Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3804
Source ID: NCT06649344
Associated Drug: Hrs9531 Injection
Title: A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: HRS9531 Injection|DRUG: Semaglutide Injection
Outcome Measures: Primary: Change in HbA1c, Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment., Week 0 to Week 36 | Secondary: Change in body weight, Change from baseline in body weight after 36 weeks of treatment., Week 0 to Week 36|Proportion of Subjects with HbA1c≤6.5%, Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment., Week 0 to Week 36|Proportion of Subjects with HbA1c<7%, Proportion of subjects with HbA1c\<7% after 36 weeks of treatment., Week 0 to Week 36|Change in FPG (fasting plasma glucose), Change from baseline in FPG after 36 weeks of treatment., Week 0 to Week 36|Change in FPG (fasting plasma glucose), Change from baseline in FPG after 52 weeks of treatment., Week 0 to Week 52|7-points SMPG profiles, 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., Week 0 to Week 36|Incidence and severity of adverse events, Severity (mild, moderate and severe) is assessed by investigator., Week 0 to Week 52+4 weeks follow-up
Sponsor/Collaborators: Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 840
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-31
Completion Date: 2026-09-30
Results First Posted:
Last Update Posted: 2024-12-02
Locations: Zhu Xianyi Memorial Hospital,Tianjin Medical University, Tianjin, Tianjin, 300000, China
URL: https://clinicaltrials.gov/show/NCT06649344