NCT06226090

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

A Randomized, Double-blind, Placebo-controlled Phase 2 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 314 (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 randomized, double-blind, placebo-controlled, parallel phase 2 study to evaluate efficacy, safety, pharmacokinetic characteristics and immunogenicity of TG103 injection for weight management in non-diabetic patients with overweight in the presence of comorbidities or obesity, in addition to lifestyle intervention.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	TG103 7.5 mg	Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.
DRUG	Placebo 7.5 mg	Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.
DRUG	TG103 15 mg	Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.
DRUG	Placebo 15 mg	Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.
DRUG	TG103 22.5 mg	Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.
DRUG	Placebo 22.5 mg	Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.

Timeline

• Start date: 2024-02-21
• Primary completion: 2024-09-26
• Completion: 2024-10-24
• First posted: 2024-01-26
• Last updated: 2025-05-14

Locations

1 site across 1 country: China