Metabolic Dysfunction-Associated Steatotic Liver DiseaseEarly Phase 1NCT07381257
Efficacy and Safety of Rifaximin-α in Treating MASLD
A Early Phase 1 study testing Rifaximin-α (Alfa Wassermann S.p.A., Italy) in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Rifaximin-α (Alfa Wassermann S.p.A., Italy)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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 ≥ 7.8 mmol/L, or HbA1c ≥ 5.7%, or documented history of type 2 diabetes mellitus (T2DM) or current use of anti-diabetic medication.
- Fasting serum triglycerides (TG) ≥ 1.70 mmol/L, or current use of medication for hypertriglyceridemia.
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- Serum high-density lipoprotein (HDL) cholesterol ≤ 1.0 mmol/L (male) and ≤ 1.3 mmol/L (female), or current use of lipid-lowering medication.
- Blood pressure ≥ 130/85 mmHg, or current use of antihypertensive medication.
- Liver fat content ≥ 8% as measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF).
Who cannot join
- 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 disease (defined as >20 g/day for females or >30 g/day for males), drug-induced liver injury, Wilson's disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis.
- 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 parenteral nutrition, hypothyroidism, inflammatory bowel disease, Cushing's syndrome, celiac disease, abetalipoproteinemia, lipodystrophic diabetes, Mauriac syndrome, hypopituitarism, hypogonadism, polycystic ovary syndrome, etc.
- 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.
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- 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 Phosphatase (ALP) > 2 times ULN.
- 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 have been reversed or removed (e.g., intragastric balloon, subcutaneous threads) for more than 12 weeks.
- 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 cancer, carcinoma in situ of the cervix, non-melanoma skin cancer, or localized prostate cancer.
- Significant comorbid conditions affecting the cardiovascular, respiratory, rheumatological/immunological, hematological, biliary, or pancreatic systems; or history of myocardial infarction, stroke, heart failure, unstable angina, or transient ischemic attack within 6 months prior to screening; or presence of psychiatric disorders.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changzheng Hospital, Naval Medical University, shanghai, China
Shanghai
Chuan Yin, 13482705212, ilse1225@163.com
About this study
Official title: Efficacy and Safety of Rifaximin-α in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized, Open-Label, Controlled Pilot Clinical Trial
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. Intervention: This trial is a multicenter, prospective, randomized, controlled study. Enrolled MASLD patients who meet the inclusion criteria, do not meet any exclusion criteria, and provide written informed consent will be randomized in a 2:1 ratio to the Rifaximin-α treatment group (40 cases) or the control group (20 cases). All patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). The Rifaximin-α treatment group will receive oral Rifaximin-α at a dose of 1200 mg per day for 24 weeks. Both groups of patients will enter a 24-week follow-up period after completing the 24-week treatment. During the study, patients' existing foundational treatments (such as liver-protecting, lipid-lowering, glucose-lowering, and antihypertensive therapies) will be maintained. Relevant indicators will be closely monitored. And avoid the use of medications known to alter the gut microbiota, such as lactulose, antibiotics, and various types of intestinal microecological preparations.
Investigational Drug: Rifaximin-α (Alfa Wassermann S.p.A., Italy).
- Being tested
- Rifaximin-α (Alfa Wassermann S.p.A., Italy)
- Keywords
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Rifaximin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin-α (Alfa Wassermann S.p.A., Italy)Drug
Participants in the treatment group will receive oral Rifaximin-α at a dosage of 1200 mg/day (400 mg, three times daily) for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). |
| Treatmnet group | Experimental | The Rifaximin treatment group will receive oral Rifaximin-α at a dose of 1200 mg per day for 24 weeks. And patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). Receives: Drug: Rifaximin-α (Alfa Wassermann S.p.A., Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative change in liver fat content measured by MRI from baseline to 24 weeks.
The relative changes in MRI-measured liver proton density fat fraction (PDFF) at 24 weeks compared to baseline.
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (24)
The absolute change in liver fat content measured by MRI from baseline to 24 weeks.
Absolute changes in MRI-measured liver proton density fat fraction (PDFF) at 24 weeks compared to baseline.
Measured: From enrollment to the end of treatment at 24 weeks
Proportion of patients achieving ≥30% reduction in liver fat content measured by MRI-PDFF at 24 weeks of treatment compared to baseline
Proportion of patients achieving ≥30% reduction in liver fat content measured by MRI-PDFF at 24 weeks of treatment compared to baseline
Measured: From enrollment to the end of treatment at 24 weeks
The change in liver fat content measured by MRI-PDFF at 12 weeks of treatment
Absolute and relative changes in MRI-measured liver PDFF at 12 weeks compared to baseline.
Measured: From enrollment to the end of treatment at 12 weeks
Proportion of patients achieving ≥30% reduction in liver fat content (PDFF) measured by MRI at 12 weeks of treatment compared to baseline.
The proportion of patients whose liver fat content (PDFF), assessed via MRI, decreased by ≥30% from baseline after 12 weeks of treatment.
Measured: From enrollment to the end of treatment at 12 weeks
Changes in serum alanine aminotransferase levels after 12 and 24 weeks of treatment compared to baseline.
Changes in serum ALT levels from baseline after 12 and 24 weeks of treatment
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in serum aspartate aminotransferase levels after 12 and 24 weeks of treatment compared to baseline.
Changes in serum AST levels from baseline after 12 and 24 weeks of treatment
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in serum Gamma-Glutamyl Transferase levels after 12 and 24 weeks of treatment compared to baseline.
Changes in serum GGT levels from baseline after 12 and 24 weeks of treatment
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in serum Alkaline Phosphatase levels after 12 and 24 weeks of treatment compared to baseline
Changes in serum AKP levels from baseline after 12 and 24 weeks of treatment
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Change in liver fat content assessed via FibroScan after 12 and 24 weeks of treatment compared to baseline.
Change in controlled attenuation parameter (CAP) values, measured by FibroScan, from baseline after 12 and 24 weeks of therapy
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in fatty liver index (FLI) after 12 and 24 weeks of treatment compared to baseline.
FLI is utilized to assess the severity of hepatic steatosis and is calculated using the following formula: FLI = (e^(0.953 * ln(triglycerides) + 0.139 * BMI + 0.718 * ln(ggt) + 0.053 * waist circumference - 15.745)) / (1 + e^(0.953 * ln(triglycerides) + 0.139 * BMI + 0.718 * ln(ggt) + 0.053 * waist circumference - 15.745)) * 100. Interpretation: A FLI value below 30 can be used to rule out steatosis (sensitivity = 87%; negative likelihood ratio [LR-] = 0.2), while a FLI value equal to or above 60 can be used to rule in hepatic steatosis.
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in NAFLD-liver fatty score（NAFLD-LFS）after 12 and 24 weeks of treatment compared to baseline.
NAFLD-LFS Calculation Formula: NAFLD-LFS = -2.89 + 0.45 × Type 2 Diabetes (yes=2, no=0) + 1.18 × Metabolic Syndrome (yes=1, no=0) + 0.15 × Insulin (mU/L) + 0.04 × AST (U/L) - 0.94 × (AST/ALT Ratio).
Interpretation of Scores:
NAFLD-LFS < -1.0: Suggests low liver fat content and a low likelihood of significant steatosis. -1.0 ≤ NAFLD-LFS ≤ 0.5: Intermediate range; further evaluation with additional tests (e.g., imaging or biopsy) is recommended. NAFLD-LFS > 0.5: Indicates high liver fat content and the presence of significant steatosis, requiring clinical intervention.
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in AST-to-Platelet Ratio Index (APRI) after 12 and 24 weeks of treatment compared to baseline.
APRI is calculated using the following formula:
APRI = [ (AST Level (U/L) / AST ULN (Upper Limit of Normal)) / Platelet Count (10⁹/L) ] × 100.
Interpretation:
APRI < 0.5: Suggests the absence of significant fibrosis (high negative predictive value). APRI > 2.0: Highly indicative of cirrhosis (high positive predictive value). Intermediate values (0.5 ≤ APRI ≤ 2.0): Further evaluation with additional tests-such as liver elastography, FIB-4 index, or liver biopsy-is recommended for accurate assessment.
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in Fibrosis 4 (FIB-4) Score after 12 and 24 weeks of treatment
The FIB-4 index is primarily used to stratify the risk of liver fibrosis and is calculated using the following formula: FIB-4= Age (years) × AST (U/L)/ [Platelet Count (10⁹/L)×√ALT(U/L)]. The criteria are categorized as follows: Low Risk (FIB-4 < 1.3) suggests minimal or no fibrosis (F0-F1). Liver biopsy or elastography may be deferred in such cases. Intermediate Risk (1.3 ≤ FIB-4 ≤ 2.67): Further evaluation with additional tests-such as liver elastography, APRI, or liver biopsy-is recommended. Significant fibrosis (F2-F3) may be present, warranting closer monitoring. High Risk (FIB-4 > 2.67): Highly suggestive of advanced fibrosis or cirrhosis (F3-F4). Confirmatory tests like elastography or liver biopsy should be prioritized. This range has a high positive predictive value.
Measured: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in NAFLD fibrosis score (NFS) after 12 and 24 weeks of treatment compared to baseline.
NFS calculation formula: NFS= [-1.675+0.037×Age (years)+0.094×BMI （kg/m2+1.13×IFG/Diabetes (yes = 1, no = 0) +0.99）× (AST/ALT Ratio)
+0.013×PLT(×109/L)-0.66×ALB（g/dl）].
Interpretation Guidelines:
NFS < -1.455: Low probability of significant fibrosis (F2-F4). NFS > 0.676: High probability of advanced fibrosis (F3-F4). NFS between -1.455 and 0.676: Indeterminate range; further evaluation with additional tests (e.g., elastography or liver biopsy) is recommended.
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in FibroScan-AST (FAST) Score after 12 and 24 weeks of treatment compared to baseline.
The FAST Score is a non-invasive composite index used to assess the likelihood of both significant fibrosis (≥F2) and active steatohepatitis (NASH) in patients withMASLD. It integrates Liver Stiffness Measurement (LSM) obtained via FibroScan® and the serum biomarker AST. FAST Score Calculation Formula: FAST = e^(-1.65 + 1.07 × ln(LSM) + 2.66 × 10^(-8) × AST^3 - 63.3 × AST^(-1) - 0.009 × PLT) / (1 + e^(-1.65 + 1.07 × ln(LSM)
+ 2.66 × 10^(-8) × AST^3 - 63.3 × AST^(-1) - 0.009 × PLT)). Interpretation Guidelines: FAST < 0.35: Low probability of significant fibrosis (≥F2) with active inflammation (NASH). Negative predictive value >90%. Liver biopsy may be avoided. FAST > 0.67: High probability of both significant fibrosis (≥F2) and active inflammation (NASH). Positive predictive value >70%. Further evaluation or intervention is recommended. FAST between 0.35-0.67: Gray zone; comprehensive assessment with additional methods.
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in Body Mass Index (BMI) at 12 and 24 weeks of treatment compared to baseline.
BMI calculation Formula:
BMI = Weight (kilograms) ÷ [Height (meters)]²
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in Waist circumference (WC) at 12 and 24 weeks of treatment compared to baseline.
Waist circumference (WC) is measured 3 cm above the navel.
Measured: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in visceral adipose tissue (VAT) at 12 and 24 weeks of treatment compared to baseline. [
VAT was quantified using 3D Slicer software by manually segmenting regions of interest (ROIs) within the intra-abdominal cavity on MRI images at the level of the third lumbar vertebra (L3).
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in abdominal subcutaneous adipose tissue (ASAT) from baseline after 12 and 24 weeks of therapy
ASAT volume was quantified using 3D Slicer software by manually segmenting regions of interest (ROIs) within the subcutaneous fat compartment on MRI images at the level of the third lumbar vertebra (L3).
Measured: From enrollment to the end of treatment at 12 and 24 weeks
Changes in Cholesterol from baseline after 12 and 24 weeks of therapy.
Cholesterol testing should be performed in the morning after an overnight fast.
Measured: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in triglyceride from baseline after 12 and 24 weeks of therapy.
Triglyceride testing should be performed in the morning after an overnight fast.
Measured: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in Hemoglobin A1c (HbA1c) from baseline after 12 and 24 weeks of therapy.
Change from baseline in HbA1c absolute concentration (mmol/mol) and percentage of total hemoglobin (%) after 12 and 24 weeks of therapy.
Measured: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline after 12 and 24 weeks of therapy.
HOMA-IR Calculation Formula: HOMA-IR = [Fasting Insulin (μIU/mL) × Fasting Glucose (mmol/L)] / 22.5. Increase in HOMA-IR suggests worsening insulin resistance. Decrease in HOMA-IR indicates improved insulin sensitivity.
Measured: From enrollment to the end of treatment at 12 and 24 weeks
The frequency and severity of treatment-related adverse events (AEs) as assessed by CTCAE 5.0.
The safety assessment involved monitoring changes in symptoms, vital signs, and laboratory parameters during treatment.
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start15 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled MASLD patients will be randomized in a 2:1 ratio to the rifaximin-α treatment group (40 cases) or the control group (20 cases). All patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). The Rifaximin treatment group will receive oral Rifaximin-α at a dose of 1200 mg per day for 24 weeks.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Fen Xie, Shanghai Changzheng Hospital
- Investigators
- Wei Fen Xie, Director, Principal investigator, Department of Gastroenterology, Changzheng Hospital, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381257
- Sponsor's protocol ID
- CZXH2025010.10
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rifaximin-α in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized, Open-Label, Controlled Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT07381257
- Acronym / sponsor ID
- CZXH2025010.10
- Keywords
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Rifaximin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Intervention: This trial is a multicenter, prospective, randomized, controlled study. Enrolled MASLD patients who meet the inclusion criteria, do not meet any exclusion criteria, and provide written informed consent will be randomized in a 2:1 ratio to the Rifaximin-α treatment group (40 cases) or the control group (20 cases). All patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). The Rifaximin-α treatment group will receive oral Rifaximin-α at a dose of 1200 mg per day for 24 weeks. Both groups of patients will enter a 24-week follow-up period after completing the 24-week treatment. During the study, patients' existing foundational treatments (such as liver-protecting, lipid-lowering, glucose-lowering, and antihypertensive therapies) will be maintained. Relevant indicators will be closely monitored. And avoid the use of medications known to alter the gut microbiota, such as lactulose, antibiotics, and various types of intestinal microecological preparations.
Investigational Drug: Rifaximin-α (Alfa Wassermann S.p.A., Italy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled MASLD patients will be randomized in a 2:1 ratio to the rifaximin-α treatment group (40 cases) or the control group (20 cases). All patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). The Rifaximin treatment group will receive oral Rifaximin-α at a dose of 1200 mg per day for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). |
| Treatmnet group | Experimental | Drug: Rifaximin-α (Alfa Wassermann S.p.A., Italy)The Rifaximin treatment group will receive oral Rifaximin-α at a dose of 1200 mg per day for 24 weeks. And patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Liver fat content ≥ 8% as measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF).
Key exclusion criteria (22 listed)
- 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 disease (defined as >20 g/day for females or >30 g/day for males), drug-induced liver injury, Wilson's disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis.
- 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 parenteral nutrition, hypothyroidism, inflammatory bowel disease, Cushing's syndrome, celiac disease, abetalipoproteinemia, lipodystrophic diabetes, Mauriac syndrome, hypopituitarism, hypogonadism, polycystic ovary syndrome, etc.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin-α (Alfa Wassermann S.p.A., Italy)Participants in the treatment group will receive oral Rifaximin-α at a dosage of 1200 mg/day (400 mg, three times daily) for 24 weeks. | Drug | Treatmnet group |
Primary outcome
The relative change in liver fat content measured by MRI from baseline to 24 weeks.
Time frame: From enrollment to the end of treatment at 24 weeks
The relative changes in MRI-measured liver proton density fat fraction (PDFF) at 24 weeks compared to baseline.
24 secondary outcomes
The absolute change in liver fat content measured by MRI from baseline to 24 weeks.
Time frame: From enrollment to the end of treatment at 24 weeks
Proportion of patients achieving ≥30% reduction in liver fat content measured by MRI-PDFF at 24 weeks of treatment compared to baseline
Time frame: From enrollment to the end of treatment at 24 weeks
The change in liver fat content measured by MRI-PDFF at 12 weeks of treatment
Time frame: From enrollment to the end of treatment at 12 weeks
Proportion of patients achieving ≥30% reduction in liver fat content (PDFF) measured by MRI at 12 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 weeks
Changes in serum alanine aminotransferase levels after 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in serum aspartate aminotransferase levels after 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in serum Gamma-Glutamyl Transferase levels after 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in serum Alkaline Phosphatase levels after 12 and 24 weeks of treatment compared to baseline
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Change in liver fat content assessed via FibroScan after 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in fatty liver index (FLI) after 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in NAFLD-liver fatty score（NAFLD-LFS）after 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in AST-to-Platelet Ratio Index (APRI) after 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in Fibrosis 4 (FIB-4) Score after 12 and 24 weeks of treatment
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in NAFLD fibrosis score (NFS) after 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in FibroScan-AST (FAST) Score after 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in Body Mass Index (BMI) at 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in Waist circumference (WC) at 12 and 24 weeks of treatment compared to baseline.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in visceral adipose tissue (VAT) at 12 and 24 weeks of treatment compared to baseline. [
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in abdominal subcutaneous adipose tissue (ASAT) from baseline after 12 and 24 weeks of therapy
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
Changes in Cholesterol from baseline after 12 and 24 weeks of therapy.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in triglyceride from baseline after 12 and 24 weeks of therapy.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in Hemoglobin A1c (HbA1c) from baseline after 12 and 24 weeks of therapy.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks.
Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline after 12 and 24 weeks of therapy.
Time frame: From enrollment to the end of treatment at 12 and 24 weeks
The frequency and severity of treatment-related adverse events (AEs) as assessed by CTCAE 5.0.
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Enrolling by invitation
Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Fen Xie, Director principal investigator
Department of Gastroenterology, Changzheng Hospital, Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rifaximin-α (Alfa Wassermann S.p.A., Italy) in people with Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHUAN YIN, M.D. (+8613482705212, ilse1225@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative change in liver fat content measured by MRI from baseline to 24 weeks. (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.