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

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.1 site in 1 country314 target enrollmentFebruary 21, 2024

ConditionsObesity Overweight

InterventionsTG103 7.5 mg Placebo 7.5 mg TG103 15 mg Placebo 15 mg TG103 22.5 mg Placebo 22.5 mg

DrugsTG103 7.5 mg Placebo 7.5 mg TG103 15 mg Placebo 15 mg TG103 22.5 mg Placebo 22.5 mg

Overview

Phase: Phase 2
Intervention: TG103 7.5 mg
Conditions: Obesity
Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Enrollment: 314
Locations: 1
Primary Endpoint: Percentage relative change from baseline in body weight at week 24
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 21, 2024

End Date

October 24, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Arms & Interventions

TG103 7.5 mg

Intervention: TG103 7.5 mg

Placebo 7.5 mg

Intervention: Placebo 7.5 mg

TG103 15 mg

Intervention: TG103 15 mg

Placebo 15 mg

Intervention: Placebo 15 mg

TG103 22.5 mg

Intervention: TG103 22.5 mg

Placebo 22.5 mg

Intervention: Placebo 22.5 mg

Outcomes

Primary Outcomes

Percentage relative change from baseline in body weight at week 24

Time Frame: From baseline to week 24

Secondary Outcomes

Change from baseline to week 24 in systolic blood pressure(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)
Title: Change from baseline to week 24 in serum low density lipoprotein cholesterol(From baseline to week 24)
Relative change from baseline in body weight at week 24(From baseline to week 24)
Title: Change from baseline to week 24 in serum high density lipoprotein cholesterol(From baseline to week 24)
Title: Change from baseline to week 24 in serum triglyceride(From baseline to week 24)
Proportion of participants with weight loss of ≥ 5% at week 24(From baseline to week 24)
Change from baseline to week 24 in diastolic blood pressure(From baseline to week 24)
Title: Change from baseline to week 24 in serum total cholesterol(From baseline to week 24)