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

NCT05997576 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 675

Last updated 2025-08-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Yan · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2025-02-17
Completion
2025-03-03

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997576 on ClinicalTrials.gov