[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nash---nonalcoholic-steatohepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nash---nonalcoholic-steatohepatitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,42,67,90,123,146,174,195,221,243,277,302],{"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":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100556685","phase-3-a-study-evaluating-efruxifermin-in-subjects-with-compensated-cirrhosis-due-to-nashmash-100556685",false,"NCT06528314","A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH\u002FMASH","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH\u002FMASH","Inclusion Criteria:\n\n* Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH\u002FMASH and NAS score of \\>=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities\n* Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH\u002FMASH\n\nExclusion Criteria:\n\n* Other causes of liver disease based on medical history and\u002For liver histology and\u002For central laboratory results\n* Type 1 diabetes or unstable Type 2 diabetes\n* Any current or prior history of decompensated liver disease\n\nOther inclusion and exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":20,"type":21},2150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH\u002FMASH.",[27,28],"NASH - Nonalcoholic Steatohepatitis","MASH - Metabolic Dysfunction-Associated Steatohepatitis","RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2024-09-04",{"date":37,"type":21},"2030-03",{"name":39,"class":40},"Akero Therapeutics, Inc","INDUSTRY",322,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100330868","vertical-sleeve-gastrectomy-and-lifestyle-modification-for-the-treatment-of-non-alcoholic-steatohepatitis-100330868","NCT03587831","Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis","Inclusion Criteria:\n\n* Age 30 to 70 years at eligibility visit.\n* At least one of the following:\n* Diagnosed with NASH with a total NAS ≥ 4 including a ballooning score of at least 1\n* Diagnosed with T2DM or prediabetes, HbA1c\\\u003C 9%\n* Body Mass Index (BMI): 35.0-60.0 kg\u002Fm2 at eligibility visit.\n* Willingness to accept random assignment to either treatment group.\n* All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all participants enrolled in the study\n* Evidence of liver fat present in the baseline MR images\n* Suitable for liver biopsy\n* Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).\n* Written informed consent.\n* English speaking\n\nExclusion Criteria:\n\n* Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.\n* Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.\n* Pulmonary embolus or thrombophlebitis in the past six months.\n* Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.\n* Significant anemia (hemoglobin 2.0 g\u002FdL or more below normal range) or history of coagulopathy. (Low range for women would be 10, low range for men would be 11)\n* Serum creatinine \\>1.8 mg\u002FdL.\n* Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome, or alkaline phosphatase or ALT or AST greater than 2.5x the upper limit of normal. Elevated INR.\n* Alcohol intake more than one drink or \\>20 grams per day\n* History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.\n* Gastric or duodenal ulcer in the past six months.\n* History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).\n* Previous organ transplantation.\n* Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.\n* Currently pregnant or nursing, or planning to become pregnant in the next two years.\n* History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.\n* Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.\n* A score of 17 or greater on the CES-D questionnaire administered on a typical week for the participant.\n* Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.\n* Serum c-peptide \\\u003C1.0 ng\u002Fml post prandial.\n* Exclusions may also be made at the discretion of the attending physician or the eligibility committee.\n* History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus.\n* Any history of dysphagia.\n* Fibrosis score \\> 3\n* Use of Rezdiffra (resmetirom).","30 Years","70 Years",{"count":51,"type":21},48,[53],"NA","Participants meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months. The primary goal for the trial is to determine if the investigators can recruit, randomize, and retain participants to perform invasive and non-invasive measurements of NASH and fibrosis, deliver lifestyle modification and demonstrate the safety of VSG. The investigators wish to also understand which of these two interventions is more effective in achieving, 12 months after entry into the trial, a reduction in NAS composed of the non-weighted scores: (1) steatosis 0-3 (2) Inflammation 0-3 and (3) ballooning 0-2. Secondary goals include comparing the two treatment groups for changes in other measured outcomes including MRI assessments of intrahepatic triglyceride and liver elasticity and serum markers. As a pilot study, a sample size of 20 in each group should offer significant information as to the difference in NAS score reduction between to two groups and achieve adequate power to distinguish clinically significant changes in the primary and secondary outcome measures. These data support the overarching objective i.e. to provide evidence that a larger, longer-term clinical outcomes trial is feasible. A goal is for a longer term follow up for 5 years to assess the durability of treatment effects and treatment differences.",[27],"2026-05-28",{"date":58,"type":33},"2026-05-29",{"date":60,"type":33},"2021-07-01",{"date":62,"type":21},"2026-09-15",{"name":64,"class":65},"University of Minnesota","OTHER",4,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100366672","non-invasive-quantification-of-liver-health-in-nash-n-quan-100366672","NCT04054310","Non-Invasive Quantification of Liver Health in NASH (N-QUAN)","Non-Invasive Quantification of Liver Health in NASH (N-QUAN): A Prospective Diagnostic Accuracy Study","Inclusion Criteria:\n\n* Male and Female subjects aged between 18 and 75 years old\n* Ability to understand and sign a written informed consent forms\n* Patients scheduled to undergo a standard of care diagnostic liver biopsy as follows\n* Percutaneous biopsy with a 16 gauged needle passed into the right lobe\n* Trans-jugular biopsy with an 18 gauged needle passed into the right lobe\n* Patients who are suspected of having NAFLD, who are being considered for treatment, and presenting with two or more of the following risk factors for NASH\n* Elevated liver enzymes (ALT≥40)\n* BMI≥25kG\u002Fm\\^2\n* Hypertension\n* Type II diabetes\n* Dyslipidameia\n* Low High-density lipoprotein (HDL) (\\\u003C40mg\u002Fdl in men or \\\u003C50mg\u002Fdl in women)\n* Hypertriglyceridemia (≥150mg\u002Fdl)\n* Hypercholestrolemia (≥200mg\u002Fdl)\n* Triglycerides (TG)\u002FHDL\\>5.0\n\nExclusion Criteria:\n\n* Prior histopathological diagnosis of NASH\n* Inability to undergo a liver biopsy\n* Prior or planned liver transplantation\n* Patient scheduled to undergo a laparoscopic or wedge liver biopsy or biopsy taken from the left lobe\n* Participation in an investigational new drug (IND) trial in the 30 days before enrolment\n* Other known causes of chronic liver disease based on clinical criteria at the study site such as the following:\n* Alcoholic liver disease\n* Primary biliary cirrhosis\n* Primary sclerosing cholangitis\n* Autoimmune Hepatitis\n* Wilson's disease, hemochromatosis, iron overload\n* Alpha\u002F1\u002FAntitrypsin (A1AT) deficiency\n* HCV, HBV\n* History or diagnosis of cirrhosis and or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding\n* Clinically relevant drug or alcohol abuse within 12 months of screening\n* Any contradiction or significant limitation to MRI scanning\n* Claustrophobia preventing MR imaging (requires 15-30 minutes in scanning)\n* Pacemaker or another implanted device\n* Metal in body (such as an aneurysm clip) that might produce artefacts on abdominal MRI or might be adversely impacted by a high magnetic field\n* Inability to lie flat, remain still or briefly hold breath as necessary during MR imaging\n* Medical condition likely to produce significant hypervolemia like congestive heart failure\n* Severe obesity complicating positioning in MR scanner\n* Weight reduction surgery within 3 years\n* Concomitant medical illnesses per investigators discretion (such as HIV infection, recent major surgery, uncontrolled heart disease, concurrent infection or fever of unknown origin, illicit drug use, cancer\n* Clinically significant medical or psychiatric condition considered a high risk participation in an investigational study\n* Failure to give informed consent","75 Years",{"count":76,"type":21},225,[53],"To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \\& F≥2 from those without.",[27],"2026-05-18",{"date":82,"type":33},"2026-05-19",{"date":84,"type":33},"2020-08-05",{"date":86,"type":21},"2026-06-01",{"name":88,"class":40},"Perspectum",7,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100321996","a-randomized-controlled-study-evaluating-bariatric-surgery-as-a-treatment-for-severe-nash-with-advanced-liver-fibrosis-in-non-severe-obese-patients-100321996","NCT03472157","A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients","Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH","NASHSURG","Inclusion Criteria:\n\n* Provide written informed consent and agree to comply to the study protocol prior to enrolment.\n* BMI and Brunt Fibriosis score:\n\n  * For F3 fibrosis patients: 35\\>BMI≥ 30kg\u002Fm² ; Fibroscan ≥ 9kPa or FibrometreVM ≥0.526 predicting a F3 fibrosis score grade within 1 month before inclusion or F3 fibrosis score grade diagnosed by hepatic biopsy performed before inclusion.\n  * For F4 fibrosis patients: 50\\>BMI≥ 30kg\u002Fm² ; Fibroscan ≥ 15kPa predicting a F4 fibrosis score grade within 1 month before inclusion or F4 fibrosis score grade diagnosed by hepatic biopsy performed before inclusion.\n* Fibroscan ≥ 9kPa or FibrometreVM ≥0.526 predicting a F3 or F4 fibrosis score grade within 1 month before inclusion Or F3 or F4 fibrosis score grade diagnosed by hepatic biopsy performed before inclusion.\n* Patient should agree to have one liver biopsy during the screening period (before randomization, the randomization will be permitted after at least a second reading performed by pathologist of CHRU Lille to confirm the histological diagnosis of NASH with advanced fibrosis (F3-F4)) for the diagnosis purpose (if no histological biopsy within 1 month before inclusion is available) and one at the end of the treatment period for assessment of the treatment effects.\n* For patients with cirrhosis, patients must fulfil all the following criteria: Platelets \\> 125 000, PT \\> 80 %, Albumin \\> 35 g\u002FL, MELD score at inclusion \\\u003C 9, CPT score \\\u003C 6, No history of previous decompensation, No oesophageal varices (endoscopy), No vascular shunt, ASA score ≤ III, Alcohol consumption lower than 20g\u002Fday for women and 30g\u002Fday for men.\n* For hypertensive patients, hypertension must be controlled by stable dose of anti-hypertensive medication for at least 2 months prior to screening (and the stable dose can be maintained throughout the study).\n* Female participating in the study must be either of non-child bearing (surgically sterilized at 6 month prior to screening or postmenopausal) or using an efficient contraception: hormonal contraception (including patch, contraceptive ring etc) intra-uterine device or other mechanical contraception\n* Patient agrees to come to the study visits within the protocol-specified delay\n\nExclusion Criteria:\n\n* Previous history of bariatric surgery (except gastric ring removed for more than 3 years).\n* Decompensated cirrhosis (MELD\\> 7 CPT score\\> 5, previous history of decompensation (encephalopathy, ascites, jaundice, varicose vein rupture)\n* Hepatocellular carcinoma\n* Platelets \\\u003C125 000; TP \\\u003C80%; bilirubin \\\u003C20 mmol \u002F l; albumin \\\u003C35 g \u002F L.\n* Other liver disease: alcohol consumption exceeding 20 g \u002F day for women and 30g \u002F day in men, HBV, HCV, CBP, CSP, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin.\n* Being processed Cancer (chemotherapy, radiotherapy or hormone therapy)\n* HIV positive patients\n* Patients who had an acute cardiovascular episode, coronary Heart Disease (Angina pectoris, myocardial infarction, revascularization procedure), stroke or TIA (Transient Ischemic Attack) within the 6 months prior to screening Recent cardiovascular events (stroke, myocardial infarcts, etc…) in the past 6 months.\n* Severe chronic respiratory disease.\n* Severe chronic cardiac insufficiency (grade III and IV of NYHA classification).\n* Pregnant or breastfeeding women.\n* Simultaneous enrollment in another clinical trial.\n* Drug abuse within the past year.\n* Patient with contra-indication for bariatric surgery\n* Gastic Banding, Biliopancreatic diversion and all the new bariatric surgery techniques are forbidden because the study design allow only the laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric Bypaass.\n* History of cancer, except:\n\n  * Patients considered in remission for at least 5 years after onset of treatment.\n  * Patients Treated and believed to be cured basal or squamous cell carcinoma of the skin or resected carcinoma of the cervix","65 Years",{"count":100,"type":21},100,[53],"The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg\u002Fm² \\> BMI ≥ 30 kg\u002Fm²) with NASH complicated of advanced fibrosis (F3 and F4 fibrosis grade according to Brunt score).",[104,105,27,106],"Surgery","Obesity","Cirrhosis",[108,109,110,111,112,106],"Gastric bypass","Sleeve gastrectomy","Lifestyle therapy","NASH","Advanced fibrosis","2026-04-21",{"date":115,"type":33},"2026-04-22",{"date":117,"type":33},"2018-06-20",{"date":119,"type":21},"2028-06-20",{"name":121,"class":65},"University Hospital, Lille",1,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100321721","phase-2-a-randomized-double-blind-placebo-controlled-study-to-assess-the-efficacy-and-safety-of-snp-610-for-the-treatment-of-patients-with-non-alcoholic-steatohepatitis-100321721","NCT03468556","A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis","Inclusion Criteria:\n\n1. Age ≥ 20 years\n2. Body weight ≥ 54 kg\n3. Diagnosis of non-alcoholic steatohepatitis (NASH) as evidenced by imaging or other diagnostic assessments. Subject should have documented liver fat content ≥ 10.0 % as measured by MRI method prior to study drug administration.\n4. Alanine aminotransferase (ALT) levels ≥ 2.0x upper limit of normal (ULN) on at least two occasions, seven or more days apart, prior to study drug administration\n5. Have adequate organ functions as defined by the following examinations prior to the start of study treatment:\n\n   1. Hematology: Hemoglobin ≥ 9 g\u002FdL, a platelet count ≥ 100 x 10\\^9\u002FL, and a white blood cell count ≥ 3.0 x 10\\^9\u002FL\n   2. Renal: creatinine clearance ≥ 90 mL\u002Fmin (by Cockcroft-Gault equation), serum uric acid \\\u003C 9.0 mg\u002FdL\n6. Able to provide written informed consent, and understand and comply with the requirements of the study\n\nExclusion Criteria:\n\n1. Decompensated or severe liver disease as evidenced by one or more of the following:\n\n   1. Confirmed cirrhosis or suspicion of cirrhosis\n   2. Liver transplant\n   3. Liver malignancy\n   4. Ascites\n   5. Bilirubin \\>2 x ULN, or ALT or AST \\> 10 x ULN\n   6. Acute or chronic hepatitis A, B, C, HIV, or other liver diseases affecting liver function.\n\n   Patients with cysts, hemangiomas, or similar abnormalities, are accepted.\n2. History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 glasses of 120-mL wine or 14 cans of 350-mL beer), or other substance abuse within the prior two years\n3. Subjects who are unable to undergo an MRI scan.\n4. Subjects have electronically, magnetically and mechanically activated implanted devices, including but not limited to automatic cardioverter defibrillators, cardiac pacemakers, insulin pumps, metallic splinters in the eye, ferromagnetic haemostatic clips in central nervous systems or vascular vessels.\n5. Significant systemic or major illness other than liver disease, including auto-immune disease, coronary artery disease, cerebrovascular disease, malignant neoplasms, pulmonary disease, renal insufficiency, serious psychiatric disease, and\u002For other serious disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study\n6. Documented history of serious allergic reaction to SNP-610 or any structurally related compounds\n7. Diabetic patients who have not maintained a stable dose of oral medication for hyperglycemia or have had more than 10 percent change in their insulin dose over the past two months\n8. Regular use of agents that are potent against hepatitis or affecting lipid metabolisms, including but not limited to HMGCoA reductase inhibitors (statins), fibrates, silymarin, N-acetylcysteine, or anti-TNF therapies.\n\n   Note: refer to Section 6.5 Prohibited agents for details.\n9. Pregnant or lactating\n10. Female of child-bearing potential who are not committed to take reliable contraception during the participation of the study and at least 4 weeks after the end of the study treatment","20 Years",{"count":131,"type":21},80,[133],"PHASE2","The primary objective of the study is to compare the changes in serum ALT level among patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg SNP-610 or the placebo. The secondary objectives will be to compare the changes in liver fat fraction, other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event \u002F serious adverse event rates among the interventional and placebo arms.",[27],"NOT_YET_RECRUITING","2026-03-16",{"date":139,"type":33},"2026-03-18",{"date":141,"type":21},"2026-04-01",{"date":143,"type":21},"2027-12-30",{"name":145,"class":40},"Sinew Pharma Inc.",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":153,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":154,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":172,"locationsCount":122},"100380359","investigating-the-link-between-type-2-immunity-and-nafld-in-human-obesity-100380359","NCT04232566","Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity","Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1","Inclusion Criteria:\n\n* Undergoing gastric bypass surgery\n* Confirmed AUROC F=0 or F\\>2 liver fibrosis\n* Age 30-70 years\n* BMI greater than 40 kg\u002Fm2\n* Negative pregnancy test (female only)\n* Lab Values: Normal TSH\n\nExclusion Criteria:\n\n* Autoimmune diseases\n* Hepatitis B or C positive\n* Heavy alcohol use\n* Active smoking history\n* Active cancer history\n* History of asthma\n* History of COPD\n* Taking Plavix or Coumadin\n* Blood donation within past 2 months\n* Glucocorticoid Therapy\n* Taking antihistamine on regular basis",true,{"count":155,"type":21},60,"OBSERVATIONAL","This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.",[159,27,160],"Obesity, Morbid","Chronic Inflammation",[162,163,164,165],"obesity","nash","adipose tissue inflammation","insulin resistance","2026-01-26",{"date":168,"type":33},"2026-01-28",{"date":170,"type":33},"2022-02-20",{"date":143,"type":21},{"name":173,"class":65},"Mayo Clinic",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":180,"minAge":181,"maxAge":49,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":122},"100426448","phase-3-estrogen-administration-for-the-treatment-of-nash-in-postmenopausal-women-100426448","NCT04833140","Estrogen Administration for the Treatment of NASH in Postmenopausal Women","Inclusion criteria:\n\n* Postmenopausal women 45-70 years old\n* NASH by biopsy or NAFLD by imaging within 6 months of screen\n* Hepatitis C antibody and hepatitis B surface antigen negative\n* Negative mammogram within 1 year\n\nExclusion criteria:\n\n* Heavy alcohol use\n* Use of NASH pharmacotherapies within 12 months of study entry\n* Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam\n* Participation in NASH clinical trial within 6 months of study entry\n* Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry\n* Known diagnosis of chronic liver disease other than NAFLD or found on biopsy\n* Contraindication to liver biopsy including INR \\> 1.5, platelets \\\u003C 50,000\u002FmL, ascites, chronic anticoagulation (other than aspirin), biliary obstruction, peritonitis, inability to lie supine for 30 minutes\n* Hgb \\\u003C 10.0 g\u002FdL or glomerular filtration rate \\\u003C 60 mL\u002Fmin\n* Contraindications to estrogen therapy\n* Any vaginal bleeding, including spotting, within the last year\n* Active malignancy\n* Severe chronic illness\n* Use of estrogen or progesterone within a year of baseline visit\n* Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip","FEMALE","45 Years",{"count":155,"type":21},[24],"Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fibrosis and fat in post-menopausal women with NASH.",[27],"2025-08-01",{"date":188,"type":33},"2025-08-03",{"date":190,"type":33},"2021-12-02",{"date":192,"type":21},"2027-05-31",{"name":194,"class":65},"Massachusetts General Hospital",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":153,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":203,"conditions":204,"keywords":207,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"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":202,"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.",[205,27,106,206],"Non-alcoholic Fatty Liver Disease (NAFLD)","Control Condition",[208,209,210,211],"Platelets","Liver","Metabolomics","Microbiota","2024-10-02",{"date":214,"type":33},"2024-10-04",{"date":216,"type":21},"2024-09-30",{"date":218,"type":21},"2025-12-24",{"name":220,"class":65},"Stefania Basili",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100416065","phase-2-namodenoson-in-the-treatment-of-non-alcoholic-steatohepatitis-nash-100416065","NCT04697810","Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)","A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. AST at Screening of ≥20 IU\u002FL.\n3. FibroScan LSM ≥8.5 kPa\n4. Diagnosis of NASH by biopsy at Screening showing NAS ≥4 by central read, with a score of at least 1 point in each of the 3 histologic categories of steatosis, inflammation, and hepatocellular ballooning (Kleiner 2005). If the subject has had a qualifying liver biopsy within 6 months prior to Baseline and the slides are available for central read prior to randomization, this biopsy can be waived.\n5. Concomitant biopsy-proven Stage 1-3 hepatic fibrosis by NASH CRN criteria by central read (Kleiner 2005).\n6. At least 2 of the following criteria for the metabolic syndrome:\n\n   * Obesity, defined waist circumference \\>88 cm for women or \\>102 cm for men\n   * Hypertriglyceridemia, defined as \\>150 mg\u002FdL (\\>1.7 mmol\u002FL) or on drug treatment for hypertriglyceridemia\n   * Reduced high-density lipoprotein (HDL) cholesterol, defined as \\\u003C40 mg\u002FdL (\\\u003C1.03 mmol\u002FL) in men or \\\u003C50 mg\u002FdL (\\\u003C1.3 mmol\u002FL) in women\n   * History of hypertension, currently controlled in the judgment of the Investigator\n   * Elevated fasting glucose, defined as ≥100 mg\u002FdL (≥5.6 mmol\u002FL).\n7. Acceptable hepatic metabolic and synthetic function, as indicated at Screening by:\n\n   * Serum albumin ≥3.5 gm\u002FdL\n   * International normalized ratio ≤1.3\n   * Serum total bilirubin ≤2.0 mg\u002FdL (unless subject has known Gilbert's Syndrome).\n8. The following laboratory values must be documented at Screening:\n\n   * Absolute neutrophil count at least 1.0 x 109\u002FL\n   * Platelet count at least 150 x 109\u002FL\n   * Estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73m2\n9. Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or are post-menopausal, defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range.\n10. Male subjects must refrain from sperm donation during treatment and until at least 90 days after the end of study drug dosing. Male subjects with fertile or pregnant partners must agree to use condoms throughout the course of the trial and for 3 months after.\n11. Patients taking herbal supplements, homeopathic medications, or other alternative treatments, must be on a stable regimen for at least 3 months prior to randomization.\n12. Understand and provide written informed consent to participate.\n13. Willing to undergo 2 liver biopsies.\n14. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.\n2. Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular carcinoma.\n3. Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.\n4. Weight loss of \\>5% within 3 months prior to Baseline.\n5. History of bariatric surgery within 5 years of Screening.\n6. Diabetes mellitus other than Type II.\n7. Hemoglobin A1c \\>9.0% (subjects with diabetes).\n8. Any contraindication to percutaneous liver biopsy.\n9. Daily alcohol intake \\>20 g (2 units)\u002Fday for women and 30 g (3 units)\u002Fday for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire.\n10. Treatment with therapeutic doses of Vitamin E (≥800-1000 IU daily), or any of the following anti-diabetic medications: GLP-1 receptor agonists (such as Januvia \\[sitagliptin\\], Byetta \\[incretin\\], etc.), pioglitazone, or SGLT2 inhibitors (\"gliflozin\" drugs); unless the dose and regimen has been stable for at least 3 months.\n11. Active rheumatoid arthritis treated with small-molecule (including methotrexate) or biologic disease-modifying anti-rheumatic agent concurrently or within 1 year.\n12. Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids \\>10 mg prednisone-equivalent concurrently or within 1 year.\n13. More than 7 days of treatment with valproic acid, tamoxifen, amiodarone, or anti-cholinergic agents within 3 months.\n14. Uncontrolled or clinically unstable thyroid disease.\n15. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4), or other heart disease which is, in the Investigator's judgment, clinically unstable.\n16. Angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months.\n17. QTcF interval on Screening Visit ECG or an average of triplicate Baseline Visit ECGs \\> 450 milliseconds (msec) for males or \\> 470 msec for females.\n18. A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome.\n19. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes.\n20. Active gastrointestinal disease which could interfere with the absorption of oral medication.\n21. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that would make the patient inappropriate for entry into this study.",{"count":229,"type":21},114,[133],"Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo liver biopsy.",[27],"2024-07-30",{"date":235,"type":33},"2024-07-31",{"date":237,"type":33},"2021-12-10",{"date":239,"type":21},"2025-10-15",{"name":241,"class":40},"Can-Fite BioPharma",24,{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":249,"enrollmentInfo":250,"targetDuration":252,"studyType":156,"phases":4,"briefSummary":253,"conditions":254,"keywords":264,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":276},"100396456","the-european-nafld-registry-100396456","NCT04442334","The European NAFLD Registry","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Clinically suspected NAFLD based on any of:\n\n   1. Patient with historical liver biopsy providing histological evidence of NAFLD or,\n   2. Patient undergoing liver biopsy for suspected NAFLD with biochemical and\u002For radiological findings consistent with NAFLD or,\n   3. Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome':\n\n      * Increased waist circumference by ethnically adjusted criteria (e.g. Europid male\u002Ffemale ≥94cm\u002F80cm) or overweight\u002Fobese (BMI ≥25);\n      * Raised fasting glucose ≥100 mg\u002FdL \\[5.6 mmol\u002FL\\], HbA1c ≥48mmol\u002Fmol (6.5%) or previously diagnosed insulin resistance\u002Ftype 2 diabetes mellitus (or on treatment);\n      * Dyslipidaemia (fasting TG level ≥150 mg\u002FdL \\[1.7 mmol\u002FL\\]; or fasting HDL \\\u003C40 mg\u002FdL \\[1.03 mmol\u002FL\\] in males and \\\u003C50 mg\u002FdL \\[1.29 mmol\u002FL\\] in females; or on treatment);\n      * Hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on treatment).\n3. Average alcohol consumption less than 21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.\n\nExclusion Criteria\n\n1. Refusal or inability (lack of capacity) to give informed consent.\n2. Average alcohol ingestion greater than approximately 21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.\n3. History or presence of Type 1 diabetes mellitus.\n4. Presence of any other form of chronic liver disease except NAFLD.\n5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \\[\\>10 days\\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).\n6. Any contra-indication to liver biopsy.\n7. Recent (within 3 months) change in dose\u002Fregimen or introduction of Vitamin E (at a dose ≥400 IU\u002Fday), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.\n8. Non-English speaking\u002Funable to access an interpreter. Due to the nature of the study, English language or access to a relevant interpreter is a necessary criterion to ensure lifestyle (diet and exercise) and symptom data are collated.\n9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.","100 Years",{"count":251,"type":21},10000,"10 Years","The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and\u002For from NAFL through NASH to fibrosis and cirrhosis.",[255,111,27,256,257,258,259,260,261,262,105,263],"NAFLD","Fibrosis, Liver","Steatosis of Liver","Hepatocellular Carcinoma","Cardiovascular Diseases","Type 2 Diabetes","Dyslipidaemia","Hypertension","Other Associated Comorbidities",[255,111,265,209,106,266],"Steatohepatitis","Non-alcoholic fatty liver disease","2023-01-05",{"date":269,"type":33},"2023-01-06",{"date":271,"type":33},"2015-05-01",{"date":273,"type":21},"2030-12-31",{"name":275,"class":65},"Newcastle University",37,{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100433533","the-french-national-nafld-cohort-french-patients-with-metabolic-steatosis-100433533","NCT04925362","THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)","Identification of Clinical and Biological Factors Determining Disease Severity and Disease Progression in NAFLD: \"THE FRENCH NATIONAL NAFLD COHORT\" FRAMES (FRench pAtients With MEtabolic Steatosis)","FRAMES","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Patients with a confirmed diagnosis of NAFLD\n3. Patients affiliated to French social security\n4. Written informed consent signed by the patient\n\nExclusion Criteria:\n\n1. Refusal or inability (lack of capacity) to give informed consent.\n2. Average alcohol ingestion greater than 21\u002F14 units\u002Fweek (males\u002Ffemales) in the preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.\n3. History or presence of Type 1 diabetes mellitus.\n4. Presence of any other form of chronic liver disease except NAFLD\n5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \\[\\>10 days\\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).\n6. Any contra-indication to liver biopsy.\n7. Recent (within 3 months) change in dose\u002Fregimen or introduction of Vitamin E (at a dose ≥400 IU\u002Fday), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.\n8. Non-French speaking\u002Funable to access an interpreter.\n9. Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. judged by the physician as unlikely to be compliant with the study protocol).\n10. Pregnant or breastfeeding women\n11. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom",{"count":286,"type":21},900,[53],"The main objective of this cohort study is to determine genetic, clinical biologic and metabolic factors associated with patient heterogeneity in regards to severity of NAFLD at diagnosis as well as during the clinical course.\n\n* at diagnosis, with the aim to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis\n* during the clinical course to better understand and predict disease progression in terms notably of fibrosis progression and progression to cirrhosis",[255,111,27,290,106],"Fibrosis",[292],"Cohort","2021-06-07",{"date":295,"type":33},"2021-06-14",{"date":297,"type":21},"2021-06",{"date":299,"type":21},"2036-06",{"name":301,"class":65},"Assistance Publique - Hôpitaux de Paris",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":311,"conditions":312,"keywords":319,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":122},"100390983","protocol-of-metabolic-and-cryptogenic-liver-disease-registry-for-integration-of-omic-studies-100390983","NCT04371042","PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies","PROMETEO","Inclusion Criteria:\n\n* Age ≥18 years\n* Clinical phenotype of NAFLD (simple steatosis, NASH, metabolic cirrhosis, NAFLD-HCC) based on any of:\n* Liver biopsy providing histological evidence of NAFLD or,\n* Biochemical and\u002For radiological findings consistent with NAFLD\n* Average alcohol consumption ≤21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.\n* Clearance of HCV infection with new DAAs drugs with a SVR (sustained virological response) period \\> 6 months\n* Presence of risk factors for NAFLD (i.e. diabetes, metabolic syndrome, obesity, psoriasis) and absence of fatty liver at US\n\nExclusion Criteria:\n\n* Refusal or inability (lack of capacity) to give informed consent.\n* Average alcohol ingestion \\>21\u002F14 units\u002Fweek (males\u002Ffemales) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.\n* History or presence of Type 1 diabetes mellitus.\n* Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.",{"count":310,"type":21},5000,"The main aim of the study is to set up an observational cohort with NAFLD (Non-alcoholic fatty liver disease) at different stage of disease (from simple steatosis to cirrhosis and\u002For HCC-Hepatocellular carcinoma) and for comparative purpose a cohort of subjects with diabetes and\u002For obesity and\u002For other risk factors (i.e. psoriasis, IBD (inflammatory bowel disease), dyslipidemia) without NAFLD in order to have a clinical phenotypical characterization and the collection of biological specimens.\n\nWe will collect clinical data, biological samples and imaging results in order to perform future cross-sectional studies and\u002For longitudinal studies for elucidating pathways of the disease and develop and validate biomarkers for diagnosis, prognosis and monitoring liver disease and comorbidities in order to contribute to precision medicine in this field.",[313,314,105,315,106,316,27,317,318],"NAFLD - Nonalcoholic Fatty Liver Disease","Diabetes","Metabolic Syndrome","Liver Cancer","HCC - Hepatocellular Carcinoma","Fatty Liver",[255,111,320,321,322,323],"NON-ALCHOLIC","LIVER","CIRRHOSIS","HEPATOCELLULAR CARCINOMA","2020-04-28",{"date":326,"type":33},"2020-05-01",{"date":328,"type":33},"2019-09-01",{"date":330,"type":21},"2035-12-31",{"name":332,"class":65},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]