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The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection |
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| Group B | Experimental | Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection |
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| Group C | Experimental | Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection |
|
| Group D | Active Comparator | Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 | Drug | Administrated SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (Safety and Tolerability) | A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events | Screening period up to Day 62 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve (AUC) of HRS9531 | Start of Treatment up to Day 62 | |
| Maximum Concentration (Cmax) of HRS9531 | Start of Treatment up to Day 62 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200000 | China |
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HRS9531 injection compared with placebo and open positive-controlled group
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| Placebo |
| Drug |
Administrated SC |
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| Dulaglutide Injection | Drug | Administrated SC |
|
| Change from Baseline in Fasting Blood Glucose (FBG) |
| Baseline up to Day 62 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline up to Day 29 |
| Change from Baseline in Weight | Baseline up to Day 62 |
| Immunogenicity: anti-HRS9531 antibody | Start of Treatment up to Day 62 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C555680 | dulaglutide |
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