NCT05063253

A Study of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy of TG103 Injection in Overweight/Obese Subjects With Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	TG103	TG103 injection, SC, once weekly
DRUG	Placebo	Placebo, SC, once weekly

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2021-10-01
• Last updated: 2021-10-01