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Clinical Trial Summary

The main purpose of this study is to evaluate the efficacy, safety, PK and PD characteristics of different doses of TG103 injection in overweight/obese subjects with type 2 diabetes mellitus.


Clinical Trial Description

This study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of TG103 injection in subjects with type 2 diabetes mellitus combined with overweight/obesity. The study will consist of 3 periods: an approximately 4-week screening period, a 20-week treatment period, and a 3-week safety follow-up period. Eligible subjects will be randomized in a 1:1:1:1 ratio into four paralleled dose groups (15 mg, 22.5 mg ,30 mg and placebo) with 52 subjects in each group. Within each group, subjects will receive TG103 injection or placebo subcutaneously (SC) once a week (QW) over a period of 20 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 Design


Related Conditions & MeSH terms


NCT number NCT05063253
Study type Interventional
Source CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Contact Le Wang
Phone +86-15511312686
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date October 2021
Completion date March 2024

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