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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG103 22.5 mg | Experimental | Administered subcutaneously once every week for 52 weeks. Doses gradually increased to 22.5 mg. |
|
| Placebo | Placebo Comparator | Administered subcutaneously once every week for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG103 22.5 mg | Drug | Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. Doses gradually increased from 7.5 mg to 22.5 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with weight loss of ≥ 5% at week 40 | Weight loss is percentage change at week 40 compared with baseline. | 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. | From baseline to week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with weight loss of ≥ 5% at week 52 | Weight loss is percentage change at week 52 compared with baseline. | From baseline to week 52 |
| Relative percentage change from baseline in body weight at week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of TEAEs and SAEs assessed by CTCAE V5.0 | From baseline to week 55 | |
| Proportion of participants categorized by patient health questionnaire-9 (PHQ-9) score | From baseline to week 52 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Yan | 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 |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Drug | Subcutaneous injections with calorie restrict diet and increased physical activity for 52 weeks. |
|
Weight loss is percentage change at week 52 compared with baseline.
| 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. | From baseline to week 40, 52 |
| Change from baseline in body weight (kg) | From baseline to week 40, 52 |
| Change from baseline in waist circumference (cm) | From baseline to week 40, 52 |
| Change from baseline in HbA1c (%) | From baseline to week 40, 52 |
| Change from baseline in fasting plasma glucose (mmol/L) | From baseline to week 40, 52 |
| Change from baseline in fasting insulin (mU/L) | From baseline to week 40, 52 |
| Change from baseline in total cholesterol (mmol/L) | From baseline to week 40, 52 |
| Change from baseline in triglyceride (mmol/L) | From baseline to week 40, 52 |
| Change from baseline in low density lipoprotein cholesterol (mmol/L) | From baseline to week 40, 52 |
| Change from baseline in high density lipoprotein cholesterol (mmol/L) | From baseline to week 40, 52 |
| Change from baseline in systolic blood pressure (mmHg) | From baseline to week 40, 52 |
| Change from baseline in diastolic blood pressure (mmHg) | From baseline to week 40, 52 |
| Concentration of TG103 (Ctrough) |
| From baseline to week 55 |
| Proportion of anti-TG103-antibody-positive participants | Plasma anti-TG103 antibody will be measured at baseline to establish a positive/negative cut-off point and during the study. | From baseline to week 55 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |