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Clinical Trials associated with Semaglutide Biosimilar(Huadong Medicine/Chongqing Peg-Bio Biopharma)A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study Comparing the Efficacy and Safety of Semaglutide Injection and WEGOVY® in Chinese Obese Patients
This is a 48-week randomized, open-label, parallel-controlled biosimilar comparison study comparing the efficacy, safety and immunogenicity of the investigational drug and WEGOVY® in patients with obesity. Eligible participants will be screened and randomized to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or WEGOVY® injection will be given once weekly for 44 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
/ Active, not recruitingPhase 3 评价司美格鲁肽注射液与原研司美格鲁肽注射液在中国肥胖受试者中安全性和有效性的多中心、随机、开放、平行对照的III期临床研究
[Translation] A multicenter, randomized, open, parallel-controlled phase III clinical study to evaluate the safety and efficacy of semaglutide injection and original semaglutide injection in obese Chinese subjects
在减少饮食热量摄入和增加体力活动基础上,评价采用试验药物司美格鲁肽注射液与对照药品原研司美格鲁肽注射液治疗44周后,在中国肥胖非糖尿病受试者中减重的等效性。
[Translation] To evaluate the equivalence of weight loss between the investigational drug semaglutide injection and the control drug original semaglutide injection in Chinese obese non-diabetic subjects after 44 weeks of treatment, based on reduced dietary calorie intake and increased physical activity.
A Randomized, Open-label, Single-dose, Parallel-controlled Phase I Clinical Trial Comparing the Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.
This study is a randomized, open-label, single-dose, parallel-controlled biosimilar comparison study comparing the pharmacokinetics, safety and immunogenicity of the investigational drug and the active comparator in healthy adult subjects. Eligible healthy participants will be screened and randomly assigned to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection 0.25mg abdominal subcutaneous injection will be given according to their groups. Follow-up for 5 weeks after administrtion.
Studies included a screening period (up to 2 weeks), baseline, administration (single dose), and a follow-up period (5 weeks). The duration of the study will be approximately 7 weeks for a participant.
100 Clinical Results associated with Semaglutide Biosimilar(Huadong Medicine/Chongqing Peg-Bio Biopharma)
100 Translational Medicine associated with Semaglutide Biosimilar(Huadong Medicine/Chongqing Peg-Bio Biopharma)
100 Patents (Medical) associated with Semaglutide Biosimilar(Huadong Medicine/Chongqing Peg-Bio Biopharma)
100 Deals associated with Semaglutide Biosimilar(Huadong Medicine/Chongqing Peg-Bio Biopharma)