[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nash\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nash":418},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,56,83,112,135,161,188,217,237,257,280,301,328,359,393],{"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":63,"minAge":18,"maxAge":64,"enrollmentInfo":65,"targetDuration":67,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":55},"100525632","androgens-and-nafld-longitudinal-cohort-study-100525632","NCT06124261","Androgens and NAFLD Longitudinal Cohort Study","Androgens and Nonalcoholic Fatty Liver Disease (NAFLD) In Reproductive-Aged Women With and Without Polycystic Ovary Syndrome (PCOS)","Inclusion Criteria:\n\n* Metabolic associated steatohepatitis (MASH) (formerly NASH)\n* PCOS\n* Non-PCOS\n\nExclusion Criteria:\n\n* High levels of alcohol use (more than 7 drinks a week)\n* Current pregnancy\n* Other causes of hepatic steatosis\n* Weight loss of more than 10% body weight in the last 6 months","FEMALE","42 Years",{"count":66,"type":22},150,"3 Years","OBSERVATIONAL","The researchers want to learn how androgens, a type of sex hormone, might affect nonalcoholic fatty liver (NAFLD) in young women over time. NAFLD happens when fat builds up in the liver which can cause damage to the liver such as inflammation or scarring.\n\nYoung women with a condition called polycystic ovary syndrome (PCOS) have a high risk for NAFLD, and they often have high androgen levels too. So the researchers are recruiting young women with PCOS as well as those without PCOS, and will compare changes in NAFLD over time between young women with and without PCOS.\n\nThis study is funded by the National Institutes of Health",[71,29,28],"PCOS",[73],"Androgen","2026-04-09",{"date":76,"type":47},"2026-04-13",{"date":78,"type":47},"2024-01-22",{"date":80,"type":22},"2028-12",{"name":82,"class":54},"University of California, San Francisco",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100559422","re-and-probiotics-in-mafldnafld-100559422","NCT06563921","RE and Probiotics in MAFLD\u002FNAFLD","PRObiotic Mixed With Exercise THErapy USe in MAFLD (PROMETHEUS in MAFLD)","Study population: Patients diagnosed with non-alcoholic or metabolically mediated fatty liver disease (NAFLD\u002FMAFLD), including the inflammatory form (NASH), confirmed by imaging (ultrasound, MRI-PDFF) or histopathological (liver biopsy) methods.\n\nInclusion criteria:\n\n* Diagnosis of NAFLD\u002FMAFLD or NASH (imaging or histological confirmation of fatty liver disease, e.g., ultrasound, MRI-PDFF, biopsy)\n* Age 18-60 years\n* Ability to understand the study procedures and provide informed consent.\n* Stable clinical condition for at least 3 months prior to study initiation.\n\nExclusion criteria:\n\n* Lack of fluency in English or Polish\n* Significant (structural) limitation of upper and\u002For lower limb mobility\n* Pregnancy or breastfeeding\n* Inability to understand instructions\n* Shift work\n* Participation in any study or research project within the last 3 months\n* Participation in an interventional drug study within the last 3 months\n* Participants with hepatic steatosis and regular alcohol consumption \\> 30 g\u002Fday\n* Individuals with any concomitant liver disease (viral hepatitis, drug-induced liver injury, metabolic\u002Fgenetic diseases (e.g., Wilson's disease))\n* Anticoagulant\u002Fantiplatelet therapy, antithrombotic therapy, immunosuppressive medications, prolonged immunosuppression (e.g., recent cytotoxic chemotherapy, HIV infection with CD4 count \\\u003C 240), antibiotics, corticosteroids, valproic acid, amiodarone, tamoxifen within 3 months prior to study enrollment\n* Use of medications such as steroids, methotrexate, metformin\n* Use of agents such as vitamin E, omega-3 fatty acids, or medications with evidence of an effect on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid)\n* Active or previous history of invasive cancer (excluding curatively treated carcinoma in situ \\[e.g., cervical\\] or benign skin cancer), unless complete remission has been achieved\n* Regular use of probiotic or prebiotic supplements within 3 months prior to study enrollment\n* Known allergy to probiotics\n* History of using an alternative diet within 3 months prior to study enrollment or changing diet during study entry\n* Previous surgery (bariatric surgery, gastric or intestinal resection)\n* Parenteral nutrition (TPN) within the last 6 months\n* Insulin therapy\n* Uncontrolled diabetes\n* Cardiovascular disease (e.g., uncontrolled blood pressure, coronary artery disease, NYHA class III-IV heart failure, severe arrhythmias, orthostatic intolerance)\n* Nervous system disorders\n* Cognitive impairment and dementia\n* Osteoporosis\u002Fosteopenia\n* Active thyroid disease\n* Cushing's syndrome\n* Any implanted battery-powered device (e.g., AICD, pacemaker, cardiac rhythm recorder, cochlear implant)","60 Years",{"count":92,"type":22},180,[94],"NA","This project aims to evaluate the roles of the autonomic nervous system (ANS) and gut microbiota as correlates of clinical improvement in metabolic dysfunction-associated fatty liver disease (MAFLD) and non-alcoholic fatty liver disease (NAFLD) in response to a therapeutic regimen comprising resistance exercise and probiotic supplementation. The primary objective is to investigate the effects of these non-pharmacological interventions on MAFLD\u002FNAFLD and to identify patient phenotypes based on baseline ANS profiles and gut microbiota composition that predict clinical responses.",[28,29,97],"MAFLD",[28,97,29,99,100,101,102],"Probiotics","Resistance training","Gut microbiota","Hypertrophy training","NOT_YET_RECRUITING","2026-04-07",{"date":74,"type":47},{"date":107,"type":22},"2026-04-10",{"date":109,"type":22},"2036-04-10",{"name":111,"class":54},"Nicolaus Copernicus University",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100608194","phase-2-trial-of-cs060380-tablets-for-non-alcoholic-steatohepatitis-nash-100608194","NCT07198386","Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)","A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of CS060380 Tablets in Patients With Non-alcoholic Steatohepatitis (NASH).","Inclusion Criteria:\n\n1. Men or women aged 18 to 70 (including the boundary value).\n2. Liver biopsy results within 6 months prior to randomization were consistent with the pathological diagnosis of NASH, and the non-alcoholic fatty liver disease activity score (NAS) was ≥4 points, with at least 1 point each for inflammation and balloon changes, and the fibrosis stage of the Clinical Study Network for Non-alcoholic Steatohepatitis (NASH-CRN) in the United States was F1-F3; Or, the liver fat content is confirmed to be ≥ 10% based on the magnetic MRI-PDFF results of this hospital within the previous 3 months..\n3. Participants with fertility and their spouses or partners voluntarily took effective contraceptive measures from screening to within 3 months after the last administration. Among them, women of childbearing age include premenopausal women and women within two years after menopause, except those who have undergone hysterectomy or bilateral oophorectomy or have medically confirmed ovarian failure.\n4. Before randomization, there were stable ALT and AST results. If the ALT or AST value during the screening period was ≥ 1.5 × (ULN), it is necessary to have continuous 2 stable evidences before randomization (the two evaluations need to be spaced at least 2 weeks apart), and one of the following evidences must be met:\n\n   * Compared with the historical data within 2 weeks to 3 months before the screening process (if any, and the value ≤5×ULN), the ALT or AST value during the screening period needs to increase by ≤30% compared with the historical data.\n   * If there is no available historical data and the ALT or AST value during the screening period is greater than 1.5×ULN, the test should be repeated at least once every two weeks. The ALT or AST value after re-testing should increase by no more than 30% compared to the screening period.\n5. Avoid strenuous exercise at least 24 hours before each visit or blood draw.\n6. Sign the ICF before the experiment and be able to complete the research as required by the protocol.\n\nExclusion Criteria:\n\n1. The following liver diseases or past medical history were present at the time of screening:\n\n   1. Patients with other clinically significant acute or chronic liver diseases or biliary tract diseases not caused by NASH, and the researchers determined that not suitable to participate in this study, Including but not limited to hepatitis B virus, Untreated hepatitis C virus, DILI, ALD, WD, AIH, PBC, PSC.\n   2. Has a history of liver cirrhosis.\n   3. Primary liver cancer. AFP \\> 50 μg\u002FL.\n2. During screening, the following medical history was present:\n\n   1. Study the history of allergies to drug ingredients and excipients.\n   2. Surgical procedures that may interfere with treatment, including but not limited to weight loss surgery, liver transplantation surgery, etc.\n   3. Screen those who have a history of malignant tumors within the previous five years.\n   4. Contraindications for any MRI scan.\n   5. Screen for a history of drug or substance abuse within the previous two years.\n   6. Screen for a history of heavy drinking for more than three consecutive months within one year prior to the screening.\n   7. Weight change ≥ 5% in the first 3 months of randomization or ≥ 10% in the first 6 months of randomization.\n   8. Individuals who have donated blood within the past 3 months prior to screening, and those who have lost a total of 400 mL or more due to blood donation or other reasons within the past 6 months.\n   9. Merge with any of the following serious cardiovascular disease or surgical histories (including but not limited to):\n\n      1. Unstable angina pectoris occurred within 3 months prior to randomization.\n      2. Combined heart failure, NYHA ≥ Ⅲ\n      3. Myocardial infarction, shock or life-threatening arrhythmia occurred within 6 months prior to randomization.\n      4. Randomized coronary artery bypass grafting surgery or percutaneous coronary intervention within the first 6 months.\n3. The following concomitant diseases or conditions occur during the screening period:\n\n   1. T1DM, uncontrolled T2DM (HbA1c \\> 9 % ), history of severe hypoglycemia.\n   2. Intestinal diseases that affect the absorption of oral medications.\n   3. There are thyroid diseases, including hyperthyroidism and hypothyroidism or pituitary disorders.\n   4. Combined with serious diseases such as circulatory, respiratory, urinary, hematological, immune, psychiatric, neurological, and renal disorders, it has been determined by the researchers that it is not suitable to participate in this study.\n   5. Uncontrolled hypertension was present during screening: systolic blood pressure \\>160mmHg or diastolic blood pressure \\>100mmHg even under regular medication control.\n   6. When screening QTcF \\>450 ms (for males) or \\>470 ms (Female).\n   7. When screening, HIV antibody positive and syphilis spiral antibody positive.\n   8. Pregnant and lactating women.\n   9. Laboratory test:\n\n      1. PLT\\\u003CLLN.\n      2. TBIL \\> 1.2×ULN, Gilbert Syndrome.\n      3. ALT or AST \\> 5 × ULN.\n      4. eGFR \\\u003C 50 mL\u002Fmin\u002F1.73 m².\n      5. IRN \\> 1.5.\n      6. THS or FT4 abnormality.\n      7. Cardiac Troponin \\> ULN.\n4. The following medication history existed before randomization:\n\n   1. No stable dose of sodium-glucose cotransporter-2 was received within 6 months prior to randomization(SGLT2), PCSK9 inhibitors (unless SGLT2 and PCSK9 inhibitor drugs have been used at a stable dose for at least 6 months).\n   2. Use of an excessively high dose of vitamin E within 6 months prior to randomization (unless the dose is stable and \\\u003C400 IU\u002Fd), pioglitazone, glucagon-like peptide-1 (GLP-1) receptor agonists GIPR\u002FGLP-1R dual agonists, GIPR\u002FGLP-1R\u002FGCGR triple agonists, compound Oral antidiabetic (OAD) regimens (three or more OADs).\n   3. Those who have received treatment for NAFLD\u002FNASH including but not limited to the following within 3 months prior to randomization Drugs, FXR agonists, FGF21 analogues, DGAT2 inhibitors, PDE inhibitors Agents, other THR-β agonists, obeticholic acid, etc.\n   4. During the first 3 months prior to the randomization, the patients did not use the hypoglycemic drugs at a stable dose (such as metformin, sulfonylurea drugs, dipeptidyl peptidase 4 inhibitors, α-glucosidase inhibitors, thiazolidinediones (except pioglitazone), etc.) (unless these hypoglycemic drugs had been used at a stable dose for at least 3 months).\n   5. The fluctuation range of insulin dosage within the previous 3 months was ≥ 30%.\n   6. For the first 3 months prior to the randomization, no stable dose of lipid-lowering drugs (such as statins, fibrates, cholesterol absorption inhibitors (such as ezetimibe), niacin, omega-3 fatty acids, etc.) was used (unless these lipid-lowering drugs had been used at a stable dose for at least 3 months).\n   7. Within 3 months prior to randomization (for unmarketed drugs or devices) or within 5 half-lives (for marketed drugs), the patient has participated in other investigational product or device clinical trials (if there is evidence that the patient participated in a clinical trial, received treatment in the inactive drug group, or has been removed from the group without receiving treatment with the investigational product, they are eligible to participate in this study for screening).\n   8. Having received drug treatment that includes but is not limited to the following drugs that may cause NAFLD\u002FNASH for at least 2 weeks within one month prior to boarding the machine For example, total parenteral nutrition (TPN), amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogen with doses greater than those used for contraception or hormone replacement, anabolic steroids, valproic acid and other known liver-toxic drugs.\n   9. During the randomization period of the previous 4 weeks or during the clinical study period, the use of hepatoprotective drugs not permitted by the protocol, including but not limited to, silymarin (Bixin), bicyclol, glycyrrhizin preparations (isoglycyrrhizinate, compound glycyrrhizin, glycyrrhizine dihydrogen monophosphate, etc.) and others (except for hepatoprotective drugs such as ursodeoxycholic acid, polyene phosphatidylcholine, reduced glutathione, etc. that have been used stably for at least 3 months with low risk).\n   10. Received anticoagulant treatment within 2 weeks prior to randomization: drugs that increase INR (e.g., FXa inhibitors, warfarin, heparin, etc.).\n   11. Those who have used CYP3A enzyme strong suppressors, CYP3A enzyme strong inducers, inhibitors of P-gp or BCRP transporters that may affect the metabolism or absorption of this drug within 14 days prior to randomization or at least 5 half-lives (whichever is longer).\n5. Other circumstances that the researcher deems unsuitable for inclusion in the trial.","70 Years",{"count":121,"type":22},120,[25],"The goal of this clinical trial is to learn if CS060380 tablets works to treat non-alcoholic steatohepatitis(NASH) in adults.It will also learn about the safety of CS060380 tablets.The main questions it aims to answer are:\n\n* After 12 weeks of administration, what was the percentage change in fat content evaluated by MRI-PDFF compared to the baseline？\n* What medical problems do participants have when taking CS060380 tablets? Researchers will compare CS060380 tablets to a placebo (a look-alike substance that contains no drug) to see if CS060380 tablets works to treat NASH.\n\nParticipants will:\n\n* Take CS060380 tablets or a placebo every day for 12 weeks\n* Visit the clinic for checkups and tests at the frequency required by the protocol\n* Keep a diary of their symptoms and the number of tablets taken",[28],"2026-03-12",{"date":127,"type":47},"2026-03-13",{"date":129,"type":47},"2025-09-30",{"date":131,"type":22},"2026-11-30",{"name":133,"class":54},"Cascade Pharmaceuticals, Inc",8,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":143,"maxAge":19,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100556290","evaluation-of-risk-of-hepatocellular-carcinoma-100556290","NCT06523179","Evaluation of Risk of hEpatocellular Carcinoma","Study for the Evaluation of Risk of hEpatocellular Carcinoma in NonAlcoholic Fatty Liver","PERSPECTIVE","Inclusion Criteria:\n\n* Diagnosis of NAFLD or cryptogenic liver disease, allowing a more liberal alcohol intake limit (\\\u003C60\u002F40 g\u002Fday in M\u002FF), so as to also include subjects with a moderate alcoholic component of liver disease, an important factor given the high epidemiological burden of this group\n* Age between 45 and 75 years\n* Any of the following criteria:\n* F3-F4 fibrosis, determined histologically, or by non-invasive techniques (stiffness \\> 7.9 kPa at Fibroscan and positivity at the NAFLD fibrosis score or at APRI or at FIB4), or evidence of cirrhosis deriving from biochemical tests or imaging methods;\n* Family history of primary liver cancer in first degree parentage, or carrier status of rare mutations associated with the development of HCC (such as mutations in APOB and TERT)\n* Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7.\n* Willingness to sign the informed consent.\n\nExclusion Criteria:\n\n* Alcohol intake \\>60\u002F40 g\u002Fday in M\u002FF\n* Chronic viral or autoimmune hepatitis\n* Any previously diagnosed genetic liver disease associated with increased risk of HCC (such as hereditary hemochromatosis, Wilson's disease, Alpha-1 Antitrypsin deficiency)\n* Use of drugs known to induce steatosis and liver disease\n* HCC diagnosed before the study start date.\n* Other pathological conditions with a prognosis of less than two years.","45 Years",{"count":145,"type":22},500,[94],"Hepatocellular carcinoma (HCC) is the fifth most common solid cancer and the second cause of cancer-related mortality worldwide. Nonalcoholic fatty liver disease (NAFLD), that is hepatic accumulation of fat in excess of 5% not explained by at risk alcohol intake, is projected to become the leading cause of HCC in Western countries within 2025.NAFLD is most frequently caused by insulin resistance due to unhealthy lifestyle. Due to the epidemics of obesity and type 2 diabetes, NAFLD now affects one in three individuals worldwide.\n\nNAFLD-HCC frequently develops without overt cirrhosis suggesting that steatosis directly promotes hepatic carcinogenesis.",[28,149,150],"HCC","Genetic Predisposition","2025-11-17",{"date":153,"type":47},"2025-11-20",{"date":155,"type":47},"2018-01-01",{"date":157,"type":22},"2035-12-31",{"name":159,"class":54},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",1,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":168,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":160},"100570342","phase-1-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-bar502-in-healthy-subjects-100570342","NCT06705998","To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAR502 in Healthy Subjects","A Phase I, Two Parts Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of BAR502 in Healthy Subjects","Inclusion Criteria:\n\n1. Informed consent: signed written informed consent before inclusion in the study\n2. Sex and Age: men\u002Fwomen, 18-55 years old inclusive\n3. Body Mass Index: 18.5-30 kg\u002Fm2 inclusive\n4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-99 bpm, measured after 5 min at rest in the sitting position\n5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study\n6. Renal functionality: estimated glomerular filtration rate calculated using the Cockcroft-Gault equation and normalized to an average surface area of 1.73 m2 ≥ 90 mL\u002Fmin at screening\n7. Tobacco: non-smokers, non-users of nicotine containing products and non-users of Vapo e-cigarettes for at least 3 months prior to study screening\n8. Contraception and fertility (women only): women of non-child-bearing potential or in post-menopausal status for at least 1 year, defined as such when there is either:\n\n   1. 12 months of spontaneous amenorrhea or\n   2. 6 weeks documented postsurgical bilateral oophorectomy with or without hysterectomy will be admitted. For all women, pregnancy test result must be negative at screening and on Day -1 of each study part.\n9. Contraception (men only): men will either be sterile or agree to use one of the following approved methods of contraception from the first investigational medicinal product administration until at least 90 days after the last administration, also in case their partner is currently pregnant:\n\n   1. A male condom with spermicide\n   2. A sterile sexual partner or a partner in post-menopausal status for at least 1 year\n   3. Use by the female sexual partner of an IUD, a female condom with spermicide, a contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit or: True abstinence\n\nExclusion Criteria:\n\n1. ECG 12-leads (supine position): clinically significant abnormalities, in particular QTcF \\> 450 ms\n2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study\n3. Laboratory analyses: clinically significant abnormal laboratory values at screening indicative of physical illness or any acute laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude participation in the study of an investigational compound. INR \\> 1.2\n4. Diseases: significant history of renal, hepatic (in particular, liver or hepatobiliary diseases as indicated by serum alanine aminotransferase, aspartate aminotransferase or total bilirubin levels exceeding the upper limit of normality), gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study\n5. Gallbladder: history of cholecystectomy, presence of gallstones or clinically significant gallbladder abnormalities that may interfere with the aim of the study\n6. Allergy: ascertained or presumptive hypersensitivity to the active principle and\u002For formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study\n7. Medications: medications, including over the counter medications, homeopathic preparations, vitamins, food supplements and herbal remedies for 3 weeks before the start of the study\n8. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study\n9. Blood donation: blood donations for 3 months before this study\n10. Drug, alcohol, caffeine, tobacco: history of drug, alcohol \\[\\>1 drink\u002Fday for females and \\>2 drinks\u002Fday for men, defined according to the USDA Dietary Guidelines 2020-2025\\] or caffeine (\\>5 cups coffee\u002Ftea\u002Fday) abuse\n11. SARS-CoV-2 test: positive Covid-19 rapid test at Day -1\n12. Cotinine: positive cotinine test at screening\n13. Drug test: positive result at the urine drug screening test at screening or Day -1\n14. Alcohol test: positive alcohol saliva test at screening or Day -1\n15. Diet: abnormal diets (\\\u003C1600 or \\>3500 kcal\u002Fday) or substantial changes in eating habits in the 4 weeks before this study; vegetarians and vegans\n16. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1; child-bearing potential, pregnant or lactating women.",true,"55 Years",{"count":171,"type":22},52,[173],"PHASE1","First-in-human, single centre, two parts, dose-escalation, parallel-group, safety, tolerability, pharmacokinetic and pharmacodynamic Phase I study. Part A: randomised, double-blind, placebo-controlled, single ascending dose study.\n\nPart B: open label, multiple ascending dose study.",[28],[177],"Non-alcoholic Fatty Liver DIsease","2025-09-19",{"date":180,"type":47},"2025-09-22",{"date":182,"type":47},"2024-12-04",{"date":184,"type":22},"2026-07-30",{"name":186,"class":187},"BAR Pharmaceuticals s.r.l.","NETWORK",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":196,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100602376","evaluation-of-non-invasive-tests-for-metabolic-liver-disease-100602376","NCT07122700","Evaluation of Non-Invasive Tests for Metabolic Liver Disease","Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) Study 2.0 - An FNIH Biomarkers Consortium Study","NIMBLE","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged \\> 18 years and \\\u003C 75 years\n4. Participants must exhibit some manifestations of metabolic dysregulation. Either:\n\nA. Physician-diagnosed T2DM for at least 90 days with HbA1c \\> 6.5 and antidiabetic therapy, if any, stable for at least 90 days prior to screening or B. At least any one of the following six metabolic syndrome criteria \\[6\\]\n\n1\\. body mass index (BMI) of \\> 25 kg\u002Fm2 2. waist circumference: i. \\> 102 cm for men ii. \\> 88.9 cm for women 3. fasting triglyceride concentration \\> 150 mg\u002FdL i. or ongoing treatment with triglyceride lowering medication 4. HDL-cholesterol concentration: i. \\\u003C 40 mg\u002FdL for men ii. \\\u003C 50 mg\u002FdL for women iii. or ongoing treatment with cholesterol lowering medication. 5. fasting glucose concentration \\> 100 mg\u002FdL 6. either semi-recumbent or supine blood pressure systolic \\> 130 mmHg and\u002F or diastolic \\> 85 mmHg i. or ongoing treatment with antihypertensive medication. 5. FIB-4 \\> 1.3 (age \\\u003C 65 years) and \\> 2.0 (age \\> 65 years) 6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\n\nExclusion Criteria:\n\n1. Known history or evidence of other forms of chronic liver disease other than MASLD\u002FMASH including but not limited to viral hepatitis B or C, autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, drug-induced liver disease, conditions involving bile duct obstructions, liver cancer, past history of HCC or HCC treatment, listed for or history of liver transplantation, prior resection of liver, etc.\n2. Current or past evidence of decompensated liver disease defined by overt ascites that is clinically obvious and requires diuretic therapy, overt encephalopathy requiring therapy or history of variceal hemorrhage\n3. Circulating Alanine aminotransferase (ALT)\\> 5xULN\n4. Ongoing or recent (within the last two years prior to screening) consumption of significantly greater than moderate amounts of alcohol.\n\n   * A standard alcoholic drink is any drink that contains about 14 g of pure alcohol, such as 12 fluid ounces of regular beer 8-10 fluid ounces of malt liquor or flavored malt beverages such as hard seltzer 5 fluid ounces of table wine 3-4 fluid ounces of fortified wine such as sherry or port 2-3 fluid ounces of cordial liqueur or aperitif 1.5 fluid ounces (a single jigger or shot) of brandy, cognac, or distilled spirits such as gin, rum, tequila, vodka, whiskey, etc.\n   * Significantly greater than moderate alcohol consumption is defined as on average over a 2-year period prior to screening:\n\n   Women\n   * \\>1 standard drink per day and\u002For\n   * \\>14 standard drinks per week Men\n   * \\>2 standard drinks per day and\u002For\n   * \\>21 standard drinks per week in men\n\n     * An Alcohol Use Disorders Identification Test (AUDIT) score of 7 or higher\n     * A PEth test score of ≥ 20ng\u002Fml.\n5. In the opinion of the investigator, any contraindications to liver biopsy including but not limited to having significant uncorrected coagulopathy or thrombocytopenia, on chronic anticoagulation with Direct Oral Anticoagulants (DOACs), or on low dose heparin or Warfarin.\n6. Uncontrolled systolic blood pressure \\> 180 mmHg and diastolic blood pressure \\> 120 mmHg at screening. Blood pressure will be obtained after at least 10 minutes of resting in a semi-recumbent or supine position.\n7. Any systemic disease that in the opinion of the investigator precludes inclusion of the patient in the trial\n8. Unable or unwilling to provide informed consent\n9. Unwilling to undergo liver biopsy procedure\n10. Unable or unwilling to comply with requirements for study procedures (such as fasting)\n11. Unable to perform study procedures in the opinion of the investigator\n12. Participants who are unwilling or unable (e.g. due active implants such as pacemaker or having a waist diameter (calculated as: diameter = circumference \u002F π) 70cm, unless a wide-bore MRI machine is available) to undergo MRI procedures.\n13. Pregnancy or planned pregnancy within 4 months of screening.\n14. Participation in another clinical trial within 30 days, or dosing with an investigational agent within 90 days prior to signing the ICF for this study.",{"count":197,"type":22},400,"The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.",[200,201,202,28,203,204,205,206],"Metabolic Associated Fatty Liver Disease","Metabolic Associated Steatotic Liver Disease","Cirrhosis, Liver","Liver Fibrosis","Liver Fat","Liver Steatoses","Liver Inflammation","2025-08-07",{"date":209,"type":47},"2025-08-14",{"date":211,"type":47},"2025-05-13",{"date":213,"type":22},"2026-07-31",{"name":215,"class":54},"Foundation for the National Institutes of Health",4,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":160},"100583662","secondary-and-tertiary-digital-prevention-of-non-alcoholic-and-dysmetabolic-liver-disease-100583662","NCT06879236","Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease","CALIBRE","Inclusion Criteria:\n\n* Diagnosed with MASLD and LSM\\>= 10 kPa\n* Age \\>= 18 years old\n* Sufficient digital literacy or supported from a caregiver with sufficient digital literacy\n* Smartphone (Android or iOS) able to download and run the App\n* Able to understand and communicate in Italian\n* Able to sign the informed consent\n\nExclusion Criteria:\n\n* Major psychiatric disorder\n* Not able to use digital technologies",{"count":225,"type":22},252,"The prevalence of Metabolic dysfunction-associated steatotic liver disease (MASLD) and its severe form, Metabolic dysfunction-associated steatohepatitis (MASH), is high and they are increasingly becoming major causes of cirrhosis, hepatocellular carcinoma (HCC), and the need for liver transplantation. Due to the lack of noticeable symptoms during the early stages, the detection of MASLD is often delayed until the disease has advanced.\n\nCurrently, the treatment options MASLD are limited to lifestyle interventions such as dietary changes and physical activity. Despite the increasing prevalence of MASLD, there are no drugs available on the market specifically for this condition.\n\nThe goal is to made new model care which integrates the standard clinical procedures with a digital approach, namely a mobile application for patients and a clinical dashboard for healthcare professionals (HCPs), integrated with simple clinical data (anthropometric, laboratory and imaging data).\n\nThis study wants to test the feasibility of integrating a digital intervention to improve the patient engagement and linkage to care in order to identify the advanced MASLD at earliest stage (secondary prevention) and mitigate the impact of ongoing advanced liver disease helping patients to manage the long-term effect of disease.\n\nTo achieve this goal the study will leverage on a mobile app named OpenTele in order to test the adherence to lifestyle changes in patient with MASLD and on the connected clinical dashboard.\n\nThe app aims at integrating the standard clinical practice with digital technologies able to guide and support patients in order to seamlessly integrate secondary prevention strategies in their everyday life with 2 main aims:\n\n* to implement a strategy for delay progression of liver disease;\n* to reduce the effect of cirrhosis (tertiary prevention).",[28,29],"2025-03-14",{"date":230,"type":47},"2025-03-17",{"date":232,"type":47},"2025-01-16",{"date":234,"type":22},"2028-01-01",{"name":236,"class":54},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":160},"100584359","optimizing-noninvasive-assessment-of-dysmetabolic-compensated-advanced-liver-disease-100584359","NCT06888310","Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease","Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease by Integration of Artificial Intelligence Model and omicS Data","MODELS","Inclusion Criteria:\n\n* age\\>=18; sex (M,F);\n* dysmetabolic liver disease according new nomenclature definition;\n* suspicion of cACLD by LSM\\>=10 with VCTE;\n* routine esogastroduodenoscopy report within 12 months of VCTE for identification of high-risk varices (HRV).\n\nExclusion Criteria:\n\n* portal vein thrombosis,\n* infiltrative liver neoplasms, and conditions are known for their potential influence on the LSM results (congestive liver disease, extrahepatic biliary obstruction, ALT \\> 5x upper normal limit).",{"count":246,"type":22},408,[94],"Non-alcoholic fatty liver disease (NAFLD) is responsible for a significant proportion of liver-related deaths and healthcare costs in the United States, accounting for approximately 36% of liver-related deaths and over one billion dollars in annual healthcare expenses. \\[PMID: 34863359\\] A recent analysis of healthcare costs in Italy showed that out of the 9,729 NAFLD\u002FNASH patients who were hospitalized and analyzed, the vast majority (97%) did not have advanced liver disease, while 1.3% had compensated advanced liver disease (cACLD), 3.1% had decompensated cirrhosis, 0.8% had hepatocellular carcinoma, and 0.1% underwent liver transplantation.\n\nThe burden of comorbidities was high across all patient cohorts, and patients with cACLD required a greater number of inpatient services, outpatient visits, and the pharmacy fills compared to those without advanced liver disease. As disease severity increased, mean total annual costs also increased primarily due to higher inpatient services costs. In Italy, as in other EU countries, most of the healthcare costs for patients were attributed to NAFLD\u002FNASH-related liver complications. Thus, the optimization of the non-invasive diagnosis of cACLD represents an urgent need in dysmetabolic liver disease. These advancements will play a crucial role in early detection, risk stratification, and effective management of highly prevalent liver diseases such as NAFLD\u002FNASH and their progression.",[28,29],{"date":251,"type":47},"2025-03-21",{"date":253,"type":47},"2024-12-06",{"date":255,"type":22},"2027-03-01",{"name":236,"class":54},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":279},"100487881","phase-2-huhuanglianzonggan-capsule-in-subjects-with-nonalcoholic-steatohepatitis-a-phase-2-trialhhl-hepar-100487881","NCT05632861","HuHuangLianzonggan Capsule in Subjects With Nonalcoholic Steatohepatitis: a Phase 2 tRial(HHL-HEPAR)","Efficacy and Safety of HuHuangLianzonggan Capsule in Subjects With Nonalcoholic steatoHEPAtitis: a Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 tRial(HHL-HEPAR)","Inclusion Criteria:\n\n1. Males and females between 18-75 years of age inclusive(including boundary values).\n2. Must have had a liver biopsy proven NASH within 6 months or in screening test. The following two requirements must be met at the same time: ① a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: Steatosis≥1, Lobular inflammation≥1, Ballooning degeneration≥1;② fibrosis stage 1 to 3.\n3. Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.\n4. No alcohol consumption or history of excessive alcohol consumption: less than 210 g of ethanol per week for men and 140 g for women in the past 12 months.\n5. Patients who are taking chronic drugs(including but not limited to antihypertensive drugs, antiatherogenic drugs, oral hypoglycemic drugs, insulin) need to have a steady dose for at least 3 months before liver biopsy.\n6. Weight was stable(the change is no more than 5%) during the 6 months prior to Screening.\n7. No attempt to change lifestyle (diet and\u002For exercise) during the 3 months prior to Screening.\n8. Ability to understand the requirements of the study and willingness to provide written informed consent.\n9. Have no pregnancy program and take effective contraceptive measures voluntarily.\n10. Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment.\n\nExclusion Criteria:\n\n1. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy (e.g. valproic acid, tamoxifen, methotrexate, amiodarone, oral corticosteroids, \\>5 mg\u002Fday of prednisone equivalent \\[one short (\\\u003C2 weeks) course of oral corticosteroids, more than 3 months before the liver biopsy is allowed\\], or oestrogens \\[at doses greater than those used for contraception or hormone replacement\\]).\n2. Documented causes of fatty liver disease other than NASH including, but not restricted to: HCV-associated fatty liver (genotype 3), hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, abetalipoproteinemia, lipoatrophy , Coeliac disease, Primary sclerosing cholangitis, Alpha-1-antitrypsin deficiency, Drug-induced liver disease.\n3. Model for End-stage Liver Disease (MELD) score \\>12.\n4. Histologically documented liver cirrhosis (fibrosis stage F4), history or current diagnosis of hepatocellular carcinoma HCC.\n5. History of or planned liver transplant.\n6. Viral hepatitis：Positive hepatitis A antibody，Positive hepatitis D antibody，Positive hepatitis E antibody，Positive hepatitis B surface antigen (HBsAg) ，Positive hepatitis C antibody.\n7. Abnormal liver function as defined by Screening central laboratory evaluation of any of the following: ALT or AST \\>5 × ULN; Alkaline phosphatase (ALP) \\>2 × ULN; albumin below the lower limit of the normal range; total bilirubin level \\>1.5 × ULN (patients with a documented history of Gilbert's syndrome can be enrolled if the direct bilirubin is within normal reference range).\n8. In patients who are not anticoagulated, INR ≥ 1.3 times ULN or other evidence of impaired coagulation.\n9. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n10. Patient currently receiving any approved treatment for NASH.\n11. HbA1c ≥9% or fasting blood-glucose\\>13.9 mmol\u002FL at Screening.\n12. Diabetes mellitus other than type 2 (e.g. type 1, diabetes caused by drugs or chemicals, and immune-mediated diabetes).\n13. Those who are underweight, of normal weight, or severely obese, i.e BMI\\\u003C23 kg\u002Fm2 or BMI≥40 kg\u002Fm2.\n14. Bariatric surgery or tumor surgery are not allowed within 5 years of the qualifying liver biopsy.\n15. Uncontrolled hypertension (values ≥160\u002F100 mm Hg) or hypotension（values \\\u003C80\u002F50 mmHg）.\n16. Acute vascular events including ACS, stroke, peripheral vascular disease worsened, or any vascular\u002Fcardiac surgery within the 6 months prior to Screening.\n17. Concomitant mental illness and poor condition control, which affects the signing of informed consent or presentation of adverse events.\n18. Do not have a liver biopsy within the 6 months prior to Screening and refuse to take liver biopsy at Screening.\n19. Allergic constitution, or allergic to the test drug or its ingredients.\n20. Women who are pregnant or lactating.\n21. Participate in clinical trials of other drugs within 3 months before screening.\n22. The researchers did not consider it appropriate to participate in this study.",{"count":265,"type":22},76,[25],"This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.",[28],"2024-08-28",{"date":271,"type":47},"2024-08-29",{"date":273,"type":47},"2023-02-21",{"date":275,"type":22},"2024-12-31",{"name":277,"class":278},"Tasly Pharmaceutical Group Co., Ltd","INDUSTRY",20,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":287,"targetDuration":67,"studyType":68,"phases":4,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100544098","precise-evaluation-criteria-for-histological-regression-of-nash-fibrosis-100544098","NCT06364462","Precise Evaluation Criteria for Histological Regression of NASH Fibrosis","Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis","Inclusion Criteria:\n\n* 18-70 years of age.\n* Liver biopsy-proven NASH fibrosis with stage F2-4.\n* Signature of written informed consent.\n\nExclusion Criteria:\n\n* Patients with other liver diseases, including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, genetic metabolic liver disease, drug-induced liver diseases, and infected with HIV.\n* Pregnant women.\n* Patients have the following conditions before liver biopsy:\n\nHepatocellular carcinoma or suspected liver cancer; Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatorenal syndrome; Other malignancy; Undergone liver transplantation surgery;\n\n* Patients with any other reasons not suitable for the study.",{"count":288,"type":22},220,"It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.",[28,203],[28,41],"2024-05-27",{"date":294,"type":47},"2024-05-29",{"date":296,"type":22},"2024-06-15",{"date":298,"type":22},"2027-04-01",{"name":300,"class":54},"Beijing Friendship Hospital",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":160},"100539816","role-of-the-very-low-calorie-ketogenic-diet-vlckd-in-patients-with-non-alcoholic-steatohepatitis-nash-with-fibrosis-100539816","NCT06308757","Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis","The Role of Very Low Calorie Ketogenic Diet (VLCKD) in Patients Affected by Non-Alcoholic Steatohepatitis (NASH) With Significant Fibrosis (KETONASH)","KETONASH","Inclusion Criteria:\n\n* Patients aged ≥18 years with histological diagnosis of NASH with evidence of fibrosis (defined according to NASH CRN) obtained no more than 6 months before enrollment;\n* Stable weight for more than 6 months with BMI between 30-40 kg\u002Fm2;\n* Patients in whom it is safe and feasible to proceed with liver biopsy and who consent to undergo liver biopsy after 12 months of enrollment to assess the effect of dietary treatment;\n* Obtained informed consent.\n\nExclusion Criteria:\n\n* BMI \\\u003C30 or BMI \\>40\n* Presence of evolved chronic liver disease into cirrhosis (histological F4 or elastometric LSM \\>14 kPa)\n* Type 1 diabetes mellitus\n* Model for End-stage Liver Disease (MELD) score \\>12, AST or ALT ≥5× ULN, HbA1c \\>9.5%, INR ≥1.4, creatinine \\>1.5 mg\u002Fdl, platelets \\\u003C100,000\u002Fmm3, and total bilirubin \\>1.5 mg\u002Fdl.\n* Concurrent presence of any other known chronic liver disease beyond MAFLD\u002FNAFLD, such as alcoholic liver disease, viral (HCV\u002FHBV), cholestatic-autoimmune (PBC\u002FPSC\u002FAIH), Wilson's disease, hemochromatosis, drug-induced liver injury (DILI), or the presence or suspicion of hepatocellular carcinoma (HCC);\n* Average alcohol consumption exceeding 4\u002F2 units\u002Fday (males\u002Ffemales) in the preceding 6 months and a history of excessive alcohol consumption in the last 5 years;\n* Previous or planned liver transplant, bariatric surgery, ileal resection, or biliary diversion;\n* History of acute cholecystitis and biliary obstructions (cholangitis);\n* Recent (in the last 12 months) or concurrent use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \\[\\>10 days\\], amiodarone, methotrexate, tamoxifen, tetracyclines, high-dose estrogens, valproic acid);\n* Recent (in the last 3 months) change in the dose\u002Fregimen or introduction of Vitamin E (at doses ≥400 IU\u002Fday), ursodeoxycholic acid (UDCA), betaine, S-adenosyl methionine, silymarin, or pentoxifylline;\n* Presence of psychiatric disorders and\u002For diagnosis of any eating disorder;\n* Life expectancy \\\u003C6 months.",{"count":310,"type":22},42,[94],"The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver\u002FEuropean Society for Clinical Nutrition and Metabolism guidelines on MAFLD\u002FNAFLD).",[28,29,314,203],"Obesity",[316,317,318],"vlckd","diet","ketogenic diet","2024-03-13",{"date":321,"type":47},"2024-03-15",{"date":323,"type":47},"2021-09-29",{"date":325,"type":22},"2026-12-12",{"name":327,"class":54},"University of Bologna",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":168,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":339,"conditions":340,"keywords":346,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":4},"100505128","study-consortium-for-evaluation-of-rnpc-program-in-obese-and-overweight-patients-scoop-rnpc-100505128","NCT05857319","Study Consortium for Evaluation of RNPC Program in Obese and Overweight Patients (SCOOP-RNPC)","Assessment of the Impact of Short, Medium and Long-term Weight Loss, Obtained by a Standardized Nutritional and Psycho-Behavioral Rehabilitation Program (RNPC Program) and in Real Life Conditions, in Obese or Overweight Patients","SCOOP-RNPC","Inclusion Criteria:\n\n* Body Mass Index (BMI) greater than or equal to 25 kg\u002Fm² and\u002For waist circumference greater than or equal to 80 cm in women and 94 cm in men;\n* Possessing a personal smartphone;\n* Subjects subject to the French health system;\n* Subjects able to sign the informed consent.\n\nExclusion Criteria:\n\n* Persons refusing to sign the participation consent;\n* Pregnant, parturient and breastfeeding women;\n* Persons with missing limb(s);\n* People with an electrical medical device such as a pacemaker, battery, insulin pump or cochlear implant;\n* People carrying any metallic material present in the body, such as prostheses or screws;\n* Persons under guardianship;\n* Subject in period of exclusion from another study;\n* Person deprived of liberty by judicial or administrative decision;\n* Person subject to a legal protection measure, who cannot be included in clinical trials;\n* People with an open wound or bleeding on the palms of the hands or soles of the feet (Neuropathy group only).","85 Years",{"count":338,"type":22},10000,"The investigators hypothesize that weight loss obtained with the French RNPC weight reduction program is beneficial for the general health of overweight\u002Fobese patients in the medium term.\n\nThe objective of this cohort study is to demonstrate the effectiveness of the RNPC program on the reduction of drug or instrumental treatments (for example, continuous positive pressure ventilation for the treatment of sleep apnea syndrome) and the improvement of overweight\u002Fobesity-associated comorbidities in the medium term.\n\nThis is a multicenter clinical study, as part of routine care, with standardized nutritional care (RNPC Program) in all RNPC centers in France. A cohort will be formed based on the clinical and biological data usually collected in the centers, enriched by data from additional clinical and biological examinations as well as by self-questionnaires completed by the participants. About 10,000 overweight or obese participants will be included for 2 years and followed 5 years.\n\nThe SCOOP-RNPC study will have benefits for individual participants, for the scientific community in terms of knowledge acquired and for society with a better definition of the impact of treatments.\n\nResponding to the major public health issue represented by overweight, this prospective cohort of overweight or obese patients will make it possible to evaluate, in real-life conditions, the effects of weight loss obtained by the RNPC Program in the short, medium and long term on biological parameters predictive of cardiometabolic risk, drug consumption, quality of life, diet and eating behavior, sleep, physical activity, stress\u002Fanxiety, as well as depression.\n\nThis cohort will make it possible to identify clinical phenotypes and biomarkers to optimize the personalization of the management of overweight or obese patients, in particular those at risk of developing comorbidities associated with excess weight.",[341,342,343,344,345,29,28],"Overweight and Obesity","Cardiovascular Diseases","Metabolic Disease","Diabete Type 2","Sleep Apnea, Obstructive",[347,348,349],"Prospective Interventional Study","Real-Life Conditions","RNPC Program","2023-05-04",{"date":352,"type":47},"2023-05-12",{"date":354,"type":22},"2023-07-15",{"date":356,"type":22},"2030-07-15",{"name":358,"class":278},"Groupe Éthique et Santé",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":365,"enrollmentInfo":366,"targetDuration":367,"studyType":68,"phases":4,"briefSummary":368,"conditions":369,"keywords":378,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":392},"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":338,"type":22},"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.",[29,28,370,371,372,373,342,374,375,376,314,377],"NASH - Nonalcoholic Steatohepatitis","Fibrosis, Liver","Steatosis of Liver","Hepatocellular Carcinoma","Type 2 Diabetes","Dyslipidaemia","Hypertension","Other Associated Comorbidities",[29,28,379,380,381,382],"Steatohepatitis","Liver","Cirrhosis","Non-alcoholic fatty liver disease","2023-01-05",{"date":385,"type":47},"2023-01-06",{"date":387,"type":47},"2015-05-01",{"date":389,"type":22},"2030-12-31",{"name":391,"class":54},"Newcastle University",37,{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":23,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"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":402,"type":22},900,[94],"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",[29,28,370,406,381],"Fibrosis",[408],"Cohort","2021-06-07",{"date":411,"type":47},"2021-06-14",{"date":413,"type":22},"2021-06",{"date":415,"type":22},"2036-06",{"name":417,"class":54},"Assistance Publique - Hôpitaux de Paris","Nash"]