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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Active Comparator |
| |
| IBI362 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI362 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| percentage change in body weight from baseline | at Week 48 | |
| percentage change in liver fat content from baseline measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) | at Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| percentage change in liver fat content from baseline measured by MRI-PDFF | at Week 8, 16, and 24 | |
| Absolute value change in liver fat content from baseline measured by MRI-PDFF | at Week 8, 16, 24, and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lixin Guo, M.D | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
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|
| semaglutide | Drug | 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 |
|
| Proportion of subjects with weight loss >10% from baseline and liver fat content <5% | at week 48 |
| percentage change in body weight from baseline | at week 24 |
| Changes in systolic blood pressure and diastolic blood pressure from baseline | 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 | at week 48 |
| Changes in serum uric acid from baseline | at week 48 |
| Changes in hemoglobin A1c (HbA1c) from baseline | at week 48 |
| Changes in Homeostasis Model Assessment 2-B (HOMA2-B) from baseline | at week 48 |
| Changes in Homeostasis Model Assessment 2-IR (HOMA2-IR) from baseline | 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 | 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 | at week 48 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
| C000591245 | semaglutide |
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