The Effect of Semaglutide on the Intestinal Flora in Obesity

Capital Medical University

Status: Not yet enrolling

Conditions: Obesity

Treatments: Drug: Semaglutide Injection

Study type: Observational

Funder types: Other

Identifiers

NCT07323134

2025-science-480

Details and patient eligibility

About

For obese individuals, semaglutide treatment was adopted. By using multi-omics techniques such as fecal metagenomic sequencing and based on in vitro strain screening platforms, the effects and specific mechanisms of semaglutide on the intestinal flora of obese patients were clarified.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 60 years old;
• BMI ≥ 30kg/m²;
• At least one self-reported history of unsuccessful lifestyle weight loss;
• Subjects who agree to participate in the project and sign the informed consent form.

Exclusion criteria

• Weight changes within 3 months prior to screening (self-reported) >5%;
• Having received any drug treatment for obesity within the three months prior to screening;
• The application of hypoglycemic drugs within 3 months before screening, or HbA1c≥ 6.5%, or a history of type 1 or type 2 diabetes;
• Participants who have received treatment with immunosuppressants, steroids, antidiarrheal drugs, antibiotics, probiotics, lipid-lowering drugs and/or other gastrointestinal motility drugs within 3 months prior to screening;
• Previously diagnosed overweight or obesity due to endocrine causes, such as Cushing's syndrome, etc;
• Triglycerides ≥500mg/dL (5.65mmol/L) during screening;
• It is known that there are clinically significant gastric emptying abnormalities (e.g., severe diabetic gastroparesis or gastric outlet obstruction), a history of gastrointestinal diseases and surgical history;
• Abnormal thyroid function;
• History of mental illness;
• History of multiple endocrine tumors or medullary thyroid cancer, family history, or calcitonin ≥6pg/mL;
• Abnormal liver function during screening, that is, alanine aminotransferase and/or aspartate aminotransferase > 3*ULN;
• Abnormal renal function during screening, that is, the estimated glomerular filtration rate is less than 60mL/min/1.75m2;
• History of cardiovascular diseases;
• History of malignant tumors;
• Pregnancy or lactation;
• As determined by the researcher, there are other physical, psychological or other conditions that make one unsuitable to participate in the trial.

Trial design