领域布局。Ocedurenone是一款口服小分子非甾体盐皮质激素受体拮抗剂，目前，正在开展用于治疗未得到控制的高血压合并晚期慢性肾病的III期临床试验，预计将在2024年9月完成。此前，Ocedurenone的Ⅱ期临床试验数据显示，在12周随机试验中，Ocedurenone能够使受试者的收缩压明显下降。此外，Ocedurenone的安全性高，高钾血症风险低于1%，并且无类固醇副作用。 2021年，诺和诺德以12亿美元收购Prothena公司，获得抗淀粉样蛋白免疫药物PRX004及其转甲状腺素蛋白淀粉样变性（ATTR）项目，目前ATTR项目正处于临床II期临床试验中。 2020年，诺和诺德以最高21亿美元收购Corvidia Therapeutics公司，获得IL-6单抗Ziltivekimab，通过阻断IL-6通路降低炎症，从而降低ASCVD和CKD患者的主要心血管不良事件风险，目前正在开展III期临床试验。这些正在孕育中的产品管线，如同未来业绩增长的“蓄水池”，随着日后的逐一兑现，还将为诺和诺德源源不断地贡献营收，成为新的重要增长点。核心产品放量增长，内生+外延并举，持续迎来研发进展，诺和诺德未来可期。参考资料： 1.诺和诺德历年业绩报告 2.诺和诺德2023年ADA会议报告 3.诺和诺德2024年资本市场日报告 4.礼来2024年中报 5.《从并购看诺和诺德业务布局思路》，华创证券声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史密斯转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

临床3期财报临床2期并购

2024-09-12

·医药笔记

诺和诺德：口服Amycretin治疗12周减重12%

2024年9月，诺和诺德在欧洲糖尿病协会年会（EASD）上汇报了口服Amycretin的首次人体实验数据。口服Amycretin 50mg剂量组治疗12周减重10.4%，50mg*2剂量组治疗12周减重13.1%，安慰剂组12周减重1.1%，安慰剂校正后，Amycretin 50mg剂量组治疗12周减重9.3%，50mg*2剂量组治疗12周减重12.0%。 Amycretin为一款GLP-1/胰淀素双靶点激动剂，每天口服一次。诺和诺德引领了GLP-1类药物对减重适应症的探索，司美格鲁肽目前为最畅销的GLP-1类药物，后续又布局了多款迭代产品，包司美格鲁肽+Cagrilintide、CB1R激动剂、每周一次GLP-1/GIP双靶点激动剂、Amycretin等。罗氏小分子GLP-1治疗12周减重13%，为口服降糖药目前最好的疗效，诺和诺德口服Amycretin与之疗效相当（非头对头）。内容来源于网络，如有侵权，请联系删除。

抗体药物偶联物

2024-09-11

·Pharmaceutical Technology

EASD 2024: Novo Nordisk’s Saxenda shows weight loss in children

Saxenda was approved by the US Food and Drug Administration (FDA) for obesity management for adolescents aged 12 years and older, in 2020. Image credit: Kittyfly / Shutterstock. Novo Nordisk showcased the efficacy of its obesity therapy, Saxenda (liraglutide), in children under 12 years of age with positive Phase III trial data. The participants in the Saxenda group saw a mean body mass index (BMI) reduction of 5.8%, compared to 1.6% in the placebo group. The Phase III trial data was presented at the European Association for the Study of Diabetes (EASD) taking place from 9-13 September in Spain. The results were also published in the New England Journal of Medicine. Novo Nordisk has dominated the obesity space with Wegovy (semaglutide) and Saxenda. The drugs raked in combined global sales of Dkr41.6bn ($6bn) last year, per the company’s financials. However, the company has been feeling the effects of increased competition from the likes of Eli Lilly’s GLP- 1 Zepbound (tirzepatide) and supply chain constraints . Novo Nordisk reported “lower-than-expected” sales for Wegovy in Q2 this year. The randomised placebo-controlled Phase III SCALE Kids trial (NCT04775082) enrolled 82 children aged 6-12 years with obesity. At 52 weeks, the trial met its primary endpoint by demonstrating a 5.8% mean reduction in BMI with Saxenda. At least a 5% reduction in BMI was observed in 46% of participants in the Saxenda group, compared to 9% of participants in the placebo group. The incidence of adverse events was comparable in both groups, 89% and 88% of participants in the liraglutide and placebo groups, respectively. See Also: Regeneron’s Dupixent approved as first adolescent CRSwNP treatment Lilly’s EBGLYSS gains FDA approval for patients aged 12 and older Saxenda has been approved by the US Food and Drug Administration (FDA) for obesity management for adolescents as young as 12 years. Novo Nordisk plans to use the Phase III SCALE Kids trial data to expand the Saxenda label to include obese children older than 6 years. Novo Nordisk has also made advances in expanding the use of its obesity products to cardiovascular indications . In March, the company’s blockbuster drug Wegovy was approved by the FDA for reducing the risk of cardiovascular diseases in obese or overweight adults. The company also plans to expand its obesity portfolio with CagriSema (cagrilintide/semaglutide) , a fixed dose combination of cagrilintide, a dual amylin and calcitonin receptor agonist and semaglutide, a glucagon-like peptide 1 (GLP-1) agonist. In May, the company shared plans to potentially evaluate the therapy across the cardiometabolic spectrum, such as heart failure, MASH (metabolic associated steatohepatitis), and even obstructive sleep apnoea.

临床3期临床结果上市批准

100 项与 Cagrilintide 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
心脏病	临床3期	美国	Novo Nordisk A/S	2023-03-01
心脏病	临床3期	日本	Novo Nordisk A/S	2023-03-01
心脏病	临床3期	阿根廷	Novo Nordisk A/S	2023-03-01
心脏病	临床3期	澳大利亚	Novo Nordisk A/S	2023-03-01
心脏病	临床3期	巴西	Novo Nordisk A/S	2023-03-01
心脏病	临床3期	保加利亚	Novo Nordisk A/S	2023-03-01
心脏病	临床3期	加拿大	Novo Nordisk A/S	2023-03-01
心脏病	临床3期	哥伦比亚	Novo Nordisk A/S	2023-03-01
心脏病	临床3期	丹麦	Novo Nordisk A/S	2023-03-01
心脏病	临床3期	法国	Novo Nordisk A/S	2023-03-01

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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


NCT04982575 (CTgov)	临床2期	2型糖尿病	92	Semaglutide+Cagrilintide (Cagrilintide 2.4 mg + Semaglutide 2.4 mg)	繭鏇鬱淵積襯鹹積淵蓋(鏇鏇膚遞餘糧鏇齋積襯) = 襯顧餘窪淵齋淵鏇遞構夢鏇繭齋網餘醖構膚餘 (製襯齋糧簾壓衊製憲鏇, 製範鏇餘憲顧簾顧窪製 ~ 願夢遞窪膚夢鑰艱遞壓) 更多	-	2023-07-27
				Placebo+Semaglutide+Cagrilintide (Semaglutide 2.4 mg + Placebo (Cagrilintide))	繭鏇鬱淵積襯鹹積淵蓋(鏇鏇膚遞餘糧鏇齋積襯) = 衊淵膚築襯廠獵製廠齋夢鏇繭齋網餘醖構膚餘 (製襯齋糧簾壓衊製憲鏇, 簾鬱憲範築構艱衊壓蓋 ~ 糧夢鑰觸鹽網壓餘醖鏇) 更多
NCT03856047 (CTgov)	临床2期	肥胖	706	Liraglutide 3.0 mg	艱鏇積願糧鏇獵醖鏇鏇(醖齋糧衊淵襯夢積衊餘) = 鬱齋襯窪鬱醖糧顧鑰構鏇壓淵顧構願鬱壓鏇淵 (鬱願鏇遞醖繭膚願夢遞, 選簾構壓築鏇範艱鏇網 ~ 齋蓋繭廠顧顧壓鹹願鑰) 更多	-	2023-07-18
NCT04982575 (ADA2023)	临床2期	2型糖尿病	92	CagriSema (co-administered semaglutide [sema] 2.4 mg and cagrilintide [cagri] 2.4 mg)	築蓋夢壓簾鹹齋遞遞鬱(鏇蓋繭糧積蓋壓遞選壓): estimated treatment difference = -20.2 (95% CI, -39.8 ~ -0.7), P-Value = 0.04	-	2023-06-23
				Semaglutide (sema) 2.4 mg