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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).
一项在饮食和运动血糖控制不佳的中国2型糖尿病患者中评价BGM0504注射液单药治疗有效性和安全性的随机、双盲、安慰剂平行对照的Ⅲ期临床研究
[Translation] A randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 injection monotherapy in Chinese patients with type 2 diabetes who have poor blood sugar control with diet and exercise
主要目的:
与安慰剂相比,在经饮食和运动治疗后血糖控制不佳的中国2型糖尿病患者中评价BGM0504注射液单药治疗32周的临床有效性。
次要目的:
与安慰剂相比, 在经饮食和运动治疗后血糖控制不佳的中国 2 型糖尿病患者中评价BGM0504 注射液单药治疗 52 周的临床有效性。
与安慰剂相比, 在经饮食和运动治疗后血糖控制不佳的中国 2 型糖尿病患者中评价 BGM0504 注射液单药治疗 52 周的临床安全性。
[Translation] Primary objective:
Compared with placebo, to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks in Chinese patients with type 2 diabetes who have poor glycemic control after diet and exercise.
Secondary objective:
Compared with placebo, to evaluate the clinical efficacy of BGM0504 injection monotherapy for 52 weeks in Chinese patients with type 2 diabetes who have poor glycemic control after diet and exercise.
Compared with placebo, to evaluate the clinical safety of BGM0504 injection monotherapy for 52 weeks in Chinese patients with type 2 diabetes who have poor glycemic control after diet and exercise.
一项在二甲双胍单药或二甲双胍联合磺脲类药物治疗血糖控制不佳的中国2型糖尿病受试者中比较BGM0504注射液和司美格鲁肽注射液的有效性和安全性的随机、开放、阳性药平行对照的Ⅲ期临床研究
[Translation] A randomized, open-label, active-controlled phase III clinical study comparing the efficacy and safety of BGM0504 injection and semaglutide injection in Chinese type 2 diabetes subjects with poor glycemic control treated with metformin alone or metformin combined with sulfonylureas
主要目的:
与司美格鲁肽注射液1.0mg比较,在经二甲双胍单药或二甲双胍和磺脲类药物治疗血糖控制不佳的中国2型糖尿病受试者中评价BGM0504注射液联合二甲双胍或二甲双胍和磺脲类药物治疗32周的临床有效性。
次要目的:
与司美格鲁肽注射液 1.0mg 比较, 在经二甲双胍单药或二甲双胍和磺脲类药物治疗血糖控制不佳的中国 2 型糖尿病受试者中, 评价 BGM0504 注射液联合二甲双胍或二甲双胍和磺脲类药物治疗 52 周的临床有效性。
与司美格鲁肽注射液 1.0mg 比较, 在经二甲双胍单药或二甲双胍和磺脲类药物治疗血糖控制不佳的中国 2 型糖尿病患者中, 评价BGM0504 注射液联合二甲双胍或二甲双胍和磺脲类药物治疗 52 周的临床安全性。
[Translation] Primary objective:
Compared with semaglutide injection 1.0 mg, to evaluate the clinical efficacy of BGM0504 injection combined with metformin or metformin and sulfonylureas for 32 weeks in Chinese type 2 diabetes subjects with poor glycemic control after metformin alone or metformin and sulfonylureas.
Secondary objective:
Compared with semaglutide injection 1.0 mg, to evaluate the clinical efficacy of BGM0504 injection combined with metformin or metformin and sulfonylureas for 52 weeks in Chinese type 2 diabetes subjects with poor glycemic control after metformin alone or metformin and sulfonylureas.
To evaluate the clinical safety of BGM0504 injection combined with metformin or metformin and sulfonylureas for 52 weeks compared with semaglutide injection 1.0 mg in Chinese patients with type 2 diabetes whose glycemic control was inadequately controlled by metformin alone or metformin and sulfonylureas.
100 Clinical Results associated with Borui Xinchuang Biomedical Technology (Wuxi) Co., Ltd
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100 Deals associated with Borui Xinchuang Biomedical Technology (Wuxi) Co., Ltd
100 Translational Medicine associated with Borui Xinchuang Biomedical Technology (Wuxi) Co., Ltd