BridgeMD
New treatment option for Obesity
Official title Probiotic Intervention on Body Weight
ClinicalTrials.gov ID: NCT06989177
What this study is testing
What is semaglutide?
semaglutide is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a randomized controlled trial with 120 overweight or obese (body-mass index, BMI, ≥ 24 kg/m²) participants and 20 normal-weight participants. Twelve weeks of energy-restricted nutritional and lifestyle intervention with placebo, Lactobacillus paracasei LC-19 (LC-19), or semaglutide (a glucagon-like peptide-1 receptor agonist, GLP-1RA) will be randomly conducted in the overweight or obese participants.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Aged 20 to 50 years.
- Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) \< 24 kg/m².
- Overweight or obese participants: BMI ≥ 28 kg/m², or 24 kg/m² ≤ BMI \< 28 kg/m² and a clinical diagnosis meeting semaglutide treatment indications...
- Willingness to participate in this study and provide signed informed consent.
You likely can't join if
- Abnormal metabolic indicators (meeting any one of the following criteria is grounds for exclusion): 1\. Normal weight (18.5 kg/m² ≤ BMI \< 24 kg/m²):
- Waist circumference ≥ 90 cm for men or ≥ 85 cm for women.
- Fasting glucose ≥ 6.1 mmol/L or 2-hour postprandial glucose ≥ 7.8 mmol/L, or a confirmed diagnosis of diabetes.
- Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or currently under antihypertensive treatment.
- Fasting triglycerides (TG) ≥ 1.7 mmol/L; high-density lipoprotein cholesterol (HDL-C) \< 0.9 mmol/L in men or \< 1.0 mmol/L in women. 2\. Overweight...
- Fasting plasma glucose \> 11.1 mmol/L or HbA1c \> 9%, or previously diagnosed diabetes, or currently using insulin or any antidiabetic medication.
See the full eligibility criteria
- Aged 20 to 50 years.
- Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) \< 24 kg/m².
- Overweight or obese participants: BMI ≥ 28 kg/m², or 24 kg/m² ≤ BMI \< 28 kg/m² and a clinical diagnosis meeting semaglutide treatment indications (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver...
- Willingness to participate in this study and provide signed informed consent.
- Abnormal metabolic indicators (meeting any one of the following criteria is grounds for exclusion): 1\. Normal weight (18.5 kg/m² ≤ BMI \< 24 kg/m²):
- Waist circumference ≥ 90 cm for men or ≥ 85 cm for women.
- Fasting glucose ≥ 6.1 mmol/L or 2-hour postprandial glucose ≥ 7.8 mmol/L, or a confirmed diagnosis of diabetes.
- Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or currently under antihypertensive treatment.
- Fasting triglycerides (TG) ≥ 1.7 mmol/L; high-density lipoprotein cholesterol (HDL-C) \< 0.9 mmol/L in men or \< 1.0 mmol/L in women. 2\. Overweight or obese (BMI ≥ 24 kg/m²):
- Fasting plasma glucose \> 11.1 mmol/L or HbA1c \> 9%, or previously diagnosed diabetes, or currently using insulin or any antidiabetic medication.
- Blood pressure ≥ 160/100 mmHg, or clinically diagnosed stage 2 or stage 3 (moderate or severe) hypertension, or currently under antihypertensive treatment.
- Use of lipid-lowering drugs (e.g., fibrates, bile acid sequestrants, statins, PCSK9 inhibitors) within the past 3 months, or TG ≥ 5.7 mmol/L, or LDL ≥ 4.9 mmol/L.
- Pregnancy or lactation.
- Self-reported weight change of more than 5 kg within the 90 days prior to screening.
- Use of antibiotics, antimicrobials, or anti-inflammatory/analgesic salicylates (e.g., aspirin) within the 3 months prior to screening for 3 days or more.
- Use of estrogen therapy or other hormonal medications within the past 6 months.
- Use of GLP-1 receptor agonists or probiotics within the past 3 months.
- Heavy alcohol consumption (females \> 40 g/day, approximately 250 mL of huangjiu [yellow rice wine], or 1000 mL of beer, or 100 mL of liquor per day; males \> 80 g/day).
- Severe liver or kidney dysfunction (ALT, AST, or serum creatinine exceeding 3 times the upper limit of normal, UACR ≥ 30 mg/g, or eGFR \< 60 mL/min).
- Gastrointestinal diseases affecting digestion and absorption (e.g., severe diarrhea, severe constipation, severe inflammatory bowel disease, peptic ulcer, gallstones, cholecystitis).
- Underwent surgery within the past year (excluding appendectomy or hernia repair).
- Severe cardiovascular or cerebrovascular diseases (e.g., heart failure, myocardial infarction, stroke, acute myocarditis, severe arrhythmia, or receiving treatment therapy).
- Presence of metallic implants such as a cardiac stent or pacemaker.
- Cancer or having received radiation or chemotherapy within the past 5 years.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, or a personal history of hyperthyroidism or hypothyroidism.
- Chronic or acute pancreatitis.
- Positive hepatitis B surface antigen (HBsAg), active tuberculosis, HIV, or other infectious diseases.
- Currently participating in another clinical study or having done so within the past 3 months.
- Claustrophobia.
- Any psychiatric disorder such as attention-deficit/hyperactivity disorder (ADHD), bipolar disorder, or epilepsy (including current use of antiepileptic medications), or use of antidepressant medications.
- Inability to read, write, operate a smartphone, or perform daily activities independently.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.