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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
314
Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.
Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Dose is 7.5mg once a week.
Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg.
Clinical Trials Information Group
Shijiazhuang, Hebei, China
Percentage relative change from baseline in body weight at week 24
Time frame: From baseline to week 24
Proportion of participants with weight loss of ≥ 5% at week 24
Time frame: From baseline to week 24
Proportion of participants with weight loss of ≥ 10% at week 24
Time frame: From baseline to week 24
Change from baseline to week 24 in waist circumference
Time frame: From baseline to week 24
Relative change from baseline in body weight at week 24
Time frame: From baseline to week 24
Change from baseline to week 24 in systolic blood pressure
Time frame: From baseline to week 24
Change from baseline to week 24 in diastolic blood pressure
Time frame: From baseline to week 24
Title: Change from baseline to week 24 in serum total cholesterol
Time frame: From baseline to week 24
Title: Change from baseline to week 24 in serum triglyceride
Time frame: From baseline to week 24
Title: Change from baseline to week 24 in serum low density lipoprotein cholesterol
Time frame: From baseline to week 24
Title: Change from baseline to week 24 in serum high density lipoprotein cholesterol
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Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 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.
Subcutaneous injections with calorie-restricted diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 22.5 mg.
Time frame: From baseline to week 24