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The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will receive HRS-7535 administered orally |
|
| Group B | Experimental | Subjects will receive HRS-7535 administered orally |
|
| Group C | Experimental | Subjects will receive escalated dose of HRS-7535 administered orally |
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| Group D | Experimental | Subjects will receive escalated HRS-7535 administered orally |
|
| Group E | Placebo Comparator | Subjects will receive Placebo administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 | Drug | HRS-7535 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in HbA1c at Week 16 | at Week 16] |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16 | at Week 16 | |
| Change From Baseline in fasting plasma glucose (FPG) at Week 16 | at Week 16 | |
| Change From Baseline in Mixed meal test at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yimei Xu | Contact | 0518-82342973 | yimei.xu@hengrui.com | |
| Shujin Cheng | Contact | 0518-82342973 | shujin.cheng@hengrui.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42234428 | Derived | Guo L, Sun Z, Zhang L, Qin G, Li Y, Chen X, Xu N, Su X, Mao L, Sun J, Cheng Z, Shi X, Wang F, Wang Q, Pan R, Ding S, Ye Z, Xu Y, Liu P. HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2615622. doi: 10.1001/jamanetworkopen.2026.15622. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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HRS-7535 tablet compared with placebo
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| Placebo |
| Drug |
Placebo |
|
| at Week 16 |
| Change From Baseline in body weight at Week 16 | at Week 16 |
| Change From Baseline in waist circumference at Week 16 | at Week 16 |
| Change From Baseline in 7-point SMBG at Week 16 | at Week 16 |
| Proportion of subjects receiving glycemic rescue medicine at Week 16 | at Week 16 |
| A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[ | at Week 18 |
| D004700 | Endocrine System Diseases |