[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mafld\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mafld":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,73,98,121,143,165,189,212,247,269],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100645204","phase-1-dihydroartemisinin-for-mafld-100645204",false,"NCT07679542","Dihydroartemisinin for MAFLD","A Single-Arm, Proof-of-Concept Study of Dihydroartemisinin in Adults With Metabolic Associated Fatty Liver Disease","Inclusion Criteria:\n\nAged 18-45 years (inclusive), any gender.\n\nMeets the diagnostic criteria for Metabolic Associated Fatty Liver Disease (MAFLD), requiring both of the following:\n\nEvidence of hepatic steatosis (at least one of the following):\n\nImaging: Ultrasound, CT, or MRI-PDFF showing liver fat content ≥5%.\n\nLiver biopsy: Histologically confirmed steatosis ≥5% (within 6 months prior to enrollment).\n\nFibroScan: Controlled Attenuation Parameter (CAP) ≥248 dB\u002Fm.\n\nEvidence of metabolic dysfunction (at least one of the following):\n\nOverweight\u002FObesity: BMI ≥24 kg\u002Fm² or waist circumference ≥90 cm (male) \u002F ≥85 cm (female).\n\nElevated blood pressure\u002FHypertension: Blood pressure ≥130\u002F85 mmHg, or on antihypertensive medication.\n\nPre-diabetes or Type 2 Diabetes: Fasting blood glucose ≥6.1 mmol\u002FL, or 2-hour post-load glucose ≥7.8 mmol\u002FL, or HbA1c ≥5.7%, or history of T2DM, or HOMA-IR ≥2.5.\n\nElevated blood triglycerides: Fasting serum TG ≥1.70 mmol\u002FL, or on lipid-lowering medication.\n\nReduced HDL-cholesterol: Serum HDL ≤1.0 mmol\u002FL (male) \u002F ≤1.3 mmol\u002FL (female), or on lipid-lowering medication.\n\nParticipants on glucose-, blood pressure-, or lipid-lowering medications must have been on a stable dose for at least 3 months prior to screening.\n\nAll participants must have stable body weight (defined as weight loss or gain not exceeding 5% within 3 months prior to screening and from screening to enrollment).\n\nVoluntary participation, willingness to cooperate with follow-up, and signed informed consent.\n\nExclusion Criteria:\n\nLiver function impairment (defined as any one of ALT, AST, GGT, ALP exceeding 2 times the upper limit of normal (ULN) and\u002For bilirubin exceeding 1.5 times ULN).\n\nLong-term use (exceeding 2 weeks) of drugs known to cause hepatic steatosis or fibrosis (e.g., glucocorticoids, valproate, methotrexate, tamoxifen, amiodarone, oral vitamin E) within the past year.\n\nExcessive alcohol consumption: weekly ethanol intake ≥210 g (male) or ≥140 g (female).\n\nPositive for Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCV-Ab).\n\nSpecific liver diseases that can cause fatty liver (e.g., autoimmune hepatitis, Wilson's disease) or other specific conditions (e.g., total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, abetalipoproteinemia, lipodystrophic diabetes, Mauriac syndrome).\n\nHistory of leukopenia or agranulocytosis.\n\nHistory of bariatric surgery within the past 2 years.\n\nPregnant, planning pregnancy, or lactating women.\n\nHistory of malignancy, cardiovascular disease, chronic kidney disease, decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome), or liver transplantation.\n\nUse of any category of antibiotics within 2 weeks prior to enrollment.\n\nConsidered by the clinical investigator to be unsuitable for participation in the study.","ALL","18 Years","45 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Brief Summary\n\nPurpose:\n\nThis is a proof-of-concept clinical trial to evaluate whether Dihydroartemisinin (DHA), a medication commonly used to treat malaria, can effectively reduce liver fat in adults with Metabolic Associated Fatty Liver Disease (MAFLD). The study will also rigorously assess the safety and tolerability of DHA in this specific patient population.\n\nStudy Design:\n\nThis is a single-center, open-label, single-arm study. All qualified participants will receive the investigational treatment, with each individual serving as their own baseline control to measure pre- and post-treatment changes. To minimize lifestyle-related confounding factors, all participants will receive standardized dietary and physical activity counseling at baseline and will be instructed to strictly maintain their established lifestyle routines throughout the study period.\n\nParticipants:\n\nThe study plans to enroll approximately 30 adult patients (ages 18 to 45 years) formally diagnosed with MAFLD. MAFLD is defined by the presence of excessive hepatic fat accumulation concurrent with specific metabolic dysfunctions, such as overweight\u002Fobesity, hypertension, elevated blood sugar, or dyslipidemia.\n\nIntervention:\n\nParticipants will be administered oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for a continuous duration of 12 weeks. Upon completion of the intervention, participants will enter a 12-week observational follow-up period to monitor the durability of the treatment effects and long-term safety.\n\nMain Things We Will Measure (Outcomes):\n\nPrimary Outcome: Absolute change in liver fat content from baseline to the end of the 12-week treatment, quantitatively assessed by the gold-standard MRI Proton Density Fat Fraction (MRI-PDFF).\n\nSecondary Outcomes: Changes in supplementary non-invasive liver fat assessments (including Ultrasound-derived Fat Fraction \\[UDFF\\] and FibroScan Controlled Attenuation Parameter \\[CAP\\]), as well as changes in body weight, blood pressure, heart rate, and routine laboratory safety panels (e.g., comprehensive liver and kidney function tests).",[28],"MAFLD","RECRUITING","2026-06-25",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2026-03-30",{"date":37,"type":21},"2026-09-01",{"name":39,"class":40},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100559422","re-and-probiotics-in-mafldnafld-100559422","NCT06563921","RE and Probiotics in MAFLD\u002FNAFLD","PRObiotic Mixed With Exercise THErapy USe in MAFLD (PROMETHEUS in MAFLD)","Study population: Patients diagnosed with non-alcoholic or metabolically mediated fatty liver disease (NAFLD\u002FMAFLD), including the inflammatory form (NASH), confirmed by imaging (ultrasound, MRI-PDFF) or histopathological (liver biopsy) methods.\n\nInclusion criteria:\n\n* Diagnosis of NAFLD\u002FMAFLD or NASH (imaging or histological confirmation of fatty liver disease, e.g., ultrasound, MRI-PDFF, biopsy)\n* Age 18-60 years\n* Ability to understand the study procedures and provide informed consent.\n* Stable clinical condition for at least 3 months prior to study initiation.\n\nExclusion criteria:\n\n* Lack of fluency in English or Polish\n* Significant (structural) limitation of upper and\u002For lower limb mobility\n* Pregnancy or breastfeeding\n* Inability to understand instructions\n* Shift work\n* Participation in any study or research project within the last 3 months\n* Participation in an interventional drug study within the last 3 months\n* Participants with hepatic steatosis and regular alcohol consumption \\> 30 g\u002Fday\n* Individuals with any concomitant liver disease (viral hepatitis, drug-induced liver injury, metabolic\u002Fgenetic diseases (e.g., Wilson's disease))\n* Anticoagulant\u002Fantiplatelet therapy, antithrombotic therapy, immunosuppressive medications, prolonged immunosuppression (e.g., recent cytotoxic chemotherapy, HIV infection with CD4 count \\\u003C 240), antibiotics, corticosteroids, valproic acid, amiodarone, tamoxifen within 3 months prior to study enrollment\n* Use of medications such as steroids, methotrexate, metformin\n* Use of agents such as vitamin E, omega-3 fatty acids, or medications with evidence of an effect on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid)\n* Active or previous history of invasive cancer (excluding curatively treated carcinoma in situ \\[e.g., cervical\\] or benign skin cancer), unless complete remission has been achieved\n* Regular use of probiotic or prebiotic supplements within 3 months prior to study enrollment\n* Known allergy to probiotics\n* History of using an alternative diet within 3 months prior to study enrollment or changing diet during study entry\n* Previous surgery (bariatric surgery, gastric or intestinal resection)\n* Parenteral nutrition (TPN) within the last 6 months\n* Insulin therapy\n* Uncontrolled diabetes\n* Cardiovascular disease (e.g., uncontrolled blood pressure, coronary artery disease, NYHA class III-IV heart failure, severe arrhythmias, orthostatic intolerance)\n* Nervous system disorders\n* Cognitive impairment and dementia\n* Osteoporosis\u002Fosteopenia\n* Active thyroid disease\n* Cushing's syndrome\n* Any implanted battery-powered device (e.g., AICD, pacemaker, cardiac rhythm recorder, cochlear implant)","60 Years",{"count":51,"type":21},180,[53],"NA","This project aims to evaluate the roles of the autonomic nervous system (ANS) and gut microbiota as correlates of clinical improvement in metabolic dysfunction-associated fatty liver disease (MAFLD) and non-alcoholic fatty liver disease (NAFLD) in response to a therapeutic regimen comprising resistance exercise and probiotic supplementation. The primary objective is to investigate the effects of these non-pharmacological interventions on MAFLD\u002FNAFLD and to identify patient phenotypes based on baseline ANS profiles and gut microbiota composition that predict clinical responses.",[56,57,28],"NASH","NAFLD",[56,28,57,59,60,61,62],"Probiotics","Resistance training","Gut microbiota","Hypertrophy training","NOT_YET_RECRUITING","2026-04-07",{"date":66,"type":33},"2026-04-09",{"date":68,"type":21},"2026-04-10",{"date":70,"type":21},"2036-04-10",{"name":72,"class":40},"Nicolaus Copernicus University",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100615218","phase-4-the-effect-of-alogliptin-combined-with-actoplus-met-on-glucose-and-lipid-metabolism-and-pancreatic-function-in-patients-with-t2dm-complicated-with-mafld-100615218","NCT07289750","The Effect of Alogliptin Combined With Actoplus Met on Glucose and Lipid Metabolism and Pancreatic Function in Patients With T2DM Complicated With MAFLD","The Effect of Alogliptin Combined With Pioglitazone and Metformin Hydrochloride Tablets on Glucose and Lipid Metabolism and Islet Function in Patients With Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-associated Fatty Liver Disease","Inclusion Criteria:\n\n* Clinical diagnosis of T2DM\n* Clinical diagnosis of MAFLD\n* HbA1c: 6.5-9.5%\n* BMI: 19-35 kg\u002Fm2\n* No hypoglycemic drugs or insulin have been used within half a year\n\nExclusion Criteria:\n\n* Severe infections, surgeries and other emergency\n* Other types of diabetes\n* Severe cardiovascular, brain, liver and kidney disorders\n* Malignant tumor","75 Years",{"count":82,"type":21},80,[84],"PHASE4","To compare the efficacy and safety of the combination of alogliptin and actoplus met with that of actoplus met alone in improving the glucose and lipid metabolism and pancreatic function in T2DM patients complicated with MAFLD.",[87,28],"T2DM",[87,28],"2026-03-20",{"date":91,"type":33},"2026-03-24",{"date":93,"type":21},"2026-05-01",{"date":95,"type":21},"2027-08-31",{"name":97,"class":40},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":41},"100629138","frequency-of-mafld-and-its-association-with-nutritional-status-and-metabolic-risk-factors-in-a-rural-population-of-bangladesh-100629138","NCT07470749","Frequency of MAFLD and Its Association With Nutritional Status and Metabolic Risk Factors in a Rural Population of Bangladesh","Inclusion Criteria:\n\n* Age 18 years or above\n* Resident of the selected community\n\nExclusion Criteria:\n\n* Pregnant women\n* Severe illness precluding participation like paralysis, bed ridden, cancer etc",true,{"count":106,"type":21},1000,"OBSERVATIONAL","Metabolic dysfunction-associated fatty liver disease (MAFLD) is an increasingly recognized cause of chronic liver disease and is closely linked with obesity, metabolic abnormalities, and nutritional status. Data on the frequency of MAFLD and its associated metabolic and nutritional factors in rural populations of Bangladesh are not up to date.\n\nThis study aims to determine the frequency of MAFLD and to evaluate its association with nutritional status and metabolic risk factors among adults in a rural population of Bangladesh. Eligible participants will undergo clinical assessment, anthropometric measurements, laboratory evaluation of metabolic parameters, and abdominal ultrasonography for the detection of hepatic steatosis. Nutritional status will be assessed using standard anthropometric and clinical criteria.\n\nThe findings of this study are expected to provide baseline epidemiological data on MAFLD in rural Bangladesh and to help identify associated metabolic and nutritional risk factors.",[28,110,111],"Metabolic Abnormalities","Obesity & Overweight","2026-03-10",{"date":114,"type":33},"2026-03-13",{"date":116,"type":33},"2025-12-04",{"date":118,"type":21},"2026-10-31",{"name":120,"class":40},"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":41},"100623025","pathogenesis-of-chronic-kidney-disease-associated-with-metabolic-dysfunction--associated-fatty-liver-disease-mafld-and-treatment-response-of-oral-semaglutide-100623025","NCT07391267","Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide.","Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide - a Randomized Controlled Trial.","Inclusion Criteria:\n\n* 1.Age above or equal to 18 years at the time of signing informed consent. 2.Diagnosed with type 2 diabetes mellitus 3.HbA1c less than or equal to 10% (less than or equal to 86 mmol\u002Fmol) 4.Renal impairment defined either by:\n* serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg\u002Fg or\n* serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg\u002Fg 5.Treatment with maximum labelled or tolerated dose of a reninangiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening.\n\nExclusion Criteria:\n\n1. Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)\n2. Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).\n3. Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.\n4. Known or suspected excessive consumption of alcohol (greater than 20 g\u002Fday for women or greater than 30 g\u002Fday for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).\n5. Treatment with vitamin E (at doses greater than or equal to 800 IU\u002Fday) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.\n6. Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).\n7. Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.\n8. Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations\n9. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.\n10. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure\n11. Planned coronary, carotid or peripheral artery revascularisation\n12. Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis 13 Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupildilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n\n    \\-",{"count":129,"type":21},90,[53],"This project aims to investigate how Chronic Kidney Disease (CKD) develops and progresses in patients who also have Non-Alcoholic Fatty Liver Disease (NAFLD) and to evaluate whether oral semaglutide (a GLP-1 receptor agonist) can slow or prevent this progression.\n\nNAFLD and CKD frequently coexist due to shared mechanisms such as insulin resistance, inflammation, oxidative stress, dyslipidemia, and metabolic syndrome. Because of these overlapping pathways, a single therapy targeting both organs may offer major benefits.\n\nSemaglutide is known to reduce liver fat, improve inflammation and fibrosis, promote weight loss, and provide renal protection. This project will test whether adding oral semaglutide to standard care leads to better kidney and liver outcomes than standard care alone.\n\nThe study is designed as a randomised controlled trial conducted at ILBS, enrolling adults having NAFLD with CKD (with specific eGFR and albuminuria criteria). Participants will be followed for 2 years, with regular assessment of kidney function (eGFR, ACR), liver health (FibroScan, ALT\u002FAST), metabolic parameters, and cardiovascular outcomes.\n\nA parallel animal study in mice with diet-induced fatty liver disease will validate mechanistic findings through liver and kidney histology, gene expression, metabolic tests, and biochemical markers after semaglutide treatment.\n\nExpected outcome: To demonstrate that semaglutide slows CKD progression and improves NAFLD, supporting its use as a therapeutic option for patients with coexisting both conditions.",[133,28],"Chronic Kidney Diseases","2026-01-29",{"date":136,"type":33},"2026-02-05",{"date":138,"type":21},"2026-02-01",{"date":140,"type":21},"2028-12-31",{"name":142,"class":40},"Institute of Liver and Biliary Sciences, India",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":41},"100610892","a-multicenter-randomized-crossover-clinical-trial-study-of-digital-intelligence-software-in-patients-with-mafld-100610892","NCT07233486","A Multicenter, Randomized, Crossover Clinical Trial Study of Digital Intelligence Software in Patients With MAFLD","DISMA","Inclusion Criteria\n\n1. Adult patients aged 18-65 years with a BMI of 24-35 kg\u002Fm².\n2. Confirmed diagnosis of Metabolic-associated Fatty Liver Disease (MAFLD), defined by a FibroScan® result \\> 248 dB\u002Fm or an MRI-PDFF \\> 5%.\n3. Willing and able to provide written informed consent and comply with the study protocol, including the use of a compatible smartphone for digital health components.\n4. If treated for Type 2 Diabetes Mellitus (T2DM), must be on a stable medication regimen for at least 3 months prior to baseline (Day 0), with the expectation to maintain stability throughout the study barring medical necessity.\n5. If taking medications with potential NASH-remitting effects (e.g., vitamin E, thiazolidinediones), must be on a stable dose for at least 3 months prior to Day 0.\n\nExclusion Criteria\n\n1. Subjects were excluded from participation if they met any of the following criteria, based on the most recent pre-randomization assessments:\n2. Evidence of cirrhosis, defined as histological stage F4 or its clinical equivalent.\n3. History of heavy alcohol consumption (\\>30 g\u002Fday for males, \\>20 g\u002Fday for females) for more than 3 consecutive months within one year prior to screening.\n4. Prior or planned solid organ transplantation (excluding corneal transplants).\n5. Planned bariatric surgery. A history of bariatric surgery was permitted only if weight had been stable (variation \\\u003C10%) for at least 3 months prior to screening.\n6. Presence of other chronic liver diseases, including:\n7. Hepatitis B surface antigen (HBsAg) positivity.\n8. Hepatitis C virus (HCV) RNA positivity.\n9. Primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, or overlap syndromes.\n10. Wilson's disease, alpha-1 antitrypsin deficiency (ZZ phenotype), or hereditary hemochromatosis.\n11. History of Type 1 Diabetes Mellitus. Uncontrolled Type 2 Diabetes Mellitus, defined as HbA1c \\>9% or current insulin therapy.\n12. History of hepatic decompensation events (e.g., ascites, hepatic encephalopathy, variceal hemorrhage).\n13. Any of the following laboratory abnormalities at screening:\n14. Platelet count \\\u003C 150,000\u002Fmm³\n15. Albumin \\\u003C 3.0 g\u002FdL\n16. International Normalized Ratio (INR) \\> 1.3\n17. Alkaline Phosphatase (ALP) \\> 2 × Upper Limit of Normal (ULN)\n18. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \\> 5 × ULN\n19. Total Bilirubin \\> 1.3 × ULN (except in cases of documented Gilbert's syndrome)\n20. Estimated Glomerular Filtration Rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m²\n21. Hemoglobin \\\u003C 10 g\u002FdL\n22. Uncontrolled thyroid dysfunction, defined as a thyroid-stimulating hormone (TSH) level \\\u003C 0.1 or \\> 10 µIU\u002FmL at screening.\n23. Documented HIV-1 or HIV-2 infection.\n24. Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.\n25. Significant cardiovascular history, including myocardial infarction, unstable angina, heart failure, uncontrolled arrhythmia, coronary artery bypass graft, or percutaneous coronary intervention within one year prior to screening.\n26. Diagnosis of malignancy within the past 2 years (except for adequately treated basal cell carcinoma or cutaneous squamous cell carcinoma).\n27. Severe co-morbid respiratory, cardiac, cerebrovascular, hepatic, or renal conditions that, in the investigator's judgment, would preclude safe participation in a diet and exercise intervention.\n28. Active, severe infection requiring parenteral antimicrobial therapy within 30 days of screening.\n29. Major surgery within 30 days prior to screening.\n30. Chronic use of medications known to promote hepatic steatosis (e.g., systemic corticosteroids, amiodarone, methotrexate, tamoxifen, valproic acid) within 3 months of screening. Short-term, low-dose corticosteroid use was permissible.\n31. Current or planned treatment with radiation therapy, cytotoxic chemotherapy, or immunomodulatory agents (e.g., interleukins, interferons).\n32. Treatment with any investigational agent within 6 months prior to screening, or prior participation in a clinical trial for NASH\u002FMAFLD within 6 months.\n\nPregnancy or lactation.\n\n1.Any other condition or circumstance that, in the opinion of the Investigator, would compromise patient safety or the validity of the study data.","65 Years",{"count":152,"type":21},2000,[53],"Cirrhosis associated with metabolic associated fatty liver disease (MAFLD) can lead to a series of adverse outcomes in and outside the liver, but there is no approved treatment so far. In recent years, the prevalence of MAFLD-related cirrhosis in our country is increasing rapidly, but its clinical, pathological characteristics and natural prognosis are not clear, and there is a lack of standardized and effective prevention and treatment strategies.Through\"Digital Intelligence software\" to assist clinicians in MAFLD patients with remote data intervention, lifestyle intervention guidance and follow-up management, to evaluate the efficacy and safety of the intervention software on body weight and blood glucose in patients with MAFLD.",[28],"2025-11-17",{"date":158,"type":33},"2025-11-18",{"date":160,"type":33},"2024-08-01",{"date":162,"type":21},"2028-08-30",{"name":164,"class":40},"The Affiliated Hospital of Hangzhou Normal University",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100611578","comparison-of-a-handheld-elastography-device-with-ilivtouch-in-chronic-liver-disease-patients-100611578","NCT07242404","Comparison of a Handheld Elastography Device With iLivTouch in Chronic Liver Disease Patients","Evaluation of Agreement Between the Handheld Elastography Device and iLivTouch for Multi-Position Liver Assessment in Chronic Liver Disease","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosed with one of the following:\n\n  * Chronic hepatitis B or compensated HBV-related cirrhosis (based on the 2022 Chinese CHB guidelines), or\n  * Metabolic dysfunction-associated fatty liver disease (MAFLD), metabolic dysfunction-associated steatohepatitis (MASH), or fibrosis\u002Fcirrhosis due to MAFLD (based on the 2024 MAFLD guidelines).\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Chronic liver disease due to other etiologies (e.g., other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic\u002Fmetabolic liver disease).\n* Evidence of decompensated cirrhosis.\n* Total bilirubin \\> 51 μmol\u002FL.\n* ALT \\> 5 × upper normal limit.\n* Presence of hepatocellular carcinoma, hepatic hemangioma, large hepatic cyst, or other space-occupying liver lesions.\n* Co-infection with HIV.\n* History of liver transplantation or TIPS.\n* Pregnancy.\n* Congestive hepatopathy.\n* Unhealed wounds in the right upper abdomen.\n* Inability to maintain the required sitting position.",{"count":173,"type":21},224,"This single-center cross-sectional study aims to evaluate the agreement between a handheld elastography device and the iLivTouch transient elastography system for the noninvasive assessment of liver fibrosis and steatosis in adults with chronic liver disease. The study compares liver stiffness measurement (LSM) and ultrasound attenuation parameter (UAP) obtained by both devices in the standard supine position, and further explores the feasibility and consistency of measurements performed in the sitting position.\n\nAll participants will undergo paired examinations using both devices in two body positions (supine and sitting). Agreement between devices and between body positions will be assessed using Bland-Altman analysis, intraclass correlation coefficients, and categorical consistency metrics. The study will also evaluate device performance indicators, including measurement success rate, procedure time, and battery endurance under simulated clinical conditions.\n\nThis study aims to provide clinical evidence on the accuracy, reliability, and feasibility of a new handheld transient elastography device, and to explore whether sitting-position measurements can serve as an alternative to standard supine assessment in chronic liver disease patients.",[28,176],"HEPATITIS B CHRONIC",[178,179,180],"Transient Elastography","Noninvasive Liver Assessment","Agreement Study",{"date":182,"type":33},"2025-11-21",{"date":184,"type":21},"2025-12-01",{"date":186,"type":21},"2026-05-31",{"name":188,"class":40},"Hong You",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100608313","diacerein-in-the-treatment-of-metabolic-dysfunction-associated-steatotic-liver-disease-100608313","NCT07199933","Diacerein in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease","A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Diacerein in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease in Adults","Inclusion Criteria:\n\n* Fully understand this study and voluntarily sign the informed consent form; willing to comply with and capable of completing all trial procedures.\n* Meet the diagnostic criteria for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).\n* Age ≥18 and ≤60 years, regardless of gender.\n\nExclusion Criteria:\n\n* Patients with other diseases that may secondarily cause fatty liver disease, including hepatitis B or C virus infection, α-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, or HIV infection.\n* Alcohol consumption ≥140 g\u002Fweek for females or ≥210 g\u002Fweek for males.\n* Patients with current or history of cirrhosis or any prior event of hepatic decompensation (i.e., ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, esophageal varices, and\u002For hepatorenal syndrome).\n\n  (4) Patients with abnormal vital signs, complete blood count (CBC), renal function, or thyroid function (Alanine Aminotransferase \\[ALT\\] \\>5× upper limit of normal \\[ULN\\]; Creatinine \\[Cr\\] \\>ULN; Albumin \\[ALB\\] \\\u003C3.5 g\u002FL; TSH \\>2× ULN; electrolyte imbalances).\n* Patients with severe cardiovascular or cerebrovascular diseases (including uncontrolled hypertension, defined as systolic blood pressure \\>170 mmHg or diastolic blood pressure \\>100 mmHg), renal diseases, hematopoietic system diseases, psychiatric disorders, autoimmune diseases, or active cancer.\n* Glycated Hemoglobin A1c (HbA1c) \\>7% (in patients without prior history of diabetes).\n* Patients with inflammatory bowel disease, intestinal obstruction or pseudo-obstruction, chronic diarrhea, or unexplained abdominal pain.\n* Use of medications related to MASLD within 3 months prior to the study (e.g., metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors \\[DPP-4i\\], glucagon-like peptide-1 receptor agonists \\[GLP-1RA\\], sodium-glucose cotransporter-2 inhibitors \\[SGLT-2i\\], S-adenosylmethionine \\[SAM-e\\], polyenphosphatidylcholine, glycyrrhizin, bicyclol, reduced glutathione, betaine, fish oil, silymarin, obeticholic acid\u002Fursodeoxycholic acid \\[OCA\u002FUDCA\\], phosphodiesterase inhibitors \\[PDEi\\], gemfibrozil, vitamin E, long-term antibiotics \\[\\>1 week\\], THR-β agonists \\[resmetirom\\], initiation or adjustment of lipid-lowering regimens, corticosteroids, immunosuppressants, or Chinese herbal extracts for MASLD treatment \\[e.g., hawthorn, cassia seed, salvia, notoginseng, kudzu, alisma\\], or herbal teas \\[e.g., Ilex chingiana, Kuding tea, Gynostemma, lotus leaf, Pu-erh tea\\]). Exclusion applies if any of the above criteria are met.\n* History of bariatric surgery within the past 2 years.\n* History of allergy to diacerein or anthraquinone derivatives.\n* Use of diacerein within the past 3 months.\n* Pregnant or lactating women, or those planning pregnancy within the next 6 months.\n* Participation in another clinical trial involving investigational drugs or devices.\n* Contraindications to conventional MRI (e.g., metal implants).\n* Inability to complete the study or comply with its requirements, as determined by the investigator.\n* Weight gain or loss \\>5% within 6 months prior to baseline, or \\>10% within 12 months prior to screening.\n* CAP value ≥248 dB\u002Fm on Fibroscan but MRI-PDFF \\\u003C5%.",{"count":197,"type":21},74,[53],"Metabolic dysfunction-associated fatty liver disease (MAFLD) is the most common chronic progressive liver disease in China, posing a significant risk for hepatic decompensation, cardiovascular disease (CVD), chronic kidney disease (CKD), and various malignancies. It severely impacts patient quality of life and life expectancy, creating a substantial socioeconomic burden. Currently, no safe and effective drug exists to reverse MAFLD.\n\nRhubarb (Dà Huáng), a classic Traditional Chinese Medicine (TCM) herb for liver disorders, has a cold nature, bitter taste, and targets the liver, spleen, stomach, large intestine, and pericardium meridians. Its primary active component, Rhein, demonstrates therapeutic potential by targeting key MAFLD pathological processes-insulin resistance, hepatic steatosis, inflammation, and fibrosis. Supporting this, a previous randomized, double-blind, placebo-controlled trial by our group on diacerein (a Rhein derivative) for simple obesity showed that it not only reduced body weight but also improved liver function, Controlled Attenuation Parameter (CAP), and Liver Stiffness Measurement (LSM).\n\nTherefore, this study will investigate diacerein-a marketed drug metabolized to Rhein in vivo-for MAFLD treatment using a randomized, double-blind, placebo-controlled design. The aim is to generate clinical evidence for diacerein and other Rhein derivatives within an integrative medicine framework, providing an evidence-based rationale for expanding the application of rhubarb in MAFLD management.",[28],[28,202],"Diacerein","2025-09-28",{"date":205,"type":33},"2025-09-30",{"date":207,"type":21},"2025-10-01",{"date":209,"type":21},"2027-10-31",{"name":211,"class":40},"Hongyan Wu",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":104,"sex":16,"minAge":4,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":223,"conditions":224,"keywords":229,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":41},"100608542","validation-of-imaging-based-liver-biomarkers-in-pediatric-patients-100608542","NCT07202910","VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients","Imaging-Based Biomarkers for Non-Invasive Pediatric Liver Diagnostics","VALiBi-PED","Inclusion Criteria (Study 1-main study)\n\n* all patients scheduled for a clinically liver biopsy at the Queen Silvia Children's Hospital\n* any form of suspected or confirmed liver disease\n* age between 0-18 years\n* consent by the child\u002Fparents to participate.\n* For controls: children scheduled for a renal biopsy\n* age between 0-18 years\n* consent by the child\u002Fparents to participate.\n\nExclusion Criteria:\n\n* technical limitations regarding the measurements\n* inability to fully understand the informed consent documents.","25 Years",{"count":222,"type":21},550,"The goal of this observational (diagnostic validation) study is to validate imaging-based biomarkers for assessing liver involvement in pediatric patients with established or suspected liver disease. The projekt involves 3 larger studies, each with specific aims specified in detailed description below.\n\nThe main study (study 1) compares imaging-based biomarkers-with liver biopsy to evaluate their correlation with histologically confirmed liver disease, including fibrosis, inflammation, and steatosis. The main question the overall project aims to answer is:\n\n• Can multiple novel imaging-based biomarkers, such as shear wave elastography (SWE), shear wave dispersion (SWD), and attenuation imaging (ATI), be used for detailed, non-invasive liver characterization in children, and if so, how should they be used?",[225,226,227,28,228],"Hepatic Disorders","Intestinal Failure-associated Liver Disease","Cystic Fibrosis Liver Disease","Pediatric Liver Transplantation",[230,231,232,233,227,234,235,236,237,28],"pediatric hepatic disease,","obesity and overweight","intestinal failiure associated liver disease","liver transplant disorder","Liver disease or abnormalities","pediatric liver transplant","pediatric abdominal imaging","elastography","2025-09-23",{"date":240,"type":33},"2025-10-02",{"date":242,"type":33},"2019-03-28",{"date":244,"type":21},"2032-12",{"name":246,"class":40},"Sahlgrenska University Hospital",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":4},"100581330","phase-2-clinical-study-on-the-treatment-of-mafld-with-ganzhixiao-capsules-100581330","NCT06848907","Clinical Study on the Treatment of MAFLD With Ganzhixiao Capsules","Re Evaluation of the Clinical Efficacy of Ganzhixiao Capsules Based on MRI-PDFF in the Treatment of Metabolic Related Fatty Liver Disease","Inclusion Criteria:\n\n* Age between 18 and 70 years old, with a body mass index (BMI) of at least 24kg\u002Fm2;\n* Diagnosis of NAFLD determined by imaging \\[ultrasound, computed tomography or magnetic resonance imaging (MRI-PDFF)\\] or liver biopsy, showing MAFLD or simple steatosis within the last 24 months prior to screening;\n* MAFLD patients conform to the damp heat syndrome type; ④ Voluntary signing of informed consent form\n\nExclusion Criteria:\n\n* Blood biochemical indicators ALT, AST, BUN are greater than 1.5 times the upper limit of normal values, Cr is greater than the upper limit of normal values, eGFR\\\u003C60ml\u002Fmin\u002F1.73m2;\n* Alcoholic fatty liver, other chronic liver diseases, cirrhosis, liver malignant tumors, etc.;\n* Type 2 diabetes and pancreatic diseases;\n* Taking some hypoglycemic, lipid-lowering, liver protective drugs or high-dose vitamin E that may affect the efficacy judgment in the past three months;\n* Patients with severe infections, cardiovascular, respiratory, renal, hematological, rheumatic connective tissue disease, neuropsychiatric, and non liver malignant tumors;\n* Pregnant or lactating women;\n* Those who require long-term hormone therapy;\n* Researchers anticipate poor compliance or inability to cooperate;\n* There are contraindications for MRI examination, including pacemakers or cochlear implants, postoperative artificial valve replacement, presence of ferromagnetic vascular clips in the body, metal foreign bodies in the eyeball, insulin pumps, ferromagnetic objects in the scanning field, metal dentures, intrauterine devices, and patients with claustrophobia.","70 Years",{"count":256,"type":21},138,[25],"This trial is expected to enroll 138 MAFLD patients in one clinical center, who will be randomly divided into a placebo group and a Ganzhixiao capsule group in a 1:1 ratio. There will be 69 patients in the Ganzhixiao group and 69 patients in the placebo group. Administer Ganzhixiao capsules or mimetics separately, intervene for 16 weeks, and compare the liver fat content、 ALT、 Changes in indicators such as cytokeratin 18 fragment, FIB-4 score, and LSM score. Among them, MRI-PDFF is the main efficacy evaluation index to evaluate the clinical efficacy of Ganzhixiao capsules in the treatment of MAFLD.",[28],"2025-05-06",{"date":262,"type":33},"2025-05-11",{"date":264,"type":21},"2025-05-30",{"date":266,"type":21},"2028-05-30",{"name":268,"class":40},"Dong Hui",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":150,"enrollmentInfo":276,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":4},"100587040","glucose-disposal-rate-as-a-metric-for-detection-of-metabolic-associated-fatty-liver-100587040","NCT06923215","Glucose Disposal Rate as a Metric for Detection of Metabolic Associated Fatty Liver","The Role of Estimated Glucose Disposal Rate as a Metric for Detection of Metabolic Associated Fatty Liver Disease and Its Severity in Patients With Metabolic Syndrome.","Inclusion Criteria:\n\n* Age 18-65 years.\n* Suspected\u002Fconfirmed MS per IDF criteria:\n* Central obesity (waist circumference ≥94 cm \\[men\\]\u002F≥80 cm \\[women\\]) plus ≥2 of: Triglycerides ≥150 mg\u002FdL.\n\nHDL \\\u003C40 mg\u002FdL (men)\u002F\\\u003C50 mg\u002FdL (women). Blood pressure ≥130\u002F85 mmHg or antihypertensive treatment. Fasting glucose ≥100 mg\u002FdL or diabetes diagnosis.\n\nExclusion Criteria:\n\n* Other liver diseases (viral\u002Fautoimmune hepatitis).\n\nAlcohol intake \\>20 g\u002Fday (men) or \\>10 g\u002Fday (women).\n\nPregnancy, malignancy, advanced cirrhosis.\n\nMedications affecting metabolism (e.g., steroids)",{"count":20,"type":21},"A 12-month prospective observational cohort study assessing eGDR's utility in diagnosing MAFLD (via FibroScan® CAP ≥248 dB\u002Fm) and correlating it with steatosis\u002Ffibrosis severity. Secondary aims compare eGDR to FLI\u002FFIB-4 scores and identify optimal diagnostic cut-offs",[28],[28,280,281],"eGDR","Fibroscan","2025-04-04",{"date":284,"type":33},"2025-04-11",{"date":286,"type":21},"2025-07-30",{"date":288,"type":21},"2026-12-30",{"name":290,"class":40},"Assiut University"]