Semaglutide's Weight Loss Effects in Obesity
ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeijing Chao Yang Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-60 years
BMI ≥ 30 kg/m²
At least one self-reported unsuccessful attempt at lifestyle weight loss
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide Subcutaneous Injection
DrugAll 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: SLR groupSham comparator 1 intervention
Group B: SHR groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Body weight
When 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.
Time frame
Weight changes will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatment2
Gut microbiota
Using 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.
Time frame
Gut microtioba will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatmentSecondary outcomes
1
Blood biochemical indicators
The study subjects were all in a fasting state. A professional nurse collected 1 tube of blood from the antecubital vein, and the blood sample was sent to the hospital's laboratory for testing on the same morning. The tests included complete blood count, fasting blood glucose, fasting insulin, glycated hemoglobin, serum triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, alanine aminotransferase (ALT), uric acid, creatinine, electrolytes, and other measurements. All tests were conducted using an automatic biochemical analyzer. Post-test blood was used to measure serum DPP4 concentration and GLP-1 activity, among others.
Time frame
Blood biochemical indicators will be measured at the following time points: before treatment, and at weeks 16 and 28 after treatment2
The blood concentration of semaglutide
At 24 weeks, all study subjects had one tube of blood collected from the antecubital vein in a fasting state by a professional nurse. After centrifugation, the plasma was collected and analyzed for semaglutide plasma drug concentration using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Time frame
concentration of semaglutide will be measured at weeks 24 after treatment3
BMI
Height (measured without shoes, accurate to 0.1 cm), weight (measured without shoes, hat, heavy clothing, and accessories, accurate to 0.1 kg), and Body Mass Index (BMI) are calculated after converting the height unit. BMI = weight / height² (kg/m²).
Time frame
BMI will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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