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

NCT05997576 | Completed Phase 3

• 1 other identifier: SYSA1803-013
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with weight loss of ≥ 5% at week 40

  Weight loss is percentage change at week 40 compared with baseline.

  From baseline to week 40

• Relative percentage change from baseline in body weight at week 40

  Weight loss is percentage change at week 40 compared with baseline.

  From baseline to week 40

Secondary Outcomes (14)

• Proportion of participants with weight loss of ≥ 5% at week 52

  From baseline to week 52

• Relative percentage change from baseline in body weight at week 52

  From baseline to week 52

• Proportion of participants with weight loss of ≥ 10%

  From baseline to week 40, 52

• Change from baseline in body weight (kg)

  From baseline to week 40, 52

• Change from baseline in waist circumference (cm)

  From baseline to week 40, 52

Other Outcomes (4)

• Number of TEAEs and SAEs assessed by CTCAE V5.0

  From baseline to week 55

• Proportion of participants categorized by patient health questionnaire-9 (PHQ-9) score

  From baseline to week 52

• Concentration of TG103 (Ctrough)

  From baseline to week 55

Study Arms (2)

TG103 22.5 mg

EXPERIMENTAL

Administered subcutaneously once every week for 52 weeks. Doses gradually increased to 22.5 mg.

Drug: TG103 22.5 mg

Placebo

PLACEBO COMPARATOR

Administered subcutaneously once every week for 52 weeks.

Drug: Placebo

Interventions

TG103 22.5 mg DRUG

Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.

TG103 22.5 mg

Placebo DRUG

Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years ≤ age ≤ 75 years.
• Body Mass Index (BMI) ≥ 28 kg/m\^2, or 24 kg/m\^2 \< BMI ≤ 28 kg/m\^2 with at least one of obesity-related complications.
• Regular diet and exercise and stable body weight (i.e., self-reported body weight change \< 5%) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
• Weight loss less than 5% or no weight loss after diet and exercise intervention for at least 12 weeks.
• Be able to understand the trial and complete the procedures, and be voluntary to participate in this study and sign the informed consent.

You may not qualify if:

• History of type 2 diabetes, type 1 diabetes or hypoglycemia.
• Overweight or obesity due to disease or drug; or weight increase due to non-fat mass increase; or monogenic obesity.
• Medications or products which are judged by investigators to cause change in weight and influence trial evaluations have been used within 12 weeks before screening or will be used during study.
• Weight loss less than 5% by monotherapy or combination with GLP-1 receptor agonists for at least 12 weeks before screening.
• Bariatric surgery within 12 months before screening; or no full recovery from any surgery or injury at screening; or gastrointestinal motility dysfunction due to gastrointestinal surgery.
• Participation in any clinical trial to receive treatment within 12 weeks before screening, or participation in clinical trial to receive TG103 before screening.
• History of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents, or suspected allergy to TG103 judged by investigator due to other severe allergy history.
• Personal history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
• History or screening ultrasound reports of chronic pancreatitis, acute pancreatitis, etc.
• History of severe gastrointestinal disease; or gastrointestinal symptom at screening; or discontinuation of GLP-1 receptor agonist, GLP-1/GIP receptor agonist, GLP-1/GCG receptor agonist or metformin due to gastrointestinal adverse reaction.
• Severe infection at screening.
• Skin disorder that influences safety evaluation at screening.
• History of severe disease or malignant tumor.
• Systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg, NYHA Grade Ⅲ-Ⅳ, QTc interval prolongation or severe arrhythmia at screening.
• History of abnormal thyroid function with requirement of medication treatment at screening, or screening TSH beyond the normal reference range.

Sponsors & Collaborators

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

Study Sites (1)

Clinical Trials Information Group

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Yan

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 18, 2023
• Study Start: November 22, 2023
• Primary Completion: February 17, 2025
• Study Completion: March 3, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)