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更新于：2026-02-02
Amycretin
更新于：2026-02-02
概要
基本信息
药物类型 多肽激素 |
别名 NN-9487、NN9487、NNC-04870111 + [1] |
作用方式 激动剂 |
作用机制 AMYR 激动剂(胰淀素受体 激动剂)、GLP-1R激动剂(胰高血糖素样肽-1激动剂) |
治疗领域 |
非在研适应症- |
原研机构 |
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1期 |
特殊审评- |
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结构/序列
Sequence Code 1372723925
关联
11
项与 Amycretin 相关的临床试验NCT07339423
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (AMAZE 1)
NCT07121153
Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Doses of Subcutaneous NNC0487-0111 in Chinese Participants With Overweight or Obesity.
NCT06820476
Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Oral Doses of NNC0487-0111 in Chinese Participants With Overweight or Obesity
100 项与 Amycretin 相关的临床结果
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100 项与 Amycretin 相关的转化医学
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100 项与 Amycretin 相关的专利（医药）
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9
项与 Amycretin 相关的文献（医药）2026-03-01VASCULAR PHARMACOLOGY
Amylin receptors as therapeutic targets in obesity: Emerging peptide-based strategies
Review
作者: Rejili, Mokhtar ; Haouala, Faouzi ; Sahoo, Samir ; Khan, Yumna ; Pal, Amrita ; Arora, Vimal ; Ganesan, Subbulakshmi ; Hussain, Md Sadique
Obesity is a chronic, relapsing metabolic disorder driven by complex genetic and environmental factors, leading to an imbalance in energy regulation. Despite the presence of GLP-1 receptor agonists with induced mild weight loss, there are significant unmet clinical needs with poor efficacy and tolerability problems. Amylin, a neuroendocrine hormone co-released with insulin, controls hunger, gastric motility, glucagon secretion, and energy metabolism via divergent amylin receptor (AMYR) subtypes (1-3), namely the calcitonin receptor (CTR) and the receptor activity-modifying proteins (RAMPs). Novel insight into the molecular make-up of AMYRs and central signaling reinforces its key function in modulating homeostatic and hedonic feeding mechanisms. The article is a review of the emerging preclinical and clinical data regarding the application of peptide-based amylin receptor agonists (AMYRAs), including pramlintide and cagrilintide, KBP-series DACRAs, and investigational drugs, including ZP8396 and amycretin. The agents show enhanced pharmacokinetics, synergy with GLP-1 receptor agonist, and favorable impact on weight regulation and metabolic plasticity. Genetic CALCR and RAMP mutations, new delivery approaches, and dual therapy by digital health technologies and bariatric surgery are also discussed in this review. Of particular interest, amylin-derived medications can have advantages over weight loss but definite disease-modifying action remains to be determined. Taken together, AMYRAs represent a potential category of therapeutics with promising disease-modifying effects that goes beyond weight loss, providing fresh perspectives for precision obesity management by 2030.
2025-12-01Metabolism open
Synthetic target trial emulation and predictive modeling of amylin-pathway therapies for obesity and type 2 diabetes
Article
作者: Alsaif, Ahmed K ; Azzam, Ahmed Y ; Aleidan, Elan A ; Almutairi, Atheer G ; Al-Harbi, Faisal A ; Alanazi, Mashael E ; Alshehri, Hussam J ; Alabdulaaly, Ghaida S
Introduction:
Amylin-pathway therapies represent a novel therapeutic class for obesity and type 2 diabetes, however head-to-head comparative data and long-term outcome predictions remain limited. We conducted target trial emulation and computational predictive modeling aiming to predict future trial outcomes and comparative effectiveness across the amylin-pathway development program.
Methods:
Following PRISMA 2020 and TARGET framework guidelines, we search in the current literature for eligible trials and extracted data from seven randomized controlled trials (N = 5,786 participants) of amylin-pathway therapies published up to September 2025. We reconstructed high-precision synthetic individual patient data (IPD) and developed computational models for virtual head-to-head comparisons, dose-response optimization, longitudinal trajectory prediction, and trial simulation. Network meta-analysis integrated evidence across CagriSema, cagrilintide, and amycretin formulations.
Results:
Synthetic IPD reconstruction achieved >99 % fidelity to source trials, validated through leave-trial-out cross-validation (efficacy RMSE: 2.9 % points, calibration slope: 0.61; discontinuation RMSE: 0.18, slope: 1.08). Virtual head-to-head modeling confirmed CagriSema superiority over amycretin subcutaneous at matched timepoints (posterior probability >0.95). Dose-response modeling identified optimal amycretin exposures (ED80: 8.88 mg subcutaneous, 95 % CI: 7.12-11.08), with benefit-risk frontier analysis delineating a therapeutic window at 10-20 mg balancing efficacy plateau against tolerability thresholds (GI-AE <75 %, discontinuation <20 %). Longitudinal kinetics showed plateau timing at 52-68 weeks for obesity outcomes and 24-32 weeks for glycemic endpoints. Heterogeneity analysis revealed complete resolution for GI adverse events (I2_DL = 0 %, τ2 = 0) and moderate variation for discontinuation (I2_DL = 13 %, τ2 = 0.03) after logit-scale correction with proper within-arm variance weighting. Machine learning models predicted treatment response with 82-87 % accuracy using baseline characteristics.
Conclusions:
Synthetic target trial emulation with structured validation (leave-trial-out, posterior predictive checks, simulation-based calibration) demonstrated promising evidence for amylin-pathway development optimization. Benefit-risk frontier analysis identified an optimal 10-20 mg subcutaneous therapeutic window, and heterogeneity quantification through maximum a posteriori (MAP) predictive interval provides design-ready estimates for confirmatory trials requiring around 800-1,200 participants per arm for 90 % power.
2025-08-01EBioMedicine
The effect of amycretin, a unimolecular glucagon-like peptide-1 and amylin receptor agonist, on body weight and metabolic dysfunction in mice and rats
Article
作者: Brand, Christian Lehn ; Raun, Kirsten ; Hjøllund, Karina Rahr ; Glendorf, Tine ; Secher, Anna ; Kruse, Thomas ; Ipsen, David Højland ; Madsen, Kim Grimstrup ; Lundh, Sofia ; Petersen, Signe Beck ; Vegge, Andreas ; Kuhre, Rune Ehrenreich ; Ballarín-González, Borja ; Hogendorf, Wouter Frederik Johan
BACKGROUND:
Amycretin is a novel unimolecular glucagon-like peptide-1 (GLP-1) and amylin receptor agonist. This study aimed to determine its role in mitigating diet-induced metabolic disorders, such as obesity, insulin resistance, and fatty liver disease, in mice and rats.
METHODS:
Preclinical studies were conducted to characterise amycretin activation of GLP-1, amylin and calcitonin receptors, and determine the effects of amycretin administration on the metabolic health of mice and rats. Investigations included measurements of body weight and body composition, energy intake and energy expenditure, insulin sensitivity, metabolic dysfunction-associated steatotic liver disease (MASLD), and access in the mouse brain.
FINDINGS:
Amycretin activated human, mouse and rat GLP-1, amylin and calcitonin receptors in cell-based systems. In diet-induced obese (DIO) rats, amycretin administration for 21 days reduced total energy intake by 47% (95% CI (mean), kcal: vehicle: 2132-2493 vs. amycretin: 1044-1390) and lowered body weight by 18% (95% CI (mean), % change relative to pre-treatment: vehicle: 6.56-8.47 vs. amycretin: -10.48 to -12.74, p < 0.0001), while maintaining energy expenditure. Amycretin targeted key areas of the mouse brain that regulate food intake. Insulin sensitivity improved significantly with amycretin administration in DIO rats compared with vehicle controls, shown by higher glucose infusion rates during a hyperinsulinaemic euglycemic clamp. Additionally, amycretin improved histological hallmarks of MASLD, primarily by reducing steatosis.
INTERPRETATION:
Amycretin had various beneficial effects on metabolic health in mice and rats; effectively reducing body weight, enhancing insulin sensitivity, and improving MASLD activity scores. Thus, amycretin could be a promising therapeutic option for metabolic diseases including obesity and type 2 diabetes, warranting further clinical trials assessing its efficacy in humans.
FUNDING:
Novo Nordisk A/S.
100 项与 Amycretin 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 |
|---|---|---|---|---|
| 肥胖 | 临床3期 | 美国 | 2026-02-24 | |
| 肥胖 | 临床3期 | 阿根廷 | 2026-02-24 | |
| 肥胖 | 临床3期 | 澳大利亚 | 2026-02-24 | |
| 肥胖 | 临床3期 | 比利时 | 2026-02-24 | |
| 肥胖 | 临床3期 | 加拿大 | 2026-02-24 | |
| 肥胖 | 临床3期 | 丹麦 | 2026-02-24 | |
| 肥胖 | 临床3期 | 法国 | 2026-02-24 | |
| 肥胖 | 临床3期 | 德国 | 2026-02-24 | |
| 肥胖 | 临床3期 | 英国 | 2026-02-24 | |
| 2型糖尿病 | 临床2期 | 美国 | 2024-08-07 |
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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2期 | 448 | (Subcutaneous, once-weekly) | 願夢淵窪鏇餘觸鏇鏇醖(糧蓋衊夢築憲網壓襯夢) = 獵製糧鏇鹹襯選築齋選 選鬱窪窪夢襯觸淵網淵 (網膚範網艱艱蓋窪夢衊 ) 达到 更多 | 积极 | 2025-11-25 | ||
Placebo (Subcutaneous) | 願夢淵窪鏇餘觸鏇鏇醖(糧蓋衊夢築憲網壓襯夢) = 範鏇願選襯願築鹽顧繭 選鬱窪窪夢襯觸淵網淵 (網膚範網艱艱蓋窪夢衊 ) 达到 更多 | ||||||
临床1/2期 | 101 | 窪簾鹽醖窪廠艱鬱醖願(構顧艱鏇簾蓋膚積遞餘) = 獵築簾糧網餘遞積鏇繭 膚窪壓醖鹽糧鏇範鏇膚 (壓憲窪鑰壓醖餘膚襯糧 ) | 积极 | 2025-06-20 | |||
Placebo | 窪簾鹽醖窪廠艱鬱醖願(構顧艱鏇簾蓋膚積遞餘) = 繭製艱糧廠選獵淵選廠 膚窪壓醖鹽糧鏇範鏇膚 (壓憲窪鑰壓醖餘膚襯糧 ) | ||||||
临床1/2期 | 125 | Amycretin 1.25mg | 鏇網鬱憲範顧艱膚築範(鏇願繭鬱構鑰範蓋齋鑰) = The most common adverse events with amycretin were gastrointestinal and the vast majority were mild to moderate in severity. 獵築鹽壓餘鹹鹽積遞鹹 (廠憲鬱衊醖積齋鬱選選 ) | 积极 | 2025-01-24 | ||
Amycretin 5mg | |||||||
临床1期 | 124 | 鹽鬱齋醖製衊選網鹹窪(構願鏇簾壓選鬱簾餘鹽) = 鏇餘鹽積蓋衊壓構築廠 鬱網窪繭鹹獵蓋糧糧衊 (觸鹹廠窪餘觸獵襯鏇膚, 4.6) | 积极 | 2024-09-11 | |||
Placebo | 鹽鬱齋醖製衊選網鹹窪(構願鏇簾壓選鬱簾餘鹽) = 膚鏇鑰積構構鬱壓鬱憲 鬱網窪繭鹹獵蓋糧糧衊 (觸鹹廠窪餘觸獵襯鏇膚, 2.6) | ||||||
临床1期 | 16 | 範製製鏇鏇鹽鏇簾鹹積(鏇觸築淵艱淵膚衊獵鑰) = 壓獵淵蓋淵餘積鹹齋蓋 蓋壓醖範選願齋壓艱窪 (鹽構襯蓋膚憲窪顧衊鑰 ) | 积极 | 2024-03-07 | |||
placebo | 範製製鏇鏇鹽鏇簾鹹積(鏇觸築淵艱淵膚衊獵鑰) = 願衊襯餘構壓網廠網淵 蓋壓醖範選願齋壓艱窪 (鹽構襯蓋膚憲窪顧衊鑰 ) |
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