[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mash---metabolic-dysfunction-associated-steatohepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mash---metabolic-dysfunction-associated-steatohepatitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,46,71,102,126,153,181,216,241,264,285,306,332,356,383,417],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100579490","time-restricted-eating-and-healthy-eating-in-patients-with-metabolic-liver-disease-or-cancer-100579490",false,"NCT06824974","Time-restricted Eating and Healthy Eating in Patients With Metabolic Liver Disease or Cancer","Feasibility Study of Time Restricted Eating and a Healthy Diet in Patients Receiving Liver-Directed Therapy for Hepatocellular Carcinoma","TRE+HE","Inclusion Criteria:\n\n1. Overweight or obese (BMI 27-45 kg\u002Fm2)\n2. Diagnosed with metabolic-dysfunction associated steatitic liver disease (MASLD\u002FNAFLD), metabolic-dysfunction associated steatohepatitis, cirrhosis or liver cancer (BCLC early to intermediate stage HCC)\n3. English or Spanish speaking over the age of 18.\n4. ECOG Performance Status ≤ 2.\n5. Usual nightly fasting \\\u003C12 hours\n6. Willing to comply with all study procedures\n7. Life expectancy of \\> 12 months\n\nExclusion Criteria:\n\n1. Advanced HCC, progression, and\u002For associated comorbidities\n2. Metastatic disease, tumor in vein, or ascites\n3. Advanced Cirrhosis (hypoalbuminemia\u002FChild-Pugh B+C).\n4. Poorly controlled or refractory (grade 3-4) hepatic encephalopathy\n5. Type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by CGM\n6. Participation in another conflicting study that requires modification of diet or food timing.\n7. Patients on GLP-1 receptor agonists\n8. Uncontrollable eating pattern (e.g., wasting, Night Eating Syndrome, disordered eating habits, food insecurity)\n9. Medications that markedly impact metabolic study biomarkers.\n10. Other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ)\n11. Serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial.\n12. Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy\n13. Active alcohol abuse or less than 6 months of sobriety\n14. Participation in a trial of an investigational agent within the prior 30 days\n15. Pregnancy or lactating, positive hCG urine test.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a feasibility study that will collect data to assess the potential effect of nutritional intervention. This prospective single-site trial will enroll adult patients with liver diseases such as metabolic-dysfunction associated steatotic liver disease (MASLD), metabolic-dysfunction associated steatohepatitis (MASH), cirrhosis and\u002For hepatocellular carcinoma (HCC). Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating plus targeted healthy changes in what they eat (TR-HE). The intervention includes dietary counseling visits with a study registered dietitian (RD) and motivational phone calls with a study Certified Health and Wellness Coach (HC). Individuals who are randomized to the control group or who elect to join the control group will be enrolled in a six-month period of observation and phlebotomy only. The main questions it aims to answer are:\n\nIs a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver disease or cancer? Does the intervention improve liver metabolism?",[27,28,29],"Liver Cancer, Adult","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Obesity and Overweight",[31,32],"Time-restricted eating","healthy diet","RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":37},"2025-08-01",{"date":41,"type":21},"2028-12",{"name":43,"class":44},"University of California, San Diego","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100641831","phase-3-a-phase-3-study-evaluating-the-safety-and-efficacy-of-hsk31679-in-patients-with-mash-100641831","NCT07581951","A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (MASH)","Key Inclusion Criteria:\n\n* 1\\. Must be willing to participate in the study and provide written informed consent.\n* 2.Male and female adults ≥ 18 years of age.\n* 3.Have at least one cardiometabolic risk factors at screening.\n* 4.MRI-PDFF fat fraction ≥8%.\n* 5.Have a liver biopsy performed within 6 months prior to randomization, with histologically confirmed MASH assessed by the central laboratory; NAS score ≥ 4 points with at least 1 point each for inflammation and hepatocellular ballooning; meanwhile, CRN fibrosis stage is F2 ≤ fibrosis \\\u003C F4. If no liver biopsy data are available within 6 months prior to randomization, a liver biopsy must be completed during the screening period.\n* 6.Body weight fluctuation \\\u003C 5% for at least 6 weeks before randomization.\n\nKey Exclusion Criteria:\n\n* 1\\. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.\n* 2.MELD score ≥12 due to hepatic disease。\n* 3.Received medication therapy that may induce MAFLD\u002FMASH for ≥ 2 weeks within 12 months prior to liver biopsy (including historical biopsy).\n* 4.Participants who had not been on stable medication with vitamin E (dose\\>400 IU\u002Fday) or polyunsaturated fatty acids or ursodeoxycholic acid within 6 months prior to liver biopsy (including historical biopsy); or had not been on stable medication with thiazolidinediones (TZD), sodium-glucose cotransporter 2 (SGLT2) inhibitors, or complex oral antidiabetic (OAD) regimens (≥3 OADs) within 3 months prior to liver biopsy (including historical biopsy).\n* 5.Participants who have undergone bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass, etc.) within 5 years prior to screening or plan to receive such surgery during the study.\n* 6.HbA1c ≥ 8.0%.\n* 7.Chronic liver diseases other than NASH.\n* 8.Active autoimmune disease. 9.Serum ALT \\> 250 U\u002FL. 10.Active, serious medical disease with a likely life expectancy \\\u003C 2 years.",{"count":54,"type":21},400,[56],"PHASE3","A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .",[28,59],"NASH (Non-Alcoholic Steatohepatitis)","NOT_YET_RECRUITING","2026-06-15",{"date":63,"type":37},"2026-06-17",{"date":65,"type":21},"2026-06-30",{"date":67,"type":21},"2032-12-30",{"name":69,"class":70},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100618744","phase-2-study-to-evaluate-resmetirom-in-post-liver-transplant-patients-with-mash-100618744","NCT07335601","Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH","Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate MGL-3196 (Resmetirom) in Patients With MASH Who Have Undergone Liver Transplant for MASH Cirrhosis or Other Etiologies","Inclusion Criteria:\n\n1. At least 12 months post-liver transplant at screening and meeting one of the following:\n\n   * Cohort 1: Liver transplant for MASH cirrhosis with recurrent hepatic steatosis ≥8% by MRI-PDFF\n   * Cohort 2: Liver transplant for non-MASH etiology with de novo hepatic steatosis ≥8% by MRI-PDFF\n2. Presence of at least one metabolic risk factor, including overweight\u002Fobesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive treatment, hypertriglyceridemia or low HDL cholesterol, or lipid-lowering therapy.\n3. MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and\u002For MRE) and a liver biopsy consistent with Stage F2\u002FF3 MASH and no evidence of other liver pathology or graft rejection.\n4. Stable renal function with estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m² prior to and during screening.\n5. Stable liver enzymes at screening, without clinically significant worsening compared with recent historical values.\n6. Stable immunosuppressive regimen for at least 3 months prior to screening.\n7. Females of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective contraception during the study and for at least 30 days after the last dose; females not of childbearing potential are eligible.\n\nExclusion Criteria:\n\n1. Participation in another interventional clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.\n2. Phosphatidylethanol (PEth) value of ≥20 ng\u002FmL measured at screening or clinically significant alcohol use within 1 year prior to screening.\n3. FibroScan VCTE \\>20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE \\> 5 kPa.\n4. Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.\n5. Evidence of active liver disease other than MASH.\n6. History of liver transplantation for an inborn error of metabolism.\n7. Evidence of hepatic impairment or decompensation at screening.\n8. Steroid resistant rejection of the transplanted liver or kidney, or a history of a rejection treated with high dose steroid within 3 months of screening.\n9. Chronic rejection or chronic plasma-cell hepatitis.\n10. Significant post-transplant vascular or biliary complications.\n11. Significant cardiovascular or cerebrovascular disease within 6 months prior to randomization.\n12. Uncontrolled hypertension at screening or randomization.\n13. Current hepatocellular carcinoma.\n14. Known human immunodeficiency virus (HIV) infection or other clinically significant immunocompromised state.\n15. Any serious medical condition with a life expectancy of less than 5 years.\n16. Current substance abuse or drug addiction.\n17. Significant psychiatric, cognitive, or social conditions that would interfere with study participation or compliance, in the Investigator's judgment.\n18. Known hypersensitivity to study drug or any of its excipients.\n19. Use of prohibited concomitant medications that may affect liver function, steatosis, thyroid function, or study outcomes, or unstable doses of allowed metabolic therapies prior to randomization.\n20. Use of statins above protocol-allowed doses or unstable lipid-lowering therapy prior to randomization.\n21. Contraindications to MRI, including implanted devices incompatible with MRI, severe claustrophobia, or inability to undergo MRI procedures.","75 Years",{"count":80,"type":21},120,[82],"PHASE2","A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH. Cohort 2 will consist of subjects who have undergone liver transplant for indications other than MASH cirrhosis who developed de novo MASH.",[28],[86,87,88,89,90,91],"Post-Liver Transplant","Cirrhosis","Metabolic dysfunction-associated steatohepatitis (MASH)","MASLD","MASH","Liver","2026-06-12",{"date":94,"type":37},"2026-06-16",{"date":96,"type":37},"2025-12-29",{"date":98,"type":21},"2029-03",{"name":100,"class":70},"Madrigal Pharmaceuticals, Inc.",17,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100556685","phase-3-a-study-evaluating-efruxifermin-in-subjects-with-compensated-cirrhosis-due-to-nashmash-100556685","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.","80 Years",{"count":111,"type":21},2150,[56],"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.",[115,28],"NASH - Nonalcoholic Steatohepatitis","2026-06-04",{"date":118,"type":37},"2026-06-08",{"date":120,"type":37},"2024-09-04",{"date":122,"type":21},"2030-03",{"name":124,"class":70},"Akero Therapeutics, Inc",322,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100643538","diagnostic-value-of-the-liver-inflammation-index-for-mash-in-patients-with-t2dm-and-mafld-100643538","NCT07632677","Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD","A Multicenter Cross-Sectional Study Evaluating the Diagnostic Accuracy of the Liver Inflammation Index for Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Patients With Concurrent Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Fatty Liver Disease","Inclusion Criteria:\n\n1. Adults aged ≥18 years, with no restrictions on sex;\n2. Patients clinically diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the Chinese Society of Hepatology guideline Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Nonalcoholic) Fatty Liver Disease (2024 Edition), and additionally diagnosed with type 2 diabetes mellitus (T2DM) based on the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2024 Edition).\n\nExclusion Criteria:\n\n1. Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination;\n2. Development of other liver diseases during follow-up, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, alcoholic liver disease, or other chronic liver diseases;\n3. History of hepatic decompensation;\n4. History of hepatectomy or liver transplantation;\n5. History of other malignancies;\n6. Presence of vascular liver disease, cystic fibrosis-associated liver disease, sarcoidosis, polycystic liver disease, congenital or rare hereditary liver diseases, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure accompanied by hepatic venous congestion;\n7. History of transjugular intrahepatic portosystemic shunt (TIPS);\n8. Occurrence of acute hepatitis during follow-up (defined as alanine aminotransferase levels \\>5 times the upper limit of normal) or acute-on-chronic liver failure (ACLF);\n9. Clinical or subclinical hypothyroidism or hyperthyroidism.",{"count":134,"type":21},10000,"OBSERVATIONAL","This observational study aims to evaluate a new diagnostic tool, the Liver Inflammation Index, in detecting Metabolic Dysfunction-Associated Steatohepatitis (MASH) among adults who have both Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).",[138,28,139],"Type 2 Diabetes Mellitus (T2DM)","Metabolic Dysfunction-associated Fatty Liver Disease",[141,90,142,143],"Type 2 Diabetes Mellitus","MAFLD","Liver inflammation index","2026-06-02",{"date":118,"type":37},{"date":147,"type":21},"2026-05-15",{"date":149,"type":21},"2027-12-31",{"name":151,"class":44},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",22,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":101},"100616299","phase-2-a-study-of-chiglitazar-in-patients-with-metabolic-dysfunction-associated-steatohepatitis-and-type-2-diabetes-mellitus-100616299","NCT07303803","A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus","Chiglitazar in Combination With Anti-Inflammatory and Hepatoprotective Therapy for the Treatment in MASH Associated With T2DM: a Prospective, Multicentre, Randomised, Double-blind, Placebo-controlled Study","CHIG-MASH","Inclusion Criteria:\n\n1. Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent.\n2. Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.\n3. Participants must take Fibroscan examination with the result of CAP ≥ 238 dB\u002Fm and LSM\\>8.5 kPa.\n4. Diagnosis of MASH by liver biopsy, with NAFLD Activity Score (NAS) ≥4 with ≥1 point for each component, and fibrosis stage 1b or more over according to the NASH Clinical Research Network (CRN) scoring system. (or liver biopsy not more than 6 months prior to screening)\n5. Stable body weight (≤10% body weight change) for at least 3 months.\n6. Possess good understanding and behavior and be able to take the medication daily as required by the trial.\n7. Willing to sign the informed consent.\n\nExclusion Criteria:\n\n1. Alcohol consumption \\>20g ethyl alcohol\u002Fday for women and \\>40g ethyl alcohol\u002Fday for men.\n2. Evidence of other forms of chronic liver disease:\n\n   1. Alcoholic liver disease,\n   2. Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,\n   3. Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),\n   4. Evidence of autoimmune liver disease as defined by compatible liver histology,\n   5. Current drug-induced liver disease as defined on the basis of typical exposure and history,\n   6. Suspected or proven liver cancer,\n   7. Any other type of liver disease other than MASH.\n3. Uncontrolled T2DM defined as HbA1c \\>9.5% at time of screening or Type 1 diabetes mellitus (T1DM).\n4. Patients with T2DM who have a history of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic maculopathy or severe non-proliferative diabetic retinopathy that requires acute treatment.\n5. Any of the following cardiovascular conditions within 6 months prior to screening:\n\n   1. acute myocardial infarction (MI),\n   2. cerebrovascular accident (stroke),\n   3. unstable angina,\n   4. hospitalization due to congestive heart failure (CHF)\n   5. New York Heart Association Functional Classification IV CHF\n6. History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.\n7. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥ 100 mm Hg).\n8. Renal impairment measured as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n9. Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility.\n10. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).\n11. Evidence of untreated hypothyroidism or hyperthyroidism based on clinical or laboratory evaluation.\n12. A transplanted organ (corneal transplants allowed) or awaiting an organ transplant.\n13. Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial (at least include one barrier contraceptive method) and breast feeding.\n14. Use of drugs associated with hepatic steatosis (e.g., amiodarone, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening.\n15. Current use of medication is associated with weight gain, except when on stable dose for at least 3 months prior to screening and remaining on stable dose during the study.\n16. Receiving or having received (within 3 months of screening) chronic (\\>2 weeks) systemic glucocorticoid therapy.\n17. Use of treatment targeting MASH for more than 2 weeks in the 3 months prior to screening (GLP-1 receptor agonists or PPAR pan agonists).\n18. Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.",{"count":162,"type":21},300,[82],"This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.",[28,166],"T2DM (Type 2 Diabetes Mellitus)",[168,169,170,171],"chiglitazar","metabolic dysfunction-associated steatohepatitis","type 2 diabetes","liver biopsy","2026-06-01",{"date":174,"type":37},"2026-06-03",{"date":176,"type":37},"2026-01-01",{"date":178,"type":21},"2030-12-01",{"name":180,"class":44},"Shanghai Jiao Tong University School of Medicine",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":200,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100561325","phase-2-digoxin-in-nash-codin-100561325","NCT06588699","Digoxin In NASH (CODIN)","Clinical Trial of Oral Digoxin In NASH (CODIN)","CODIN","Inclusion Criteria\n\n* Stable body weight (≤ 5% self-reported change in body weight) in the 30 days prior to screening\n* Biopsy-confirmed non-alcoholic steatohepatitis (NASH) as defined by the NASH clinical research network (NASH CRN) histological scoring system, with non-alcoholic fatty liver disease score (NAS) ≥4 and with a score ≥1 for each of the three components (steatosis, hepatocellular ballooning, and lobular inflammation) on a liver biopsy performed within 6 months of screening\n* Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening\n* Agrees to have a liver biopsy performed to assess baseline histology if one has not been performed up to 6 months before screening, and at 24 weeks after randomization Exclusion Criteria\n\nLiver-related:\n\n* Documented causes of chronic liver disease other than NASH\n* History or clinical evidence of cirrhosis or portal hypertension\n* History of positive HBsAg, positive anti-HIV, positive HCV-RNA\n* AST or ALT \\> 5 times upper limit of normal (ULN) at screening\n* Total bilirubin \\> 1.5 mg\u002FdL at screening unless conjugated bilirubin is \\\u003C 1.5 × ULN\n* International normalized ratio (INR) \\> 1.3 at screening\n* Known or suspected alcohol use \\> 20 g\u002Fday for women or \\> 30 g\u002Fday for men\n* Treatment initiation or dose adjustment of vitamin E, pioglitazone, GLP-1RA, or SGLT-2 inhibitors within 30 days of signing the informed consent or 30 days prior to liver biopsy\n* Treatment initiation or anticipated treatment (\\>14 consecutive days) with medications known to affect steatosis (e.g., systemic corticosteroids, tamoxifen, valproic acid, methotrexate, tetracycline or amiodarone) within 30 days of signing the informed consent or 30 days prior to liver biopsy\n\nCardiac related:\n\n* Heart rate less than 60 bpm at screening (visit 1) or at baseline (visit 2)\n* Current diagnosis of severe aortic valve disease\n* History of Accessory arterio-ventricular pathway (e.g., Wolf-Parkinson-White syndrome)\n* History of complete heart block or second degree arterio-ventricular block without pacemaker or implantable cardiac device\n* Current diagnosis of permanent atrial fibrillation\n* Any of the following within the previous 6 months of signing informed consent: myocardial infarction, percutaneous intervention, pacemaker\u002Fimplantable cardiac device implantation, cardiac surgery, or stroke\n* Current use of the following medications: inotropic drugs such as (dopamine, dobutamine, noradrenaline, milrinone), anti-arrhythmics (amiodarone, dofetilide, sotalol, dronedarone, digoxin), parathyroid hormone analog (teriparatide), sympathomimetics (epinephrine, norepinephrine, dopamine), neuromuscular blocking agents (succinylcholine), calcium supplement, nondihydropyridine calcium channel blockers, ivabradine, and disulfiram.\n\nObesity related:\n\n* Treatment initiation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) with orlistat, zonisamide, topiramate, phentermine, bupropion, and naltrexone alone or in combination or any other medication that could promote weight loss in the opinion of the investigator\n* Participation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) in an organized diet-based weight reduction program (e.g., WeightWatchers, Optifast)\n* Recent surgical treatment (\\\u003C6 months of signing informed consent) for obesity\n\nGeneral safety related:\n\n* Presence or history of malignant neoplasms (in the past 5 years prior to screening), except basal and squamous cell skin cancer and any carcinoma in-situ\n* Surgery scheduled or anticipated during the trial period, except for minor surgical procedures, in the opinion of the investigator\n* Language barrier, mental incapacity, unwillingness, or inability to adequately understand or comply with study procedures\n* Known or suspected hypersensitivity to the trial product or related products including allergy to milk, egg, soy, peanuts, and sulfites\n* Recent participation (within 90 days prior to signing the informed consent) in any clinical trial of an approved or non-approved investigational medicinal product\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method\n* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* TSH \\> 6 mIU\u002FL or \\\u003C 0.4 mIU\u002FL at screening\n* Current use of the following medications: calcium supplementation, parathyroid hormone analog (teriparatide), neuromuscular blocking agents (succinylcholine) and disulfiram.\n* Claustrophobia to an extent that would prevent tolerance of MRI\n* Metallic implant that would prevent MRI examination including, metallic foreign body, aneurysm clips, vascular grafts or cardiac implants, neural stimulator, cochlear implant, metallic contraceptive device, body piercing that cannot be removed, cochlear implant, or any other contraindication to MRI",{"count":190,"type":21},144,[82],"Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans. The mainstay of treatment for NASH, which was recently renamed metabolic associated steatohepatitis (MASH), involves lifestyle interventions to promote weight loss and to treat comorbidities such as hypertension, hyperlipidemia, and diabetes mellitus. There is thus, a substantial unmet need for pharmacological therapies that are effective for treatment of NASH, especially in those with fibrosis which is the main predictor of disease progression and mortality among NASH patients. The repurposing of presently available drugs would help expedite the search for agents effective in treating NASH. The cardiac glycoside digoxin is currently used in the management of heart failure and supraventricular tachyarrhythmias. The investigators and other groups have demonstrated that digoxin protects the liver from various forms of acute and chronic liver injury. The investigators preliminary data in healthy human subject indicate an immunomodulatory effect of low dose oral digoxin with no adverse side effects. This study proposes to demonstrate the clinical benefits of digoxin on NASH and on liver fibrosis, thus supporting the repurposing of digoxin as treatment for NASH.",[194,195,28,196,197,89,198,199],"NASH","NAFLD","Mash","MASH With Fibrosis","Fatty Liver Disease","Fatty Liver Disease, Nonalcoholic",[194,90,201,202,203,204,205,195],"Metabolic dysfunction associated steatohepatitis","Digoxin","Drug repurposing","Liver fibrosis","Fatty liver disease","2026-05-22",{"date":208,"type":37},"2026-05-26",{"date":210,"type":37},"2025-06-05",{"date":212,"type":21},"2029-01",{"name":214,"class":44},"Yale University",2,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":223,"sex":17,"minAge":18,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":45},"100625826","phase-1-study-of-tgm-312-sc01-in-healthy-participants-and-adults-with-mash-100625826","NCT07427680","Study of TGM-312-SC01 in Healthy Participants and Adults With MASH","RESTORE-MASH: A Phase 1\u002F2 Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of TGM-312-SC01 in Healthy Participants and Adults With MASH","Inclusion Criteria:\n\n* Adults aged 18 to 70 years who are able to provide written informed consent.\n* Medically suitable for study participation based on protocol-defined assessments.\n* For the disease cohort, participants with clinical features consistent with metabolic dysfunction-associated steatohepatitis, as defined in the protocol.\n\nExclusion Criteria:\n\n* Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk, interfere with study participation, or confound interpretation of study results.\n* Recent participation in another investigational study.\n* Use of medications that are prohibited by the protocol.\n* Any other condition that would make the individual unsuitable for study participation as determined by the investigator.",true,"70 Years",{"count":226,"type":21},99,[228,82],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with metabolic dysfunction-associated steatohepatitis (MASH).",[231,28],"Healthy Participants","2026-05-18",{"date":234,"type":37},"2026-05-19",{"date":236,"type":37},"2026-03-03",{"date":238,"type":21},"2028-06",{"name":240,"class":70},"Tangram Therapeutics Plc",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":17,"minAge":249,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100630729","phase-2-a-trial-to-investigate-safety-exposure-and-efficacy-of-hu6-compared-with-placebo-in-adult-participants-with-metabolic-dysfunction-associated-steatohepatitis-mash-100630729","NCT07491458","A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Parallel Treatment Group, Phase 2a, Double-blind, 4-arm Trial to Evaluate the Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Male and Female Participants Aged 30 Years or Older With Metabolic Dysfunction-associated Steatohepatitis (MASH)","AMPLIFY","Inclusion Criteria:\n\n* Male and female ≥30 years of age at time of signing the informed consent.\n* Diagnosed with metabolic dysfunction-associated steatohepatitis (MASH)\n* Women of childbearing potential must not be pregnant or breastfeeding and must use and agree to continue to use a highly effective contraceptive method throughout time on study.\n* Body Mass Index (BMI) ≥27.0 kg\u002Fm2 to ≤44 kg\u002Fm2\n\nExclusion Criteria:\n\n* Have acute or chronic hepatitis, signs, and symptoms of any other liver disease (eg, Wilson's disease) other than MASH\n* Cholecystectomy or any other surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment.\n* History (including any family history) of malignant hyperthermia.\n* History of malignancy within 5 years (except cutaneous basal or squamous cell carcinoma, carcinoma-in-situ, or low-grade prostate cancer).\n* History of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, hospitalization due to congestive heart failure (CHF), or acute CHF.\n* Significant and unstable lung disease (chronic obstructive pulmonary disease \\[COPD\\], emphysema, pulmonary fibrosis, or asthma) requiring oxygen or chronic daily medication. Note that mild, stable COPD and asthma on inhalers are allowed.\n* Monogenetic diabetes or type 1 diabetes.\n* History of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to Screening.\n* History of agranulocytosis.\n* History of or active evidence of ophthalmological conditions\n* Untreated, uncontrolled, or unstable hypertension\n* Use of any of the following medications\u002Ftherapies: Vitamin E: use of ursodiol or high-dose vitamin E (\\>400 IU\u002Fday) for a duration of \\>1 month within 6 months or started high dose vitamin E for any duration within 3 months prior to screening\n* Within 3 months prior to screening or plan to use prior to coming off study drug: resmetirom (Rezdiffra®), GLP 1 agonists and gastric inhibitory polypeptide (GIP)\u002FGLP-1 agonists, Weight loss medications\u002Ftherapies including: herbal preparation, over the counter (OTC) drug, mail order or prescription drug, Oral antidiabetic medications\u002Ftherapies including: insulin, meglitinides, thiazolidinediones. Prescription or OTC stimulants. Recent or current use of obeticholic acid (Ocaliva®), systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines. Warfarin, heparin, factor Xa inhibitors due to risk of bleeding, Medications with high risk of idiosyncratic drug-induced neutropenia (IDIN) or agranulocytosis.\n* History of hepatitis or human immunodeficiency virus (HIV1 \\& HIV2)\n* Intolerance to MRI or with conditions contraindicated for MRI procedures\n* Participation in another clinical trial at the time of screening or exposure to any investigational product, including topical agents, within 28 days prior to starting study treatment\n* Additional inclusion\u002Fexclusion criteria could apply","30 Years",{"count":251,"type":21},180,[82],"Rivus Pharmaceuticals. Inc. is sponsoring this research study to assess the safety and tolerability of HU6 as a possible treatment for patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). The study will also assess safety, pharmacokinetics (PK) and changes in liver fat content related to patients diagnosed with MASH.",[28],"2026-05-14",{"date":232,"type":37},{"date":258,"type":37},"2026-02-13",{"date":260,"type":21},"2028-02",{"name":262,"class":70},"Rivus Pharmaceuticals, Inc.",31,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":223,"sex":271,"minAge":4,"maxAge":4,"enrollmentInfo":272,"targetDuration":274,"studyType":135,"phases":4,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":45},"100634575","rezdiffra-pregnancy-and-lactation-registry-100634575","NCT07541469","Rezdiffra Pregnancy and Lactation Registry","A Phase 4, Decentralized Observational Registry to Evaluate the Safety in Women With NASH and Their Infants Exposed to REZDIFFRA™ (Resmetirom) During Pregnancy and\u002For Lactation","Inclusion Criteria:\n\n1. Female patients with NASH who have been exposed to at least 1 dose of resmetirom at any time during pregnancy (defined as having received resmetirom within 3 days prior to the date of conception and\u002For during pregnancy) and\u002For during lactation, and their infants (up to 12 months of age).\n2. Patient or parent\u002Flegally authorized representative must be able to understand and provide consent through an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC)-approved informed consent or assent form.\n\nExclusion Criteria:\n\nNONE","FEMALE",{"count":273,"type":21},10,"21 Months","To evaluate pregnancy and clinical outcomes in women with NASH and their infants after exposure to Rezdiffra at any time during pregnancy and\u002For lactation.",[28],"2026-04-14",{"date":279,"type":37},"2026-04-21",{"date":281,"type":37},"2026-03-04",{"date":283,"type":21},"2030-04-08",{"name":100,"class":70},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":224,"enrollmentInfo":291,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":45},"100628565","high-risk-transcriptome-molecular-prediction-study-of-mash-associated-colorectal-polyps-100628565","NCT07463287","High-Risk Transcriptome Molecular Prediction Study of MASH-Associated Colorectal Polyps","Inclusion Criteria:\n\n1. Diagnosis of MAFLD conforms to the \"Guidelines for the Prevention and Treatment of Non-alcoholic Fatty Liver Disease\" (2018 Edition);\n2. Male or female patients aged 18-70 years;\n3. Signed informed consent form and explanation of the specific study protocol.\n\nExclusion Criteria:\n\n1. Chronic liver disease due to other etiologies (alcoholic, viral, autoimmune, drug-induced, etc.), decompensated cirrhosis, primary liver cancer;\n2. Underlying diseases of other vital organs (heart, kidney, lung, etc.) and bleeding disorders;\n3. Individuals lacking legal capacity or with poor insight.",{"count":292,"type":21},100,"The goal of this observational study is to learn about the molecular characteristics of colorectal polyps in patients with metabolic dysfunction-associated steatohepatitis (MASH) compared to individuals without fatty liver, and to identify potential transcriptomic biomarkers for high-risk polyps. The main questions it aims to answer are: What are the key gene expression differences in adenomatous polyps between MASH patients and non-fatty liver individuals? Can specific high-risk transcriptional molecules in plasma and polyp tissue serve as biomarkers for MASH-related colorectal polyps? Participants already scheduled for colonoscopic polypectomy as part of their routine care will provide a small portion of their polyp tissue, residual plasma from standard blood tests, and allow use of their stored pathological slides for research; they will also be followed up every six months.",[28],[296,90],"colorectal polyps","2026-03-10",{"date":299,"type":37},"2026-03-11",{"date":301,"type":37},"2025-04-30",{"date":303,"type":21},"2027-04-30",{"name":305,"class":44},"Shanghai East Hospital",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":314,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":45},"100628889","exercise-for-an-aging-liver-exaliver-100628889","NCT07467512","Exercise for an Aging Liver (EXALIVER)","Evaluation of the Impact of Physical Exercise on Metabolic Dysfunction-associated Steatotic Liver Disease in the Elderly","EXALIVER","Inclusion Criteria:\n\n* Middle-aged adults (40 to 60 years old) and older adults (aged 70 years or older)\n* People diagnosed with Metabolic Disfunction-Associated Steatotic Liver Disease (MASLD); defined as the presence of hepatic steatosis (≥5% fat content) in conjunction with at least one cardiometabolic risk factor (overweight or obesity, dysglycaemia or Type II diabetes, elevated plasma triglycerides, reduced HDL-cholesterol or high blood preassure) with no other discernable cause.\n* People diagnosed with at-risk Metabolic Disfunction-Associated SteatoHepatitis (MASH) according to the following criteria: I) a positive liver biopsy (NAS score ≥ 4 points (with at least one point in each of the components of the score: steatosis, lobular inflammation and ballooning, AND significant (F2) or advanced (F3) fibrosis), or II) a FAST score \\>0.65.\n\nExclusion Criteria:\n\n* Descompensated cirrhosis or end-stage liver disease.\n* Other causes of liver disease, such as alcohol abuse or drug-induced, virus-related, or hereditary disease.\n* History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV\u002FAIDS, known inflammatory and\u002For rheumatologic disease, cancer, or other medical condition in which exercise is absolute contraindicated.\n* Recent or planned major surgery, as well as anticancer therapies.\n* Participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate\u002Fvigorous intensity).\n* Body weight instability. Participants must have maintained the body weight registered at screening visit (tolerance: 5%) for more than 3 months.\n* Regular use of medication or compounds that may affect study outcomes based on research staff criteria.\n* Pregnancy and lactation or planned pregnancy (within the study period).\n* Frequent travel over time zones during the study period.\n* Fear of needles and claustrophobia to magnetic resonance imaging (MRI).\n* Low physical function (ie, ambulation dependency)\n* Being unable to understand and to accept the instructions or the study objectives and protocol.","40 Years",{"count":316,"type":21},40,[24],"The goal of this clinical trial is to learn how physical exercise affects liver health in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) or at-risk metabolic dysfunction-associated steatohepatitis (MASH); comparing responses between middle-aged adults (40-60 years old) and older adults (70 years and older) of any sex, as well as between participants with low-risk MASLD and high-risk MASH. The main question it aims to answer is:\n\nCould an exercise program reduce liver fat, inflammation and fibrosis, regardless of age and disease severity?\n\nResearchers will compare 4 different groups:\n\nA) older adults with at risk MASH who will exercise B) middle-aged people with at risk MASH who will exercise C) middle-aged people with low-risk MASLD who will exercise D) middle-aged people with low-risk MASLD who will not exercise, receiving usual care.\n\nParticipants in the exercise groups will take part in a supervised 12-week exercise program that includes both strength and aerobic training, completed twice a week.\n\nAll participants, including those receiving usual care, will have health asssessments before and after the 12-week period to measure changes in liver health.",[320,28,321],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","Liver Fibrosis\u002FNASH","2026-03-09",{"date":324,"type":37},"2026-03-12",{"date":326,"type":21},"2026-03",{"date":328,"type":21},"2027-10",{"name":330,"class":331},"Consorcio Centro de Investigación Biomédica en Red (CIBER)","OTHER_GOV",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":344,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":4},"100614177","phase-2-betaine-vs-placebo-for-serologically-diagnosed-metabolic-dysfunction-associated-steatohepatitis-mash-100614177","NCT07276204","Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase II, Double-masked, Placebo-controlled, Randomized, Parallel Treatment Group Trial to Investigate the Safety and Efficacy of Betaine + Standard of Care (SOC) vs. Placebo + SOC Among Participants With Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH) and Elevated Serum Alanine Aminotransferase (ALT) Level","Patients must satisfy all the following criteria to be eligible for enrollment.\n\n1. Outpatient\n2. Receiving health care at a clinical site that is participating in this trial.\n3. A clinical diagnosis of metabolic dysfunction-associated steatotic liver disease based in having 1 or more components of the metabolic syndrome.\n4. ALT ≥50 U\u002FL on the most recent measurement and within 28 days prior to randomization\n5. NIS2+ ≥0.6815 within 60 days prior to randomization\n6. Age 18 to 75 years (inclusive).\n7. BMI≥28.\n8. MRI PDFF ≥10%.\n9. Participants with type 2 diabetes must be receiving stable doses of medicines for the 4 months prior to randomization.\n10. Ability to consume oral medication and willing to adhere to the study medicine regimen.\n11. Stated willingness to comply with all study procedures, including returning study medicines at each clinic visit, and availability for the duration of the trial.\n12. Agreement to adhere to comprehensive lifestyle modification (involving nutrition, exercise, and behavior modification) throughout study duration.\n13. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study medicine administration (ie, after the Week 24 study visit).\n14. Provision of a signed and dated informed consent form.\n\nAn individual who meets any of the following criteria will be excluded from participating in this trial.\n\n1. Use of FDA-approved medications for the treatment of MASH within the prior 6 months or anticipated to use an FDA-approved medications for MASH during the next 12 months.\n2. Use of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or GLP-1\u002FGIP receptor agonist in the prior 6 months or anticipated use during the next 12 months.\n3. Use of a medicine designed to reduce weight within the prior 6 months or anticipated use in the next 12 months.\n4. Received insulin within the past 90 days or anticipation of needing insulin in the next 6 months.\n5. Uncontrolled diabetes defined as HbA1c of 9.5% or higher within 60 days prior to enrollment.\n6. Unstable body weight defined as \\>5% self-reported (or documented) change in body weight in the period in the 90 days prior to screening.\n7. Moderate or heavy alcohol more than 1 week\u002Fmonth during the 3 months prior to screening. Moderate alcohol use is defined as more than 20 g\u002Fday (\\>14 drinks\u002Fweek) in females or more than 30 g\u002Fday (\\>21 drinks per week) in males. A drink is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of 80-proof spirits, or the equivalent amount of alcohol in other alcoholic drinks.\n8. Phosphatidylethanol (PEth) test \\> 50 ug\u002FL. (NOTE: PEth will be performed at screening. Participants with PEth \\>50 ug\u002FL will be excluded. Repeat testing of PEth in participants with a PEth \\>50 ug\u002FL at screening is not permitted.)\n9. Inability to reliably quantify alcohol consumption based upon local study physician judgement.\n10. Use of corticosteroids at a does equal to or greater than 10 mg\u002Fday of prednisone, for more than 5 days within the prior 30 days.\n11. Continued use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the 6 months prior to randomization.\n12. Cirrhosis of the liver, defined as any of the following:\n\n    * FibroScan® liver stiffness \\>18 kPa. Note: Participants with FibroScan® liver stiffness between 18 and 20 kPa can be enrolled if they have a liver biopsy that does not demonstrate cirrhosis, provided they do not have another exclusion criteria.\n    * MRE liver stiffness \\>5.0 kPa\n    * Prior liver biopsy demonstrating cirrhosis\n    * History of esophageal varices, ascites, or hepatic encephalopathy\n13. The following laboratory tests during screening (or on blood tests performed within 60 days prior to randomization, if they are not repeated during screening):\n\n    * HDL \\>46 mg\u002FdL for a male or \\>58 mg\u002FL for a woman\n    * AST or ALT \\>5 x ULN for the clinical laboratory at the local study site\n    * Serum albumin \\\u003C3.5 g\u002FdL\n    * Direct bilirubin \\>0.6 mg\u002FdL\n    * Platelet count less than 125,000 \u002Fmm3\n    * eGFR \\\u003C 40 mL\u002Fmin\n    * INR \\>1.2 (in a participant not receiving anticoagulation medicines)\n14. Evidence of other forms of chronic liver disease:\n\n    * Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg)\n    * Hepatitis C as defined by the presence of hepatitis C virus (HCV) RNA or prior treatment for hepatitis C\n    * A diagnosis of autoimmune liver disease as defined by compatible liver histology or receipt of treatment for presumed autoimmune liver disease.\n    * Primary biliary cholangitis diagnosed by at least 2 of the following Biochemical evidence of cholestasis based mainly on alkaline phosphatase elevation Anti-mitochondrial antibody (AMA) \\>25 Histological evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts\n15. Primary sclerosing cholangitis\n16. Known history of Wilson disease, alpha-1-antitrypsin liver disease, or hemochromatosis. Any other type of liver disease that is currently active other than MASH such as drug-induced liver disease, liver cancer, or bile duct obstruction.\n17. History of biliary diversion or evidence of current biliary obstruction.\n18. Hospitalization for more than 3 days during the prior 60 days.\n19. Known positivity for Human Immunodeficiency Virus (HIV) infection.\n20. Any of the following in the past: myocardial infarction, stroke, or classification of heart failure New York Heart Association (NYHA) Class II, III, or IV\n21. Hospitalization for unstable angina pectoris or transient ischemic attack within 6 months prior to randomization.\n22. Current suspected cancer or a prior history of cancer, other than basal cell carcinoma of the skin that was surgically removed.\n23. Active, serious medical disease with likely life expectancy less than 5 years\n24. Active substance abuse including inhaled or injection drugs in the year prior to screening.\n25. Female who is pregnant, breast-feeding, or intends to become pregnant, or is of\n26. childbearing potential and not using a highly effective contraceptive method.\n27. Current use of choline, betaine, or S-adenosylmethionine supplements, or refusal to abstain from their use during the study.\n28. Participation in an IND trial in the 60 days before randomization\n29. Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study, including inability to swallow treatment capsules.\n30. Failure or inability to give informed consent.",{"count":340,"type":21},70,[82],"The study will evaluate whether betaine reduces liver injury in people with metabolic dysfunction-associated steatohepatitis (MASH). MASH is a type of liver disease that occurs in some people with fatty liver. Betaine is a normal component in the human body and will be taken as a pill.\n\nSeventy (70) participants will be randomized to receive either betaine or placebo for 24 weeks. After stopping treatment, participants will be seen in clinic for another 24 weeks (total participation in the study is approximately 1 year). Procedures performed during the study include blood tests, MRI examinations, questionnaires, and clinic visits.\n\nWe will measure improvement in liver injury with blood tests and with MRI.",[28],[90,345,346],"ALT","Betaine","2026-01-06",{"date":349,"type":37},"2026-01-08",{"date":351,"type":21},"2026-03-31",{"date":353,"type":21},"2035-12-31",{"name":355,"class":44},"Southern California Institute for Research and Education",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":45},"100612146","phase-4-resmiterom-efficacy--safety-in-patients-with-mash-100612146","NCT07249788","Resmiterom Efficacy & Safety in Patients With MASH","Clinical Evaluation of Safety and Efficacy of Resmiterom in Patients With MASH (Metabolic Dysfunction-Associated Steato-Hepatitis) A Prospective, Open-label, Interventional Study","REZMASH","Inclusion Criteria:\n\n* • At least one metabolic comorbidity (e.g., T2DM, obesity, dyslipidemia and hypertension)\n\n  * Clinical diagnosis of MASH using:\n\n    * LSM ≥ 8.5kpa And\u002For\n    * FAST score ≥0.67 And\u002For\n    * FibroScan CAP ≥ 275 dB\u002Fm And\u002For\n    * FIB-4 \\> 1.3\n\nExclusion Criteria:\n\n* • History of drug addiction and alcoholism\n\n  * Cirrhosis or decompensated liver disease\n  * Chronic viral hepatitis HBV, HCV)\n  * MACE including MI, Stroke, PE etc.\n  * Pregnant\u002Flactating women\n  * Concurrent use of other investigational drugs\n  * History of other liver diseases (viral, autoimmune, drug-induced, alcohol)\n  * Previous use of resmetirom in last 6 months\n  * Significant renal impairment (eGFR \\\u003C30)",{"count":365,"type":21},165,[367],"PHASE4","Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.",[28],[371,90,372,373],"Resmetirom","Safety","Efficacy","2025-11-25",{"date":376,"type":37},"2025-12-03",{"date":378,"type":37},"2025-10-17",{"date":380,"type":21},"2026-12-31",{"name":382,"class":70},"Nabiqasim Industries (Pvt) Ltd",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":397,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100566936","evaluation-of-a-new-ultrasound-system-for-the-non-invasive-assessment-of-liver-steatosis-in-masldmash-patients-100566936","NCT06661655","Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD\u002FMASH Patients","ACOUSTIQ","Inclusion Criteria:\n\n* Adult patient below 80 yo\n* Patients with MASLD\u002FMASH recruited in interventional trials requiring MRI PDFF +\u002F- MRE per interventional protocol, OR\n* Patients with MASLD\u002FMASH recruited in prospective cohorts requiring MRI PDFF +\u002F- MRE per interventional protocol, OR\n* Patients referred to MRI-PDFF or MRE.\n* Patients who consented in written to participate in the study\n* Patients with ongoing social security coverage\n\nExclusion Criteria:\n\n* Patient in their minority (less than 18 yo) or older than 80 yo,\n* Patient with active implants,\n* Patient presenting with a wound where the Hepatoscope exam shall be performed (abdominal right upper quadrant)\n* Patient with a history of decompensated cirrhosis,\n* Patient with a history of hepatocellular carcinoma,\n* Adult patient under tutorship, or unable to express informed consent,\n* Pregnant or breast-feeding\n* Person deprived from their liberty\n* Patient hospitalized without providing consent or in case of an emergency\n* Patient presenting with another know liver disease",{"count":80,"type":21},[24],"The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.",[394,395,28,89,59,396,195],"Metabolic Syndrome X","Fatty Liver","Steatosis, Liver",[91,398,399,400,401,402,403,404,405,406],"Fibrosis","Steatosis","Elastography","Ultrasound","Attenuation","Backscattering coefficient","Sound speed","MRI PDFF","Hepatoscope","2025-08-12",{"date":409,"type":37},"2025-08-15",{"date":411,"type":37},"2025-07-24",{"date":413,"type":21},"2026-09-01",{"name":415,"class":70},"E-Scopics",3,{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":223,"sex":17,"minAge":424,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":432,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":215},"100594013","fructose-is-a-metabolic-and-inflammatory-pathogenic-factor-in-metabolic-dysfunction-associated-steatohepatitis-mash-100594013","NCT07013916","Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)","FLOURISH","Inclusion Criteria:\n\n* Able and willing to give written informed consent\n* Age 45-65 at consent\n* HbA1c \\\u003C 48 mmol\u002Fmol\n* Overweight and stage I obesity using BMI thresholds adjusted for ethnicity:\n\n  * 23.0kg\u002Fm2 - 32.4kg\u002Fm2 in South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean populations\n  * 25kg\u002Fm2 - 34.9kg\u002Fm2 in White populations\n\nMASH Patients:\n\nClinical diagnosis of MASH and F2 - F3 fibrosis:\n\nEither:\n\nLiver biopsy within 12 months of baseline\n\nOr:\n\n• History of histologically-diagnosed MASH with current evidence of fatty liver, AST\\>20 and Fibroscan CAP≥248 dB\u002Fm and stiffness 9.5kPa -14kPa\n\nOr:\n\n• FAST score \\>0.67\n\nPatients with steatosis:\n\n• defined by Fibroscan CAP≥248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nHealthy controls:\n\n• defined by Fibroscan CAP\\\u003C248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nExclusion Criteria:\n\n* Unwilling or unable to give consent\n* Age \\\u003C45 or \\>65\n* Any form of diabetes mellitus\n* Currently pregnant\n* Known fructose intolerance or food allergy\n* Diagnosis of cirrhosis or Fibroscan stiffness \\>14kPa\n* Current Child-Pugh B\u002FC or episode of decompensation in last year\n* Non-MASLD liver disease known to participant (including viral hepatitis, auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, sarcoidosis, cystic fibrosis, sickle cell disease)\n* Regular alcohol intake \\> 14 units a week for females and \\>21 units a week for males (participant-reported)\n* Smoking, vaping or use of nicotine-containing products within the last month\n* Taking prohibited medication:\n\n  * Probiotic or antibiotic use within last 4 weeks (Note: participants will be considered eligible if they have undergone a 4-week washout from probiotics or 4-weeks after discontinuing antibiotic use)\n  * any oral steroids within the last 6 weeks\n  * current, or within 3 months, use of immunosuppressive medication\n  * Amiodarone, nitrofurantoin, or anti-fungals within 3 months\n  * Use of anti-obesity medication - orlistat or GLP-1 receptor agonist-containing treatments within 6 months\n  * Use of vitamin E, pioglitazone or other medication for MASH including current or within 3 months enrolment in clinical trial unless documented to have been on placebo\n* History of malignancy (except basal cell carcinoma), or medication for malignancy within the last 2 years\n* Any major organ transplant (excluding corneal or hair)\n* Clinical diagnosis of chronic kidney disease 3 or above, or of heart failure (NYHA 3 or 4)\n* COPD requiring home oxygen\n* Known eating disorder (e.g. anorexia nervosa) or severe mental illness (e.g. schizophrenia)\n* Investigator opinion that study is unsuitable for patient","45 Years","65 Years",{"count":427,"type":21},72,[24],"MASLD (Metabolic dysfunction-associated steatotic liver disease) is a condition where fat builds up in the liver. It is the most common cause of liver disease worldwide. In some people, the fat can irritate the liver (inflammation) and cause damage. This is a more serious condition called MASH (Metabolic dysfunction-associated steatohepatitis). People with MASH more at risk of liver cirrhosis (advanced scarring in the liver) and liver cancer.\n\nIt is not fully understood why MASLD becomes MASH, or why this happens in some people but not in others. However, it is known that our diet plays a role. Research shows a diet high in a type of sugar called fructose might make MASLD worse. Fructose is found in fruit, honey and table sugar, and lots of processed food and drinks. The body deals with fructose differently to other sugars, which is why fructose may be a problem. Although scientists have studied the effects of fructose in healthy people, no studies so far have included people with MASH, so it is not known if fructose might make the condition worse.\n\nTo answer this question, the researchers will conduct a four-week randomised, double-blind study to compare the effects of fructose with another sugar called glucose in 36 people with MASH, 18 people with 'simple' MASLD, and 18 controls without liver disease. Participants will follow a low-sugar diet and, after 14 days on this diet, they will add either a glucose or fructose supplement for another 14 days. Participants will attend 3 study visits, where blood, urine, stool, and saliva samples will be taken. The main question is whether fructose causes more inflammation in people with MASH compared to those with MASLD, or people without liver disease. The researchers will also investigate how fructose affects liver fat content, the gut microbiota, and other processes relevant to MASLD\u002FMASH.",[28,197,431],"Steatosis of Liver",[433,90,89,434,435],"fructose","liver","inflammation","2025-07-18",{"date":438,"type":37},"2025-07-23",{"date":440,"type":37},"2025-06-30",{"date":442,"type":21},"2026-04-01",{"name":444,"class":44},"Queen Mary University of London"]