The main purpose of this study is to assess the safety and tolerability of multiple doses of TG103 injection in overweight/obese subjects without diabetes
This study is a randomized, double-blind, placebo-controlled, multiple-doses, parallel-group study to characterize the safety (including the anti-drug antibodies (ADA)), tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TG103 injection. The study will consist of 3 periods: an approximately 4-week screening period, followed by a 12-week treatment period, and a 3-week safety follow-up period. Eligible subjects will be enrolled into three paralleled dose groups (15 mg, 22.5 mg and 30 mg) with 16 subjects in each group. Within each group, subjects will be randomized in a 3:1 ratio to receive TG103 injection or placebo subcutaneously (SC) once a week (QW) over a period of 12 weeks. Each group will be started at a low dose of 7.5 mg and gradually up-titrated at weekly intervals until the target dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
TG103 injection, SC, once weekly
Placebo control, SC, once weekly
Gao Huanhuan
Beijingcun, Hebei, China
Safety and tolerability assessed by incidence and severity of adverse events
Time frame: Up to 99 days
PK profile-AUC: Area under the plasma concentration versus time curve
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- Cmax: Peak Plasma Concentration
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- Tmax: Time to maximum plasma concentration
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- t1/2: Half time
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PK profile- CL/F: Apparent clearance
Time frame: Day1, 8, 15, 22, 29, 64, 71, and 78
PD profile- Weight change relative to baseline
Time frame: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 and 99
PD profile- Proportion of subjects with a baseline weight loss of more than 5 percent
Time frame: Day1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 and 99
PD profile- Waistline change relative to baseline
Time frame: Day8, 15, 22, 29, 43, 57, 71, 78, 85 and 99
PD profile- Change of waist-hip ratio relative to baseline
Time frame: Day8, 15, 22, 29, 43, 57, 71, 78, 85 and 99
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PD profile- Change of blood pressure(systolic blood pressure and diastolic blood pressure)relative to baseline
Time frame: Day15, 22, 29, 43, 85 and 99
PD profile- Change of blood fat levels relative to baseline
Time frame: Day15, 22, 29, 43, 85 and 99
The occurrence of TG103 anti-drug antibodies (ADA)
Time frame: Day1, 15, 29, 57, and 99