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This is a multicenter, randomized, Open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 6 mg OW versus Semalgutide 1 mg OW in obese(BMI≥28kg/m2) early T2D subjects. Subjects will be randomly assigned to IBI362 6 mg and Semalgutide 1 mg groups for 32 weeks (active-controlled treatment period). In the extension period, participants originally on mazdutide were assigned to continue for an additional 24 weeks with mazdutide 9 mg or 6 mg based on whether they achieved the weight-loss target. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 32-week active-controlled treatment period, a 24 week extension period and a 4-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 IBI362 2.0 mg, continuous After 4 weeks of administration, increase to IBI362 4.0 mg. After 4 weeks of continuous administration, continue to increase to IBI362. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥10% weight loss | Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥15% weight loss | Week 32 | |
| Proportion of subjects who achieve composite endpoint of HbA1c <7.0% and ≥5% weight loss | Week 32 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100010 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
| C000591245 | semaglutide |
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| Semaglutide | Drug | Once-weekly injections of gradually increased doses of Semaglutide, subcutaneously (SC),starting dose is semaglutide 0.25mg, after 4 weeks of continuous administration, increase to semaglutide 0.5mg, after 4 weeks of continuous administration, continue Upgrade to semaglutide 1.0 mg for 24 weeks. |
|
| Proportion of subjects who achieve composite endpoint of HbA1c<6.5% and ≥5%, ≥10% or ≥15% weight loss | Week 32 |
| Change from Baseline in HbA1c | Week 32 |
| Change in fasting plasma glucose(FPG) from baseline | Week 32 |
| Change in 7-point self-monitored blood glucose(SMBG) from baseline | Week 32 |
| Proportion of subjects achieving HbA1c < 7.0%, ≤ 6.5%, and < 5.7% | Week 32 |
| Change in body weight from baseline | Week 32 |
| Percent change in body weight from baseline | Week 32 |
| Change in waist circumference from baseline | Week 32 |
| Change in body mass index (BMI) from baseline | Week 32 |
| Proportion of subjects achieving weight loss of ≥ 5%, ≥ 10%, or ≥ 15% | Week 32 |
| Proportion of patients achieving 24 kg/m 2≤ BMI < 28 kg/m 2 and 18.5 kg/m 2≤ BMI < 24 kg/m 2 | Week 32 |
| Change in systolic blood pressure(SBP) and diastolic blood pressure(DBP) from baseline | Week 32 |
| Change in lipids [total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG)] from baseline | Week 32 |
| Changes in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from baseline | Week 32 |
| Change in serum uric acid from baseline | Week 32 |
| Change in quality of life (IWQoL-Lite-CT) from baseline | Week 32 |
| Change in quality of life (SF-36 v2) from baseline | Week 32 |
| Change in HOMA2-β from baseline | Week 32 |
| Change in HOMA2-IR from baseline | Week 32 |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |