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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
675
Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.
Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks.
Clinical Trials Information Group
Shijiazhuang, Hebei, China
Proportion of participants with weight loss of ≥ 5% at week 40
Weight loss is percentage change at week 40 compared with baseline.
Time frame: 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.
Time frame: From baseline to week 40
Proportion of participants with weight loss of ≥ 5% at week 52
Weight loss is percentage change at week 52 compared with baseline.
Time frame: From baseline to week 52
Relative percentage change from baseline in body weight at week 52
Weight loss is percentage change at week 52 compared with baseline.
Time frame: From baseline to week 52
Proportion of participants with weight loss of ≥ 10%
Weight loss is percentage change at week 40 and week 52 compared with baseline.
Time frame: From baseline to week 40, 52
Change from baseline in body weight (kg)
Time frame: From baseline to week 40, 52
Change from baseline in waist circumference (cm)
Time frame: From baseline to week 40, 52
Change from baseline in HbA1c (%)
Time frame: From baseline to week 40, 52
Change from baseline in fasting plasma glucose (mmol/L)
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Time frame: From baseline to week 40, 52
Change from baseline in fasting insulin (mU/L)
Time frame: From baseline to week 40, 52
Change from baseline in total cholesterol (mmol/L)
Time frame: From baseline to week 40, 52
Change from baseline in triglyceride (mmol/L)
Time frame: From baseline to week 40, 52
Change from baseline in low density lipoprotein cholesterol (mmol/L)
Time frame: From baseline to week 40, 52
Change from baseline in high density lipoprotein cholesterol (mmol/L)
Time frame: From baseline to week 40, 52
Change from baseline in systolic blood pressure (mmHg)
Time frame: From baseline to week 40, 52
Change from baseline in diastolic blood pressure (mmHg)
Time frame: From baseline to week 40, 52