The Effect of Semaglutide on the Intestinal Flora in Obesity

NCT07323134 | Not Yet Recruiting

• 1 other identifier: 2025-science-480
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• The composition of the gut microbiota changes relative to the baseline

  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

Interventions

Semaglutide Injection DRUG

Semaglutide Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jia Liu

CONTACT

13810662843; liujiacy@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: January 7, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-07