[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-alcoholic-fatty-liver-disease-nafld\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-alcoholic-fatty-liver-disease-nafld":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,43,87,109,138,165,188,216,246,274,295,318],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100492966","screening-in-primary-care-of-advanced-liver-fibrosis-in-nafld-andor-alcoholic-patients-100492966",false,"NCT05699018","Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and\u002For Alcoholic Patients","SOPRANO","Inclusion Criteria:\n\n* NAFLD and\u002For ALD patient defined by at least 1 of the following criteria:\n\n  * Excessive alcohol consumption: higher than 210 g \u002F week (men), or 140 g \u002F week (women)\n  * Type 2 diabetes\n  * at least 2 metabolic factors among BMI higher than or equal to 25 kg \u002F m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg\u002Fdl (men) \u002F 50mg\u002Fdl (women), or triglycerides higher than or equal to150mg\u002Fdl); Hyperferritinemia (higher than upper limit of normal from the laboratory)\n  * Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)\n\nFollowing a protocol amendment, the 3 last investigating primary care centres will include NAFLD and\u002For ALD patients according to these updated criteria:\n\n* Excessive alcohol consumption: \\>210 g\u002Fweek in men or \\>140 g\u002Fweek in women,\n* AND\u002FOR type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments,\n* AND with the following stratification:\n\n  30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments)\n* Patient's agreement to have a blood sample collected in a local laboratory participating in the study\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n\nExclusion Criteria:\n\n* Already ongoing specialized follow-up for a chronic liver disease\n* Altered health status with poor short-term prognosis, not compatible with a screening procedure\n* Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)\n* Acute infection\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure\n* Person unable to express consent","ALL","40 Years","80 Years",{"count":20,"type":21},1788,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and\u002For ALD from primary care centers.",[27,28,29],"Non-alcoholic Fatty Liver Disease (NAFLD)","Alcoholic Liver Disease (ALD)","Liver Fibrosis","RECRUITING","2026-06-26",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2023-03-13",{"date":38,"type":21},"2026-09-12",{"name":40,"class":41},"University Hospital, Angers","OTHER_GOV",13,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100641243","automated-passive-case-finding-for-advanced-liver-fibrosis-in-masld-the-liverseek-programme-100641243","NCT07658755","Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD: The LiverSeek Programme","Towards Universal Screening for Metabolic Dysfunction-Associated Liver Fibrosis in Primary Care: Evaluation of a Single-Step, Laboratory Informatión System-Driven Automated Case-Finding Strategy (LiverSeek)","LiverSeek","Inclusion Criteria:\n\n1. Age between 50 and 75 years (inclusive)\n2. Routine blood test processed in the Clinical Biochemistry Laboratory of Hospital General Universitario Gregorio Marañón, ordered by a primary care physician in one of the 11 affiliated SERMAS primary care centres\n3. Presence of at least one of the following metabolic risk factor combinations:\n\n   * ALT above the upper limit of normal AND HbA1c ≥6.5%\n   * ALT above the upper limit of normal AND BMI \\>30 kg\u002Fm²\n   * BMI \\>30 kg\u002Fm² AND HbA1c ≥6.5%\n\nExclusion Criteria:\n\n1. Age \\\u003C50 years or \\>75 years\n2. Known pre-existing liver disease (significant or advanced fibrosis, cirrhosis, hepatocellular carcinoma, prior liver transplantation)\n3. Prior fibrosis assessment within the preceding 12 months.","50 Years","75 Years",{"count":54,"type":21},3000,"24 Months","OBSERVATIONAL","LiverSeek is a fully automated, passive case-finding programme for advanced liver fibrosis associated with metabolic dysfunction-associated steatotic liver disease (MASLD) in primary care. The programme operates through the Laboratory Information System (LIS; Modulab\u002FBiwer Analytics) of the Clinical Biochemistry Laboratory at Hospital General Universitario Gregorio Marañón (HGUGM), covering approximately 350,000 inhabitants across 11 peri-urban primary care centres affiliated to SERMAS (Servicio Madrileño de Salud) in Madrid, Spain.\n\nWhen a high-risk patient (age 50-75 years with ≥1 of: ALT above ULN + HbA1c ≥6.5%; ALT above ULN + BMI \\>30; BMI \\>30 + HbA1c ≥6.5%) undergoes a routine blood test in primary care, the LIS automatically calculates FIB-4. If FIB-4 \\>1.30, the system reflexively orders ELF and MASEF from the same serum sample, without any action required from the primary care clinician. Patients with a positive second-step NIT (ELF ≥9.8 or MASEF ≥0.33) receive an automatic alert directing them to the Hepatology Advanced Practice Nurse for VCTE (FibroScan) and clinical evaluation.\n\nThe primary objective is to evaluate the prevalence of hepatic fibrosis in the high-risk population using this single-step automated strategy. Secondary objectives include head-to-head diagnostic comparison of FIB-4+ELF vs FIB-4+MASEF vs FIB-4+FAST for histologically-confirmed endpoints (significant fibrosis ≥F2, advanced fibrosis ≥F3, at-risk MASH), evaluation of the Liver Risk Score, and a health-economic analysis. A sub-study evaluates a nurse-led structured lifestyle intervention in NIT-positive patients.",[59,29,60,61,62,63],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Non-alcoholic Fatty Liver Disease NAFLD","Type 2 Diabetes Mellitus","Obesity","Obesity Type 2 Diabetes Mellitus",[65,66,67,68,69,70,71,72,73,74,75],"MASLD","MAFLD","NAFLD","liver fibrosis","FIB-4","ELF","MASEF","screening","passive screening","advanced practice nurse","lifestyle intervention","2026-06-14",{"date":78,"type":34},"2026-06-22",{"date":80,"type":34},"2024-10-01",{"date":82,"type":21},"2027-09-01",{"name":84,"class":85},"Hospital General Universitario Gregorio Marañon","OTHER",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100564199","exploratory-study-of-mri-biomarkers-of-nash-100564199","NCT06626074","Exploratory Study of MRI Biomarkers of NASH","IRM-NASH","Inclusion Criteria:\n\n* Patient included in the SNIFF cohort of the Angers hospital where there is a suspicion of NASH requiring a biopsy for which an MRI is requested by a hepatologist as part of the initial assessment of the disease.\n* Adult patient\n* Free, informed and express (oral) consent of the patient to participate in the study\n\nExclusion Criteria:\n\n* Contraindication to MRI\n* Time between the establishment of the Steatosis\u002FNASH status and the MRI greater than 3 months\n* Pregnant, parturient and breastfeeding woman\n* Person deprived of liberty by judicial or administrative decision\n* Person under compulsion to psychiatric care\n* Person subject to a legal protection measure\n* Person not affiliated or not covered by a social security scheme.","18 Years",{"count":96,"type":21},110,[24],"Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries.\n\nNAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Non-invasive quantification, on the other hand, requires MRI.\n\nNonalcoholic steatohepatitis (NASH) is the aggressive form of the disease that promotes the accumulation of fibrosis in the liver, which can progress to cirrhosis and its complications.\n\nCurrently there is no non-invasive biomarker of NASH and the diagnosis is based solely on liver biopsy.\n\nThere is therefore a need for non-invasive biomarkers of NASH in patients with steatosis to diagnose NASH without the use of liver biopsy.",[60],"2026-06-12",{"date":102,"type":34},"2026-06-16",{"date":104,"type":34},"2025-09-05",{"date":106,"type":21},"2027-09-06",{"name":40,"class":41},2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":52,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":114,"conditions":120,"keywords":124,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":86},"100635513","phase-1-evaluating-the-pharmacokinetics-and-safety-of-miricorilant-100635513","NCT07553663","Evaluating the Pharmacokinetics and Safety of Miricorilant","A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* Evidence of presumed MASH with either FibroScan liver stiffness measurement ≥ 8 kPa and controlled attenuation parameter (CAP) ≥ 280 dB\u002Fm OR historical biopsy within 12 months of screening that meets the following criteria:\n\n  1. Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 3 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis score of F1 OR\n  2. NAS ≥ 2 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F2 or 3.\n* Aspartate aminotransferase (AST) \\> 17 U\u002FL for women and AST \\> 20 U\u002FL for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of Screening.\n* Presence of at least 1 of the following metabolic conditions that increase the risk of MASH:\n\n  1. Diagnosis of type 2 diabetes OR\n  2. Presence of 2 or more components of metabolic syndrome:\n\n     * Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or treatment for elevated blood glucose\n     * Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension\n     * Serum triglycerides ≥ 150 mg\u002FdL (1.7 mmol\u002FL) or drug treatment for elevated triglycerides\n     * Serum high-density lipoprotein (HDL) cholesterol \\\u003C 40 mg\u002FdL (1 mmol\u002FL) in men and \\\u003C 50 mg\u002FdL (1.3 mmol\u002FL) in women or drug treatment for low HDL\n     * Overweight or obese (body mass index \\[BMI\\] ≥ 25 kg\u002Fm2 \\[BMI ≥ 23 kg\u002Fm2 in Asians\\]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (men ≥ 90 cm \\[35.4 in\\]; women ≥ 80 cm \\[31.5 in\\] in Asians).\n\nExclusion Criteria:\n\n* Women who are pregnant, planning to become pregnant, or are lactating.\n* Have a BMI \\\u003C 18 kg\u002Fm2 or \\> 45 kg\u002Fm2.\n* Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire\n* Have had liver transplantation or plan to have liver transplantation during the study.\n* Have type 1 diabetes.\n* Have poorly controlled type 2 diabetes with a glycated hemoglobin (HbA1c)\n\n  * 9.5%.\n* Have any other chronic liver disease\n* History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation\n* Have hepatic decompensation\n\nOther exclusion criteria may apply",{"count":117,"type":21},15,[119],"PHASE1",[121,122,123,27],"Nonalcoholic Steatohepatitis (NASH)","Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis","Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)",[125,121,126,127],"Nonalcoholic Fatty Liver Disease (NAFLD)","Metabolic dysfunction-Associated Steatohepatitis (MASH)","Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)","2026-05-21",{"date":130,"type":34},"2026-05-26",{"date":132,"type":34},"2026-04-30",{"date":134,"type":21},"2026-10-30",{"name":136,"class":137},"Corcept Therapeutics","INDUSTRY",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":144,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":145,"targetDuration":147,"studyType":56,"phases":4,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":86},"100613358","single-cell-multiomics-and-spatiotemporal-omics-analyze-the-mechanism-of-liver-degenerative-disease-100613358","NCT07265544","Single-cell Multiomics and Spatiotemporal Omics Analyze the Mechanism of Liver Degenerative Disease","Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form;\n2. No restrictions on age and gender;\n3. Patients diagnosed with hepatic hemangioma or focal nodular hyperplasia of the liver in accordance with the \"Guidelines for the Diagnosis and Treatment of Focal Liver Lesions (2014 Edition)\" and the \"Guidelines for the Diagnosis and Treatment of Hemangiomas and Vascular Malformations (2019 Edition)\";\n4. Patients with hepatic hemangioma, focal nodular hyperplasia of the liver, fatty liver, HBV infection, liver fibrosis, and cirrhosis who clinically require liver surgery or liver biopsy.\n\nExclusion Criteria:\n\n1. Individuals with concurrent infections such as HIV will be excluded.\n2. Patients with coagulation system disorders, such as hemophilia or idiopathic thrombocytopenic purpura, will not be included.\n3. Those with severe underlying diseases that affect the body's immune status will be excluded.\n4. Individuals whom the investigator deems unsuitable for participation in this study will be excluded.",true,{"count":146,"type":21},240,"7 Days","The purpose of this observational study is to employ single-cell multi-omics and spatial omics technologies to characterize the spatial and immune structures within the livers of patients with fatty liver, hepatic hemangioma, focal nodular hyperplasia, liver fibrosis, cirrhosis, and HBV infection. The primary questions it aims to address are:\n\nInvestigate the mechanisms of liver degenerative changes during the processes of liver aging, fatty liver, HBV infection, liver fibrosis, and cirrhosis.\n\nCharacterize the molecular features and cellular networks at different stages of liver degeneration and identify new targets and mechanisms for the cure of the aforementioned diseases.\n\nThe study will collect peripheral blood and discarded liver tissue from patients with hepatic hemangioma, fatty liver, HBV infection, liver fibrosis, and cirrhosis who are undergoing hepatectomy or liver biopsy.",[150,151,60,29],"Liver Neoplasm","HBV Infection",[153,154,155],"single-cell multi-omics","HBV infection","liver degenerative changes","2026-04-13",{"date":158,"type":34},"2026-04-14",{"date":160,"type":34},"2023-03-01",{"date":162,"type":21},"2027-02-12",{"name":164,"class":85},"Nanfang Hospital, Southern Medical University",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":52,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":86},"100588891","phase-1-evaluation-of-miricorilant-on-liver-fat-in-patients-with-masld-100588891","NCT06947304","Evaluation of Miricorilant on Liver Fat in Patients With MASLD","A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* AST \\> 17 U\u002FL for women and AST \\> 20 U\u002FL for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of screening showing one of the following:\n\n  1. NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research Network (CRN) fibrosis score of F0 OR\n  2. NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR\n  3. NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3\n* MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.\n* Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH:\n\n  a. Diagnosis of type 2 diabetes managed with diet alone or diet and metformin (metformin dose must be stable for at least 1 month prior to screening) OR b. Presence of 3 or more components of metabolic syndrome: i. Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or treatment for elevated blood glucose with metformin ii. Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension iii. Serum TG ≥ 150 mg\u002FdL (1.7 mmol\u002FL) iv. Serum high-density lipoprotein cholesterol (HDL) \\\u003C 40 mg\u002FdL (1 mmol\u002FL) in men and \\\u003C 50 mg\u002FdL (1.3 mmol\u002FL) in women or drug treatment for low HDL v. Having overweight or obesity (body mass index \\[BMI\\] ≥ 25 kg\u002Fm2 \\[BMI\n  * 23 kg\u002Fm2 in Asians\\]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (men ≥ 90 cm \\[35.4 in\\]; women ≥ 80 cm \\[31.5 in\\] in Asians).\n\nOther inclusion criteria may apply\n\nExclusion Criteria:\n\n* Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months.\n* Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer.\n* Women who are pregnant, planning to become pregnant, or lactating.\n* BMI \\\u003C 18 kg\u002Fm² or \\> 45 kg\u002Fm².\n* Significant alcohol consumption exceeding 20 g\u002Fday for women or 30 g\u002Fday for men within 1 year prior to screening.\n* Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids.\n* Known or suspected cirrhosis or signs of hepatic decompensation.\n* Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease.\n* History of myocardial infarction, unstable angina, or stroke within 3 months prior to screening.\n* Uncontrolled hypertension (systolic \\> 160 mm Hg or diastolic \\> 100 mm Hg).\n* Current use of medications prohibited due to potential drug-drug interactions with study treatment.\n* Contraindications to magnetic resonance imaging (MRI).\n\nOther exclusion criteria may apply",{"count":173,"type":21},8,[119],"A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)",[121,177,178,27],"Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)",[125,121,126,127],"2026-02-09",{"date":182,"type":34},"2026-02-11",{"date":184,"type":34},"2025-08-22",{"date":186,"type":21},"2026-05",{"name":136,"class":137},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":86},"100552750","phase-2-milk-thistle-clinical-trial-in-pediatric-nafld-100552750","NCT06477146","Milk Thistle Clinical Trial in Pediatric NAFLD","Pilot Study of Milk Thistle for the Treatment of Pediatric Non-Alcoholic Fatty Liver Disease (NAFLD)","Inclusion Criteria:\n\nSubjects between the age of 9 to 22 years old diagnosed with non-Alcoholic Fatty Liver Disease (NAFLD) based on current North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Guidelines:\n\n* a. Elevated ALT levels greater than 2 times the sex specific upper limit of normal at baseline; (for boys ALT greater than 50 U\u002FL, and girls ALT greater than 44 U\u002FL) i. AND either overweight (with risk factors as noted below) or obese children:\n\n  * 1\\. In children, obesity is defined as BMI greater than or equal to 95th percentile in weight and overweight is defined as greater than or equal to the 85th percentile to less than the 95th percentile.\n  * 2\\. Risk factors associated with overweight child that warrant screening and inclusion are:\n\n    a. Central obesity, Family history of NAFLD\u002Fnon-alcoholic steatohepatitis(NASH), pre-diabetic or diabetic, dyslipidemia, sleep apnea)\n  * 3\\. For participants 18 years or older: Obesity is defined as BMI greater than or equal to 30 kg\u002Fm2; overweight is defined as BMI greater than or equal to 25 kg\u002Fm2 and less than 30 kg\u002Fm2.\n* b. Evidence of Sonographic presence of hepatic steatosis with greater than 5% steatosis on Ultrasound or FibroScan \\[with a controlled attenuation parameter (CAP) score of 238 or greater)\\] prior to start of trial starting.\n* c. (Or) previous findings on Liver Biopsy consistent with NAFLD including hepatic macro-vesicular steatosis, ballooning degeneration or Mallory Denk Bodies\n\nContraception Requirements for Enrollment of adult population:\n\n1. Female participants are eligible if the participant is of reproductive potential and have a negative -serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use two highly effective birth control methods during the study OR if the participant is not of child-bearing potential (i.e., surgically \\[bilateral oophorectomy, hysterectomy, or tubal ligation\\] or naturally sterile \\[\\> 12 consecutive months without menses\\]).\n\n   Highly effective birth control methods include condoms with spermicide, diaphragm with spermicide, hormonal and nonhormonal intrauterine device, hormonal contraception (estrogens stable ≥ 3 months), a vasectomized male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from screening, throughout the study, and for at least 30 days after the last dose of study drug administration. Reliance on abstinence from heterosexual intercourse is acceptable only if it is the patient's habitual practice.\n2. Male patients who are sexually active with a partner of child-bearing potential must either be sterile (vasectomy with history of a negative sperm count at least 90 days following the procedure); practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable); use a male condom with any sexual activity; or agree to use a birth control method considered to be appropriate by the Investigator (such as one of the methods identified above for female patients of childbearing potential) from the time of screening until 30 days after the last dose of study drug administration. Male patients must agree not to donate sperm for a period of 30 days after the last dose of study drug administration.\n\nExclusion Criteria:\n\n1. Patients with cardiovascular disorders (such as history of myocardial infarction, stroke, DVT)\n2. Medical conditions including history of malignancy, transplantation, immunologic diseases (rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, autoimmune thyroiditis, idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis etc.), poorly controlled thyroid disease, uncontrolled hypertension.\n3. Patients with cirrhosis and hepatic decompensation will be excluded from the study. Hepatic biomarker parameters will be excluded:\n\n   * ALT greater than 200 U\u002FL\n   * AST greater than 200 U\u002FL\n   * Total bilirubin greater than 2.0 mg\u002FdL\n   * ALP greater than 500 U\u002FL\n   * INR greater than 1.4\n   * GGT greater than 200 U\u002FL\n4. Subjects with history or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for participation in the trial (such as poorly controlled psychiatric illness).\n5. Subjects with unstable diabetes, or HbA1c \\>9% will be excluded from the study.\n6. Subjects who report binge drinking will be excluded from this study.\n7. Subjects who partake or state consumption history of tobacco use, vaping, marijuana use, or illicit drug abuse will be excluded from the study.\n8. Subjects with severe hepatic dysfunction and synthetic dysfunction with hypoalbuminemia (Albumin \\\u003C 3.0 g\u002FdL), thrombocytopenia (platelet count \\\u003C140,000\u002Fml3), or coagulopathy (INR \\>1.4) will be excluded from the study.\n9. Exclude subjects with abnormal renal function characterized as serum creatinine greater than the upper limit of normal range (based on the University of Iowa, Department of Pathology Lab Services Handbook):\n\n   Pediatric Age Group Premature 0.3 - 1.0 mg\u002FdL Neonates 0.2 - 0.9 mg\u002FdL 2-12 months 0.2 - 0.4 mg\u002FdL 1-2 years 0.2 - 0.5 mg\u002FdL 3-4 years 0.3 - 0.7 mg\u002FdL 5-6 years 0.3 - 0.7 mg\u002FdL 7-8 years 0.2 - 0.6 mg\u002FdL 9-10 years 0.3 - 0.7 mg\u002FdL 11-12 years 0.3 - 0.9 mg\u002FdL 13-15 years 0.4 - 0.9 mg\u002FdL\n\n   Males 16 years and older 0.6 - 1.2 mg\u002FdL Females 16 years and older 0.5 - 1.0 mg\u002FdL\n10. Breast feeding women will be excluded from this clinical trial.\n11. Subjects who are participating in other drug trials will be excluded from participating.\n12. Subjects with a reported or known history of allergy or anaphylactic reaction to Ragweed will be excluded from this study.","9 Years","22 Years",{"count":198,"type":21},20,[200],"PHASE2","Pediatric Fatty Liver disease is a growing problem in the United States and is expected to be the leading cause of Liver Transplantation in Adults in 20 years. Following lifestyle changes such as diet restrictions and exercise may be difficult to consistently maintain. The purpose of this study is to investigate alternative medical therapy with an herbal supplement called Milk Thistle (MT) which may improve fatty liver disease and would be easier to follow than diet and exercise.",[203],"Non-Alcoholic Fatty Liver Disease (NAFLD)",[205,206],"Silymarin","Fatty Liver","2026-01-23",{"date":209,"type":34},"2026-01-27",{"date":211,"type":34},"2024-12-19",{"date":213,"type":21},"2029-01-31",{"name":215,"class":85},"University Hospitals Cleveland Medical Center",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":86},"100606837","phase-4-empagliflozin-versus-statins-in-non-alcoholic-fatty-liver-disease-100606837","NCT07180745","Empagliflozin Versus Statins in Non-Alcoholic Fatty Liver Disease","Assessment of Efficacy of Empagliflozin Versus Statins in Treatment of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis","Inclusion Criteria:\n\n* Adult\n* Obese\n* Hyperlipidemic\n* Diabetic patients\n* Diagnosed with non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis\n\nExclusion Criteria:\n\n* Pregnant women\n* Breast feeding women\n* Diabetic patients with ketoacidosis\n* Hyperlipidemic patients with cardiovascular dysfunction\n* Patients with NAFLD or NASH induced hepatocellular carcinoma\n* Hyperlipidemic obese diabetic patients diagnosed with NAFLD or NASH who will refuse to sign the informed consent","65 Years",{"count":225,"type":21},400,[227],"PHASE4","The goal of this clinical trial is to assess the efficacy of Empagliflozin versus Statins as monotherapy and polytherapy in non-alcoholic fatty liver disease and non-alcoholic Steatohepatitis.\n\nDoes drug ABC Empagliflozin versus Statins as monotherapy and polytherapy improve the controlled attenuation parameter (CAP), the liver stiffness measurement (LSM), the proportion of patients with at least one point improvement or one-stage reduction in the histological scores with respect to hepatic steatosis, hepatocellular ballooning, lobular inflammation, and fibrosis after treatment?\n\nWhat medical problems do participants have when taking Empagliflozin versus Statins as monotherapy and polytherapy?\n\nParticipants will:\n\n* Take Empagliflozin alone or Empagliflozin plus statins or Pioglitazone plus Statins or Pioglitazone alone as standard therapy every day for 3 months\n* Be directed to complete history taking. FibroScan®, abdominal ultrasound and laboratory tests of ALT, AST, ALP, platelets count, Triglycerides, Cholesterol, LDL, HDL, serum insulin and insulin resistance will be conducted at baseline and after the drug administration for 3 months.\n* Keep a diary of recording any side effects they use a rescue inhaler",[60,230],"Non-alcoholic Steatohepatitis NASH",[232,233,234,67,235],"Empagliflozin","Statin","Pioglitazone","NASH","NOT_YET_RECRUITING","2025-09-16",{"date":239,"type":34},"2025-09-18",{"date":241,"type":21},"2025-11-01",{"date":243,"type":21},"2026-03-01",{"name":245,"class":85},"Badr University",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":52,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":4},"100571978","assessment-of-tolerability-of-specialized-food-products-made-out-of-vegetable-protein-and-their-influence-on-lipid-profile-in-patients-with-non-alcoholic-fatty-liver-disease-100571978","NCT06727279","Assessment of Tolerability of Specialized Food Products Made Out of Vegetable Protein and Their Influence on Lipid Profile in Patients With Non-alcoholic Fatty Liver Disease","Assessment of Tolerability of Specialized Foods of Vegetable Proteins and Their Influence on Lipid Profile in Patients With Non-alcoholic Fatty Liver Disease","Inclusion Criteria:\n\n* Willingness to participate;\n* Confirmed diagnosis of non-alcoholic fatty liver disease based on EASL guidelines.\n\nExclusion Criteria:\n\n* Pregnancy and breastfeeding;\n* excessive alcohol intake (\\>20 g\u002Fday women and \\>30 g\u002Fday men)\n* Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM \\> or =14 kPa by Fibroscan), or APRI \\> or= 1; or BARD score \\> or = 2.\n* Chronic heart failure (I-IV class by NYHA).\n* Past bariatric surgery.\n* Clinically relevant acute cardiovascular event within 6 months prior to screening.\n* Uncontrolled arterial hypertension despite optimal anti-hypertensive therapy.\n* Diabetes mellitus type 1.\n* Serum glycated hemoglobin \\[HbA1c\\] concentrations \\>9.0%.\n* Hypersensitivity to the studied product or any of its components.\n* The intake of any medications that may affect the absorption, distribution, metabolism or excretion of investigational products or may lead to the induction or inhibition of microsomal enzymes (for example, indomethacin) - from the moment of randomization to the end of treatment.\n* Any medical conditions that may significantly affect life expectancy, including known cancers;\n* Any clinically significant immunological, endocrine, haematological, gastrointestinal, neurological or psychiatric diseases;\n* Mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with study protocol requirements.\n* Positive test for to human immunodeficiency virus antibodies .\n* Aspartate aminotransferase (AST) and\u002For ALT \\>10 x upper normal limits.\n* conjugated bilirubin \\> 26 mcmol\u002Fl (patients with Gilbert's disease are allowed to the study).\n* International normalized ratio \\>1.40.\n* Platelet count \\\u003C100 x10\\^9\u002FL due related to portal hypertension.\n* Clinically relevant renal dysfunction, including nephrotic syndrome, chronic kidney disease (determined based on the estimated glomerular filtration rate \\[eGFR\\] less than 60 ml\u002Fmin\u002F1.73 m\\^2).",{"count":254,"type":21},50,[24],"To this single-centre randomized controlled comparative study it is planned to enroll 50 patients with non-alcoholic fatty liver disease. All these subjects will receive standard isocaloric diet for 14 days. Subjects of the main group will receive vegetable protein-and-fat cutlet or schnitzel insted of the same amount of standard (animal meat based) cutlet or schnitzel. Subjects of the control group will receive standard diet, with cutlets or schnitzels made of animal meat. It is planned to make repeated measurements of serum lipid profile and assess general well-being and tolerability of newly developed product compared to regular meal",[60],[259,260,261,262,263,264],"non-alcoholic fatty liver disease","vegetable protein","specialized foods","plant-based meat analogs","meat substitutes","tolerability","2025-08-01",{"date":267,"type":34},"2025-08-03",{"date":269,"type":21},"2025-09-15",{"date":271,"type":21},"2026-02-28",{"name":273,"class":85},"Federal State Budgetary Scientific Institution \"Federal Research Centre of Nutrition, Biotechnology",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":144,"sex":16,"minAge":94,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":86},"100297397","longitudinal-observational-study-of-chinese-with-nafldnash-100297397","NCT03151473","Longitudinal Observational Study Of Chinese With NAFLD\u002FNASH","Prospective Cohort Assessing The Prevalence And Progress Of Non-Alcoholic Fatty Liver Disease (NAFLD)\u002FNon-Alcoholic Steatohepatitis (NASH) In Chinese Subjects","Inclusion Criteria:\n\n* Males or females aged 18 and older;\n* Adults being managed or treated for NAFL or NASH;\n* Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.\n\nExclusion Criteria:\n\n* Incompetent to understand and\u002For sign the informed consent;\n* Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female;\n* Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis\n* Diagnosis of liver cirrhosis and\u002For hepatocellular carcinoma;\n* Diagnosis of chronic inflammatory disease (i.e. inflammatory bowel disease, rheumatoid arthritis, inflammatory lung disease, severe infectious diseases), other than NAFL\u002FNASH.",{"count":282,"type":21},20000,"This is a 10-year, longitudinal, observational study of patients with NAFLD\u002FNASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, the biospecimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.",[203,285],"Non-Alcoholic Steatohepatitis (NASH)","2025-03-21",{"date":288,"type":34},"2025-03-24",{"date":290,"type":34},"2017-05-08",{"date":292,"type":21},"2027-09-30",{"name":294,"class":85},"Humanity and Health Research Centre",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":94,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":86},"100569491","phase-1-a-phase-1b-study-of-qx1206-in-t2dm-patients-with-nafld-100569491","NCT06694935","A Phase 1b Study of QX1206 in T2DM Patients With NAFLD","A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)","Inclusion Criteria:\n\n* Signed written informed consent must be obtained and documented\n* 18 years of age and \\\u003C 65 years old\n* BMI ≥ 18 kg\u002Fm\\^2 and \\\u003C 45 kg\u002Fm\\^2\n* T2DM diagnosed per 2021 American Diabetes Association criteria\n* Diagnosis of NAFLD\n* For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study\n* Women of child-bearing potential (WOCBP) must have a negative pregnancy test\n* Serum creatinine \\\u003C 1.5×ULN or creatinine clearance ≥ 60 ml\u002Fmin\n* Participating patients must be able to comply with all study requirements and the study center must have appropriate means of ensuring protocol compliance for each participating patient\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Patients with an active, serious medical disease that limit activities of daily living\n* Patients with current, significant alcohol consumption or a history of significant alcohol consumption\n* Patients with any of the following clinical laboratory abnormalities at screen and confirmed by a single repeat if deemed necessary:\n* Fasting triglycerides \\> 500 mg\u002FdL\n* Fasting direct LDL-C \\> 190 mg\u002FdL\n* AST \\> 5.0 × upper limit of normal (ULN)\n* ALT \\> 5.0 × ULN\n* Alkaline phosphatase (ALP) ≥ 2 × ULN\n* HbA1c \\> 10.5%\n* Fasting plasma glucose (FPG) \\> 240 mg\u002FdL (13.3 mmol\u002FL)\n* Platelets count \\\u003C 140,000\u002Fmm\\^3\n* Patient takes drugs historically associated with NAFLD and other known hepatotoxins\n* Treatment with drugs (e.g., vitamin E \\> 400 IU\u002Fday) or herbal supplements with potential anti-NAFLD effect","64 Years",{"count":304,"type":21},52,[119],"This is an open label phase 1b trial of QX1206 in patients with T2DM and with NAFLD. Laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout the study to determine the recommended phase 2 dose. In addition, the preliminary effects of QX1206 on antidiabetic activity and other metabolic parameters will also be evaluated.",[308,203],"Type 2 Diabetes Mellitus (T2DM)","2025-01-09",{"date":311,"type":34},"2025-01-13",{"date":313,"type":34},"2025-01-06",{"date":315,"type":21},"2025-12",{"name":317,"class":137},"1Globe Health Institute",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":144,"sex":16,"minAge":94,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":326,"conditions":327,"keywords":331,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":4},"100563970","integrated-phenotyping-of-the-gut-platelet-liver-axis-in-the-progression-of-chronic-liver-disease-igal-axis-100563970","NCT06623084","Integrated Phenotyping of the Gut-plAtelet-Liver AXIS in the Progression of Chronic Liver Disease (iGAL-AXIS)","Inclusion Criteria:\n\n* age\\>18;\n* NAFLD patients according to EASL Guidelines 2016.\n\nExclusion Criteria:\n\n* decompensated cirrhosis, other causes of chronic liver disease (infectious and immune-mediated); malabsorption syndromes (i.e., celiac disease, food allergy, small bowel bacterial overgrowth);\n* inflammatory bowel disease; previous GI surgery;\n* immunodeficiencies; neurological handicaps;\n* use of NSAIDs, antibiotics, probiotics, or anti-secretory drugs within the 2 months preceding enrollment;\n* abnormality of hemostasis and thrombosis; malignancies.",{"count":325,"type":21},132,"Objective of the study Our working hypothesis is that platelets activated by gut-derived metabolites dock in the liver of NAFLD patients and amplify the inflammatory state by releasing pro-inflammatory cytokines\u002Fchemokines, which in turn recruit and activate leukocytes in the liver sinusoids. Combined stimuli from leukocytes and platelets would then lead to metabolic reprogramming of hepatocytes, progression to NASH and eventually cirrhosis.\n\nTo test this hypothesis, the investigators propose 2 objectives. Primary objective: To identify platelet features that correlate with liver disease progression.\n\nSecondary objective: To study the mechanistic relationship between gut dysbiosis, metabolome composition, inflammation, and platelet activation in chronic liver disease.",[27,328,329,330],"NASH - Nonalcoholic Steatohepatitis","Cirrhosis","Control Condition",[332,333,334,335],"Platelets","Liver","Metabolomics","Microbiota","2024-10-02",{"date":338,"type":34},"2024-10-04",{"date":340,"type":21},"2024-09-30",{"date":342,"type":21},"2025-12-24",{"name":344,"class":85},"Stefania Basili"]