Not yet recruiting NCT07323134
The Effect of Semaglutide on the Intestinal Flora in Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide Injection.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Semaglutide Injection
Semaglutide Injection
Primary outcome measures
- The composition of the gut microbiota changes relative to the baseline [Time frame: Baseline,4weeks,8weeks,12weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07323134 · 2025-science-480