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更新于：2025-10-18
Visepegenatide
维培那肽
更新于：2025-10-18
概要
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特殊审评特殊审批 (中国) |
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结构/序列
Sequence Code 102903
来源: *****
关联
15
项与 维培那肽 相关的临床试验NCT06350812
A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects
CTR20241107
一项单中心、随机、双盲、安慰剂对照、剂量递增研究评价聚乙二醇化艾塞那肽注射液（PB-119）在中国肥胖受试者中的安全性、耐受性和药代动力学特征
CTR20221248
一项在健康受试者中评价多次皮下注射PB-119注射液对单次口服瑞舒伐他汀钙片或缬沙坦胶囊的药代动力学特征影响的I期、开放、固定序列研究
100 项与 维培那肽 相关的临床结果
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100 项与 维培那肽 相关的转化医学
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100 项与 维培那肽 相关的专利（医药）
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8
项与 维培那肽 相关的文献（医药）2024-10-01Lancet Regional Health-Western Pacific
Efficacy and safety of visepegenatide as an add-on therapy to metformin in patients with type 2 diabetes: a randomised, double-blind, parallel, placebo-controlled, phase 3 study
Article
作者: Bian, Fang ; Ji, Linong ; Liu, Li ; Hou, Minghui ; Cai, Xiaoling ; Pang, Wuyan ; Li, Wenhui ; Xu, Michael ; Yuan, Mingxia ; Yan, Shuang ; Ma, Jianhua ; Zhou, Huimin ; Ding, Ke ; Jia, Ying ; Li, Sheli
Background:
Visepegenatide, a once-weekly glucagon-like peptide-1 receptor agonist injection, demonstrated effective glycaemic control and good tolerability without the requirement of dose titration in the two completed phase 2 studies. We aimed to evaluate the efficacy and safety of visepegenatide in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin monotherapy in this phase 3 clinical study.
Methods:
This multicentre phase 3 clinical study included a 24-week, randomised, placebo-controlled, double-blind period followed by a 28-week open-label extended treatment period. Patients (N = 620) aged ≥18 and ≤75 years with glycated haemoglobin (HbA1c) ≥7.0% and ≤10.5% [≥53.0 and ≤91.27 mmol/mol], were randomized in a 1:1 ratio to receive visepegenatide 150-μg or placebo once-weekly subcutaneous injection during the double-blind period. Subsequently, the patients in the placebo group were switched to visepegenatide treatment (placebo→visepegenatide group), and the patients in the visepegenatide group continued the same treatment during the open-label extended treatment period. The primary endpoint was the change in HbA1c from baseline to week 24.
Findings:
At week 24, the placebo-adjusted least squares mean (LSM) change of HbA1c was -0.57% (95% CI -0.71 to -0.43) with visepegenatide (p < 0.001). The proportion of patients achieving HbA1c < 7.0% and ≤6.5% [<53 and ≤ 48 mmol/mol] was higher in the visepegenatide group versus the placebo group (115 [40.5%] vs 50 [17.9%]; p < 0.001, and 60 [21.1%] vs 17 [6.1%]; p < 0.001). Visepegenatide demonstrated a significant reduction in fasting plasma glucose and 2-h postprandial glucose compared with placebo. Trends in the improvement of these variables were maintained during the open-label extended treatment period. No severe gastrointestinal adverse event or severe hypoglycaemia was reported during the 52-week study period.
Interpretation:
Once-weekly injection of visepegenatide 150 μg as an add-on treatment to metformin therapy significantly improved glycaemic control and was generally well tolerated in Chinese patients with T2DM who were inadequately controlled with metformin monotherapy.
Funding:
The study was funded by PegBio Co., Ltd, Suzhou, China.
2024-06-01Lancet Regional Health-Western Pacific
Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial
Article
作者: Liu, Jie ; Jia, Ying ; Zhu, Yikun ; Mo, Zhaohui ; Wang, Xuhong ; Liu, Li ; Lin, Jingna ; Xu, Michael ; Yan, Xiang ; Li, Sheli ; Ma, Jianhua ; Ding, Ke ; Zhou, Zhiguang ; Liu, Yan ; Yan, Shuang
Background:
Type 2 diabetes (T2DM) remains a challenge to treat despite the expansion of various therapeutic classes. Visepegenatide (PB-119) is a once a week, subcutaneous, glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection without the requirement of dose titration that has shown glycaemic control and safety profile in two phase 2 studies conducted in China and the United States, respectively. The aim of this study was to evaluate the efficacy and safety of visepegenatide as a monotherapy in treatment-naïve patients with T2DM.
Methods:
This was a multicentre, double-blind, parallel, placebo-controlled, phase 3 trial conducted in 30 centres in China. Adult participants (aged 18-75 years) with T2DM, glycated haemoglobin (HbA1c) of 7.5%-11.0% [58.47-96.73 mmol/mol], body mass index (BMI) of 18-40 kg/m2, and who had been treated with diet and exercise alone for at least 8 weeks before the screening visit were eligible for enrolment. After a 4-week placebo injection run-in period, participants with HbA1c of 7.0%-10.5% [53.0-91.3 mmol/mol] and fasting plasma glucose (FPG) < 15 mmol/L were randomised in a ratio of 1:1 to receive visepegenatide (150 μg) or placebo subcutaneous injections once a week for 24 weeks. The treatment was extended to another 28 weeks during which all participants received visepegenatide. The primary outcome was a change in HbA1c from baseline to week 24. This study was registered with ClinicalTrials.gov, as NCT04504370.
Findings:
Between November 2, 2020, and November 2, 2022, we randomly assigned 273 adult participants to the visepegenatide (n = 137) and placebo (n = 136) groups. In total, 257 (94.12%) participants, 131 (95.6%) on visepegenatide, and 126 (92.6%) on placebo, completed the double-blinded treatment period. At baseline, the mean (SD) HbA1c was 8.47% (0.81) [69.07 [8.81] mmol/mol], which rapidly decreased to 7.63% (0.80) [59.94 [8.70] mmol/mol] with visepegenatide by week 4 of treatment, and the change from baseline was significantly greater than that in the placebo group (-0.82% [-0.90 to -0.74]; [-8.99 [-9.89 to -8.10] mmol/mol] vs -0.30% [-0.41 to -0.19]; [-3.30 [-4.50 to -2.09] mmol/mol]). At week 24, when evaluating the effects of treatment with treatment policy estimand, the least square mean (LSM change in HbA1c from baseline was -1.36 (95% confidence interval [CI] -1.52 to -1.20) [-14.84 [-16.60 to -13.08] mmol/mol] in the visepegenatide group vs -0.63 (-0.79 to -0.46) [-6.84 [-8.61 to -5.07] mmol/mol] in the placebo group. The reduction in HbA1c was significantly greater with visepegenatide than placebo (LSM difference -0.73, 95% CI -0.96 to -0.50; p < 0.001). When evaluating the treatment estimand with hypothetic policy, the LSM change in HbA1c from baseline in the visepegenatide group (-1.37 [-1.53 to -1.20]) [-14.95 [-16.76 to -13.14] mmol/mol] was significantly greater than the placebo group (-0.63 [-0.81 to -0.45]) [6.90 (-8.89 to -4.90) mmol/mol]. The LSM difference was (-0.74, 95% CI -0.98 to -0.49; [-8.00 [-10.50 to -5.50] mmol/mol]; p < 0.001]. A significantly greater proportion of the visepegenatide group achieved a target HbA1c level of <7% (<53 mmol/mol) than the placebo (50.4% vs 14.2%; p < 0.05) and stringent HbA1c level of ≤6.5% (≤48 mmol/mol) (26.7% vs 7.9%), respectively. There was also a significantly greater improvement in FPG, 2-h postprandial glucose, homeostasis model assessment (HOMA) of beta cell function, post-prandial insulin, fasting, and post-prandial C-peptide level (p < 0.05) with visepegenatide treatment. The number (3 [2.2%]) of participants who received rescue therapy in the visepegenatide group was remarkably lower compared with those (17 [12.5%]) in the placebo group (p < 0.05). During the extended treatment period, visepegenatide consistently maintained the efficacy till week 52 confirmed by all the above endpoints. The reduction in HbA1c at week 52 was -1.39% (-1.58 to -1.19) [-15.14 [-17.28 to -13.01] mmol/mol], which was even greater than that at week 24. There was also a significant improvement in HOMA-insulin resistance (p = 0.004) at week 52 compared with the baseline value. For the placebo→visepegenatide group, which received visepegenatide in the extended treatment period, a notable decrease in HbA1c at week 52 compared to baseline was observed. The change from baseline in HbA1c was -1.49% (-1.68 to -1.30) [-16.27 [-18.37 to -14.16] mmol/mol]. The outcome was in the same direction as the visepegenatide group from the double-blind treatment period. Comprehensive benefits of visepegenatide including weight loss, improvement in lipid profile, and reduction in blood pressure have been demonstrated in this study. Visepegenatide reduced the body weight in a BMI-dependent manner that was prominent in BMI ˃32 kg/m2 with a mean (SD) reduction of -4.77 (13.94) kg at week 52 (p < 0.05). Incidences of gastrointestinal adverse events were less common than other weekly GLP-1 RA in the market, and most of the adverse events were mild and moderate in nature, occurring in the first weeks of the treatment, and were transient. No serious hypoglycaemia or grade 2 hypoglycaemia (blood glucose: ≤3 mmol/L) was reported during the study.
Interpretation:
As a monotherapy, visepegenatide provided rapid without the risk of hypoglycaemia, significant, and sustainable glycaemic control by improving islet β-cell function and insulin resistance. Treatment with visepegenatide induced early treatment response in reducing HbA1c and maintaining glycaemic control for 52 weeks. Meanwhile, visepegenatide provided a comprehensive benefit in body weight loss, lipids, and blood pressure reduction. Visepegenatide had a better safety profile than other weekly GLP-1 RA in participants with T2DM even without the requirement of dose titration. Visepegenatide would provide an optimal treatment approach with its high benefit and low-risk balance.
Funding:
PegBio Co., Ltd.
2021-08-01Diabetologia
Correction to: Efficacy and safety of PEGylated exenatide injection (PB-119) in treatment-naive type 2 diabetes mellitus patients: a Phase II randomised, double-blind, parallel, placebo-controlled study
作者: Lv, Wenshan ; Zhou, Haifeng ; Yao, Minxiu ; Song, Weihong ; Chen, Lei ; Li, Wenhui ; Xu, Min ; Li, Ping ; Li, Jiarui ; Guan, Qingbo ; Chen, Tao ; Jin, Hui ; Pang, Shuguang ; Liu, Jie ; Tan, Huiwen ; Mo, Zhaohui ; Wang, Yanjun ; Ji, Linong ; Geng, Houfa ; Lin, Jingna ; Lei, Minxiang ; Yang, Jing ; Ye, Shandong ; Liu, Hui ; Li, Yufeng ; Ma, Jianhua ; Zhou, Xiangjun ; Qin, Guijun ; Shen, Feixia ; Ran, Jianmin ; Du, Yinghong ; Li, Shiyun ; Jiang, Xiaohong ; Du, Ying ; Yang, Jinkui
A Correction to this paper has been published: 10.1007/s00125-021-05460-0
100 项与 维培那肽 相关的药物交易
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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 | 申请上市 | 中国 | 2023-09-26 | |
| 肥胖 | 临床2期 | 中国 | 2024-05-27 | |
| 阿尔茨海默症 | 临床前 | 美国 | 2023-09-27 |
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临床结果
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临床2期 | 251 | Placebo | 廠網艱簾鹽衊鬱鬱網夢(憲顧齋構蓋襯網醖醖構) = 餘鹽範簾壓簾獵壓繭簾 憲構獵網繭構蓋築構簾 (夢蓋選夢衊憲膚艱餘淵, -9.23, ~ 4.63) | 积极 | 2021-05-01 | ||
PB-119 75 μg | 廠網艱簾鹽衊鬱鬱網夢(憲顧齋構蓋襯網醖醖構) = 憲齋夢蓋廠齋夢餘壓選 憲構獵網繭構蓋築構簾 (夢蓋選夢衊憲膚艱餘淵, -1.01, ~ 0.43) | ||||||
临床1期 | - | 36 | 醖醖鏇膚網鬱網鹹製鏇(鏇鏇鑰膚蓋艱網構積顧) = 觸鏇網構積構網蓋淵簾 願觸顧鏇選選遞製餘範 (網構淵醖獵繭願夢廠遞 ) 更多 | 积极 | 2021-03-01 | ||
临床1期 | - | 70 | 淵鑰築顧衊簾遞鏇觸選(鹹夢窪醖鏇觸構襯憲醖) = Several subjects in the 100-µg and 200-µg groups had tolerable gastrointestinal tract reactions, and all subjects in the 400-µg group experienced adverse reactions, mainly gastrointestinal tract reactions and liver dysfunction. 選網構窪壓齋鹽選壓遞 (鑰獵鹽積製願憲憲蓋鹹 ) | 积极 | 2020-06-01 | ||
Placebo | |||||||
临床2期 | 251 | 範範範觸繭艱蓋襯壓鬱(憲襯衊製淵蓋襯選衊廠) = 糧構壓鏇觸簾築鏇繭獵 壓選繭鹽構衊鏇選艱觸 (鏇鹽鑰憲衊蓋夢範網襯, -1.32 ~ -0.91) | 积极 | 2020-06-01 | |||
範範範觸繭艱蓋襯壓鬱(憲襯衊製淵蓋襯選衊廠) = 窪齋淵網膚製網鹽憲製 壓選繭鹽構衊鏇選艱觸 (鏇鹽鑰憲衊蓋夢範網襯, -1.78 ~ -1.37) |
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