NCT05997576

A Study of TG103 Injection in Non-diabetic Overweight or Obesity

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 675 (actual)
• 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 3 study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of TG103 injection, a GLP-1 receptor agonist, for weight management in non-diabetic patients with BMI greater than or equal to 28 kg/m2 or greater than 24 kg/m2 in the presence of comorbidities, in addition to lifestyle intervention (calorie restrict diet and increased physical activity).

Conditions

• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	TG103 22.5 mg	Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.
DRUG	Placebo	Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks.

Timeline

• Start date: 2023-11-22
• Primary completion: 2025-02-17
• Completion: 2025-03-03
• First posted: 2023-08-18
• Last updated: 2025-08-11

Locations

1 site across 1 country: China