This is a multicenter, randomized, open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 9 mg QW versus Semaglutide 2.4 mg QW in overweight or obese (BMI≥27kg/m2) MAFLD subjects. Subjects will be randomly assigned to IBI362 9 mg and Semaglutide 2.4 mg groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week open-label treatment period, and a 12-week drug withdrawal safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
470
Once-weekly injections of gradually increased doses of IBI362, subcutaneously (SC): starting dose is 2.0 mg, after 4 weeks of administration, increase to 4.0 mg; After another 4 weeks, increase to 6mg; After another 4 weeks, increase to the maximum dose 9mg for 36 weeks
Once-weekly injections of gradually increased doses, subcutaneously (SC): starting dose is 0.25 mg, after 4 weeks of administration, increase to 0.5 mg; After another 4 weeks, increase to 1mg; After another 4 weeks, increase to 1.7mg; After another 4 weeks, increase to the maximum 2.5mg for 32 weeks
Beijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGpercentage change in body weight from baseline
Time frame: at Week 48
percentage change in liver fat content from baseline measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Time frame: at Week 48
percentage change in liver fat content from baseline measured by MRI-PDFF
Time frame: at Week 8, 16, and 24
Absolute value change in liver fat content from baseline measured by MRI-PDFF
Time frame: at Week 8, 16, 24, and 48
Proportion of subjects with weight loss >10% from baseline and liver fat content <5%
Time frame: at week 48
percentage change in body weight from baseline
Time frame: at week 24
Changes in systolic blood pressure and diastolic blood pressure from baseline
Time frame: at week 48
percentage changes in total cholesterol,triglyceride (TG), non-High Density Lipoprotein Cholesterol (non-HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), HDL-C (High Density Lipoprotein Cholesterol) from baseline
Time frame: at week 48
Changes in serum uric acid from baseline
Time frame: at week 48
Changes in hemoglobin A1c (HbA1c) from baseline
Time frame: at week 48
Changes in Homeostasis Model Assessment 2-B (HOMA2-B) from baseline
Time frame: at week 48
Changes in Homeostasis Model Assessment 2-IR (HOMA2-IR) from baseline
Time frame: at week 48
Changes of scores in 36-item Short-Form Health Survey version 2(SF-36v2) questionnaire from baseline
Using norm-based scoring (NBS),each subscale has a different maximum and minimum score, with higher scores reflecting better levels of functioning
Time frame: at week 48
Changes of scores in The Impact of Weight on Quality of Life-Lite Clinical Trials Version(IWQoL-Lite-CT) questionnaire from baseline
Total score ranging from 0 to 100, with higher scores reflecting better levels of functioning
Time frame: at week 48
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