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

Fudan University

Status and phase

Not yet enrolling

Phase 4

Conditions

Non-diabetic Obesity

Treatments

Drug: PEG-rhGH Injection + Semaglutide Injection

Drug: Semaglutide Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06863363

GS24-B046-401

Details and patient eligibility

About

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.

Enrollment

212 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 years (minimum age) and 50 years (maximum age), inclusive
Gender: Male or female, with a ratio of male to female being 2:1;
Body Mass Index (BMI) ≥28 kg/m²;
No prior use of semaglutide injection or antidiabetic medications;
Free Thyroxine (FT4) levels within normal range at screening;
Testosterone levels within normal range at screening (males only);
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;
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

Unable to accept regular follow-up;
Those who have difficulty with self-injection;
Weight change >5.0% in the 12 weeks prior to screening (self-reported);
History of allergic reactions to the study drug or similar drugs;
Evaluated by the investigator as unable to tolerate subcutaneous injection, such as those undergoing anticoagulant therapy, thrombocytopenia, known bleeding disorders, or idiopathic thrombocytopenic purpura;
Planning surgery within 1 year; history of gastrointestinal surgery (excluding polypectomy and appendectomy);
Positive blood HCG during screening; breastfeeding women; postmenopausal women; women with FSH >30 IU/L during screening;
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;
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;
Triglycerides ≥500 mg/dL (5.65 mmol/L);
Current or past history of malignancy, or currently having nodules with malignant potential such as thyroid nodules with TIRADS grade ≥4;
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);
Hemoglobin A1c ≥6.5% during screening;
History of diabetes (type 1, type 2, special types, or gestational diabetes) or currently using injectable or oral antidiabetic medications;
Current or past history of acromegaly;
Proliferative or severe non-proliferative diabetic retinopathy at screening; fundus examination within 90 days before randomization: proliferative retinopathy or macular edema requiring acute treatment;
Used growth hormone therapy in the past 6 months;
Used any weight loss medications in the past 3 months; previously underwent obesity surgery or planned obesity surgery during the study;
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;
IGF-1 SDS >2.0 (age and gender matched);
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;
History of pancreatitis, or current acute or chronic pancreatitis;
History of cholecystitis, or current gallbladder/biliary disease symptoms, or treatable gallstones or polyps;
Family or personal history of multiple endocrine neoplasia type 2 or thyroid cancer (family defined as first-degree relatives);
Prior history of pituitary mass;
History of seizures;
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);
History of substance abuse and/or alcoholism, or mental disorders; during screening, had impaired consciousness including somnolence, stupor, coma, confusion;
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);
Other reasons for exclusion as deemed by the investigator, such as any situation endangering participant safety or affecting compliance with the protocol.