[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mash-with-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mash-with-fibrosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,82,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100532662","phase-3-a-study-evaluating-efruxifermin-in-subjects-with-non-cirrhotic-nonalcoholic-steatohepatitis-nashmetabolic-dysfunction-associated-steatohepatitis-mash-and-fibrosis-100532662",false,"NCT06215716","A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)\u002FMetabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)\u002FMetabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","Inclusion Criteria:\n\n* Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.\n* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.\n* Cohort 1: Biopsy-proven NASH\u002FMASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and 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:\n\n  * Steatosis (scored 0 to 3),\n  * Ballooning degeneration (scored 0 to 2), and\n  * Lobular inflammation (scored 0 to 3).\n* Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \\\u003C4 may be enrolled and are not required to meet 1 point in each of the components of NAS.\n\nExclusion Criteria:\n\n* Other causes of liver disease based on medical history and\u002For liver histology and\u002For central laboratory results.\n* Presence of cirrhosis on liver biopsy (fibrosis stage 4).\n* Type 1 or uncontrolled Type 2 diabetes.\n\nOther inclusion and exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":20,"type":21},1650,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH\u002FMASH and fibrosis stage 2 or 3 (F2 or F3).\n\nThe study will enroll subjects in two cohorts for a total samples size of 1650 subjects.",[27,28],"NASH With Fibrosis","MASH With Fibrosis","RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-25","ACTUAL",{"date":35,"type":33},"2023-12-01",{"date":37,"type":21},"2033-02",{"name":39,"class":40},"Akero Therapeutics, Inc","INDUSTRY",356,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100561325","phase-2-digoxin-in-nash-codin-100561325","NCT06588699","Digoxin In NASH (CODIN)","Clinical Trial of Oral Digoxin In NASH (CODIN)","CODIN","Inclusion Criteria\n\n* Stable body weight (≤ 5% self-reported change in body weight) in the 30 days prior to screening\n* Biopsy-confirmed non-alcoholic steatohepatitis (NASH) as defined by the NASH clinical research network (NASH CRN) histological scoring system, with non-alcoholic fatty liver disease score (NAS) ≥4 and with a score ≥1 for each of the three components (steatosis, hepatocellular ballooning, and lobular inflammation) on a liver biopsy performed within 6 months of screening\n* Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening\n* Agrees to have a liver biopsy performed to assess baseline histology if one has not been performed up to 6 months before screening, and at 24 weeks after randomization Exclusion Criteria\n\nLiver-related:\n\n* Documented causes of chronic liver disease other than NASH\n* History or clinical evidence of cirrhosis or portal hypertension\n* History of positive HBsAg, positive anti-HIV, positive HCV-RNA\n* AST or ALT \\> 5 times upper limit of normal (ULN) at screening\n* Total bilirubin \\> 1.5 mg\u002FdL at screening unless conjugated bilirubin is \\\u003C 1.5 × ULN\n* International normalized ratio (INR) \\> 1.3 at screening\n* Known or suspected alcohol use \\> 20 g\u002Fday for women or \\> 30 g\u002Fday for men\n* Treatment initiation or dose adjustment of vitamin E, pioglitazone, GLP-1RA, or SGLT-2 inhibitors within 30 days of signing the informed consent or 30 days prior to liver biopsy\n* Treatment initiation or anticipated treatment (\\>14 consecutive days) with medications known to affect steatosis (e.g., systemic corticosteroids, tamoxifen, valproic acid, methotrexate, tetracycline or amiodarone) within 30 days of signing the informed consent or 30 days prior to liver biopsy\n\nCardiac related:\n\n* Heart rate less than 60 bpm at screening (visit 1) or at baseline (visit 2)\n* Current diagnosis of severe aortic valve disease\n* History of Accessory arterio-ventricular pathway (e.g., Wolf-Parkinson-White syndrome)\n* History of complete heart block or second degree arterio-ventricular block without pacemaker or implantable cardiac device\n* Current diagnosis of permanent atrial fibrillation\n* Any of the following within the previous 6 months of signing informed consent: myocardial infarction, percutaneous intervention, pacemaker\u002Fimplantable cardiac device implantation, cardiac surgery, or stroke\n* Current use of the following medications: inotropic drugs such as (dopamine, dobutamine, noradrenaline, milrinone), anti-arrhythmics (amiodarone, dofetilide, sotalol, dronedarone, digoxin), parathyroid hormone analog (teriparatide), sympathomimetics (epinephrine, norepinephrine, dopamine), neuromuscular blocking agents (succinylcholine), calcium supplement, nondihydropyridine calcium channel blockers, ivabradine, and disulfiram.\n\nObesity related:\n\n* Treatment initiation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) with orlistat, zonisamide, topiramate, phentermine, bupropion, and naltrexone alone or in combination or any other medication that could promote weight loss in the opinion of the investigator\n* Participation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) in an organized diet-based weight reduction program (e.g., WeightWatchers, Optifast)\n* Recent surgical treatment (\\\u003C6 months of signing informed consent) for obesity\n\nGeneral safety related:\n\n* Presence or history of malignant neoplasms (in the past 5 years prior to screening), except basal and squamous cell skin cancer and any carcinoma in-situ\n* Surgery scheduled or anticipated during the trial period, except for minor surgical procedures, in the opinion of the investigator\n* Language barrier, mental incapacity, unwillingness, or inability to adequately understand or comply with study procedures\n* Known or suspected hypersensitivity to the trial product or related products including allergy to milk, egg, soy, peanuts, and sulfites\n* Recent participation (within 90 days prior to signing the informed consent) in any clinical trial of an approved or non-approved investigational medicinal product\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method\n* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n* TSH \\> 6 mIU\u002FL or \\\u003C 0.4 mIU\u002FL at screening\n* Current use of the following medications: calcium supplementation, parathyroid hormone analog (teriparatide), neuromuscular blocking agents (succinylcholine) and disulfiram.\n* Claustrophobia to an extent that would prevent tolerance of MRI\n* Metallic implant that would prevent MRI examination including, metallic foreign body, aneurysm clips, vascular grafts or cardiac implants, neural stimulator, cochlear implant, metallic contraceptive device, body piercing that cannot be removed, cochlear implant, or any other contraindication to MRI","75 Years",{"count":52,"type":21},144,[54],"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.",[57,58,59,60,28,61,62,63],"NASH","NAFLD","MASH - Metabolic Dysfunction-Associated Steatohepatitis","Mash","MASLD","Fatty Liver Disease","Fatty Liver Disease, Nonalcoholic",[57,65,66,67,68,69,70,58],"MASH","Metabolic dysfunction associated steatohepatitis","Digoxin","Drug repurposing","Liver fibrosis","Fatty liver disease","2026-05-22",{"date":73,"type":33},"2026-05-26",{"date":75,"type":33},"2025-06-05",{"date":77,"type":21},"2029-01",{"name":79,"class":80},"Yale University","OTHER",2,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":16,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":81},"100594013","fructose-is-a-metabolic-and-inflammatory-pathogenic-factor-in-metabolic-dysfunction-associated-steatohepatitis-mash-100594013","NCT07013916","Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)","FLOURISH","Inclusion Criteria:\n\n* Able and willing to give written informed consent\n* Age 45-65 at consent\n* HbA1c \\\u003C 48 mmol\u002Fmol\n* Overweight and stage I obesity using BMI thresholds adjusted for ethnicity:\n\n  * 23.0kg\u002Fm2 - 32.4kg\u002Fm2 in South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean populations\n  * 25kg\u002Fm2 - 34.9kg\u002Fm2 in White populations\n\nMASH Patients:\n\nClinical diagnosis of MASH and F2 - F3 fibrosis:\n\nEither:\n\nLiver biopsy within 12 months of baseline\n\nOr:\n\n• History of histologically-diagnosed MASH with current evidence of fatty liver, AST\\>20 and Fibroscan CAP≥248 dB\u002Fm and stiffness 9.5kPa -14kPa\n\nOr:\n\n• FAST score \\>0.67\n\nPatients with steatosis:\n\n• defined by Fibroscan CAP≥248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nHealthy controls:\n\n• defined by Fibroscan CAP\\\u003C248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nExclusion Criteria:\n\n* Unwilling or unable to give consent\n* Age \\\u003C45 or \\>65\n* Any form of diabetes mellitus\n* Currently pregnant\n* Known fructose intolerance or food allergy\n* Diagnosis of cirrhosis or Fibroscan stiffness \\>14kPa\n* Current Child-Pugh B\u002FC or episode of decompensation in last year\n* Non-MASLD liver disease known to participant (including viral hepatitis, auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, sarcoidosis, cystic fibrosis, sickle cell disease)\n* Regular alcohol intake \\> 14 units a week for females and \\>21 units a week for males (participant-reported)\n* Smoking, vaping or use of nicotine-containing products within the last month\n* Taking prohibited medication:\n\n  * Probiotic or antibiotic use within last 4 weeks (Note: participants will be considered eligible if they have undergone a 4-week washout from probiotics or 4-weeks after discontinuing antibiotic use)\n  * any oral steroids within the last 6 weeks\n  * current, or within 3 months, use of immunosuppressive medication\n  * Amiodarone, nitrofurantoin, or anti-fungals within 3 months\n  * Use of anti-obesity medication - orlistat or GLP-1 receptor agonist-containing treatments within 6 months\n  * Use of vitamin E, pioglitazone or other medication for MASH including current or within 3 months enrolment in clinical trial unless documented to have been on placebo\n* History of malignancy (except basal cell carcinoma), or medication for malignancy within the last 2 years\n* Any major organ transplant (excluding corneal or hair)\n* Clinical diagnosis of chronic kidney disease 3 or above, or of heart failure (NYHA 3 or 4)\n* COPD requiring home oxygen\n* Known eating disorder (e.g. anorexia nervosa) or severe mental illness (e.g. schizophrenia)\n* Investigator opinion that study is unsuitable for patient",true,"45 Years","65 Years",{"count":93,"type":21},72,[95],"NA","MASLD (Metabolic dysfunction-associated steatotic liver disease) is a condition where fat builds up in the liver. It is the most common cause of liver disease worldwide. In some people, the fat can irritate the liver (inflammation) and cause damage. This is a more serious condition called MASH (Metabolic dysfunction-associated steatohepatitis). People with MASH more at risk of liver cirrhosis (advanced scarring in the liver) and liver cancer.\n\nIt is not fully understood why MASLD becomes MASH, or why this happens in some people but not in others. However, it is known that our diet plays a role. Research shows a diet high in a type of sugar called fructose might make MASLD worse. Fructose is found in fruit, honey and table sugar, and lots of processed food and drinks. The body deals with fructose differently to other sugars, which is why fructose may be a problem. Although scientists have studied the effects of fructose in healthy people, no studies so far have included people with MASH, so it is not known if fructose might make the condition worse.\n\nTo answer this question, the researchers will conduct a four-week randomised, double-blind study to compare the effects of fructose with another sugar called glucose in 36 people with MASH, 18 people with 'simple' MASLD, and 18 controls without liver disease. Participants will follow a low-sugar diet and, after 14 days on this diet, they will add either a glucose or fructose supplement for another 14 days. Participants will attend 3 study visits, where blood, urine, stool, and saliva samples will be taken. The main question is whether fructose causes more inflammation in people with MASH compared to those with MASLD, or people without liver disease. The researchers will also investigate how fructose affects liver fat content, the gut microbiota, and other processes relevant to MASLD\u002FMASH.",[59,28,98],"Steatosis of Liver",[100,65,61,101,102],"fructose","liver","inflammation","2025-07-18",{"date":105,"type":33},"2025-07-23",{"date":107,"type":33},"2025-06-30",{"date":109,"type":21},"2026-04-01",{"name":111,"class":80},"Queen Mary University of London",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":120,"targetDuration":122,"studyType":123,"phases":4,"briefSummary":124,"conditions":125,"keywords":131,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100489331","global-research-initiative-for-patients-screening-on-mash-100489331","NCT05651724","Global Research Initiative for Patients Screening on MASH","Global Research Initiative for Patients Screening on MASH - Implementation of an International Transmural Patient Care Pathway","GRIPonMASH","Inclusion Criteria:\n\n* Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, following the study definitions.\n* Subjects that are currently being treated for type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, should have had a prior diagnosis based on study definitions.\n\nStudy definitions:\n\nType 2 diabetes mellitus\n\n* At least 2 times a fasting glucose \\> 7,0 mmol\u002FL\n* Or elevated non-fasting glucose \\>11,1 mmol\u002FL 2 hrs after OGTT\n* Or HbA1c ≥48 mmol\u002Fmol (≥6.5%)\n* Or being actively treated for previously diagnosed type 2 diabetes by a health care provider\n\nObesity\n\n* Body mass index (BMI) \\> 30\n* Or waist circumferences Caucasian: male ≥ 94 cm, female ≥ 80 cm South-Asian\u002FChinese: male ≥90 cm, female ≥80 cm Japanese: male ≥85 cm, female ≥90 cm\n\nArterial hypertension\n\n* Systolic BP ≥ 140 mmHg and\u002For diastolic BP ≥ 90 mmHg\n* Or being actively treated for previously diagnosed arterial hypertension by a health care provider\n\nMetabolic syndrome\n\n\\- Central obesity defined as waist circumference (see above), if BMI is \\>30 kg\u002Fm2, central obesity can be assumed and waist circumference does not need to be measured\n\nAND any two of the following:\n\n* Raised triglycerides: ≥ 150 mg\u002FdL (1.7 mmol\u002FL), or specific treatment for this lipid abnormality\n* Reduced HDL cholesterol: \\\u003C 40 mg\u002FdL (1.03 mmol\u002FL) in males, \\\u003C 50 mg\u002FdL (1.29 mmol\u002FL) in females, or specific treatment for this lipid abnormality\n* Raised blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension\n* Raised fasting plasma glucose (FPG): FGP ≥ 100 mg\u002FdL (5.6 mmol\u002FL), or previously diagnosed type 2 diabetes (if above \\>5.6 mmol\u002FL or 100 mg\u002FdL, an oral glucose tolerance test is strongly recommended, but is not necessary to define presence of the syndrome)\n\nExclusion Criteria:\n\n* The patient is known with hepatitis B, C or HIV or any other liver condition (like hemochromatosis, sarcoidosis, Wilson's disease etc);\n* The patient is known with any other condition that may lead to liver fibrosis or cirrhosis;\n* The patient engages in (excessive) alcohol use: \\> 3 units\u002Fday in males \\[30 grams\u002Fday\\] and \\> 2 units\u002Fday in females \\[20 grams\u002Fday\\];\n* The patient has a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the Investigator, may compromise the patient's safety or ability to be included in this study;\n* The patient is an employee or contractor of the facility that is conducting the study or is a family member of the Investigator, sub-Investigator, or any Sponsor personnel;\n* The patient is not able to understand the details of the protocol and\u002For is not able to provide written informed consent;\n* The patient is pregnant or breastfeeding.\n* The patient underwent bariatric surgery in the last 12 months.",{"count":121,"type":21},10000,"5 Years","OBSERVATIONAL","GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.",[65,61,28,126,98,127,128,129,130],"Fibrosis, Liver","Type 2 Diabetes","Obesity","Metabolic Syndrome","Arterial Hypertension",[61,65,132,133],"Screening","Patient care pathway","2024-07-30",{"date":136,"type":33},"2024-08-01",{"date":138,"type":33},"2023-06-30",{"date":140,"type":21},"2031-03-31",{"name":142,"class":40},"Julius Clinical",13]