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NOT YET RECRUITING
NCT06863363
PHASE4

PEG-rhGH and Semaglutide Combination Therapy in Non-Diabetic Obese Adults

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter, Randomized, Open-label, Parallel-controlled Clinical Trial Comparing the Efficacy and Safety of PEG-rhGH Injection Combined with Semaglutide Injection Versus Semaglutide Injection Monotherapy in Body Composition of Non-Diabetic Obese Adults

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

212

Start Date

Not specified

Completion Date

Not specified

Last Updated

2025-03-07

Healthy Volunteers

No

Interventions

DRUG

PEG-rhGH Injection + Semaglutide Injection

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

DRUG

Semaglutide Injection

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

Locations (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China