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

NCT06226090 | Completed Phase 2

• 1 other identifier: SYSA1803-017
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage relative change from baseline in body weight at week 24

  From baseline to week 24

Secondary Outcomes (10)

• Proportion of participants with weight loss of ≥ 5% at week 24

  From baseline to week 24

• Proportion of participants with weight loss of ≥ 10% at week 24

  From baseline to week 24

• Change from baseline to week 24 in waist circumference

  From baseline to week 24

• Relative change from baseline in body weight at week 24

  From baseline to week 24

• Change from baseline to week 24 in systolic blood pressure

  From baseline to week 24

Other Outcomes (7)

• Number of TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events)

  From baseline to week 27

• Change from baseline to week 24 in serum calcitonin

  From baseline to week 24

• Change from baseline to week 24 in serum alanine transaminase

  From baseline to week 24

Study Arms (6)

TG103 7.5 mg

EXPERIMENTAL

Drug: TG103 7.5 mg

Placebo 7.5 mg

PLACEBO COMPARATOR

Drug: Placebo 7.5 mg

TG103 15 mg

EXPERIMENTAL

Drug: TG103 15 mg

Placebo 15 mg

PLACEBO COMPARATOR

Drug: Placebo 15 mg

TG103 22.5 mg

EXPERIMENTAL

Drug: TG103 22.5 mg

Placebo 22.5 mg

PLACEBO COMPARATOR

Drug: Placebo 22.5 mg

Interventions

TG103 7.5 mg DRUG

Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.

TG103 7.5 mg

Placebo 7.5 mg DRUG

Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.

Placebo 7.5 mg

TG103 15 mg DRUG

Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.

TG103 15 mg

Placebo 15 mg DRUG

Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.

Placebo 15 mg

TG103 22.5 mg DRUG

Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.

TG103 22.5 mg

Placebo 22.5 mg DRUG

Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.

Placebo 22.5 mg

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.

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

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Li Yan Study Principal Investigator

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 26, 2024
• Study Start: February 21, 2024
• Primary Completion: September 26, 2024
• Study Completion: October 24, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)