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Inactive Indication- |
Drug Highest PhasePhase 3 |
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一项在经单纯饮食运动干预体重控制不佳的中国非糖尿病的中、重度肥胖受试者中评估BGM0504注射液和替尔泊肽注射液用于体重控制的初步疗效和安全性的多中心、随机、开放标签的探索性Ⅱ期临床研究
[Translation] A multicenter, randomized, open-label, exploratory Phase II clinical study to evaluate the preliminary efficacy and safety of BGM0504 injection and telpotide injection for weight control in Chinese non-diabetic moderate to severe obese subjects whose weight is not well controlled by diet and exercise intervention alone
主要目的:
与替尔泊肽注射液比较,初步评价BGM0504注射液在非糖尿病的中、重度肥胖受试者(BMI>35.0 kg/m2)中用于体重控制的有效性。
次要目的:
与替尔泊肽注射液比较,评价BGM0504注射液在非糖尿病的中、重度肥胖受试者(BMI>35.0 kg/m2)中的安全性、耐受性。
[Translation] Primary objective:
Compared with telportin injection, to preliminarily evaluate the effectiveness of BGM0504 injection for weight control in non-diabetic moderate to severe obese subjects (BMI>35.0 kg/m2).
Secondary objective:
Compared with telportin injection, to evaluate the safety and tolerability of BGM0504 injection in non-diabetic moderate to severe obese subjects (BMI>35.0 kg/m2).
在超重或肥胖志愿者中评价BGM0504注射液的胃排空延迟效应及与盐酸二甲双胍、华法林钠片的药物相互作用
[Translation] Evaluation of the delayed gastric emptying effect of BGM0504 injection and its drug interactions with metformin hydrochloride and warfarin sodium tablets in overweight or obese volunteers
主要目的:
评价超重或肥胖志愿者中BGM0504注射液对胃排空速率及对盐酸二甲双胍、S-华法林的主要PK参数的影响。
次要目的:
a.评价超重或肥胖志愿者中BGM0504注射液对二甲双胍、S-华法林和对乙酰氨基酚次要PK参数的影响及安全性。
b.评价超重或肥胖志愿者中BGM0504注射液的药代动力学参数。
[Translation] Main purpose:
To evaluate the effect of BGM0504 injection on gastric emptying rate and the main PK parameters of metformin hydrochloride and S-warfarin in overweight or obese volunteers.
Secondary purpose:
a. To evaluate the effect and safety of BGM0504 injection on the secondary PK parameters of metformin, S-warfarin and acetaminophen in overweight or obese volunteers.
b. To evaluate the pharmacokinetic parameters of BGM0504 injection in overweight or obese volunteers.
一项在中国非糖尿病的超重或肥胖受试者中评价 BGM0504 注射液用于体重控制的有效性和安全性的Ⅲ期多中心、随机、双盲、安慰剂平行对照的临床研究
[Translation] A Phase III multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of BGM0504 injection for weight management in Chinese non-diabetic overweight or obese subjects
主要目的:
与安慰剂相比,评价BGM0504注射液给药36周作为饮食、运动和行为干预的辅助手段用于中国非糖尿病的超重或肥胖成人体重管理的临床有效性。
次要目的:
与安慰剂相比,评价BGM0504注射液给药52周用于中国非糖尿病的超重或肥胖成人体重管理的临床有效性。
评价BGM0504注射液给药52周用于中国非糖尿病的超重或肥胖成人体重管理的临床安全性。
[Translation] Primary objective:
Compared with placebo, to evaluate the clinical effectiveness of BGM0504 injection for 36 weeks as an adjunct to diet, exercise and behavioral intervention for weight management in Chinese non-diabetic overweight or obese adults.
Secondary objective:
Compared with placebo, to evaluate the clinical effectiveness of BGM0504 injection for 52 weeks for weight management in Chinese non-diabetic overweight or obese adults.
To evaluate the clinical safety of BGM0504 injection for 52 weeks for weight management in Chinese non-diabetic overweight or obese adults.
100 Clinical Results associated with Borui Xinchuang Biomedical Technology (Wuxi) Co., Ltd
0 Patents (Medical) associated with Borui Xinchuang Biomedical Technology (Wuxi) Co., Ltd
100 Deals associated with Borui Xinchuang Biomedical Technology (Wuxi) Co., Ltd
100 Translational Medicine associated with Borui Xinchuang Biomedical Technology (Wuxi) Co., Ltd