Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, placebo and active-control, multiple-dose, phase IIa trial. Patients were randomly assigned to receive HS-20094 (12 patients), placebo (3 patients), or active control drug Semaglutide injection (3 patients) in a 4:1:1 ratio to each of four dose cohorts of 5 mg, 10 mg, 15 mg, and 20 mg. HS-20094 and placebo were administered in a double-blind design by subcutaneous injection once a week for a total of four times, and the dose was gradually increased weekly (2.5-2.5-5-5 mg, 5-510-10 mg, 5-10-15-15 mg, 5-10-15-20 mg). The active control drug semaglutide was administered by open-label, titrated subcutaneous injection once a week for a total of four times, and the dose was increased gradually every week until 1.0 mg (0.25-0.5-0.5-1.0 mg). The primary study objective was to 1) Evaluate the safety and tolerability of multiple subcutaneous injections of HS-20094 in subjects with type 2 diabetes mellitus (T2DM) with or without overweight or obesity;2) Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of multiple subcutaneous injections of HS-20094.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20094 5mg | Experimental | Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection |
|
| HS-20094 10mg | Experimental | Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection |
|
| HS-20094 15mg | Experimental | Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection |
|
| HS-20094 20mg | Experimental | Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20094 5mg | Drug | Administrated by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug | A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module | From Baseline to Day 57. |
| The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function | From Baseline to Day 57 | |
| The changes ECG examination assessed by PR, R-R, QRS and QTcF | 12-lead electrocardiogram (ECG) parameters | From Baseline to Day 57 |
| The changes in Blood pressure | Vital signs | From Baseline to Day 57 |
| Pulse rate | Vital signs | From Baseline to Day 57 |
| Respiratory rate | Vital signs | From Baseline to Day 57 |
| Temperature | Vital signs | From Baseline to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Cmax of HS-20094 | PK: Cmax of HS-20094 | Baseline to Day 57 |
| Pharmacokinetics (PK): Tmax of HS-20094 | PK: Tmax of HS-20094 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HS-20094 10mg | Drug | Administrated by subcutaneous injection |
|
|
| HS-20094 15mg | Drug | Administrated by subcutaneous injection |
|
|
| HS-20094 20mg | Drug | Administrated by subcutaneous injection |
|
|
| Baseline to Day 57 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094 | PK: AUC of HS-20094 | Baseline to Day 57 |
| Pharmacodynamics (PD): HbA1c | PD: change of HbA1c | Baseline to Day 29 |
| D004700 | Endocrine System Diseases |