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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a combination treatment of two medications, PEG-rhGH and Semaglutide, to see how effective and safe they are for helping non-diabetic adults who are obese. The goal is to find out if this combination can improve body composition, which includes muscle and fat levels, and also to monitor changes in body weight and other health indicators like blood sugar.

To participate in this study, you need to be between 18 and 50 years old and have a body mass index (BMI) of 28 or higher, which indicates obesity. You should not have used any diabetes medications before and should be in good health overall. The trial is not yet recruiting participants, but if you qualify and decide to join, you will attend regular visits and follow specific treatment plans. This study hopes to provide valuable information about new ways to manage obesity, which could be beneficial for many people in the future.

Gender

ALL

Eligibility criteria

• 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.