Opening soonNot applicableInterventional
What this study is about
This is a non-randomized, concurrent, parallel-controlled clinical trial. The objective of this trial is to determine the relationship between weight loss responsiveness to semaglutide in obese patients and their gut microbiota.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity
Full registry criteria
Inclusion Criteria: * Age 18-60 years * BMI ≥ 30 kg/m² * At least one self-reported unsuccessful attempt at lifestyle weight loss Exclusion Criteria: * Weight change (self-reported) \> 5% in the past 3 months prior to screening * Use of any medication for obesity indication in the past 3 months prior to screening. * Use of antidiabetic medications in the past 3 months, or HbA1c ≥ 6.5%, or a history of Type 1 or Type 2 diabetes. * Use of immunosuppressants, corticosteroids, antidiarrheal drugs, antibiotics, probiotics, lipid-lowering medications, and/or other gastrointestinal motility drugs in the past 3 months prior to screening. * A history of endocrine-related overweight or obesity diagnoses, such as Cushing's syndrome. * Triglycerides ≥ 500 mg/dL (5.65 mmol/L) at screening. * Known clinically significant gastric emptying abnormalities (e.g., severe diabetic gastroparesis or gastric outlet obstruction), gastrointestinal diseases, or surgical history. * Thyroid dysfunction. * History of mental illness. * History or family history of multiple endocrine neoplasia or medullary thyroid cancer, or calcitonin ≥ 6 pg/mL. * Abnormal liver function at screening, defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 3\*ULN. * Abnormal kidney function at screening, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.75m². * History of cardiovascular disease. * History of malignancy. * Pregnancy or breastfeeding. * Any other physiological, psychological, or other conditions deemed by the investigator as unsuitable for participation in the trial.
Treatments and study arms
Semaglutide Subcutaneous Injection
Drug
All subjects received subcutaneous injections of semaglutide over a 28-week treatment period, which included an initial 16-week dose-escalation phase. The escalation protocol began with a starting dose of 0.25 mg administered once weekly. Every 4 weeks, the dose was gradually increased in a stepwise manner to 0.5 mg, 1.0 mg, 1.7 mg, and finally 2.4 mg, each administered once weekly.
Primary outcomes
Body weightWeight changes will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatmentWhen measuring the subject's body weight, ensure shoes, hats, and heavy clothing or accessories are removed, and record the measurement to the nearest 0.1 kg.
Gut microbiotaGut microtioba will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatmentUsing metagenomic sequencing to assess changes in the composition and abundance of gut microbiota between two groups of subjects. By analyzing the metagenomic data, we will identify specific microbial taxa and functional genes that show significant variation between the groups. This approach will provide insights into the microbial diversity, stability, and metabolic capabilities of the gut microbiome.
Study locations
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No public site location was included in this record. Check the original registry for updates.