[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fatty-liver-disease-nonalcoholic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fatty-liver-disease-nonalcoholic":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,56,81,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100561325","phase-2-digoxin-in-nash-codin-100561325",false,"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","ALL","18 Years","75 Years",{"count":21,"type":22},144,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.",[28,29,30,31,32,33,34,35],"NASH","NAFLD","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Mash","MASH With Fibrosis","MASLD","Fatty Liver Disease","Fatty Liver Disease, Nonalcoholic",[28,37,38,39,40,41,42,29],"MASH","Metabolic dysfunction associated steatohepatitis","Digoxin","Drug repurposing","Liver fibrosis","Fatty liver disease","RECRUITING","2026-05-22",{"date":46,"type":47},"2026-05-26","ACTUAL",{"date":49,"type":47},"2025-06-05",{"date":51,"type":22},"2029-01",{"name":53,"class":54},"Yale University","OTHER",2,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100607851","phase-2-investigation-of-the-efficacy-of-a-probiotic-mixture-in-moderate-metabolic-dysfunction-associated-steatotic-liver-disease-masld-a-mechanistic-trial-100607851","NCT07193927","Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial","Investigation of the Efficacy of a Probiotic Mixture in Subjects With Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial","Inclusion Criteria:\n\n* Patients aged from 18 to 75 years old\n* BMI 25 - 42kg\u002Fm2\n* Diagnosed with MASLD and CAP value \\> 268 dB\u002Fm evaluated by FibroScan®\n* High ALT levels (\\>30 U\u002FL in males and \\>19 U\u002FL in females)\n* Having at least three of the following features compatible with metabolic syndrome:\n\n  i. Waist circumference ≥ 102 cm in males and ≥ 88 cm in females. ii. Fasting serum glucose (≥ 5.6 mmol\u002FL or 100 mg\u002Fdl). iii. Glycated haemoglobin (HbA1c ≥ 5.7%\u002F 39 mmol\u002FL). iv. Diagnosed or treated for type 2 diabetes. v. High blood pressure (≥ 130\u002F85 mmHg). vi. High plasma triglycerides (≥ 1.70 mmol\u002FL or 150 mg\u002Fdl). vii. Lower plasma of High-Density Lipoprotein (HDL cholesterol) (≤ 1.0 mmol\u002FL or 40 mg\u002Fdl for males and ≤ 1.3 mmol\u002FL or 50 mg\u002Fdl for females).\n* Stable weight in the last 3 months (less than ± 4% weight variation).\n* Stable medication or intake of food supplements for a medical condition that can affect study outcomes according to the Investigator's judgement in the last three months prior to study entry (bile salt sequestrants are not permitted).\n* Not planning to change their dietary and lifestyle habits during the study.\n* Willing and able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Fibrosis scores equal or higher than F2 (≥ 8.0 kPa).\n* History of acute or chronic hepatitis A, B or C, autoimmune hepatitis, drug-induced liver diseases, severe liver diseases.\n* Prior or pending liver transplantation.\n\nPatients with at least one of the following concurrent conditions:\n\ni. Type I diabetes ii. Uncontrolled type II diabetes (HbA1c \\>8%) iii. Hypertriglyceridemia \\> 350mg\u002Fdl iv. Human Immunodeficiency Virus (HIV) infection v. Diagnosis of hemochromatosis\n\n* Current use of pioglitazone, SGLT-2 inhibitors, or approved drugs for MASLD or steatohepatitis within 8 weeks.\n* Current use of bile salt sequestrants within 8 weeks.\n* Significant gastrointestinal disease, such as inframmatory bowel disease (IBD, short bowel syndrome, chronic or recurrent diarrhoea, coeliac condition.\n* Pancreatic failure, biliary dysfunction (including cholecystectomy and blood bilirubin abnormalities)\n* Thyroid dysfunction, as assessed by the investigator (clinical criteria)\n* History of:\n\n  i. Cardiovascular disease (ischemic heart disease, heart failure, cerebrovascular disease, periphreal vascular disease).\n\nii. Cancer or immunosuppression. iii. Gastrointestinal surgery in the previous year (with the exception of appendicitis).\n\n* Patients with a history of chronic alcohol or drug abuse: \\> 14 units\u002Fweek for females and \\> 21 units\u002Fweek for male\n* Chronic and heavy smoking (\\>20 cigarettes a day)\n* Regular intake (\\> 3 days\u002Fweek) of other probiotics (including food complements or diary foods with other probiotic strains, e.g. Activia®, Actimel® or similar).\n* Intake of nutraceuticals with an effect on hepatic function such as \\> 500 mg\u002Fday omega-3 fatty acids, high-dose vitamin E supplements or milk thistle (sylibum marianum) extract ot their active ingredients (silymarin, silybin) regularly (\\> 7 days) in the 15 days before study entry.\n* Current use of systemic corticosteroids, androgens, clopidogrel, digoxin, acenocoumarol, warfarin, phenytoin, topiramate, lithium, tricyclic antidepressants, MAOIs or second-generation antipsychotics, amiodarone, tamixofen and\u002For diltiazem.\n* History of use (\\> 3 days) of oral or parenteral antibiotics one month before the study initiation.\n* Chronic use of laxatives.\n* Debilitating illnesses (advanced liver or kidney disease, severe depression, psychotic symptoms, neurological diseases).\n* Current pregnancy (positive urine test) or planning to become pregnant during the study.\n* Breastfeeding at the time of eligibility assessment.\n* Patients who have participated in a clinical trial in the six-month period before the study.",{"count":64,"type":22},60,[25],"The goal of this clinical trial is to evaluate whether a specific probiotic mixture can improve liver health in adults with moderate metabolic dysfunction-associated steatotic liver disease (MASLD).\n\nThe main questions it aims to answer are:\n\nCan the probiotics improve liver fat and stiffness as measured by non-invasive imaging (FibroScan® CAP and FAST scores)? Does the probiotic affect other health markers like cholesterol, blood sugar, inflammation, and gut bacteria?\n\nResearchers will compare people taking the probiotic to those taking a placebo (a capsule with no active ingredients) to see if the probiotic has beneficial effects.\n\nParticipants will:\n\nBe randomly assigned to take either the probiotic or placebo daily for 6 months.\n\nAttend 3 study visits (at the start, 3 months, and 6 months). Provide blood and stool samples. Undergo liver scans (FibroScan®). Complete a health and nutrition questionnaire.\n\nThis study includes adults aged 18-65 with moderate MASLD and certain metabolic health conditions. Participants must not be pregnant, breastfeeding, or taking certain medications or supplements that could interfere with the study.",[68,35,69],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","Overweight (BMI > 25)","2026-04-29",{"date":72,"type":47},"2026-04-30",{"date":74,"type":47},"2026-03-20",{"date":76,"type":22},"2027-06-01",{"name":78,"class":79},"AB Biotics, SA","INDUSTRY",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":80},"100617692","thermoacoustic-method-for-estimating-liver-fat-fraction-100617692","NCT07321925","Thermoacoustic Method for Estimating Liver Fat Fraction","Thermoacoustic Method for Estimating Liver Fat Fraction - Pilot Study I","Inclusion Criteria:\n\n* Study participants are 18 or older.\n* Able to understand, read, and provide written informed consent in English.\n* Able to tolerate both ultrasound and MRI examinations.\n* Able to lie flat, or on their side, for 20 minutes and pause breathing for up to 10 seconds.\n\nExclusion Criteria:\n\n* Metal or electronic implants, including, but not limited to: pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices, contraindicates for MRI.\n* Known pregnancy the day of consent or becoming pregnant during study participation based on start date of last menstrual period).\n* Liver diseases other than MASLD\u002FMASH\u002Ffibrosis including, but not limited to:\n* Cirrhosis\n* Hepatocellular carcinoma\n* Ascites\n* Patients with broken, or injured skin, in the right upper abdominal quadrant.\n* Body habitus, or anatomical variation, where the liver capsule is not accessible with ultrasound through the patient's right intercostal imaging window used in conventional ultrasound liver imaging.\n* BMI greater than 50 kg\u002Fm2\n* Patients with subcutaneous fat at measurement location less than or equal to 6mm.\n* Patients with a missing liver lobe.\n* Patients with peri-hepatic fat in the measurement location.\n* Patients with focal liver lesions or anatomical structures in the measurement location, as detected by ultrasound.",true,{"count":90,"type":22},49,"OBSERVATIONAL","The goal of this study is to use our Thermoacoustic Enhanced Ultrasound device to measure the fat levels in your liver and compare it to the the gold standard MRI PDFF measurements. Participants will have a scan with our device, then they will go have an abdominal MRI completed. The goal is to create a more accessible device to measure liver fat as it is an indicator for overall health and metabolic diseases.",[94,35],"MASLD\u002FMASH (Metabolic Dysfunction-Associated Steatotic Liver Disease \u002F Metabolic Dysfunction-Associated Steatohepatitis)",[96,33,37,97],"Fatty Liver","Thermoacoustic","2026-01-05",{"date":100,"type":47},"2026-01-07",{"date":102,"type":47},"2025-08-15",{"date":104,"type":22},"2025-12-31",{"name":106,"class":79},"Endra Lifesciences",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":88,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100523565","quantitative-us-for-evaluation-of-hepatic-steatosis-in-mafld-with-udff-100523565","NCT06097338","Quantitative US for Evaluation of Hepatic Steatosis in MAFLD With UDFF","Inclusion Criteria:\n\n1. Chinese citizens aged 18 ≤ 85;\n2. Routine ultrasound reveals diffuse or non-uniform fatty liver disease in the liver;\n3. Conform to the MAFLD diagnostic criteria issued by the international guidelines: histological (liver biopsy), imaging or blood biomarker evidence based on liver fat accumulation (hepatocyte steatosis), and combine one of the following three conditions: overweight\u002Fobesity (BMI ≥ 23 kg\u002Fm2), type 2 diabetes, and metabolic dysfunction. The definition of metabolic dysfunction is the presence of at least two of the following metabolic risk factors: 1. waist circumference (for Asians) ≥ 90\u002F80 cm (male\u002Ffemale);2. Arterial blood pressure ≥ 130\u002F85 mmHg is being treated with antihypertensive drugs; 3. Hypertriglyceridemia (TG): fasting serum TG ≥ 150 mg\u002Fdl (≥ 1.70 mmol\u002FL) or being treated with lipid-lowering drugs; 4. High density lipoprotein cholesterol (HDL-c) emia: fasting serum HDL-c\\\u003C40 mg\u002Fdl (\\\u003C1.0 mmol\u002FL) for males,\\\u003C50 mg\u002Fdl (\\\u003C1.3 mmol\u002FL) for females, or specific medication treatment;5. Pre diabetes (i.e. fasting blood glucose level 100-125 mg\u002Fdl \\[5.6-6.9 mmol\u002FL\\], or blood glucose level 140-199 mg\u002Fdl \\[7.8-11.0 mmol\\] 2 hours after meal or HbA1c 5.7% -6.4% \\[39-47 mmol\u002Fmol\\]);6. Steady state model evaluation of insulin resistance score ≥ 2.5;7. Plasma C-reactive protein levels\\>2 mg\u002FL.\n4. Those who plan to undergo liver histopathological diagnosis or MRI-PDFF assessment of the degree of fatty liver within one week;\n5. No significant risk of bleeding (platelet ≥ 50x109\u002FL, international standardized ratio of prothrombin time INR ≤ 1.5);\n6. The patient agrees to join this study and signs an informed consent form.\n\nExclusion Criteria:\n\n* 1\\. No histopathological diagnosis or MRI-PDFF was found;\n* 2\\. The interval between the ultrasound UDFF examination and the histopathological examination or MRI-PDFF examination is more than one week;\n* 3\\. Pregnancy;\n* 4\\. Incomplete medical history information.","85 Years",{"count":115,"type":22},200,"Ultrasound Derived Fat Fraction (UDFF) Evaluation of Metabolic Related Fatty Liver Disease (MAFLD) in obesity Patients Metabolic fatty liver disease (MAFLD), formerly known as Nonalcoholic Fatty Liver Disease (NAFLD), is the most common chronic liver disease in the world at present, with a incidence rate of about 30%. In the United States, NAFLD is the third leading cause of hepatocellular carcinoma, and early assessment and diagnosis of liver steatosis characteristics are crucial for timely treatment or intervention to reduce the risk of liver fibrosis and inhibit disease progression. Liver biopsy is considered as the \"gold standard\" for evaluating, grading, and determining inflammatory activity of liver steatosis and fibrosis. However, liver biopsy are invasive and pathological evaluation differences among observers, which makes it difficult to widely use and repeat, especially for dynamic evaluation of patients during the treatment process.\n\nUltrasound Derviced Fat Fraction (UDFF) is a unique technology for non-invasive quantification of liver fat content, which is equipped on the Siemens ACUSON Sequoia ultrasound system. UDFF is calculated from two parameter values: attenuation coefficient (AC) and backscatter coefficient (BSC). SWE (shear wave elastography) is becoming widely used, and is recommended for the evaluation of liver fibrosis by some guidelines in patients with chronic liver diseases, such as viral hepatitis. These two technologies (UDFF+SWE) can be achieved on the same probe, and this detection technology is non-invasive, painless, simple, and reliable.\n\nBariatric surgery (BS), also known as metabolic weight loss surgery, is currently recognized as the most significant and long-lasting method for treating obesity. It can significantly improve obesity related comorbidities, as well as long-term improvement in postoperative quality of life and mental state.\n\nThis study will aim on analysis of the liver ultrasound characteristics of patients who plan to undergo bariatric surgery. By using UDFF and elastic shear wave technology (UDFF+SWE), a new non-invasive ultrasound evaluation method for MAFLD grading diagnosis of simple fatty liver, fatty hepatitis, liver fibrosis, and related cirrhosis will be proposed, and the incidence and risk factors of MAFLD in overweight and obese patients will be explored, The reversal effect of weight loss therapy on MAFLD in obese patients.",[35],[119,120,121,122],"metabolism related fatty liver disease (MAFLD)","Ultrasound Derived Fat Fraction (UDFF)","bariatric surgery","Shear wave elastography","NOT_YET_RECRUITING","2023-10-18",{"date":126,"type":47},"2023-10-24",{"date":128,"type":22},"2023-10",{"date":130,"type":22},"2026-09",{"name":132,"class":54},"Qianfoshan Hospital"]