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Not yet recruiting

The Effect of Semaglutide on the Intestinal Flora in Obesity

Asset

Semaglutide

GLP-1 agonist

Listed sites

0

Recruiting sites

Enrollment

40

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoint

Composition of the gut microbiota changes

Identifiers

Registered as

NCT IDNCT07323134
Org study ID2025-science-480

Timeline

Milestones

Study first posted2026-01-07actual
Last update posted2026-01-07actual
Study start2026-02-01estimated
Primary completion2026-08-01estimated
Study completion2026-08-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted
Sampling methodProbability sample

Study population text

Obese patients who visited the Department of Endocrinology of Beijing Chaoyang Hospital Affiliated to Capital Medical University

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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

The composition of the gut microbiota changes relative to the baseline

Time frame:Baseline,4weeks,8weeks,12weeks

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.