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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG103 7.5 mg | Experimental |
| |
| Placebo 7.5 mg | Placebo Comparator |
| |
| TG103 15 mg | Experimental |
| |
| Placebo 15 mg | Placebo Comparator |
| |
| TG103 22.5 mg | Experimental |
| |
| Placebo 22.5 mg | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage relative change from baseline in body weight at week 24 | From baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Yan Study Principal Investigator | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Information Group | Shijiazhuang | Hebei | 050011 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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 |
| 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 |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |