NCT05299697

A Study of TG103 Injection in Overweight or Obesity

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study of TG103 Injection in the Management of Overweight or Obesity

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase II study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of two dose levels of TG103 injection, a GLP-1 receptor agonist, in the management of overweight or obesity, to support dose selection for further development.

Conditions

• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	TG103 15 mg	Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.
DRUG	TG103 22.5 mg	Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg, 15 mg to 22.5 mg.
DRUG	Placebo	Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks.

Timeline

• Start date: 2022-05-20
• Primary completion: 2023-06-30
• Completion: 2023-09-30
• First posted: 2022-03-29
• Last updated: 2022-05-23

Locations

1 site across 1 country: China