更新于：2024-06-20
Beinaglutide
贝那鲁肽
更新于：2024-06-20
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2016-12-13), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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序列信息
Sequence Code 1312
来源: *****
关联
15
项与 贝那鲁肽 相关的临床试验贝那鲁肽注射液经皮下泵给药在超重/肥胖成人中的药代动力学研究
Pharmacokinetic study of continuous subcutaneous beinaglutide infusion in adults with overweight or obesity
Short-Term Beinaglutide (rGLP-1) treatment in Acute Ischemic Stroke (STB-AIS) with hyperglycemia: a randomized, open-label, parallel-group study
100 项与 贝那鲁肽 相关的临床结果
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100 项与 贝那鲁肽 相关的转化医学
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100 项与 贝那鲁肽 相关的专利（医药）
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11
项与 贝那鲁肽 相关的文献（医药）2024-02-01Diabetes, obesity & metabolism
Beinaglutide for weight management in Chinese individuals with overweight or obesity: A phase 3 randomized controlled clinical study
Article
作者: Qin, Guijun ; Mu, Yiming ; Hsieh, Tsung-Han ; Chen, Li ; Wang, Guixia ; Shan, Zhongyan ; Yu, Xuefeng ; Xin, Weiquan ; Chen, Kang ; Qu, Shen
Abstract:
Aim:
To investigate the efficacy and safety of beinaglutide as an adjunct to lifestyle intervention among non‐diabetic Chinese individuals with overweight or obesity.
Methods:
This multicentre, randomized, double‐blind, placebo‐controlled trial (ChiCTR1900023428) included 427 Chinese adults with a body mass index of 28 kg/m2 or higher (obesity) or 24‐27.9 kg/m2 (overweight) with weight‐related complications. Patients were randomized in a 2:1 ratio to receive 0.2 mg of beinaglutide (subcutaneous) thrice daily or placebo for 16 weeks. Co‐primary endpoints were body weight change and the proportion of patients with a weight reduction of 5% or more.
Results:
Mean body weight change from baseline to week 16 was −6.0% and −2.4% in the beinaglutide (n = 282) and placebo (n = 138) groups, respectively; the mixed model repeated measures difference was −3.6% (95% confidence interval: −4.6% to −2.6%; P < .0001). At week 16, more beinaglutide‐treated patients achieved a weight reduction of 5% or more (58.2% vs. 25.4% [placebo], odds ratio: 4.4; P < .0001) and of 10% or more (21.3% vs. 5.1% [placebo], odds ratio: 5.5; P < .0001). Beinaglutide also resulted in greater waist circumference reduction (difference: −1.81 cm; P < .01). The weight regain rate 12 weeks after beinaglutide treatment was 0.78%. Nausea (transient and mild‐to‐moderate) was the most common adverse event in the beinaglutide group (49.3% vs. 7.1% [placebo]). More patients receiving beinaglutide discontinued treatment because of adverse events (5.9% vs. 0.7% [placebo]). Pancreatitis or an increased resting heart rate was not observed in the beinaglutide group.
Conclusion:
Beinaglutide combined with lifestyle intervention resulted in significant and clinically meaningful weight reduction with good tolerance in non‐diabetic Chinese individuals with overweight or obesity.
2024-02-01Diabetes, obesity & metabolism
Efficacy of beinaglutide in the treatment of hepatic steatosis in type 2 diabetes patients with nonalcoholic fatty liver disease: A randomized, open‐label, controlled trial
Letter
作者: Xia, Mingfeng ; Fan, Yujuan ; Yan, Hongmei ; Li, Xiaoying ; Chang, Xinxia
2024-02-01Journal of diabetes
The efficacy and safety of beinaglutide alone or in combination with insulin glargine in Chinese patients with type 2 diabetes mellitus who are inadequately controlled with oral antihyperglycemic therapy: A multicenter, open‐label, randomized trial
Article
作者: Wang, Li ; Fu, Jianfang ; Liu, Xiangyang ; Liu, Jianrong ; Fang, Yujie ; Yang, Wenjuan ; Ji, Qiuhe ; Huang, Xinxi ; Ming, Jie ; Lai, Jingbo
Abstract:
Background:
To compare glycemic control in Chinese patients with type 2 diabetes mellitus (T2DM) whose blood glucose levels were inadequately controlled with oral antidiabetic drugs after beinaglutide alone or combined with insulin glargine (IGlar).
Methods:
In this 16‐week multicenter, randomized clinical trial, 68 participants randomly received beinaglutide or IGlar for 8 weeks, then the two drugs in combination for 8 weeks. The primary outcomes were the proportion of individuals achieving their glycemic target and the change in glucose variability as measured with a continuous glucose monitoring system from baseline to 8 and 16 weeks.
Results:
Both the beinaglutide and IGlar groups showed increased proportions achieving their glycemic target at 8 weeks, and the combination augmented the proportion reaching the glycated hemoglobin target from 25.42% at 8 weeks to 40.68% at 16 weeks. The beinaglutide group showed a significant reduction in body weight, body mass index, waist circumference, and systolic blood pressure. Beinaglutide elevated high‐density lipoprotein cholesterol by 0.08 mmol/L (95% confidence interval [CI], 0.00–0.16), and diminished low‐density lipoprotein cholesterol by 0.21 mmol/L (95% CI, 0.05–0.48), whereas IGlar showed no effect. Though IGlar was more efficient in lowering fasting plasma glucose than beinaglutide at comparable efficacies (to −1.57 mmol/L [95% CI, −2.60 to −0.54]), this difference was abolished in patients whose fasting C‐peptide was ≥0.9 ng/mL.
Conclusion:
Beinaglutide exhibited a favorable hypoglycemic effect on patients with T2DM, and in combination with IGlar, glucose level was further decreased. Low fasting C‐peptide in patients may reduce the glycemic response to beinaglutide therapy. We recommend that C‐peptide levels be evaluated when using or switching to the novel glucagon‐like peptide‐1 receptor agonists beinaglutide.
Trial Registration:
ClinicalTrials.gov: NCT03829891.
115
项与 贝那鲁肽 相关的新闻（医药）100 项与 贝那鲁肽 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 肥胖 | 中国 | 2023-07-25 | |
| 2型糖尿病 | 中国 | 2016-12-13 |
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临床结果
临床结果
适应症
分期
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NEWS 人工标引  | N/A | - | 願壓壓膚鏇餘築製積簾(膚鹽選構鏇壓憲鏇簾築) = 膚鏇膚範鑰淵鏇壓鹹齋 積築築鏇積蓋齋選鏇憲 (壓夢鹽選壓廠遞願構鑰 ) 更多 | 积极 | 2023-07-28 | ||
N/A | 88 | Benaglutide 0.2 mg ih tid + MET 1000 mg bid | 構窪壓鹽醖繭獵襯簾糧(艱蓋範構壓夢壓糧構築) = 鬱窪齋願鏇積壓築鑰襯 糧願衊範襯築膚夢遞糧 (襯襯願壓簾鑰襯顧淵憲 ) 更多 | - | 2019-06-01 | ||
構窪壓鹽醖繭獵襯簾糧(艱蓋範構壓夢壓糧構築) = 艱築顧獵蓋壓膚積築廠 糧願衊範襯築膚夢遞糧 (襯襯願壓簾鑰襯顧淵憲 ) 更多 |
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