Obesity
Conditions
Interventions
Semaglutide group:Subcutaneous injection of semaglutide and oral placebo
Semaglutide plus probiotics group:Subcutaneous injection of semaglutide and oral probiotics
probiotics group:Take probiotics orally after meals
Sponsors
The First Affilliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 at the time of signing the informed consent; 2. Body mass Index (BMI) during the screening period meets any of the following conditions: (1) BMI>= 28.0 kg/m^2; (2) BMI>=24.0kg/m^2 , with at least one weight-related diseases, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease, which requires a combination of drugs under the guidance of a physician after comprehensive evaluation; 3. understanding and finishing questionnaires; 4. Willing and able to comply with the study protocol, understanding and willing to sign subject informed consent (ICF) prior to screening.
Exclusion criteria
Exclusion criteria: 1.History of diabetes; 2. Screening period HbA1c >= 6.5%; 3. History of chronic pancreatitis; 4. History of acute pancreatitis within 180 days to the screening period; 5. Aspartate aminotransferase (AST) >3 times upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) during the screening period; 6. History of surgical treatment for obesity; 7. Use of other approved weight loss drugs in the 90 days prior to the screening period, such as sibutramine and orlistat; 8. Pregnancy and planning pregnancy; 9. Self-reported weight change greater than 5% in the 90 days prior to the screening period; 10. Personal or first-degree relatives have a history of multiple endocrine neoplasia or medullary thyroid cancer; 11. Known history of malignant tumor; 12. Participating in other interventional clinical studies. 13. Received dietary supplements (omega-3 fatty acids, phytosterols, etc.) that affect lipid and cholesterol levels in the 30 days prior to screening, and used oral probiotics or antibiotics; 14. Received lipid-lowering drugs, especially cholesterol-lowering drugs (such as statins), in the 90 days prior to screening; 15. It is known that there are other co-diseases that researchers consider inappropriate to participate in this study or co-diseases that may lead to death of patients or have an impact on the results of this study, such as serious liver and kidney damage diseases, cardiovascular and cerebrovascular diseases, etc.; 16. Subjects who are known to be allergic to the investigational drug (Semaglutide or WONDERRLAB SHAPE100) or its excipients; 17. Long-term (daily use for more than 1 month) treatment with lubricants other than glycerin enemas and laxatives for stool softeners; 18. Other chronic gastrointestinal diseases (e.g. Ulcerative colitis, Crohn's disease, pancreatic insufficiency) are known to exist that may affect investigators' evaluation of subjects' gastrointestinal function; 19. A known disease or mental condition that interferes with the patient's self-assessment of function or quality of life (e.g. mental disorders, Alzheimer's disease, alcohol or drug addiction); 20. Other circumstances deemed by the investigator to interfere with participants' adherence to the study protocol, other circumstances that may affect data interpretation, or other circumstances determined by the investigator to be inappropriate for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline at week 24;Interleukin 6 IL-6(pg/ml) changes from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects who achieved a minimum clinical benefit of weight loss (weight loss greater than or equal to 5%) after the intervention;Percentage of subjects with weight loss greater than or equal to 10% after the intervention;Waist circumference changes from baseline;Hip circumference changes from baseline;Upper arm circumference changes from baseline;Thigh circumference changes from baseline;Fat-free mass changes from baseline;Total fat mass changes from baseline;Muscle mass changes from baseline;Body fat percentage (%) changes from baseline;Visceral fat area (cm2) changes from baseline;Basal metabolic rate (J/h·kg) changes from baseline;Triglyceride TG(mmol/L) changes from baseline;High-density lipoprotein cholesterol HDL-CH(mmol/L) changes from baseline;Low-density lipoprotein cholesterol LDL-CH(mmol/L) changes from baseline;Total cholesterol CHOL(mmol/L) changes from baseline;Apolipoprotein ApoA?, ApoB, ApoCII, ApoCIII, ApoE, ApoAII changes from baseline;Fasting blood glucose (mmol/L) changes from baseline;Insulin (uIU/ml) changes from baseline;HbA1c (%) changes from baseline;Leptin changes from baseline;Adiponectin ADP changes from baseline;Homocysteine changes from baseline;hypersensitive C-reactive protein hsCRP changes from baseline;16s RNA changes from baseline by microbial sequencing;Changes in the non-targeted metabolomics of the gut flora from baseline;Changes in the constipation Symptom Assessment Scale from baseline;Changes in the gastrointestinal symptom grading scale from baseline; | — |
Countries
China
Contacts
Public ContactHong Hua
The First Affilliated Hospital, Sun Yat-sen University
Outcome results
None listed