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更新于：2025-07-16
Cagrilintide
更新于：2025-07-16
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
Sequence Code 720102737
来源: *****
关联
34
项与 Cagrilintide 相关的临床试验NCT07010432
The Role of the Amylin Analogue Cagrilintide in Bone Metabolism During Weight Loss in Postmenopausal Women With Obesity
NCT06719011
A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male Participants With Overweight or Obesity.
NCT06716307
Comparing the Pharmacokinetics of Cagrilintide and Semaglutide Following Single Subcutaneous Doses of Different CagriSema Presentations, in a Crossover Manner in Adult Participants With Overweight or Obesity
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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61
项与 Cagrilintide 相关的文献（医药）2025-08-01EBioMedicine
Cagrilintide lowers bodyweight through brain amylin receptors 1 and 3
Article
作者: Lundh, Sofia ; Hassan, Shad ; Raun, Kirsten ; Secher, Anna ; Carvas, Alexandra Oliveira ; Pers, Tune ; Coester, Bernd ; Lutz, Thomas A ; Le Foll, Christelle ; Lommi, Greta ; Leuthardt, Andrea ; Kulka, Patricia
BACKGROUND:
Amylin (AmyR) and calcitonin (CTR) receptor co-agonists are currently in Phase II/III clinical trials for obesity treatment. Amylin binds to a heterodimeric receptor composed of CTR and the receptor activity modifying proteins 1, 2 or 3 (RAMP1-3).
METHODS:
We investigated the role of amylin 1 and 3 (AMY1R, AMY3R) receptors in modulating the pharmacological effects of the dual amylin-calcitonin receptor agonists, cagrilintide and salmon calcitonin (sCT), in RAMP1/3 knockout (KO) mice. Male wild-type (WT) and KO littermate mice were fed high-fat diet for 23 weeks prior to the 3-week treatment period with vehicle, 150 nmol/kg sCT or 3 nmol/kg cagrilintide (subcutaneously, SID).
FINDINGS:
Body weight loss was observed in WT cagrilintide-treated mice (-3.4 ± 0.51 g, P < 0.005; n = 8/group), whereas sCT rather increased it (0.60 ± 0.38 g, P < 0.01; n = 8/group). The absence of RAMP1 and RAMP3 impeded cagrilintide's potency but improved sCT's efficacy on weight loss. Cagrilintide and sCT both decreased food intake during the first few days of treatment in WT mice only (Day 1: vehicle 2.7 ± 0.2 g; cagrilintide 1.2 ± 0.1 g, P < 0.0001; sCT 1.5 ± 0.2 g, P < 0.0021; n = 7-8/group). Both peptides activated cFos signal in neurons of the dorsal vagal complex (DVC) and lateral parabrachial nucleus (LPBN) of WT mice while AP cFos signal was decreased in cagrilintide-treated RAMP1/3 KO mice by 57% compared to WT cagrilintide-injected mice (P < 0.001, n = 5-6/group). Differential gene expression was analysed in the DVC, LPBN and mediobasal hypothalamic area of WT and RAMP1/3 KO mice. After 3 weeks of treatment, neither sCT nor cagrilintide significantly altered gene expression in the DVC or LPBN in WT mice. However, mRNA bulk sequencing points to a role of RAMP1/3 in synaptic function and receptor trafficking.
INTERPRETATION:
Altogether, these results demonstrate the dependency of cagrilintide on AMY1R and AMY3R to lower body weight.
FUNDING:
This work was supported by an investigator led Novo Nordisk Consortium grant, Swiss National Foundation and the University of Zurich.
2025-07-01LIFE SCIENCES
Characterization of 0839 – A tool compound for pre-clinical mode-of-action studies of amylin analogues such as cagrilintide
Article
作者: Kuhre, Rune Ehrenreich ; Gabery, Sanaz ; Raun, Kirsten ; Kruse, Thomas ; Glendorf, Tine ; Pedersen, Kent ; Ballarin-Gonzalez, Borja
Cagrilintide (also known as 0833) is an amylin and calcitonin receptor agonist in clinical development for weight management and type-2-diabetes in a fixed-dose combination with semaglutide. Here, we introduce 0174-0839 (0839) as a tool compound for mouse and rat in vivo and in vitro studies of amylin analogues such as cagrilintide. Structurally, 0839 shares 95 % sequence homology with 0833 and contains an identical acylation sidechain. Acute administration of 0839 and 0833 to normal weight rats' dose-dependently reduced food intake to a similar degree. Sub-chronically, 0839 and 0833 had comparable small and transient reducing effects on food intake and body weight in DIO mice, with similar additional add-on effects on top of semaglutide. In DIO rats, sub-chronic administration of 0833 and 0839 profoundly reduced food intake and body weight, and both potentiated semaglutide's effects on food intake and body weight to an equal extended. Both compounds mainly reduced body weight by fat mass reduction and equally improved metabolic parameters. Notably, 0839 is available through Novo Nordisk Compound Sharing, enabling advancement of mode-of-action studies in mice and rats whilst usage of cagrilintide and other amylin analogues in clinical development are restricted due to pharmacovigilance rules.
2025-06-22NEW ENGLAND JOURNAL OF MEDICINE
Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity.
Article
作者: Osorto Contreras, Cynthia Karenina ; Zeuthen, Niels ; Rubino, Domenica ; Winning Lehmann, Eva ; Blüher, Matthias ; Wadden, Thomas ; Wilding, John P H ; Garvey, W Timothy ; Pietiläinen, Kirsi H ; Sbraccia, Paolo ; Davies, Melanie J
BACKGROUND:
Semaglutide at a dose of 2.4 mg has established weight-loss and cardiovascular benefits, and cagrilintide at a dose of 2.4 mg has shown promising results in early-phase trials; the efficacy of the combination (known as CagriSema) on weight loss in persons with either overweight and coexisting conditions or obesity is unknown.
METHODS:
In a phase 3a, 68-week, multicenter, double-blind, placebo-controlled and active-controlled trial, we enrolled adults without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or higher or a BMI of 27 or higher with at least one obesity-related complication. Participants were randomly assigned in a ratio of 21:3:3:7 to receive the combination of semaglutide at a dose of 2.4 mg and cagrilintide at a dose of 2.4 mg, semaglutide alone at a dose of 2.4 mg, cagrilintide alone at a dose of 2.4 mg, or placebo, plus lifestyle interventions for all groups. The coprimary end points were the relative change in body weight and a reduction of 5% or more in body weight from baseline to week 68 with cagrilintide-semaglutide as compared with placebo. Body-weight reductions of 20% or more, 25% or more, and 30% or more were assessed as confirmatory secondary end points. Effect estimates were assessed with the treatment-policy estimand (consistent with the intention-to-treat principle). Safety was assessed.
RESULTS:
A total of 3417 participants underwent randomization, with 2108 assigned to receive cagrilintide-semaglutide, 302 to receive semaglutide, 302 to receive cagrilintide, and 705 to receive placebo. The estimated mean percent change in body weight from baseline to week 68 was -20.4% with cagrilintide-semaglutide as compared with -3.0% with placebo (estimated difference, -17.3 percentage points; 95% confidence interval, -18.1 to -16.6; P<0.001). Participants receiving cagrilintide-semaglutide were more likely than those receiving placebo to reach weight-loss targets of 5% or more, 20% or more, 25% or more, and 30% or more (P<0.001 for all comparisons). Gastrointestinal adverse events (affecting 79.6% in the cagrilintide-semaglutide group and 39.9% in the placebo group), including nausea, vomiting, diarrhea, constipation, or abdominal pain, were mainly transient and mild-to-moderate in severity.
CONCLUSIONS:
Cagrilintide-semaglutide provided significant and clinically relevant body-weight reductions in adults with overweight or obesity, as compared with placebo. (Funded by Novo Nordisk; REDEFINE 1 ClinicalTrials.gov number, NCT05567796.).
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 |
|---|---|---|---|---|
| 2型糖尿病 | 临床3期 | 美国 | 2023-09-27 | |
| 2型糖尿病 | 临床3期 | 中国 | 2023-09-27 | |
| 2型糖尿病 | 临床3期 | 日本 | 2023-09-27 | |
| 2型糖尿病 | 临床3期 | 阿根廷 | 2023-09-27 | |
| 2型糖尿病 | 临床3期 | 澳大利亚 | 2023-09-27 | |
| 2型糖尿病 | 临床3期 | 巴西 | 2023-09-27 | |
| 2型糖尿病 | 临床3期 | 保加利亚 | 2023-09-27 | |
| 2型糖尿病 | 临床3期 | 加拿大 | 2023-09-27 | |
| 2型糖尿病 | 临床3期 | 克罗地亚 | 2023-09-27 | |
| 2型糖尿病 | 临床3期 | 捷克 | 2023-09-27 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | - | 3,417 | Cagrilintide-Semaglutide | 範製鏇窪顧襯繭夢選選(衊繭鬱壓範齋鏇顧遞遞) = Gastrointestinal adverse events (affecting 79.6% in the cagrilintide-semaglutide group and 39.9% in the placebo group), including nausea, vomiting, diarrhea, constipation, or abdominal pain, were mainly transient and mild-to-moderate in severity 醖鑰顧餘壓鑰艱壓襯膚 (醖衊鹽糧廠繭齋廠膚獵 ) | 积极 | 2025-06-22 | |
N/A | - | - | Cagrilintide 3 nmol/kg | 鹽選襯鏇夢鑰範糧築齋(鬱鹹製憲範壓醖齋糧膚) = 廠膚構壓蓋鏇廠願遞簾 顧蓋選構願顧鹽選壓夢 (膚製蓋網廠構襯窪鑰夢 ) | - | 2024-06-14 | |
Cagrilintide 10 nmol/kg | 鹽選襯鏇夢鑰範糧築齋(鬱鹹製憲範壓醖齋糧膚) = 壓醖觸顧窪鬱醖糧願鏇 顧蓋選構願顧鹽選壓夢 (膚製蓋網廠構襯窪鑰夢 ) | ||||||
临床2期 | 92 | (Cagrilintide 2.4 mg + Semaglutide 2.4 mg) | 顧鑰廠壓廠製網願鹽鹽(觸餘積網構醖窪糧憲顧) = 遞鑰壓鏇構鏇淵齋選膚 齋製顧蓋構壓齋鬱餘艱 (網築窪糧窪膚糧鑰範構, 0.9) 更多 | - | 2023-07-27 | ||
(Semaglutide 2.4 mg + Placebo (Cagrilintide)) | 顧鑰廠壓廠製網願鹽鹽(觸餘積網構醖窪糧憲顧) = 簾窪鏇遞齋遞選積鏇繭 齋製顧蓋構壓齋鬱餘艱 (網築窪糧窪膚糧鑰範構, 1.0) 更多 | ||||||
临床2期 | 706 | 襯鬱膚選製廠鏇膚夢願(艱蓋顧壓壓願衊鬱觸觸) = 鏇構築淵餘膚鏇觸簾憲 鑰淵遞製蓋窪積繭獵願 (顧範廠廠齋艱獵鑰觸蓋, 5.6) 更多 | - | 2023-07-18 | |||
临床2期 | 92 | 衊遞範積憲夢襯艱壓襯(膚艱觸遞遞廠願醖鹹製): estimated treatment difference = -20.2 (95% CI, -39.8 ~ -0.7), P-Value = 0.04 | - | 2023-06-23 | |||
临床1期 | - | 96 | 醖獵鹽廠鏇窪觸齋壓選(憲獵觸餘淵鏇獵艱獵遞) = 壓鏇憲遞廠築構簾夢構 鏇窪製構鑰蓋廠夢壓簾 (構願顧鏇鹹壓選蓋淵夢 ) 更多 | - | 2021-04-22 | ||
醖獵鹽廠鏇窪觸齋壓選(憲獵觸餘淵鏇獵艱獵遞) = 簾簾餘蓋糧餘願鹽衊窪 鏇窪製構鑰蓋廠夢壓簾 (構願顧鏇鹹壓選蓋淵夢 ) 更多 |
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