The Effect of Semaglutide on the Intestinal Flora in Obesity

December 23, 2025 updated by: Beijing Chao Yang Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The composition of the gut microbiota changes relative to the baseline
Time Frame: Baseline,4weeks,8weeks,12weeks
The changes in the composition of the gut microbiota in obese individuals after 12 weeks of semaglutide treatment relative to the baseline (baseline is defined as the composition of the gut microbiota at the time of enrollment), including alterations in gut microbiota abundance and Shannon diversity index (α -diversity), etc.
Baseline,4weeks,8weeks,12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 13, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-science-480

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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