Non-diabetic Obesity
Conditions
Brief 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.
Interventions
DRUGPEG-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
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
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 years (minimum age) and 50 years (maximum age), inclusive 2. Gender: Male or female, with a ratio of male to female being 2:1; 3. Body Mass Index (BMI) ≥28 kg/m²; 4. No prior use of semaglutide injection or antidiabetic medications; 5. Free Thyroxine (FT4) levels within normal range at screening; 6. Testosterone levels within normal range at screening (males only); 7. No plans for pregnancy from the time of signing the ICF until 2 months after the study ends, willingness to take effective contraceptive measures to prevent pregnancy or causing a partner's pregnancy, and no plans for sperm or egg donation during the study period; 8. Participants must voluntarily agree to and be able to comply with all scheduled visits, treatment plans, laboratory tests, special examinations, neurological assessments, and other trial procedures, and sign a written informed consent form.
Exclusion criteria
1. Unable to accept regular follow-up; 2. Those who have difficulty with self-injection; 3. Weight change \>5.0% in the 12 weeks prior to screening (self-reported); 4. History of allergic reactions to the study drug or similar drugs; 5. Evaluated by the investigator as unable to tolerate subcutaneous injection, such as those undergoing anticoagulant therapy, thrombocytopenia, known bleeding disorders, or idiopathic thrombocytopenic purpura; 6. Planning surgery within 1 year; history of gastrointestinal surgery (excluding polypectomy and appendectomy); 7. Positive blood HCG during screening; breastfeeding women; postmenopausal women; women with FSH \>30 IU/L during screening; 8. Any of the following: myocardial infarction, stroke, unstable angina requiring hospitalization, or transient ischemic attack within 180 days before screening, classified as NYHA class III or higher; 9. Clinically significant severe ECG abnormalities (e.g., QT prolongation \[\>450 ms in men, \>470 ms in women\], ventricular Flutter, ventricular fibrillation, torsades de pointes, sick sinus syndrome, third-degree heart block without pacemaker therapy, and other severe abnormalities as assessed by the investigator), uncontrolled blood pressure despite treatment/untreated (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg during screening, systolic BP \<90 mmHg and/or diastolic BP \<50 mmHg), or other cardiovascular diseases deemed unsuitable for the study by the investigator; 10. Triglycerides ≥500 mg/dL (5.65 mmol/L); 11. Current or past history of malignancy, or currently having nodules with malignant potential such as thyroid nodules with TIRADS grade ≥4; 12. Tumor markers during screening: CA125 (for women), CA199, CEA, AFP above upper limit of normal range; PSA above upper limit of normal range (for men); 13. Hemoglobin A1c ≥6.5% during screening; 14. History of diabetes (type 1, type 2, special types, or gestational diabetes) or currently using injectable or oral antidiabetic medications; 15. Current or past history of acromegaly; 16. Proliferative or severe non-proliferative diabetic retinopathy at screening; fundus examination within 90 days before randomization: proliferative retinopathy or macular edema requiring acute treatment; 17. Used growth hormone therapy in the past 6 months; 18. Used any weight loss medications in the past 3 months; previously underwent obesity surgery or planned obesity surgery during the study; 19. Any of the following laboratory tests at screening: AST or ALT \>2.5 ULN; total bilirubin \>1.5 ULN; TSH \<0.4 or \>6 mIU/L; calcitonin \>50 ng/L; 20. IGF-1 SDS \>2.0 (age and gender matched); 21. Serum creatinine \>1.5 ULN, eGFR \<60 mL/min/1.73 m² \[using the modified simplified MDRD equation: eGFR = 175 × (serum creatinine in mg/dL)\^-1.234 × age\^-0.179 × 0.79 for women\], or kidney impairment requiring dialysis; 22. History of pancreatitis, or current acute or chronic pancreatitis; 23. History of cholecystitis, or current gallbladder/biliary disease symptoms, or treatable gallstones or polyps; 24. Family or personal history of multiple endocrine neoplasia type 2 or thyroid cancer (family defined as first-degree relatives); 25. Prior history of pituitary mass; 26. History of seizures; 27. Participated in another clinical trial with approved or investigational drugs/devices within 90 days before screening (excluding those who only signed the consent without receiving any intervention); 28. History of substance abuse and/or alcoholism, or mental disorders; during screening, had impaired consciousness including somnolence, stupor, coma, confusion; 29. Questionnaire PHQ-9 score ≥15; history of suicidal behavior; Columbia-Suicide Severity Rating Scale (C-SSRS) question 1 or 2 indicating suicidal ideation (answering yes to question 1 or 2); 30. Other reasons for exclusion as deemed by the investigator, such as any situation endangering participant safety or affecting compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in lean body weight (kg) from baseline | Week 40 |
Secondary
| Measure | Time frame |
|---|---|
| Change in appendicular muscle mass (kg) | During 40 weeks |
| Change in trunk muscle mass (kg) | During 40 weeks |
| Change in appendicular fat mass (kg) | During 40 weeks |
| Change in trunk fat mass (kg) | During 40 weeks |
| Change in lean body mass percentage (%) | 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 |
| Percentage change in total fat mass (%) | During 40 weeks |
Countries
China
Contacts
Primary ContactXiaoying LI, doctor
Backup ContactLin ZHAO
Outcome results
None listed