更新于：2024-07-16
TG-103
重组人源胰高血糖素样肽-1（hGLP-1）Fc融合蛋白(石药集团百克(山东))
更新于：2024-07-16
概要
基本信息
原研机构 |
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- |
关联
27
项与 重组人源胰高血糖素样肽-1（hGLP-1）Fc融合蛋白(石药集团百克(山东)) 相关的临床试验一项多中心、非随机、开放、平行对照、单次给药，评价TG103注射液在肾功能正常和肾功能不全受试者中的药代动力学特征的Ⅰ期临床试验
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial of TG103 Injection Monotherapy Subjects With Type 2 Diabetes Mellitus
A Multicenter, Randomized, Open-label, Controlled Phase 3 Trial of TG103 Injection in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus
100 项与 重组人源胰高血糖素样肽-1（hGLP-1）Fc融合蛋白(石药集团百克(山东)) 相关的临床结果
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100 项与 重组人源胰高血糖素样肽-1（hGLP-1）Fc融合蛋白(石药集团百克(山东)) 相关的转化医学
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100 项与 重组人源胰高血糖素样肽-1（hGLP-1）Fc融合蛋白(石药集团百克(山东)) 相关的专利（医药）
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11
项与 重组人源胰高血糖素样肽-1（hGLP-1）Fc融合蛋白(石药集团百克(山东)) 相关的文献（医药）2023-06-01European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
Safety, pharmacokinetics, and pharmacodynamics of TG103, a novel long-acting GLP-1/Fc fusion protein after a single ascending dose in Chinese healthy subjects
Article
作者: Wang, Lei ; Qiu, Xueying ; Lu, Tong ; Jin, Jiangli ; Li, Ziyan ; Xiao, Chunyan ; Li, Jintong ; Niu, Huikun ; Cui, Gang ; Wu, Wei ; Han, Mai ; Wang, Jing ; Zhang, Xin ; Mi, Na ; Wu, Zhaoxi
BACKGROUND AND OBJECTIVE:
TG103 is a novel GLP-1/Fc fusion protein, developed for the treatment of type 2 diabetes and obesity. This trial was designed to assess the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) profiles after single ascending dose of TG103 in healthy Chinese subjects.
METHOD:
In this double-blind, randomized, placebo-controlled phase I study, Chinese healthy subjects were admitted consecutively to TG103 3 mg, 7.5 mg, 15 mg, and 22.5 mg group with 8 subjects per group and randomized in a 3:1 ratio to receive TG103 treatment or placebo. Following a single subcutaneous(s.c.) injections of TG103, safety and tolerability were evaluated and blood samples were collected for PK and PD analysis at the specified time-points.
RESULT:
Overall, 32 healthy subjects were enrolled and completed the study. During the study, a total of 84 adverse effects (AEs) were reported in 25 subjects, all were mild or moderate and resolved spontaneously without intervention. The most common treatment related AEs in TG103 group were decreased appetite (41.7%), nausea, flatulence, elevated urinary β2-microglobulin, increased serum total bile acid (20.8% each), decreased high-density lipoprotein (16.7%), abdominal distension (12.5%). After a single s.c. administration of TG103 3-22.5 mg, the median Tmax was 36∼48 h, and mean t1/2 was about 147.16∼184.72 h. The mean Cmax for each group was 94.35±52.19, 337.67±56.71, 757.67±206.99, 1236.33±666.25 ng/mL, with AUC0-t of 14.93±7.67, 59.15±7.39, 91.79±20.41, 163.61±55.99 μg·h/mL, respectively. It showed a linear pharmacokinetic profile in the single dose of TG103 3 mg to 22.5 mg. Compared with placebo, fasting blood glucose decreased in all dose groups, most notably in the 15 mg group, which was consistent with the changes in blood glucose during OGTT, while 2-hour postprandial glucose decreased in all dose groups except 3 mg group.
CONCLUSION:
TG103 offers a potential option for hypoglycemic therapy with good tolerability and safety.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov NCT03990090; registered 18 June 2019.
2022-11-01Cell reports
Acute changes in systemic glycemia gate access and action of GLP-1R agonist on brain structures controlling energy homeostasis
Article
作者: Prevot, Vincent ; Duquenne, Manon ; Imbernon, Monica ; Salinas, Casper Gravesen ; Secher, Anna ; Castel, Julien ; Nielsen, Heidi Solvang ; Leger, Caroline ; Denis, Raphael G P ; Lundh, Sofia ; Hecksher-Sørensen, Jacob ; Hassouna, Rim ; Moro Chao, Daniela Herrera ; Gangarossa, Giuseppe ; Schwaninger, Markus ; Bakker, Wineke ; Pedersen, Thomas Åskov ; Luquet, Serge ; Peter, Andreas ; Johan Hogendorf, Wouter Frederic ; Maetzler, Walter ; Heni, Martin ; Martin, Claire ; Morel, Chloe
Therapies based on glucagon-like peptide-1 (GLP-1) long-acting analogs and insulin are often used in the treatment of metabolic diseases. Both insulin and GLP-1 receptors are expressed in metabolically relevant brain regions, suggesting a cooperative action. However, the mechanisms underlying the synergistic actions of insulin and GLP-1R agonists remain elusive. In this study, we show that insulin-induced hypoglycemia enhances GLP-1R agonists entry in hypothalamic and area, leading to enhanced whole-body fat oxidation. Mechanistically, this phenomenon relies on the release of tanycyctic vascular endothelial growth factor A, which is selectively impaired after calorie-rich diet exposure. In humans, low blood glucose also correlates with enhanced blood-to-brain passage of insulin, suggesting that blood glucose gates the passage other energy-related signals in the brain. This study implies that the preventing hyperglycemia is important to harnessing the full benefit of GLP-1R agonist entry in the brain and action onto lipid mobilization and body weight loss.
2022-02-01British journal of pharmacology
Glucagon‐like peptide‐1 (GLP‐1) receptor agonists and their cardiovascular benefits—The role of the GLP‐1 receptor
Review
作者: Steven, Sebastian ; Daiber, Andreas ; Münzel, Thomas ; Küster, Leonie ; Keppeler, Karin ; Helmstädter, Johanna
LINKED ARTICLES:
This article is part of a themed issue on GLP1 receptor ligands (BJP 75th Anniversary). To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v179.4/issuetoc
39
项与 重组人源胰高血糖素样肽-1（hGLP-1）Fc融合蛋白(石药集团百克(山东)) 相关的新闻（医药）2024-06-23
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100 项与 重组人源胰高血糖素样肽-1（hGLP-1）Fc融合蛋白(石药集团百克(山东)) 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 | 中国 | 2024-02-02 | |
| 肥胖 | 临床3期 | 中国 | 2023-09-01 | |
| 糖尿病 | 临床1期 | 德国 | 2017-08-31 | |
| 阿尔茨海默症 | 临床申请批准 | 中国 | 2022-08-31 | |
| 非酒精性脂肪性肝炎 | 临床申请批准 | 中国 | 2022-08-30 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 147 | TG103 15.0 mg | 願壓獵襯衊鏇顧蓋鑰壓(繭醖遞醖積糧鬱鏇淵蓋) = A total of 466 AEs occurred in 45 of the 48 participants, with 35 (97.2%) in the TG103 group and 10 (83.3%) in the pooled placebo group. Most AEs were grade 1 or 2 in severity 鹽築衊壓願艱繭網鹽構 (遞製齋遞襯糧鏇選鬱範 ) 更多 | 积极 | 2024-05-29 | ||
TG103 22.5 mg | |||||||
N/A | 22 | GIP infusion | 獵壓遞範願齋積構觸積(鬱艱鏇膚夢淵簾廠蓋淵) = 繭憲鏇醖鑰願窪觸範膚 鹽醖壓夢鬱選餘觸積顧 (鹽製製齋鬱顧鬱艱窪鏇 ) | - | 2020-03-01 | ||
Placebo infusion | 獵壓遞範願齋積構觸積(鬱艱鏇膚夢淵簾廠蓋淵) = 獵築淵襯壓鏇壓蓋餘簾 鹽醖壓夢鬱選餘觸積顧 (鹽製製齋鬱顧鬱艱窪鏇 ) |
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