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This study aims to evaluate the efficacy and safety of PEG-rhGH Injection combined with Semaglutide Injection versus Semaglutide Injection monotherapy in improving body composition (lean body mass, fat mass, etc.) in non-diabetic obese adults, while also analyzing changes in body weight, blood glucose, and other metabolic parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhGH Injection + Semaglutide Injection | Experimental |
| |
| Semaglutide Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhGH Injection + Semaglutide Injection | Drug | Polyethylene Glycol Recombinant Human Growth Hormone Injection (PEG-rhGH Injection), 54 IU/9.0 mg/1.0 mL/amp.; Subcutaneous injection using pen-injector, once weekly at a dose of 2 mg per week (weeks 1-40). Semaglutide Injection, 0.68 mg/mL,1.5 mL;1.34 mg/mL,1.5 mL;1.34 mg/mL,3 mL;2.27 mg/mL,3 mL;3.2 mg/mL,3 mL; Subcutaneous injection once weekly using pre-filled pen including dosage escalation period (W1-W16): starting dose 0.25 mg, increasing every 4 weeks (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) and maintenance treatment period (W17-W40): at a dose of 2.4 mg for 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change in lean body weight (kg) from baseline | Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lean body mass percentage (%) | During 40 weeks | |
| Change in appendicular muscle mass (kg) | During 40 weeks | |
| Change in trunk muscle mass (kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoying LI, doctor | Contact | +86 136 5191 3857 | xiaoying_li@hotmail.com | |
| Lin ZHAO | Contact | 13917902849 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| C562190 | polyethylene glycol-recombinant human growth hormone |
| C000591245 | semaglutide |
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|
| Semaglutide Injection | Drug | Semaglutide Injection, 0.68 mg/mL,1.5 mL;1.34 mg/mL,1.5 mL;1.34 mg/mL,3 mL;2.27 mg/mL,3 mL;3.2 mg/mL,3 mL; Subcutaneous injection once weekly using pre-filled pen including dosage escalation period (W1-W16): starting dose 0.25 mg, increasing every 4 weeks (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) and maintenance treatment period (W17-W40): at a dose of 2.4 mg for 24 weeks |
|
| During 40 weeks |
| Change in appendicular fat mass (kg) | During 40 weeks |
| Change in trunk fat mass (kg) | During 40 weeks |
| Percentage change in total fat mass (%) | During 40 weeks |
| Change in total fat mass (kg) | During 40 weeks |
| Waist circumference change (cm) | During 40 weeks |
| Body weight change (kg) | During 40 weeks |
| Glycated hemoglobin change (%) | During 40 weeks |