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The aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin. This study will last 20 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS9531 Tablet | Experimental |
| |
| Treatment group B: HRS9531 Tablet | Experimental |
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| Treatment group C: HRS9531 Tablet | Experimental |
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| Treatment group D: HRS9531 Tablet | Experimental |
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| Treatment group E: HRS9531 Tablet | Experimental |
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| Treatment group F:Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 Tablet | Drug | HRS9531 Tablet dose 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated hemoglobin (HbA1c) relative to baseline | Week 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving HbA1c < 7.0% | Week 20 | |
| Percentage change in fasting body weight relative to baseline | Week 20 | |
| Change in fasting plasma glucose (FPG) relative to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junmeng Shi | Contact | 17721288226 | junmeng.shi.js12@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Beijing | Beijing Municipality | 100020 | China |
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| HRS9531 Tablet |
| Drug |
HRS9531 Tablet dose 2 |
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| HRS9531 Tablet | Drug | HRS9531 Tablet dose 3 |
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| HRS9531 Tablet | Drug | HRS9531 Tablet dose 4 |
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| HRS9531 Tablet | Drug | HRS9531 Tablet dose 5 |
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| HRS9531 Tablet placebo | Drug | HRS9531 Tablet placebo |
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| Week 20 |
| Incidence of hypoglycemic events across all groups | Week 20 |
| Incidence of adverse events (AEs) across all groups | Week 20 |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
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