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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks
Placebo single subcutaneous injection + Semaglutide QW for 4 weeks
Ascletis Clinical Site
San Antonio, Texas, United States
Adverse events
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time frame: up to 71 days
Change From Baseline in Body Weight
Change from baseline (week 1) to week 10 in body weight was evaluated
Time frame: up to 71 days
Cmax of ASC47
Evaluate the Peak Plasma Concentration of ASC47 in combination with semaglutide.
Time frame: up to 71 days
AUC of ASC47
Evaluate the Area under the plasma concentration versus time curve of ASC47 in combination with semaglutide.
Time frame: up to 71 days
T1/2 of ASC47
Evaluate the Terminal-Phase Half-Life of ASC47 in combination with semaglutide.
Time frame: up to 71 days
CL/F of ASC47
Evaluate the Apparent Systemic Clearance of ASC47 in combination with semaglutide.
Time frame: up to 71 days
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