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

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT06863363
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Non-diabetic Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
  • 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

Study Details

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.

Key Dates

Status verified
Feb 2025

Study Design

Enrollment
212 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PEG-rhGH Injection + Semaglutide Injection
  • Active Comparator: Semaglutide Injection

Primary Outcome Measure

The change in lean body weight (kg) from baseline [ Time Frame: Week 40 ]

Central Contacts