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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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

Первичные конечные точки

• The change in lean body weight (kg) from baseline [Срок оценки: Week 40]

Вторичные конечные точки (10)

• Change in lean body mass percentage (%) [Срок оценки: During 40 weeks]
• Change in appendicular muscle mass (kg) [Срок оценки: During 40 weeks]
• Change in trunk muscle mass (kg) [Срок оценки: During 40 weeks]
• Change in appendicular fat mass (kg) [Срок оценки: During 40 weeks]
• Change in trunk fat mass (kg) [Срок оценки: During 40 weeks]
• Percentage change in total fat mass (%) [Срок оценки: During 40 weeks]
• Change in total fat mass (kg) [Срок оценки: During 40 weeks]
• Waist circumference change (cm) [Срок оценки: During 40 weeks]
• Body weight change (kg) [Срок оценки: During 40 weeks]
• Glycated hemoglobin change (%) [Срок оценки: During 40 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Hospital Affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT06863363 · GS24-B046-401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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