weight management
Conditions
Interventions
control group:Injection of semaglutide solution under the trade name Novo Ray
experimental group:Semaglutide solution is injected
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age ranging from 18 to 75 years old (including the boundary values), regardless of gender; 2. Body Mass Index (BMI) >= 28 kg/m²; 3.The weight change amplitude within the first 3 months before screening does not exceed 5% through simple diet and exercise control (subject to self-report). The weight change calculation formula is: (the highest weight within the first 3 months before screening - the lowest weight) / the highest weight * 100%; 4.Be able to understand the informed consent form, and voluntarily participate in and sign the informed consent form; 5.Be able to complete the trial by complying with the research protocol.
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed with endocrine diseases or obesity caused by single gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, hypogonadism, etc; 2.Patients with type 1, type 2, or other types of diabetes; 3.Those who are known to be allergic to any component of semaglutide injection or allergic to other GLP-1 receptor agonist drugs or have contraindications; 4.Within the first 3 months before screening, any drugs or products that can cause weight changes and affect weight assessment have been used, including but not limited to: a) Any approved or unapproved weight-loss drugs (such as GLP-1 receptor agonists or compound preparations containing GLP-1 receptor agonists, orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, etc.) or Chinese herbal medicines, health products, meal replacements that affect weight; b) Drugs that may cause significant weight gain have been used, including systemic glucocorticoid treatment for more than 1 week; antipsychotic or antiepileptic drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valeric acid and its derivatives, lithium preparations, thioridazine, etc.), growth hormones, etc; 5. Have previously or plan to receive surgery or treatment for the purpose of weight loss during the study (except acupuncture weight loss, liposuction and abdominal liposuction that are more than one year away from screening); 6. Have a history of major surgery within the first 6 months before screening, or plan to undergo surgery that may affect the completion of the study or compliance; 7.Those whose skin at the injection site is not suitable for subcutaneous injection due to trauma, surgery, allergy, skin lesions or other reasons. 8. Laboratory test results at screening meet any of the following criteria: a) Glycated hemoglobin (HbA1c) >= 6.5% or fasting plasma glucose (FPG) >= 7.0 mmol/L; b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 2.5 × upper limit of normal (ULN) or total bilirubin (TBIL) >= 2 × ULN; c) Triglyceride (TG) >= 5.7 mmol/L (500 mg/dL); d) Serum amylase (AMY) or serum lipase (LIP) >= 3 × ULN; e) Calcitonin >= 50 ng/L (pg/mL); f) Estimated glomerular filtration rate (eGFR) = 160 mmHg and/or diastolic blood pressure = 100 mmHg after using conventional antihypertensive drugs); 11. Personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia syndrome (MEN2); 12. Previous history of acute or chronic pancreatitis, symptomatic gallbladder history (except cholecystectomy), history of pancreatic injury, and other possible high-risk factors for pancreatitis; 13. An episode of hypoglycemia of unknown cause occurred from 3 months before screening to before randomization; 14. Thyroid function abnormalities that have not been controlled with a stable drug dose (referring to a stable dose for 3 months or more) {except for subclinical hypothyroidism that does not require treatment (thyroid stimulating hormone [TSH] < 10.0 mIU/L, fr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI?Waist Circumference?Hip Circumference; | — |
Countries
China
Contacts
Public ContactJi linong
Peking University People's Hospital
Outcome results
None listed