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Tests treatment safety and results for Metabolic Dysfunction-Associated Steatotic Liver Disease
Official title Efficacy and Safety of Rifaximin-α in Treating MASLD
ClinicalTrials.gov ID: NCT07381257
What this study is testing
What is Rifaximin-α (Alfa Wassermann S.p.A., Italy)?
Rifaximin-α (Alfa Wassermann S.p.A., Italy) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metabolic dysfunction-associated steatotic liver disease.
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
- Study Objective: To evaluate the efficacy and safety of Rifaximin-α in the treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), and investigate the underlying mechanisms by which Rifaximin-α influences MASLD progression. Target Population: Patients diagnosed with MASLD.
- Phase 1: an early, usually small safety study
- Which group you join is 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 18 to 75
You may be able to join if
- Willingness to provide written informed consent.
- Aged 18 to 75 years, inclusive, regardless of gender.
- Diagnosis of hepatic steatosis (fatty liver) within the past 6 months.
- Presence of at least one metabolic/cardiovascular risk factor: A. BMI ≥ 23.0 kg/m², or waist circumference ≥ 90 cm (male) / 80 cm (female). B...
- Liver fat content ≥ 8% as measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF).
You likely can't join if
- Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, and/or liver biopsy findings.
- Evidence of other specific etiologies of chronic liver disease confirmed by history or laboratory tests, including but not limited to: viral...
- Other identifiable causes of hepatic steatosis confirmed by history or laboratory tests, such as: specific medications (e.g., tamoxifen, amiodarone...
- Use of medications known to alter gut microbiota (e.g., lactulose, systemic antibiotics, any intestinal microecological preparations) within 4 weeks...
- Dose of hepatoprotective or lipid-lowering medications not stabilized for at least 4 weeks prior to screening.
- Received any Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or remeglutide treatment within 12 weeks prior to screening, or plans to receive...
See the full eligibility criteria
- Willingness to provide written informed consent.
- Aged 18 to 75 years, inclusive, regardless of gender.
- Diagnosis of hepatic steatosis (fatty liver) within the past 6 months.
- Presence of at least one metabolic/cardiovascular risk factor: A. BMI ≥ 23.0 kg/m², or waist circumference ≥ 90 cm (male) / 80 cm (female). B. Fasting plasma glucose (FPG) ≥ 5.6 mmol/L, or 2-hour postprandial glucose ≥...
- Liver fat content ≥ 8% as measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF).
- Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, and/or liver biopsy findings.
- Evidence of other specific etiologies of chronic liver disease confirmed by history or laboratory tests, including but not limited to: viral hepatitis (B or C, etc.), autoimmune liver disease, alcohol-related liver...
- Other identifiable causes of hepatic steatosis confirmed by history or laboratory tests, such as: specific medications (e.g., tamoxifen, amiodarone, valproate, methotrexate, glucocorticoids, olanzapine), total...
- Use of medications known to alter gut microbiota (e.g., lactulose, systemic antibiotics, any intestinal microecological preparations) within 4 weeks prior to screening.
- Dose of hepatoprotective or lipid-lowering medications not stabilized for at least 4 weeks prior to screening.
- Received any Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or remeglutide treatment within 12 weeks prior to screening, or plans to receive such treatment during the study.
- Dose of medications that may affect MASLD, anti-diabetic agents (excluding GLP-1 RAs and remeglutide), or weight-loss drugs not stabilized for at least 12 weeks prior to screening.
- Self-reported weight change \>5% within 4 weeks prior to screening.
- BMI \> 35 kg/m².
- Poorly controlled glycemia: HbA1c \> 9%.
- Total bilirubin \> 1.5 mg/dL (except with normal direct bilirubin), or Alanine Aminotransferase (ALT) \> 5 times the Upper Limit of Normal (ULN), or Aspartate Aminotransferase (AST) \> 5 times ULN, or Alkaline...
- Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m².
- History of or planned bariatric/metabolic therapy, including but not limited to endoscopic interventions, surgical procedures, or Traditional Chinese Medicine therapies. Exceptions may be made if previous interventions...
- History of or current hepatocellular carcinoma (HCC).
- Diagnosis of any malignancy within the past 5 years, except for malignancies with low risk of metastasis or death (estimated 5-year overall survival \>90%), such as effectively treated early-stage gastrointestinal...
- Significant comorbid conditions affecting the cardiovascular, respiratory, rheumatological/immunological, hematological, biliary, or pancreatic systems; or history of myocardial infarction, stroke, heart failure...
- HIV infection.
- Known allergy or hypersensitivity to rifaximin.
- Contraindications to MRI, such as incompatible metallic implants, claustrophobia, or body size exceeding scanner capacity.
- Pregnant or lactating women, women of childbearing potential not using effective contraception, or individuals planning pregnancy.
- Participation in another investigational drug trial within 3 months prior to screening.
- Any other condition deemed by the investigator to be unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.