Not Yet RecruitingPhase 4

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

China212 participants

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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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;

What they're measuring

The change in lean body weight (kg) from baseline

Timeframe: Week 40

Trial details

NCT IDNCT06863363

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Contact for this trial

Xiaoying LI, doctor

+86 136 5191 3857 xiaoying_li@hotmail.com

View on ClinicalTrials.gov More Non-diabetic Obesity trials