Obesity, Overweight
Conditions
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.
Interventions
DRUGTG103 7.5 mg
Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.
DRUGPlacebo 7.5 mg
Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.
DRUGTG103 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.
DRUGPlacebo 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.
DRUGTG103 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.
DRUGPlacebo 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.
Sponsors
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. * 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. * One of the followings at screening: 1) HbA1c ≥ 6.5%, or FPG ≥ 7.0mmol/L or\<2.8mmol/L; 2) calcitonin ≥ 50 ng/L; 3) ALT or AST\>3 × UNL (upper normal limit), or total bilirubin\>1.5 × UNL; 4) blood amylase or lipase\>1.5 × UNL, 5) TG>5.6mmol/L, 6) eGFR\<60ml/min/1.73m\^2 , 7) positive of HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody, 8) WBC< 3×10\^9/L, or Hb <100g/L, 9) INR\>1.2. * History of drug abuse, drug dependence or alcoholism. * History of moderate to severe depression, or screening Patient Health Questionaire-9 (PHQ-9) score ≥ 15. * The fertile female who is pregnant, breast-feeding or with blood HCG positive at screening; or the fertile participants and their partner cannot use an effective contraceptive method during the trial and within 3 months after the end of treatment. * Other situations unsuitable for this study in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage relative change from baseline in body weight at week 24 | From baseline to week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with weight loss of ≥ 10% at week 24 | 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 |
| 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 |
| Title: Change from baseline to week 24 in serum triglyceride | From baseline to week 24 |
| Title: Change from baseline to week 24 in serum low density lipoprotein cholesterol | From baseline to week 24 |
| Title: Change from baseline to week 24 in serum high density lipoprotein cholesterol | 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 waist circumference | From baseline to week 24 |
Other
| Measure | Time frame |
|---|---|
| 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 |
| Change from baseline to week 24 in serum creatinine | From baseline to week 24 |
| Change from baseline to week 24 in serum HCG (Human Chorionic Gonadotophin) | From baseline to week 24 |
| Plasma concentration of TG103 | From baseline to week 27 |
| Number of patients with positive TG103 antibody | From baseline to week 27 |
| Number of TEAEs (Treatment Emergent Adverse Events) and SAEs (Serious Adverse Events) | From baseline to week 27 |
Countries
China
Outcome results
None listed