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 2diabetes inadequately controlled on metformin, SGLT2 inhibitor or both - REIMAGINE 5

开始日期2024-11-05

申办/合作机构-

NCT06534411 / Recruiting临床3期

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 / Active, not 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

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）

2024-12-01·ARCHIVES OF BIOCHEMISTRY AND BIOPHYSICS

Development of the novel amylin and calcitonin receptor activators by peptide mutagenesis

Article

作者: Lee, Sangmin

The amylin peptide hormone receptor is the complex of the calcitonin peptide hormone receptor and an accessory protein. The calcitonin receptor activation controls calcium homeostasis, while it also functions as the main component of the amylin receptor. Amylin receptor activation in brains controls blood glucose and appetite. Currently, non-selective amylin and calcitonin receptor activators have been tested for body weight reduction to treat obesity. Here, multiple peptide activators for human amylin and calcitonin receptors were developed by introducing comprehensive mutagenesis to rat amylin peptide. The rat amylin peptide C-terminal fragment that interacts with amylin receptor extracellular domain was used to screen for affinity-enhancing mutations. Up to twelve mutational combinations were found to significantly increase peptide affinity both for amylin and calcitonin receptor extracellular domains by over 100-fold. Using these affinity-enhancing mutations, three representative rat amylin analogs with thirty-seven amino acids were made to test the potency increase for amylin and calcitonin receptor activation. All three mutated rat amylin analogs showed significant potency increases by 5- to 10-fold compared to endogenous rat amylin. These mutated peptide activators also showed higher potency for human amylin and calcitonin receptor activation than a clinically available amylin receptor activator pramlintide. These amylin and calcitonin receptor activators developed in this study may be useful as the valuable pharmacological tools that activate amylin receptors in cell-based systems.

2024-12-01·DIABETES OBESITY & METABOLISM

Cagrilintide is not associated with clinically relevant QTc prolongation: A thorough QT study in healthy participants

Article

作者: Sinn, Angela ; Eliasen, Astrid ; Berthelsen, Kasper K. ; Bækdal, Tine A. ; Nejad, Ayna B. ; Fuhr, Rainard ; Kuhlman, Anja B. ; Gabe, Maria B. N.

Abstract:

Aims:

The combination of cagrilintide and semaglutide (CagriSema) is being developed for the treatment of obesity and type 2 diabetes. The objective of this thorough QT study was to confirm that cagrilintide does not result in a clinically relevant prolongation in cardiac repolarization compared with placebo.

Materials and Methods:

This was a double‐blind study (NCT05804162) in which healthy participants were randomized to cagrilintide, administered as a once‐weekly subcutaneous injection dose escalated to 4.5 mg, or a placebo. The primary end point was the time‐matched change from baseline in Fridericia heart rate–corrected QT interval (QTcF) at 12‐, 24‐, 48‐ and 72 h after the last cagrilintide 4.5‐mg dose. To conclude that cagrilintide does not induce a clinically relevant prolongation, the upper limit of the two‐sided 90% confidence interval (CI) for the treatment difference at each of the four time points must fall below 10 ms. To establish QT assay sensitivity, participants in the placebo arms received a single 400‐mg oral moxifloxacin dose as a positive control and moxifloxacin placebo in a nested cross‐over fashion.

Results:

A total of 105 participants received cagrilintide (n = 53) or placebo (n = 52). No clinically relevant QTcF prolongation occurred after the last cagrilintide 4.5‐mg dose; the upper limits of the two‐sided 90% CIs of the placebo‐adjusted QTcF changes from baseline were below 10 ms at all time points. QT assay sensitivity was demonstrated with moxifloxacin as a positive control.

Conclusions:

Cagrilintide did not result in clinically relevant QTcF prolongation, indicating no increased risk of ventricular tachyarrhythmias.

2024-10-02·Expert Review of Clinical Pharmacology

Amylin analogs for the treatment of obesity without diabetes: present and future

Review

作者: Papanas, Nikolaos ; Popovic, Djordje S. ; Gouveri, Evanthia ; Panou, Theodoros

INTRODUCTION:

Obesity is a pandemic, linked with increased morbidity including diabetes mellitus (DM) and certain cancer types. Amylin is a major regulatory hormone for satiation and food intake perception in humans. Amylin analogs (pramlintide and cagrilintide) are emerging as promising anti-obesity agents in non-DM subjects.

AREAS COVERED:

Pramlintide, the first amylin analog, initially used for the treatment of both type 1 and type 2 DM, has demonstrated weight-lowering action. Clinical trials confirmed a weight loss exceeding 3% in the study period without major untoward effects, which was maintained beyond the follow-up period. Recently, cagrilintide, a long-lasting synthetic amylin analog has been introduced. Cagrilintide has achieved adequate weight loss, reaching even more than 10% of the total weight in early clinical trials. However, adverse gastrointestinal effects, particularly nausea, were more frequent compared with pramlintide. Clinical trials have also confirmed the effectiveness of cagrilintide in comparison with glucagon-like peptide 1 receptor agonists.

EXPERT OPINION:

Amylin analogs will certainly enrich the growing therapeutic armamentarium aimed at tackling obesity. The most exciting future research venue could be the development of their combinations with other weight-lowering drugs, especially dual and triple incretin-based co-agonists, thus potentially providing massive weight-loss effects.

124

项与 Cagrilintide 相关的新闻（医药）

2024-11-18

·Healthcare Digital

Novo Nordisk's CagriSema Next Gen Weight-Loss Treatment

Novo Nordisk is the most valuable company in Europe Novo Nordisk's journey as Europe's most valuable pharmaceutical company has led it to pioneer the next generation of weight-loss treatments Pharma giant Novo Nordisk is working on its ‘next generation’ weight-loss drug, CagriSema, which it believes will pioneer GLP-1 treatments. Glucagon-like peptide-1 (GLP-1) is a hormone which plays a vital role in glucose metabolism and appetite regulation. For over a century, Danish pharma Novo Nordisk has been working to prevent and cure chronic diseases. Now, it is the most valuable company in Europe. Novo Nordisk’s treatments benefit millions of people who live with diabetes or obesity, as well as those with rare blood and endocrine diseases. The company also produces 50% of the world’s insulin supply, including over 600m insulin pens and an estimated 36m people use the company’s diabetes care products. Novo Nordisk faces investor scepticism amid weight loss pill challenges Investor confidence in Novo Nordisk's capacity to satisfy product demand has diminished, compounded by disappointing results from an experimental weight loss pill announced in September. As a result, Novo Nordisk's shares have lagged behind those of its primary competitor in the weight-loss sector, Eli Lilly . Novo Nordisk expects data on the drug CagriSema to prove that the drug reduces weight by 25% in just over a year. This in comparison to: 16% from Novo Nordisk’s Wegovy Up to 22.5% by Eli Lilly’s rival Mounjaro However, the results are also expected to show that CagriSema only works when administered alongside a patients’ healthy diet and adequate amounts of exercise and sleep. “CagriSema is really important for us. It’s a next-generation product and it has the potential to be best in class,” said CEO Lars Fruergaard Jørgensen. CagriSema targets obesity and diabetes CagriSema is a novel combination therapy that mixes: Semaglutide, the active component in Novo Nordisk's Ozempic and Wegovy Cagrilintide, an amylin-based compound. This weekly injectable medication combines the GLP-1 mimicking effects of semaglutide with the properties of the pancreatic hormone amylin. The development of CagriSema has broader implications for the pharmaceutical industry, as other companies are also working on amylin-based treatments. These drugs, like GLP-1 agonists, aim to decrease food intake and improve blood glucose regulation. If CagriSema is successful, it could increase confidence in other companies developing amylin-based therapies. For instance, Zealand Pharma, a Danish company working on an amylin-only drug, has seen its market value double this year due to growing enthusiasm for this drug class. Novo Nordisk is currently conducting clinical trials for CagriSema in both obesity and type-2 diabetes treatment. The company is also running a head-to-head trial comparing CagriSema with Eli Lilly's Mounjaro. These efforts are part of Novo Nordisk's unprecedented investment in research and development to maintain its competitive edge. Novo Nordisk CEO advocates for affordable healthcare Over his 33 years at the company CEO Lars Fruergaard Jørgensen , leads the company through its various scientific breakthroughs, expanding access to medicine and working to cure diseases. Lars was invited to represent Novo Nordisk at a Senate hearing in the US, where he explained the pricing differences between medicine for sale in the US compared to other locations. Lars Fruergaard Jørgensen, President and CEO, Novo Nordisk “I reaffirmed our focus on providing innovation, support and care for the people we serve,” he said. “Importantly, I also expressed my frustration that even though we're working hard to make our treatments more affordable, patients aren't seeing the reduction in prices, all too often.” Lars amplified the need for real change and practical solutions for people living with chronic and misunderstood diseases, such as diabetes and obesity. Make sure you check out the latest industry news and insights at Healthcare Digital and also sign up to our global conference series - Healthcare LIVE 2025 Healthcare Digital is a BizClik brand

2024-11-13

·Firstwordpharma

Danish biotech Gubra touts early win for long-acting amylin in obesity

Two weeks after Boehringer Ingelheim pulled the plug on a partnered obesity programme, Gubra is reporting "positive" Phase I data for its long-acting amylin analogue GUBamy (GUB014295), indicating that the Danish biotech's independent assets may offer promising alternatives.In the single ascending dose study, subjects receiving the highest doses (3.5-6.0 mg) achieved approximately 3% weight reduction over six weeks, while the placebo group gained about 1%. The study was conducted in healthy lean and overweight male subjects with a mean body mass index (BMI) of about 26.7 who were randomised into six cohorts treated with either GUBamy or placebo."We are very pleased to see that our data confirms the potential of GUBamy as an anti-obesity treatment," said CEO Henrik Blou. "GUBamy was well tolerated, and the very long half-life supports a weekly dosing regimen."Gubra said the treatment's pharmacokinetic profile revealed a half-life of 270 hours, or 11 days, supporting weekly subcutaneous administration. Adverse events aligned with expectations for the drug class, primarily presenting as gastrointestinal effects including frequent nausea and reduced appetite, with occasional vomiting.Investors are paying close attention to trial outcomes of amylin-based drugs, which could soon represent a new category in weight-loss therapies. Before the end of the year, Novo Nordisk plans to release data from a large study of CagriSema, a combination of the dual amylin and calcitonin receptor agonist cagrilintide, plus GLP-1 agonist semaglutide, the active ingredient in its popular obesity drug Wegovy. The drugmaker recently reiterated its expectation that the new injection will deliver 25% weight loss.Meanwhile, Zealand Pharma has its own amylin compound, petrelintide, and is actively seeking partners to advance the treatment to the next development phases.

临床结果临床1期

2024-11-06

·药智网

司美格鲁肽大卖203亿美元！

11月6日，诺和诺德发布2024年第三季度报，今年前9个月，销售额增长了23%，达到2047亿丹麦克朗，其中糖尿病和肥胖症治疗药物的销售额增长了25%，达到1918亿丹麦克朗。明星产品司美格鲁肽（Semaglutide）继续高歌猛进，3个品牌（降糖针剂Ozempic，降糖片剂Rybelsus，和减肥针剂Wegovy）今年前9个月销售额达到1412.13亿丹麦克朗，约203亿美元。数据来源：诺和诺德财报不久前，礼来也公布了其业绩，其中GIPR/GLP-1R双重激动剂Tirzepatide（替尔泊肽）2个品牌（降糖针剂Mounjaro，减肥针剂Zepbound）在今年前三个季度销售额达到110.284亿美元。具体来看，Mounjaro销售收入80.10亿美元，Zepbound销售收入30.18美元。 Zepbound去年11月份上市以来放量迅速，累计处方患者超过60万人。图片来源：礼来司美格鲁肽和替尔泊肽两款药物在今年都实现了销售额大幅增长，而且两大制药巨头还在探索GLP-1R药物其他适应症，或许新的惊喜已在酝酿中。就在几天前，诺和诺德公布了ESSENCE关键临床3期试验第1部分的主要结果。分析显示，司美格鲁肽（Wegovy）与安慰剂相比，可显著缓解代谢功能障碍相关脂肪性肝炎（MASH）患者的肝纤维化并实现脂肪性肝炎消退，实现了其主要终点。在第72周，接受2.4 mg司美格鲁肽治疗的患者中，37.0%的人肝纤维化得到改善，脂肪性肝炎没有恶化；而接受安慰剂治疗的患者中，这一比例为22.5%。接受2.4 mg司美格鲁肽治疗的患者中，62.9%的人脂肪性肝炎得到缓解，肝纤维化没有恶化，而接受安慰剂治疗的患者中，这一比例为34.1%。相比其他MASH新药，司美格鲁肽在肝纤维化改善数据方面表现并不算优秀，但这次研究至少证明了GLP-1R靶点确实有改善纤维化的潜力，意味着GLP-1R药物在治疗MASH领域迈出了具有重要意义的一步。诺和诺德预计将于2025年上半年向美国和欧盟监管单位递交Wegovy用于治疗MASH的监管申请。该试验第2部分将继续进行，预计于2029年公布结果。 01 新一代减肥药酝酿中司美格鲁肽和替尔泊肽的成功打破了多年来肥胖赛道无好药可用的僵局，但这两款药物也并非完美无缺，例如需要通过注射给药；由于需求火爆，产能受到挑战。而且不少使用者被其副作用所困扰，包括恶心、呕吐、腹泻和腹痛等胃肠道副作用，对肌肉损失的担忧，以及停药反弹。因此，诺和诺德和礼来两家制药巨头还在开发更便捷、更高效且安全的新一代减肥药。礼来推出了GLP-1R/GIPR/GCGR三靶点激动剂Retatrutide和口服小分子GLP-1R激动剂Orforglipron。 Retatrutide 该药为GLP-1R/GIPR/GCGR三靶点激动剂，是替尔泊肽的潜在迭代产品，给药频率为每周一次。礼来预期最高剂量可以减重22-24%，主要是脂肪的减少，预计降糖效果可以将Hb1Ac降低2%。目前，礼来围绕Retatrutide已经注册了9项三期临床试验：3项2型糖尿病、6项减重试验，包括一项Retatrutide头对头替尔泊肽用于减重研究。该研究计划入组800例肥胖患者，预计2027年4月完成。 Orforglipron 该药是一种新型的口服小分子GLP-1R激动剂，给药频率为每日一次。目前，该药处于临床Ⅲ期阶段，适应症包括肥胖、2型糖尿病、心血管疾病等。 Orforglipron的Ⅱ期临床数据显示，治疗36周，45mg剂量组减重14.7%，相较安慰剂组减重12.4%。 Orforglipron减重临床数据图片来源：参考资料1 对比口服Semaglutide 50mg组临床Ⅲ期OASIS 1试验36周减重约14%，orforglipron减重效果似乎更胜一筹。作为GLP-1R小分子赛道的领头羊，orforglipron的表现，让人们对其Ⅲ期临床数据充满了期待。诺和诺德则推出了司美格鲁肽与胰淀素类似物cagrilintide的药物组合CagriSema，以及口服药物monlunabant、amycretin。图片来源：诺和诺德 CagriSema CagriSema是司美格鲁肽与胰淀素类似物cagrilintide的固定剂量药物组合，给药频率为每周一次皮下注射。 2022年，诺和诺德开始了CagriSema肥胖症的Ⅲ期临床系列研究REDEFINE，包括一项CagriSema与替尔泊肽头对头对照用于减肥的Ⅲ期临床试验（REDEFINE 4）。该研究计划入组800例肥胖或超重患者，接受2.4mg Cagrilintide+2.4mg司美格鲁肽或替尔泊肽高剂量15mg治疗，预计于2025年8月完成。图片来源：诺和诺德 Monlunabant Monlunabant（曾用名INV-202）是一种小分子口服大麻素受体1（CB1）反向激动剂。诺和诺德于2023年8月以超10亿美元收购加拿大公司Inversago pharma囊获了这一疗法。其2a期临床试验结果显示，从基线体重110.1公斤开始，经过16周治疗，每日一次服用10 mg剂量monlunabant的参与者平均体重减少了7.1公斤，而安慰剂组仅减少了0.7公斤。然而，monlunabant高剂量组看到的减重效果提升有限。 Amycretin 该药是一款GLP-1受体和胰淀素受体的长效共激动剂，诺和诺德开发了口服和皮下注射两种剂型，其中口服剂型在临床进展上更快，给药频率为每日一次。在减重方面，接受治疗12周后，Amycretin组患者体重下降幅度达13.1%，相较之下，安慰剂组患者的体重下降幅度仅为1.1%。 02 结语在崛起的减重、代谢领域，国产创新药也占据了重要地位。 2023年11月，中国biotech公司诚益生物与阿斯利康就小分子GLP-1R激动剂ECC-5004达成一项超20亿美元的独家许可协议。 2024年5月，中国制药巨头江苏恒瑞医药将其GLP-1R药物组合的中国以外权利授权给新成立的美国生物技术公司Hercules，交易总金额超过60亿美元，且由此开辟的newco模式正在成为创新药出海的新潮流。随着国产GLP-1R药物的研发推进，有望在这一新领域实现突破性的进展，分得一杯羹。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 | 小月石转载开白 | 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

财报临床3期

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
血管疾病	临床3期	美国	Novo Nordisk A/S	2023-03-01
血管疾病	临床3期	日本	Novo Nordisk A/S	2023-03-01
血管疾病	临床3期	阿根廷	Novo Nordisk A/S	2023-03-01
血管疾病	临床3期	澳大利亚	Novo Nordisk A/S	2023-03-01
血管疾病	临床3期	巴西	Novo Nordisk A/S	2023-03-01
血管疾病	临床3期	保加利亚	Novo Nordisk A/S	2023-03-01
血管疾病	临床3期	加拿大	Novo Nordisk A/S	2023-03-01
血管疾病	临床3期	哥伦比亚	Novo Nordisk A/S	2023-03-01
血管疾病	临床3期	丹麦	Novo Nordisk A/S	2023-03-01
血管疾病	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

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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


ADA2024	N/A	-	-	Cagrilintide 3 nmol/kg	齋餘鹽壓夢衊憲網繭顧(憲衊製遞繭夢選鑰築選) = 廠鏇觸艱鹽鬱繭艱衊窪膚顧糧鹹艱製積膚遞繭 (醖鑰顧獵鹽襯艱願範遞 )	-	2024-06-14
				Cagrilintide 10 nmol/kg	齋餘鹽壓夢衊憲網繭顧(憲衊製遞繭夢選鑰築選) = 範鹹餘簾廠築鬱選製艱膚顧糧鹹艱製積膚遞繭 (醖鑰顧獵鹽襯艱願範遞 )
NCT04982575 (CTgov)	临床2期	2型糖尿病	92	Semaglutide+Cagrilintide (Cagrilintide 2.4 mg + Semaglutide 2.4 mg)	膚鑰艱糧簾鏇遞網廠範(範積蓋餘齋糧憲鑰鏇膚) = 簾鹹鹽鬱積繭壓繭繭選積餘網膚窪窪顧獵鏇願 (積膚廠繭襯鹹繭膚築壓, 構衊鹹艱繭鏇夢膚夢糧 ~ 襯壓醖範窪醖壓範顧艱) 更多	-	2023-07-27
				Placebo+Semaglutide+Cagrilintide (Semaglutide 2.4 mg + Placebo (Cagrilintide))	膚鑰艱糧簾鏇遞網廠範(範積蓋餘齋糧憲鑰鏇膚) = 築鏇獵構餘窪遞築積鑰積餘網膚窪窪顧獵鏇願 (積膚廠繭襯鹹繭膚築壓, 糧夢選選衊製選醖選願 ~ 窪鬱願鬱餘糧遞蓋觸夢) 更多
NCT03856047 (CTgov)	临床2期	肥胖	706	Liraglutide 3.0 mg	獵壓製壓願網餘壓製壓(顧顧餘製製糧夢壓顧簾) = 膚夢餘觸壓蓋顧齋鹽鹹願壓範艱鏇膚鏇壓遞繭 (觸齋簾夢醖窪簾憲網選, 蓋遞築製觸衊簾網餘獵 ~ 鹹糧範鹽築鏇繭鹹餘鬱) 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)	願膚選艱鬱繭餘廠蓋壓(觸齋艱鑰艱觸製餘鏇襯): estimated treatment difference = -20.2 (95% CI, -39.8 ~ -0.7), P-Value = 0.04	-	2023-06-23
				Semaglutide (sema) 2.4 mg
NCT03600480 (Pubmed \| Lancet)	临床1期	-	96	Cagrilintide	(願衊衊獵鬱衊顧衊艱蓋) = 壓鬱獵觸壓願鹽獵壓壓淵鏇鑰積淵鬱醖餘鹹獵 (構襯範鑰獵鏇衊製鬱糧 ) 更多	-	2021-04-22
				Semaglutide 2·4 mg	(願衊衊獵鬱衊顧衊艱蓋) = 襯艱鏇願衊餘鹽夢鏇鑰淵鏇鑰積淵鬱醖餘鹹獵 (構襯範鑰獵鏇衊製鬱糧 ) 更多