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
Not provided
Not provided
This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combo Cohort 1 in participants with obesity | Experimental | Cohort 1, dose 1 |
|
| Combo Cohort 2 in participants with obesity | Experimental | Cohort 2, dose 2 |
|
| Combo Cohort 3 in participants with obesity | Experimental | Cohort 3, dose 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC47 +Semaglutide | Drug | ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) | up to 71 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Change from baseline (week 1) to week 10 in body weight was evaluated | up to 71 days |
| Cmax of ASC47 | Evaluate the Peak Plasma Concentration of ASC47 in combination with semaglutide. |
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 |
|---|---|---|---|---|---|---|
| Ascletis Clinical Site | San Antonio | Texas | 78209 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo+Semaglutide | Drug | Placebo single subcutaneous injection + Semaglutide QW for 4 weeks |
|
| up to 71 days |
| AUC of ASC47 | Evaluate the Area under the plasma concentration versus time curve of ASC47 in combination with semaglutide. | up to 71 days |
| T1/2 of ASC47 | Evaluate the Terminal-Phase Half-Life of ASC47 in combination with semaglutide. | up to 71 days |
| CL/F of ASC47 | Evaluate the Apparent Systemic Clearance of ASC47 in combination with semaglutide. | up to 71 days |