Zhu Xianyi Memorial Hospital,Tianjin Medical University
Tianjin, Tianjin Municipality, 300000, China
NCT Number: NCT06649344
The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Tianjin, Tianjin Municipality, 300000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HRS9531 injected subcutaneously once weekly.
Semaglutide injected subcutaneously once weekly.
Time frame: Week 0 to Week 36
Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.
Time frame: Week 0 to Week 36
Change from baseline in body weight after 36 weeks of treatment.
Time frame: Week 0 to Week 36
Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment.
Time frame: Week 0 to Week 36
Proportion of subjects with HbA1c<7% after 36 weeks of treatment.
Time frame: Week 0 to Week 36
Change from baseline in FPG after 36 weeks of treatment.
Time frame: Week 0 to Week 52
Change from baseline in FPG after 52 weeks of treatment.
Time frame: Week 0 to Week 36
Fluctuation of 7-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime.
Time frame: Week 0 to Week 52+4 weeks follow-up
Severity (mild, moderate and severe) is assessed by investigator.
Fujian Shengdi Pharmaceutical Co., Ltd.
Industry
A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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