Metabolic Dysfunction-associated Fatty Liver CirrhosisPhase 4NCT07663643
Fuzheng Huayu Tablets for Metabolic Dysfunction-Associated Fatty Liver Cirrhosis (Compensated): A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study
A Phase 4 study testing Fuzheng Huayu Tablets in people with Metabolic Dysfunction-associated Fatty Liver Cirrhosis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Fuzheng Huayu Tablets in patients with metabolic dysfunction-associated fatty liver cirrhosis (compensated). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-associated Fatty Liver Cirrhosis
- What is being tested?
- Fuzheng Huayu Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 459 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2026to 2 Apr 2029
- Phase
- Phase 4
- 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
- Aged 18 to 75 years (inclusive of both upper and lower limits).
- Diagnosed with compensated metabolic dysfunction-associated fatty liver cirrhosis, meeting all three of the following conditions:
- At screening, FibroScan liver stiffness measurement (LSM) ≥ 20 kPa, OR LSM ≥ 15 kPa AND any one of the following: platelet count < 150×10⁹/L, or FIB-4 ≥ 3.48, or Agile4 ≥ 0.57; (2) Has a history of metabolic dysfunction or metabolic dysfunction-associated fatty liver disease (MAFLD); (3) Child-Turcotte-Pugh score < 7 and MELD score < 12. 3. Voluntarily participates in the clinical study and agrees to sign the informed consent form.
Who cannot join
- History or current hepatic decompensation events at screening, including but not limited to the following: a) Esophagogastric variceal bleeding; b) Hepatic ascites requiring diuretic treatment; c) Hepatic encephalopathy (West Haven grade 2 or above); d) Hepatorenal syndrome.
- Having a history or evidence of other chronic liver diseases, such as alcoholic liver disease, drug-induced liver disease, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis, history of biliary obstruction or biliary shunt, metastatic liver cancer; Hepatitis B (HBsAg positive); Hepatitis C (HCV antibody positive and HCV-RNA positive). Subjects with previous hepatitis C treatment must maintain negative HCV-RNA results for at least 3 years before screening to be eligible.
- History of liver transplantation, on the liver transplantation waiting list, or history of TIPS operation.
- Use of anti-obesity drugs within 3 months prior to screening and during the whole trial is prohibited, including bupropion-naltrexone, orlistat, phentermine, phentermine/topiramate and anti-obesity supplements. Subjects planning to receive metabolic bariatric surgery during the study will be excluded (excluding acupuncture weight loss, liposuction or abdominal lipectomy performed more than 1 year before screening).
- Type 1 diabetes mellitus; uncontrolled type 2 diabetes mellitus, defined as HbA1c > 9% at screening or within 60 days before randomization. Subjects with HbA1c > 9% may be re-screened once no less than 3 months after the initial screening failure; insulin dosage adjustment more than 20% within 60 days before randomization is also excluded.
- Unstable use of drugs that may affect efficacy evaluation within 3 months prior to screening, including but not limited to Vitamin E (dose > 400 IU/d), thiazolidinediones (TZDs), SGLT-2 inhibitors, GLP-1 receptor agonists, and chiglitazar. Those who have taken stable dosage continuously until screening visit and will maintain relatively stable dosage throughout the study period are allowed to enroll.
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- Use of drugs that may induce hepatic steatosis or steatohepatitis for at least 4 weeks within 6 months prior to screening (e.g., valproic acid, tamoxifen, methotrexate, amiodarone, long-term oral corticosteroids > 5 mg/d prednisone equivalent, or estrogen at doses higher than contraception or hormone replacement therapy). The above drugs are prohibited throughout the trial until the end of follow-up. Subjects requiring bronchodilators, topical, inhaled, nasal corticosteroids or caudal steroid injections are not excluded.
- Use of Chinese herbal medicine and proprietary Chinese medicines with anti-fibrotic or MAFLD therapeutic effects within 3 months prior to screening, including but not limited to Compound Biejia Ruangan Capsules, Anluo Huaxian Pills, Qianggan Capsules/Tablets. If the medication course is no more than 3 months, subjects can be enrolled after a 1-month washout period.
- Uncontrolled hypertension at screening, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.
- Occurrence of myocardial infarction, unstable angina, malignant arrhythmia, percutaneous coronary intervention, coronary artery bypass grafting, ischemic or hemorrhagic stroke, transient ischemic attack, acute peripheral vascular events within 6 months prior to screening.
- Active severe diseases or malignant tumors with a life expectancy of less than 5 years.
- Uncontrolled hypothyroidism or hyperthyroidism at screening (assessed by the investigator). Participants with hypothyroidism receiving stable-dose thyroid hormone replacement therapy for at least 2 months before screening can be enrolled.
- Abnormal laboratory indicators at screening: ALT > 5 × ULN, AST > 5 × ULN, ALP ≥ 2 × ULN (unless ALP elevation is non-hepatic origin), eGFR < 45 mL/min/1.73m², INR > 1.5 × ULN, total bilirubin > 1.5 × ULN (for participants with Gilbert syndrome, TBIL threshold ≥ 3 × ULN), ALB < 28 g/L.
- Thrombocytopenia caused by hematological diseases such as immune thrombocytopenic purpura, drug influence or active infection.
- Female subjects who are pregnant, breastfeeding or planning to become pregnant during the trial.
- Allergy to the investigational drug or its ingredients.
- Subjects who are expected to be unable to comply with the study protocol or fail to complete the trial as planned.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Fuzheng Huayu Tablets in Patients With Metabolic Dysfunction-Associated Fatty Liver Cirrhosis (Compensated): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study
This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Fuzheng Huayu Tablets in patients with metabolic dysfunction-associated fatty liver cirrhosis (compensated). Eligible patients will be randomly assigned to receive either Fuzheng Huayu Tablets or placebo for 72 weeks. The primary objective is to assess the improvement in liver fibrosis, measured by liver stiffness reduction via FibroScan. Secondary objectives include changes in liver function indicators, liver fibrosis markers, Child-Pugh score, and safety profile.
Read the detailed description
This study aims to enroll 459 eligible patients aged 18-75 years with compensated metabolic dysfunction-associated fatty liver cirrhosis. Patients will be randomized to the treatment group (Fuzheng Huayu Tablets, 4 tablets three times daily) or the control group (matching placebo, 4 tablets three times daily) for 72 weeks. The primary efficacy endpoint is the proportion of patients with ≥10% reduction in liver stiffness measurement (LSM) at Week 24 compared to baseline. Secondary endpoints include changes in liver function, fibrosis markers, Child-Pugh score, and adverse event incidence. All safety assessments will be performed throughout the study.
- Being tested
- Fuzheng Huayu Tablets
- Keywords
- Metabolic dysfunction-associated fatty liver cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzheng Huayu TabletsDrug
Test group: Fuzheng Huayu Tablets, 4 tablets each time, 3 times daily, orally administered.
Control group: Fuzheng Huayu Tablets placebo, 4 tablets each time, 3 times daily, orally administered.
| Study group | Role | What they receive |
|---|---|---|
| Fuzheng Huayu Tablets Group | Experimental | Oral administration, 4 tablets three times daily, for 72 consecutive weeks Receives: Drug: Fuzheng Huayu Tablets |
| Placebo Group | Placebo comparator | Oral administration, 4 tablets three times daily, for 72 consecutive weeks Receives: Drug: Fuzheng Huayu Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients with ≥20% Reduction in Liver Stiffness Measurement (LSM) at Week 72 Compared to Baseline
Proportion of Patients with ≥20% Reduction in Liver Stiffness Measurement (LSM) at Week 72 Compared to Baseline
Measured: Week 72
Proportion of Patients with ≥20% Reduction in Liver Stiffness Measurement (LSM) at Week 72 Compared to Baselin
he primary efficacy endpoint is the proportion of patients with a ≥20% reduction in liver stiffness measurement (LSM) at Week 72 compared to baseline, as assessed by FibroScan.
Measured: week72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start25 May 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion2 Apr 2029 (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 Fatty Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the Fuzheng Huayu Tablets group or the placebo group in a 1:1 ratio. Both groups will receive the assigned treatment for 72 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 459 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiangao Fan, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663643
- Sponsor's protocol ID
- FZHY-V1.1
- Other IDs
- FZHY-V1.1
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fuzheng Huayu Tablets in Patients With Metabolic Dysfunction-Associated Fatty Liver Cirrhosis (Compensated): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07663643
- Acronym / sponsor ID
- FZHY-V1.1
- Keywords
- Metabolic dysfunction-associated fatty liver cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 459 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 2 Apr 2029 (estimated)
- First posted
- 23 Jun 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.
This is a multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Fuzheng Huayu Tablets in patients with metabolic dysfunction-associated fatty liver cirrhosis (compensated). Eligible patients will be randomly assigned to receive either Fuzheng Huayu Tablets or placebo for 72 weeks. The primary objective is to assess the improvement in liver fibrosis, measured by liver stiffness reduction via FibroScan. Secondary objectives include changes in liver function indicators, liver fibrosis markers, Child-Pugh score, and safety profile.
Detailed description
This study aims to enroll 459 eligible patients aged 18-75 years with compensated metabolic dysfunction-associated fatty liver cirrhosis. Patients will be randomized to the treatment group (Fuzheng Huayu Tablets, 4 tablets three times daily) or the control group (matching placebo, 4 tablets three times daily) for 72 weeks. The primary efficacy endpoint is the proportion of patients with ≥10% reduction in liver stiffness measurement (LSM) at Week 24 compared to baseline. Secondary endpoints include changes in liver function, fibrosis markers, Child-Pugh score, and adverse event incidence. All safety assessments will be performed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the Fuzheng Huayu Tablets group or the placebo group in a 1:1 ratio. Both groups will receive the assigned treatment for 72 weeks.
| Arm | Type | Receives |
|---|---|---|
| Fuzheng Huayu Tablets Group | Experimental | Drug: Fuzheng Huayu TabletsOral administration, 4 tablets three times daily, for 72 consecutive weeks |
| Placebo Group | Placebo comparator | Drug: Fuzheng Huayu TabletsOral administration, 4 tablets three times daily, for 72 consecutive weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 75 years (inclusive of both upper and lower limits).
- Diagnosed with compensated metabolic dysfunction-associated fatty liver cirrhosis, meeting all three of the following conditions:
- At screening, FibroScan liver stiffness measurement (LSM) ≥ 20 kPa, OR LSM ≥ 15 kPa AND any one of the following: platelet count < 150×10⁹/L, or FIB-4 ≥ 3.48, or Agile4 ≥ 0.57; (2) Has a history of metabolic dysfunction or metabolic dysfunction-associated fatty liver disease (MAFLD); (3) Child-Turcotte-Pugh score < 7 and MELD score < 12. 3. Voluntarily participates in the clinical study and agrees to sign the informed consent form.
Key exclusion criteria (17 listed)
- History or current hepatic decompensation events at screening, including but not limited to the following: a) Esophagogastric variceal bleeding; b) Hepatic ascites requiring diuretic treatment; c) Hepatic encephalopathy (West Haven grade 2 or above); d) Hepatorenal syndrome.
- Having a history or evidence of other chronic liver diseases, such as alcoholic liver disease, drug-induced liver disease, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis, history of biliary obstruction or biliary shunt, metastatic liver cancer; Hepatitis B (HBsAg positive); Hepatitis C (HCV antibody positive and HCV-RNA positive). Subjects with previous hepatitis C treatment must maintain negative HCV-RNA results for at least 3 years before screening to be eligible.
- History of liver transplantation, on the liver transplantation waiting list, or history of TIPS operation.
- Use of anti-obesity drugs within 3 months prior to screening and during the whole trial is prohibited, including bupropion-naltrexone, orlistat, phentermine, phentermine/topiramate and anti-obesity supplements. Subjects planning to receive metabolic bariatric surgery during the study will be excluded (excluding acupuncture weight loss, liposuction or abdominal lipectomy performed more than 1 year before screening).
- Type 1 diabetes mellitus; uncontrolled type 2 diabetes mellitus, defined as HbA1c > 9% at screening or within 60 days before randomization. Subjects with HbA1c > 9% may be re-screened once no less than 3 months after the initial screening failure; insulin dosage adjustment more than 20% within 60 days before randomization is also excluded.
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 |
|---|---|---|
| Fuzheng Huayu TabletsTest group: Fuzheng Huayu Tablets, 4 tablets each time, 3 times daily, orally administered. Control group: Fuzheng Huayu Tablets placebo, 4 tablets each time, 3 times daily, orally administered. | Drug | Fuzheng Huayu Tablets Group, Placebo Group |
Primary outcome
Proportion of Patients with ≥20% Reduction in Liver Stiffness Measurement (LSM) at Week 72 Compared to Baseline
Time frame: Week 72
Proportion of Patients with ≥20% Reduction in Liver Stiffness Measurement (LSM) at Week 72 Compared to Baseline
Proportion of Patients with ≥20% Reduction in Liver Stiffness Measurement (LSM) at Week 72 Compared to Baselin
Time frame: week72
he primary efficacy endpoint is the proportion of patients with a ≥20% reduction in liver stiffness measurement (LSM) at Week 72 compared to baseline, as assessed by FibroScan.
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fuzheng Huayu Tablets in people with Metabolic Dysfunction-associated Fatty Liver Cirrhosis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 3 inclusion and 17 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: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Fanjian Gao, MD (13818868519, fattyliver2004@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with ≥20% Reduction in Liver Stiffness Measurement (LSM) at Week 72 Compared to Baseline (time frame: Week 72). The study lists 2 primary outcomes in all. 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 23 Jun 2026.