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Clinical Trial Summary

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

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

NCT number NCT04855292
Study type Interventional
Source CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Contact Yi Sun
Phone +86 13260872090
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date May 2021
Completion date May 2022

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