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Clinical Trial Details

Trial ID: L4953
Source ID: NCT06849843
Associated Drug: Efsubaglutide Alfa Injection
Title: A Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients.
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type2 Diabetes
Interventions: DRUG: Efsubaglutide Alfa Injection|DRUG: Efsubaglutide Alfa Injection
Outcome Measures: Primary: HbA1c, The change in mean HbA1c concentrations (%)from baseline with Efsubaglutide Alfa 3mg QoW versus Efsubaglutide Alfa 1mg QW, 12 weeks | Secondary: TIR, Changes in the percentage of time in range (TIR) relative to baseline, 12 weeks|HbA1c<7.0% and <6.5%, The proportion of participants who achieved HbA1c target (HbA1c\<7.0% and \<6.5% Patient percentage), 12 weeks|fasting lipid profiles, Changes in fasting lipid(TC/TG/HDL-C/LDL-C) profiles relative to baseline(mmol/L), 12 weeks|weight, Weight change from baseline(kg), 12 weeks|waist circumference, Absolute changes in waist circumference(cm) from baseline, 12 weeks|hip circumference, Absolute changes in hip circumference(cm) from baseline, 12 weeks|waist-to-hip ratio (WHR), Absolute changes in waist-to-hip ratio (WHR) from baseline, 12 weeks|salvage treatment, Percentage of subjects receiving salvage treatment(%), 12 weeks|body fat composition, Changes in body fat composition from baseline, 12 weeks|FPG, Changes in FPG (mmol/L) relative to baseline, 12 weeks
Sponsor/Collaborators: Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-18
Completion Date: 2025-12-30
Results First Posted:
Last Update Posted: 2025-04-15
Locations: Nanjing First Hospital, Nanjing, Jiangsu, 210008, China
URL: https://clinicaltrials.gov/show/NCT06849843