[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-dysfunction-associated-steatohepatitis-mash\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-dysfunction-associated-steatohepatitis-mash":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,77,105,131,159,185,214,233,259,280,301,321,346,366],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100564689","liverage-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-moderate-or-advanced-liver-fibrosis-100564689",false,"NCT06632444","LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Moderate or Advanced Liver Fibrosis","A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction-associated Steatohepatitis (NASH\u002FMASH) and (F2) - (F3) Stage of Liver Fibrosis","Inclusion criteria:\n\n1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent\n2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4\n3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used\n4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply\n\nExclusion criteria:\n\n1. Any of the following liver laboratory test abnormalities at screening:\n\n   * Serum AST and\u002For alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)\n   * Platelet count \\\u003C140 000\u002Fmm\\^3 (\\\u003C140 GI\u002FL)\n   * Alkaline phosphatase \\>2x upper limit of normal (ULN)\n   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:\n\n     * Albumin below \\\u003C3.5 g\u002FdL (35.0 g\u002FL)\n     * OR International normalised ratio (INR) of prothrombin time \\>1.3\n     * OR total serum bilirubin concentration ≥1.5x ULN\n2. Any history or evidence of acute or chronic liver disease other than MASH\n3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy\n4. History of or current diagnosis of hepatocellular carcinoma\n5. History of or planned liver transplant\n6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.\n7. History of portal hypertension or presence of decompensated liver disease\n8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply","ALL","18 Years",{"count":19,"type":20},1800,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study is open to adults who are at least 18 years old living with obesity and have:\n\n* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)\u002Fmetabolic associated steatohepatitis (MASH) and\n* moderate or advanced liver fibrosis\n\nPeople with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.\n\nThis study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.",[26,27],"Metabolic Dysfunction Associated Steatohepatitis (MASH)","Liver Fibrosis","RECRUITING","2026-08-20",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":32},"2024-10-14",{"date":36,"type":20},"2031-12-27",{"name":38,"class":39},"Boehringer Ingelheim","INDUSTRY",528,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100649188","isocaloric-navy-bean-substitution-in-adults-with-masld-100649188","NCT07730853","Isocaloric Navy-Bean Substitution in Adults With MASLD","Randomized Feasibility Trial of Isocaloric Navy-Bean Substitution in Adults With MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)","BEAN-MASLD","Inclusion Criteria:\n\n* Adults 18-75 years of age with capacity to provide informed consent\n* Clinical diagnosis of MASLD, confirmed by imaging (MRI-PDFF or VCTE) or prior liver biopsy.\n* Intermediate-stage fibrosis (F2-F3) confirmed by one of the following (most recent qualifying result): VCTE (FibroScan) 8.0-14 kPa, MRE 3.0-4.6 kPa (2D EPI @ 60 Hz), or liver biopsy read as F2-F3\n* Body mass index 25-45 kg\u002Fm²\n* Stable medications for ≥12 weeks for diabetes, hypertension, dyslipidemia, or weight management\n* Alcohol intake below MASLD thresholds (≤15 drinks\u002Fweek for men, ≤10 drinks\u002Fweek for women)\n* Willing and able to consume study navy beans and complete dietary recalls (ASA-24\u002FDSQ)\n* Able to undergo MRI and MRE (no contraindications) and attend study visits\n* Agrees to biospecimen collection (blood, stool, saliva) and patient-reported outcomes\n\nExclusion Criteria:\n\n* Other chronic liver disease (hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis)\n* Decompensated liver disease (ascites, variceal bleeding, encephalopathy) or Child-Pugh B\u002FC cirrhosis, or clinical portal hypertension\u002Fdecompensation\n* Heavy alcohol use above MASLD thresholds, or alcohol use disorder within 12 months\n* Legume\u002Fbean allergy or intolerance\n* Initiation or dose change of antidiabetic, lipid-lowering, antihypertensive, or weight-loss medications within the past 12 weeks, or anticipated changes during the trial\n* Recent initiation of agents known to affect hepatic fat or fibrosis (e.g., GLP-1 receptor agonist, SGLT2 inhibitor, pioglitazone, resmetirom) within 12 weeks\n* Use of hepatotoxic drugs likely to confound liver enzymes in the prior 12 weeks (per investigator judgment)\n* New supplements targeting weight loss, liver health, or the microbiome within 8-12 weeks (e.g., berberine, high-dose omega-3, pre\u002Fprobiotics)\n* Antibiotics, probiotics, or colonoscopy preparation within 8 weeks\n* Planned bariatric surgery or other major weight-loss intervention during the study\n* Recent weight change \\>5% within 8-12 weeks prior to baseline\n* Severe gastrointestinal disease (inflammatory bowel disease, celiac disease, short bowel syndrome) that may impair tolerance\n* Uncontrolled diabetes (HbA1c \\>10%), severe renal dysfunction (eGFR \\\u003C45), or unstable cardiovascular, thyroid, or psychiatric illness\n* Pregnant or breastfeeding\n* Contraindications to MRI (e.g., non-compatible implants, severe claustrophobia)\n* Participation in another interventional study within the last 30 days","75 Years",{"count":51,"type":20},40,[53],"NA","This study is a 24-week randomized crossover feasibility trial evaluating an isocaloric navy-bean dietary substitution in 40 adults with metabolic dysfunction-associated steatotic liver disease (MASLD) and intermediate-stage (F2-F3) fibrosis. Participants are randomized to one of two sequences-habitual diet followed by a navy-bean-rich diet, or a navy-bean-rich diet followed by habitual diet-with each 12-week phase guided by registered dietitians so that navy beans replace an equivalent caloric load without changing total energy intake. The primary aim is to establish feasibility and acceptability, measured by recruitment and retention, adherence with biomarker (plasma pipecolic-acid) concordance, and patient acceptability.",[56,27,57],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)",[59,60,61,62,63,64],"Navy beans","Dietary intervention","Isocaloric substitution","Gut microbiome","Gut-liver axis","Liver stiffness","NOT_YET_RECRUITING","2026-08-10",{"date":68,"type":32},"2026-08-12",{"date":70,"type":20},"2026-09-01",{"date":72,"type":20},"2029-08-31",{"name":74,"class":75},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100544898","phase-4-fibrosis-lessens-after-metabolic-surgery-100544898","NCT06374875","Fibrosis Lessens After Metabolic Surgery","A Prospective Multicenter International Randomized Controlled Trial Comparing Surgical and Medical Therapies in the Treatment of Advanced Metabolic Dysfunction Associated Steatohepatitis","FLAMES","Inclusion Criteria\n\nEntry into the study would require that the patient:\n\n1. Is a candidate for general anesthesia\n2. Is eligible for metabolic surgery (RYGB or SG) based on the ASMBS\u002FIFSO 2022 guidelines\n3. Has insurance coverage for metabolic surgery (the requirements may vary in each country)\n4. Is ≥18 and ≤75 years old at the time of signing the informed consent\n5. Has a BMI ≥35 and ≤70 kg\u002Fm2 at the time of first study visit\n6. FIB-4 ≥ 1.3\n7. At least one of the following 5 criteria suggesting presence of advanced fibrosis:\n\n   * LSM ≥ 12 kPa by VCTE using FibroScan®\n   * LSM ≥ 12 kPa by SWE\n   * LSM ≥ 1.7 m\u002Fs by ARFI\n   * LSM ≥ 3.63 kPa MRE\n   * ELF score ≥ 9.8\n8. Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin but not semaglutide or tirzepatide or liraglutide) for at least 3 months prior to entry, with glycated hemoglobin (HbA1c) ≤12%.\n9. Self-reported stable weight in 6 months before the first study visit (no weight loss \\>10% within 6 months prior to the first study visit)\n\n   a. In patients with a historical noninvasive tests or liver biopsy, weight loss of no more than 10% is allowed from 6 months prior to the historical tests until the first study visit\n10. Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study\n11. Can understand the options and comply with the requirements of each arm, including one liver biopsy performed during the screening period (if no adequate biopsy within 12 months before screening is available) and one liver biopsy after 2-years\n12. Has a negative urine pregnancy test at the first and at the randomization visits for women of childbearing potential.\n13. Women of childbearing age must agree to use reliable method of contraception for 2 years\n\n8.2 Exclusion Criteria\n\nPatients who meet the following criteria will be excluded from the study:\n\n1. Known history of other chronic liver diseases (drug induced, viral hepatitis, autoimmune, and genetic):\n\n   * Hepatitis B as detected by presence of hepatitis B surface antigen (HBsAg)\n   * Hepatitis C as detected by presence of hepatitis C virus (HCV) RNA (in case the screening test for hepatitis C is positive, the confirmative test is decisive)\n   * Autoimmune liver disease as diagnosed by antibodies or compatible liver histology\n   * Primary biliary cirrhosis as defined by the presence of at least 2 criteria (elevated alkaline phosphatase, presence of anti-mitochondrial antibody, and histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts)\n   * Primary sclerosing cholangitis\n   * Wilson's disease as diagnosed by low ceruloplasmin or compatible liver histology\n   * Alpha-1-antitrypsin deficiency as diagnosed by alpha1-antitrypsin level or liver histology\n   * Hemochromatosis as diagnosed by HFE mutations (C282Y, H63D), ferritin and transferrin saturation levels, or presence of 3+ or 4+ stainable iron on liver biopsy\n   * Drug-induced liver disease diagnosed by medical history\n   * Known bile duct obstruction\n   * Suspected or proven liver cancer\n2. Weight change \\>10% within 6 months prior to the first study visit or prior to the historical liver biopsy\n3. Treatment with semaglutide, tirzepatide, or liraglutide (for obesity or for T2DM) \\\u003C90 days before the first study visit.\n\n   • However, patients are allowed to participate if they have been on a low dose (or are on older generation GLP-1 agonists) and have lost less than 10% of their body weight since starting the medication.\n4. Type 1 diabetes or autoimmune diabetes\n5. Known cases of human immunodeficiency virus infection\n6. Prior bariatric and metabolic surgery of any kind\n\n   • Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed.\n7. Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery\n8. Any surgery requiring general anesthesia within 1 month prior to signing the consent\n9. History of solid organ transplant\n10. Severe pulmonary disease defined as FEV1 \\\u003C 50% of predicted value\n11. Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)\n12. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V\n13. Classified as New York Heart Association Class IV\n14. Left ventricular ejection fraction \\\u003C25% at the time of screening\n15. Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months\n16. Chronic renal insufficiency with eGFR below 30 mL\u002Fmin\u002F1.73 m2, or being on dialysis\n17. Presence of large hiatal hernia (\\>7 cm)\n18. Presence of Crohn's disease\n19. Psychiatric disorders including (but not limited to) dementia, active psychosis, severe depression requiring 3 or more medications, history of suicide attempts, active alcohol, or substance abuse within the previous 12 months that in the opinion of the investigators could disqualify the patient from metabolic surgery\n20. Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures\n21. Breastfeeding\n22. Diagnosis of malignancy within the preceding 3 years (except squamous cell and basal cell cancer of the skin)\n23. Anemia defined as hemoglobin less than 9 g\u002FdL\n24. On therapeutic dose of anticoagulants such as warfarin or direct oral anticoagulants (DOACs)\n25. Known history of clotting disorders, including pulmonary embolus and deep vein thrombosis\n26. Clinical judgment that life expectancy is less than 3 years\n27. Use of investigational therapy within 3 months prior to signing the consent\n28. History of pancreatic carcinoma\n29. Acute pancreatitis \\\u003C 180 days before screening\n30. History or presence of chronic pancreatitis\n31. Presence of concerning thyroid nodule\n32. Uncontrolled thyroid disease: thyroid stimulating hormone (TSH) \\> 6.0 mIU\u002FL or \\\u003C 0.1 mIU\u002FL before the first study visit\n\n    * Patients receiving treatment for hypothyroidism can be included if their thyroid hormone replacement dose has been stable for at least 3 months.\n    * Patients whose TSH is outside the rang but they have normal levels of thyroid hormones can be included.\n33. A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n34. Evidence or history of ascites or spontaneous bacterial peritonitis that require(d) treatment\n\n    • Trace ascites identified only by an abdominal imaging without other evidence of clinically significant portal hypertension and esophageal varices is not an exclusion criterion.\n35. Evidence or history of hepatic encephalopathy\n36. Evidence or history of variceal bleeding\n37. Evidence or history of portosplenic vein thrombosis\n38. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to the first study visit.\n\n    • Defined as more than 14 units\u002Fweek for females (\\>1 drink per day) and more than 21 units\u002Fweek for males (\\>2 drinks per day) on average, where one unit of alcohol is equivalent to a 12-oz beer, 4-ounce glass of wine, or 1-ounce shot of hard liquor.\n39. Treatment with medications (for more than 14 consecutive days) with known effect on liver steatosis (e.g., treatment with systemic corticosteroids \\[oral or intravenous\\], methotrexate, tamoxifen, valproic acid, amiodarone, or tetracycline) in the 3 months prior to the first study visit (or historical liver biopsy).\n40. ALT or AST or Alkaline phosphatase \\>200 U\u002FL\n41. Recurrent major hypoglycemia or hypoglycemic unawareness\n42. Inability to safely obtain a liver biopsy\n43. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study\n44. Unable to understand the risks, benefits, and compliance requirements of study\n45. Lack capacity to give informed consent\n46. Plans to move outside the primary location of study (country) within the next 24 months\n47. Known or suspected allergy to semaglutide, tirzepatide, liraglutide, excipients, or related products\n48. Previous participation in this trial and got randomized to one of the study groups but did not proceed.\n49. Hospitalization due to COVID-19 within 2 months prior to screening.\n50. Platelet count \\\u003C80,000\n51. International Normalized Ratio (INR) \\>1.7\n52. Child-Pugh score B or C\n53. MELD score ≥15\n54. Upper endoscopy showing gastroesophageal varices\n55. Upper endoscopy showing more than mild portal hypertensive gastropathy\n56. Liver vascular ultrasound (duplex ultrasonography) showing significant portal hypertension characterized by dilated portal vein (\\>13 mm), biphasic or reverse flow in the portal vein, enlarged paraumbilical veins, splenorenal collaterals, or dilated left and short gastric veins.\n\n    Note: Negative findings on upper endoscopy and liver duplex ultrasound (done within one year of the first study visit for both tests) are necessary to establish eligibility for the FLAMES.\n    * Ruling out clinically significant portal hypertension is particularly important in patients with a liver stiffness ≥20 kPa or with a platelet count \\\u003C150,000 per μL or with a (historical) liver biopsy showing cirrhosis.\n    * A subset of patients without having upper endoscopy and liver duplex ultrasound can be eligible for enrollment if their:\n\n      * liver stiffness (by transient elastography using FibroScan®) is between 12 and 15 kPa and their platelet count is \\>150,000 per μL, or\n      * a (historical) liver biopsy showing absence of cirrhosis, or\n      * a (historical) HVPG \\\u003C 5 mmHg\n57. Cross-sectional abdominal imaging (if available historically) indicating presence of large portosystemic collaterals or ascites\n\n    • Splenomegaly alone (in the absence of other radiological and laboratory findings) is not considered to be a sign of clinically significant portal hypertension and is not an exclusion criterion.\n58. HVPG ≥ 12 mmHg (if available historically or if measured at the time of de novo liver biopsy)\n59. Liver biopsy characteristics:\n\n    * F0 in de novo biopsy; Enrollment cap of 20% for F1 in de novo biopsy.\n    * F0 and F1 in historical liver biopsy\n    * Absence of all three components of MASH (steatosis, hepatocyte ballooning, and lobular inflammation) in patients with F1, F2, and F3\n    * Absence of steatosis (\\\u003C5%) in patients with F4\n    * Diagnosis other than MASH",true,{"count":87,"type":20},120,[89],"PHASE4","Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.\n\nPatients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.",[92,93,57,27,94],"Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","Non-Alcoholic Fatty Liver Disease","Obesity","2026-07-29",{"date":97,"type":32},"2026-07-31",{"date":99,"type":32},"2024-07-11",{"date":101,"type":20},"2029-12-31",{"name":103,"class":75},"The Cleveland Clinic",22,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100649255","phase-1-a-study-of-vv-14303-for-the-treatment-of-metabolic-dysfunction-associated-steatohepatitis-mash-100649255","NCT07732400","A Study of VV-14303 for the Treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 1\u002F2, First-in-Human, Multi-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Efficacy of VV-14303, an Adeno-associated Virus Vector-mediated Fibroblast Growth Factor 21 (FGF21) Gene Therapy, in Adults With Metabolic Dysfunction-associated Steatohepatitis (MASH)","RESTORE","Inclusion Criteria:\n\n* Participant is capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n* Must be 18 to 75 years of age (inclusive) at Screening\n* Body Mass Index (BMI) of 25 to \\\u003C40 kg\u002Fm2 (inclusive)\n* Male participants must agree to use a highly effective contraception during the Treatment Period and at least 12 months after administration of VV-14303. Female participants must not be a woman of child-bearing potential (WOCBP)\n* Biopsy-confirmed MASH\n* Previous history or presence of ≥2 of the following metabolic risk factors: obesity (BMI ≥25 kg\u002Fm²), hypertension (blood pressure \\[BP\\] ≥140\u002F90 mmHg or on antihypertensive medication), dyslipidemia (triglycerides ≥150 mg\u002FdL or high-density lipoprotein cholesterol \\[HDL-C\\] \\\u003C40 mg\u002FdL in men\u002F\\\u003C50 mg\u002FdL in women or on lipid-lowering therapy), type 2 diabetes mellitus\n* Must be willing to refrain from the donation of blood, plasma, platelets, eggs, or sperm during the 12-month post-treatment follow-up period\n\nExclusion Criteria:\n\n* Presence of alternate and\u002For additional liver disease etiologies at Screening, including but not limited to chronic viral hepatitis, autoimmune hepatitis\n* Use of treatments for metabolic syndrome management, including oral antidiabetic drugs (OADs) (e.g., metformin), incretin mimetics (GLP-1 receptor agonists or GLP-1\u002Fgastric inhibitory polypeptide \\[GIP\\] agonists) or other glucose-lowering agents that has not been stable for at least 6 months prior to Screening\n* Use of Resmetirom that has not been stable for at least 6 months prior to Screening visit\n* Any medical, cognitive, or psychiatric condition that, in the opinion of the Investigator, could contraindicate the use of the investigational drug, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or would make the participant an unsafe study candidate.\n* Type 1 diabetes, or poorly controlled type 2 diabetes (HbA1c \\> 8.0% at Screening)\n* History of major trauma to the muscle(s) intended for IM injection meeting any of the following criteria:\n\n  1. Within 6 months prior to Screening, or\n  2. At any timepoint prior to Screening with continued neurologic or musculoskeletal symptoms\n* Prior participation in any systemic experimental treatment or receiving any other systemic investigational treatment including within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of Screening\n* Any vaccination or planned vaccination 30 days prior to dosing, or planned vaccination 8 weeks post dosing\n* Previously received AAV or adenoviral therapy or participation in any previous gene therapy trial",{"count":114,"type":20},56,[116,117],"PHASE1","PHASE2","A Study of VV-14303 for the Treatment of Metabolic dysfunction-associated steatohepatitis (MASH)",[120],"Metabolic Dysfunction-associated Steatohepatitis (MASH)","2026-07-23",{"date":123,"type":32},"2026-07-28",{"date":125,"type":20},"2026-07",{"date":127,"type":20},"2029-07",{"name":129,"class":39},"Kriya Therapeutics, Inc.",3,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100479168","phase-2-a-precision-medicine-approach-using-gene-silencing-to-treat-a-chronic-liver-disease-called-metabolic-dysfunction-associated-steatohepatitis-mash-in-adult-participants-at-increased-genetic-risk-for-this-condition-100479168","NCT05519475","A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of siRNA Gene Silencing for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Participants With Genetic Risk Factors","NASHGEN-2","Key Inclusion Criteria:\n\n1. Adult male or female ≥18 years (or country's legal age of adulthood)\n2. A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN\n3. NAS score ≥3, as defined in the protocol\n4. Meets genotype criteria for study enrollment, as defined in the protocol\n5. Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening\n\nKey Exclusion Criteria:\n\n1. Evidence of other forms of known chronic liver disease, as defined in the protocol\n2. Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol\n3. History of Type 1 diabetes\n4. Bariatric surgery within approximately 5 years prior to or planned during the study period\n5. Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)\n\nNote: Other protocol-defined Inclusion\u002FExclusion Criteria apply",{"count":87,"type":20},[117],"This study is researching an investigational drug, ALN-HSD called \"study drug\". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH). MASH is a form of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring related to MASH.\n\nThe study is looking at several other research questions, including:\n\n* How ALN-HSD works to improve liver function and lessen MASH-related inflammation in the liver\n* What side effects may happen from receiving the study drug\n* How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times\n* Better understanding of the study drug and MASH",[143],"Metabolic Dysfunction-Associated SteatoHepatitis (MASH)",[145,146,147,148],"Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)","Histologically confirmed MASH","Genetic risk alleles for MASH at the HSD17B13 locus","Non-Alcoholic SteatoHepatitis (NASH)","2026-07-07",{"date":151,"type":32},"2026-07-08",{"date":153,"type":32},"2023-02-09",{"date":155,"type":20},"2028-12-07",{"name":157,"class":39},"Regeneron Pharmaceuticals",71,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":76},"100645258","phase-4-nutrition-intervention-combined-with-resmetirom-for-mash-100645258","NCT07680478","Nutrition Intervention Combined With Resmetirom for MASH","Assessing Nutrition-aligned Resmetirom Roll-out","NOURISH-MASH","Inclusion Criteria:\n\n* Provide informed consent\n* Be 18-75 years old\n* Have non-cirrhotic MASH with fibrosis stage F2-F3 (VCTE 8-20 kPa and CAP =280 dB\u002Fm)\n* Be initiating resmetirom per standard of care\n* Be able to comply with study procedures, including fasting visits\n* Reside in one of the five New York City boroughs\n\nExclusion Criteria:\n\n* Have cirrhosis or decompensated liver disease\n* Have other chronic liver diseases\n* Are pregnant or breastfeeding\n* Consume alcohol above defined thresholds or have PEth =20 ng\u002FmL\n* Have recent major surgery or hospitalization\n* Are on glucagon-like peptide-1 agonist therapy (e.g., exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), unless the dose is stable for 12 weeks prior to the baseline evaluation and they have not experienced a \\>5% weight loss in the 6 months preceding resmetirom initiation.\n* Are undergoing bariatric surgery\n* Are living with any other end-stage organ disease (e.g., heart, lung or kidney failure requiring dialysis) or have any active malignancy in the last 5 years.\n* Have conditions preventing consumption of provided meals",{"count":87,"type":20},[89],"This randomized control trial aims to evaluate the effectiveness of combining resmetirom therapy (first approved pharmacological therapy for treating metabolic dysfunction-associated steatohepatitis (MASH)) with a nutritional intervention compared to resmetirom therapy alone over one year in improving liver health among 120 patients living with non-cirrhotic MASH. We hypothesize that patients receiving resmetirom and nutritional intervention will experience more significant improvements in liver function than those receiving only resmetirom therapy.",[57],[172,173,174,175],"MASLD\u002FMASH","Resmetirom therapy","Medically tailored meal (MTM)","Nutrition-based intervention","2026-07-02",{"date":178,"type":32},"2026-07-06",{"date":180,"type":20},"2026-10-01",{"date":182,"type":20},"2028-06-30",{"name":184,"class":75},"City University of New York",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":85,"sex":16,"minAge":17,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":200,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":76},"100617006","assessment-of-gut-microbiota-derived-amino-acid-metabolite-production-in-patients-with-masld-100617006","NCT07313007","Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD","Evaluation of the Production of Amino Acid-Derived Metabolites by the Gut Microbiota of Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","MASLD-GUT","Inclusion Criteria:\n\n* For patients and healthy volunteers:\n\n  * Age between 18 and 80 years.\n  * Non-diabetic participant (fasting blood glucose \\\u003C 1.26 g\u002FL, or absence of insulin therapy or oral antidiabetic medication).\n  * Body mass index (BMI) between 18 and 30 kg\u002Fm².\n  * For women of childbearing potential, use of at least one recognized effective contraceptive method.\n  * Very regular bowel movements every 24 to 48 hours.\n  * Participant living within 100 km of the Lyon Sud Hospital Center (CHLS).\n  * Participant willing to participate in the study and providing written informed consent.\n  * Participant affiliated with the general French Social Security system or an equivalent scheme.\n* For patients:\n\n  * Presence of MASLD according to the definition of the European Association for the Study of the Liver (EASL), defined by hepatic steatosis on imaging performed within the previous year (abdominal ultrasound, abdominal CT scan, magnetic resonance imaging, or controlled attenuation parameter (CAP) measured by FibroScan) and at least one cardiometabolic criterion among: dyslipidemia, arterial hypertension, overweight (BMI ≥ 25 kg\u002Fm²), impaired glucose tolerance, or type 2 diabetes.\n  * No history of liver transplantation.\n  * No excessive alcohol consumption (less than 20 g\u002Fday for women and less than 30 g\u002Fday for men).\n  * Patient followed in the Endocrinology, Diabetes and Nutrition Department at Lyon Sud Hospital.\n\nExclusion Criteria:\n\n* For patients and healthy volunteers:\n\n  * Participant with active inflammatory, infectious, cardiovascular, or neoplastic disease.\n  * Participant with a history of colectomy, small bowel resection, or cholecystectomy.\n  * Participant who received antibiotics, prebiotics, or probiotics within the past 3 months.\n  * Participant using laxatives (more than 2 doses per day over the past 3 months).\n  * Participant with chronic constipation.\n  * Pregnant, parturient, or breastfeeding women.\n  * Participant deprived of liberty by judicial or administrative decision.\n  * Participant receiving psychiatric care.\n  * Participant institutionalized for reasons other than research.\n  * Adult participant under legal protection (guardianship or trusteeship).\n  * Participant who does not understand the French language and cannot provide informed consent.\n  * Participant already enrolled in a study presenting a conflict of interest with the present study.\n* For healthy volunteers\n\n  * Known liver disease\n  * No long-term drug medication except oral contraception for women.","80 Years",{"count":195,"type":20},24,[53],"Metabolic dysfunction-associated steatotic liver disease (MASLD) encompasses a spectrum of liver disorders ranging from simple steatosis-a relatively benign and non-progressive condition-to metabolic dysfunction-associated steatohepatitis (MASH), characterized by hepatocellular inflammation. MASLD is now the leading cause of chronic liver disease worldwide, affecting approximately one in three adults, particularly those with obesity or type 2 diabetes.\n\nRecent studies have highlighted a strong interconnection between the gut microbiota, the liver, metabolism, and the immune system, collectively referred to as the gut-liver axis. Alterations in the gut microbiota are observed at all stages of MASLD, and several microbial metabolites-such as trimethylamine, bile acids, short-chain fatty acids, and ethanol-have been implicated in disease progression.\n\nEmerging evidence points to a role for gut-derived metabolites of tryptophan (Trp) and phenylalanine (Phe), including phenylacetic acid (PAA), 3-(4-hydroxyphenyl)-lactate (HPL), and phenyllactate (PL). These compounds have been associated with the severity of MASLD, particularly with hepatic steatosis and fibrosis. Elevated plasma levels of aromatic amino acids (AAAs), such as L-phenylalanine and L-tyrosine, are also correlated with increased hepatic fat content.\n\nA newly identified Phe-derived metabolite, N-acetyl-phenylalanine (NAPA), together with PAA, HPL, and PL, has been shown to correlate with hepatic steatosis. These metabolites can induce steatosis both in vitro and in vivo, acting through the disruption of endoplasmic reticulum-mitochondria interactions. They therefore represent potential new therapeutic targets.\n\nThese four metabolites of interest (NAPA, PAA, HPL, PL) can be produced both by gut bacteria and through endogenous human metabolism. Positive correlations between plasma NAPA concentrations and specific bacterial species have been observed, although the responsible taxa remain to be identified.\n\nHYPOTHESIS\n\nWe hypothesize that the gut microbiota of MASLD patients produces aromatic amino acid-derived metabolites, contributing to the elevated plasma concentrations observed in these patients\n\nTwo complementary strategies will be used : Human Microbiota Culture and Fecal Microbiota Transplantation",[199,57],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease",[201,202,203,204],"MASLD","MASH","GUT MICROBIOTA","N-acétyl-phenylalanine (NAPA)","2026-06-17",{"date":207,"type":32},"2026-06-22",{"date":209,"type":32},"2026-06-16",{"date":211,"type":20},"2027-01-16",{"name":213,"class":75},"Hospices Civils de Lyon",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100641350","phase-2-a-study-of-hrs-4729-injection-and-hrs9531-injection-in-participants-with-metabolic-dysfunction-associated-steatohepatitis-100641350","NCT07660848","A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Master Protocol Clinical Trial to Investigate the Efficacy and Safety of HRS-4729 Injection and HRS9531 Injection in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Participants must have histologic diagnosis of MASH by liver biopsy\n3. Have liver fat content ≥8%\n4. Participants must have a body mass index (BMI) ≥24 kilograms per square meter (kg\u002Fm²) and ≤40 kg\u002Fm² with stable body weight for at least 3 months\n\nExclusion Criteria:\n\n1. Model for End-Stage Liver Disease (MELD) score \\> 12, or Child-Pugh (CTP) score \\> 6\n2. Known or suspected history of excessive alcohol consumption or alcohol dependence within 12 months prior to screening\n3. History of liver cirrhosis and\u002For liver decompensation, including but not limited to ascites, hepatic encephalopathy, esophageal or gastric variceal bleeding, etc.\n4. Previous or current liver disease due to other causes, including but not limited to: alcoholic steatohepatitis (ASH), drug-induced liver injury (DILI), viral hepatitis, autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hereditary hepatobiliary diseases (e.g., hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, etc.), occupational toxic liver disease, known or suspected hepatocellular carcinoma (HCC), etc.\n5. History of or planned organ transplantation (e.g., liver transplant) or bone marrow transplantation during the study period\n6. Use of GLP-1 receptor agonists (including multi-target drugs or compound preparations containing GLP-1 receptor agonists) within 3 months prior to screening, or previous discontinuation of GLP-1 receptor agonists due to safety\u002Ftolerance reasons\n7. Known or suspected hypersensitivity to GLP-1 and\u002For GIP and\u002For GCG receptor agonists and\u002For their excipient",{"count":222,"type":20},160,[117],"The purpose of this study is to investigate the efficacy and safety of HRS-4729 injection and HRS9531 injection in adult participants with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.",[57],{"date":207,"type":32},{"date":125,"type":20},{"date":229,"type":20},"2028-07",{"name":231,"class":39},"Fujian Shengdi Pharmaceutical Co., Ltd.",2,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100643120","phase-2-study-to-evaluate-aln-cideb-in-adults-with-fibrotic-metabolic-dysfunction-associated-steatohepatitis-mash-100643120","NCT07631637","Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Key Inclusion Criteria:\n\n1. A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers and clinical risk factors, including having a history of 1 or more elements of metabolic syndrome as described in the protocol\n2. Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol\n3. Has a FibroScan Aspartate aminotransferase (FAST) score \\>0.35 either at Screening Visit 1 or within approximately 3 months of Screening Visit 1 as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Known chronic liver disease other than Metabolic dysfunction-Associated steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol\n2. Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1\n3. History of liver transplantation, current placement on a liver transplant list, or MELD score \\>12\n4. Known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion and\u002For a score on the AUDIT questionnaire ≥8\n5. Prior current, or planned future use of a Glucagon-Like Peptide-1 (GLP-1) receptor agonist-based therapy or any medication approved for the treatment of MASH unless used at a generally stable dose and regimen since at least 3 months prior to Screening Visit 1 or the qualifying historical liver biopsy and throughout the screening period with no change to the dose or regimen anticipated during the treatment period as described in the protocol\n\nNOTE: Other Protocol-defined Inclusion\u002FExclusion Criteria Apply",{"count":241,"type":20},150,[117],"This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH.\n\nIn this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver injury, and liver scarring. The study will compare ALN-CIDEB with placebo to understand how well ALN-CIDEB works to lower the amount of fat in the liver.\n\nThe study is looking at:\n\n* What side effects ALN-CIDEB might cause\n* How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring\n* How the body and the liver change after having ALN-CIDEB, which can help researchers understand why ALN-CIDEB works better for some people than others",[57],[246,247,248,145,249,27,250],"F2 or F3 MASH","Fibrotic MASH","Nonalcoholic Fatty Liver Disease (NAFLD)","Liver Inflammation","Cirrhosis","2026-06-01",{"date":253,"type":32},"2026-06-08",{"date":255,"type":20},"2026-07-15",{"date":257,"type":20},"2029-02-06",{"name":157,"class":39},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":193,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":4},"100639643","phase-2-to-evaluate-the-efficacy-and-safety-of-ql2401-in-patients-with-metabolic-dysfunction-associated-steatohepatitis-and-liver-fibrosis-f2-f3-100639643","NCT07620366","To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3)","A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3).","Inclusion Criteria:\n\n1. Males and females between 18 - 75 years of age inclusive, based on the date of signation of ICF.\n2. Presence of type 2 diabetes, or diagnosed at least 1 diseases of obesity, dyslipidemia, hypertension, elevated fasting glucose.\n3. Any one criterion as follow:\n\n   * Liver biopsy proved MASH (NAS ≥ 4 with steatosis, ballooning degeneration and lobular inflammation ≥ 1) with fibrosis stage 2 to 3 at screening or within 6 months; or\n   * VCTE measured liver stiffness 8.0 kPa ≤ LSM \\\u003C 20.0 kPa, CAP\\>302 dB\u002Fm.\n4. Hepatic fat fraction \\> 10% measured by MRI-PDFF at screening or within 3 months.\n5. Participants using weight loss, blood sugar-lowering, or lipid-regulating medications must maintain a stable dose for ≥3 months before randomization.\n6. Participants maintain a stable body weight (±5%) within 2 months prior screening.\n\nExclusion Criteria:\n\n1. Currently or prior history of hepatocellular carcinoma.\n2. Previous or planned liver transplant.\n3. History or evidence of any acute or chronic liver disease other than MASH.\n4. Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).\n\nOther inclusion and exclusion criteria may apply.",{"count":267,"type":20},132,[117],"This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis (F2-F3).",[120],"2026-05-27",{"date":273,"type":32},"2026-06-02",{"date":275,"type":20},"2026-06",{"date":277,"type":20},"2028-03",{"name":279,"class":39},"Qilu Pharmaceutical Co., Ltd.",{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":202,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":76},"100604102","phase-2-a-study-of-ubt251-in-participants-with-metabolic-dysfunction-associated-steatohepatitis-mash-100604102","NCT07145151","A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)","A Phase 2, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of UBT251 Injection in Adult Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)","Inclusion Criteria:\n\nAge 18-75 years (inclusive) at screening; sex unrestricted.\n\nSubjects with centrally confirmed MASH (metabolic dysfunction-associated steatohepatitis) based on liver histopathology must meet all the following criteria:\n\n1. NAS (Appendix 1) ≥ 4 （with at least 1 point each for lobular inflammation and ballooning degeneration）;\n2. CRN fibrosis stage (see Appendix 2) of F2 or F3 (a liver biopsy obtained ≤ 6 months before screening is acceptable if it meets the above criteria).\n\n3.Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥ 8 % at screening (MRI-PDFF results obtained within 2 months prior to screening at the trial site are acceptable).\n\n4.Subjects must have \\\u003C5% body weight fluctuation during the 6 weeks prior to randomization (based on self-reported data), calculated as: \\[(Highest weight - Lowest weight) \u002F Highest weight\\] × 100%. For subjects using historical liver biopsy, documented weight change from biopsy to randomization must also be \\\u003C 5 %.\n\n5.At least one cardiometabolic risk factor at screening:\n\n1. Body mass index (BMI) ≥ 24.0 kg\u002Fm², or waist circumference ≥90 cm for males or ≥85 cm for females;\n2. Blood pressure ≥ 130\u002F85 mmHg, or on antihypertensive therapy;\n3. Fasting triglycerides ≥ 1.70 mmol\u002FL and \\\u003C 5.6 mmol\u002FL, or on lipid-lowering therapy;\n4. Fasting HDL-C ≤ 1.0 mmol\u002FL for males or ≤ 1.3 mmol\u002FL for females; or on lipid-lowering therapy;\n5. Fasting glucose ≥ 6.1 mmol\u002FL or glycated hemoglobin (HbA1c) ≥ 5.7 %, or documented history of type 2 diabetes mellitus (T2DM), or Homeostatic Model Assessment of Insulin Resistance index ≥ 2.5.\n\n6.Subjects with type 2 diabetes mellitus (T2DM) must meet glycated hemoglobin (HbA1c) ≤ 9.0 % at screening (local result obtained ≤ 2 weeks before randomization accepted), and stable glycemic control regimen for at least 3 months prior to screening: subjects must be on diet and exercise control alone, or in combination with stable-dose glucose-lowering medications, with the following requirements::\n\n1. Diet and exercise alone;\n2. Stable-dose use of metformin, sulfonylureas, sodium-glucose cotransporter-2 (SGLT2) inhibitors, or insulin, stable insulin dose defined as ≤35% variation in total daily insulin dose; 7. Subjects (including partners) must have no pregnancy plans from screening through 6 months post-trial and must practice contraception during the study, with no plans to donate sperm\u002Foocytes for 6 months after trial completion.\n\n8\\. Subjects must provide informed consent prior to trial participation and voluntarily sign the written informed consent form.\n\n9.Voluntarily comply with all trial follow-up requirements, demonstrate good protocol adherence, and be willing and able to undergo protocol-specified liver biopsies.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the investigational product or any of its excipients, or allergy to other GLP-1 receptor agonists, or clinically significant history of multiple\u002Fsevere drug allergies, or current allergic diseases or hypersensitivity diathesis;\n2. Previous use of any of the following drugs or treatments:\n\n1\\) Use of GLP-1 receptor agonists (GLP-1R), or GLP-1R\u002FGCGR agonists, or GLP-1R\u002FGIPR\u002FGCGR agonists within 3 months prior to screening; 2) Cumulative use for ≥4 weeks within 3 months prior to screening, use within 1 month prior to screening, or planned use during the trial of vitamin E (dose \\>400 IU\u002Fday), thiazolidinediones, polyunsaturated fatty acids, or ursodeoxycholic acid; 3) Cumulative use for ≥4 weeks within 3 months prior to screening, use within 1 month prior to screening, or planned use during the trial of drugs associated with liver injury, hepatic steatosis, or steatohepatitis: including amiodarone, methotrexate, systemic glucocorticoids (dose \\>5 mg\u002Fday prednisone equivalent), estrogens (dose exceeding hormone replacement therapy or contraceptive use), tetracyclines, tamoxifen, anabolic steroids, valproate, or restricted drugs, or any drug deemed likely to interfere with efficacy or safety evaluations; 4) Unstable doses of statins, fibrates, or PCSK9 inhibitors within 1 month prior to screening; 3.History or evidence of any of the following diseases:\n\n1. Chronic liver disease other than MASH (e.g., autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, chronic liver disease-related ascites, esophageal varices, hepatic encephalopathy, etc.).\n2. Diagnosis of type 1 diabetes or other specific types of diabetes, except resolved gestational diabetes;\n3. Acute pancreatitis or chronic pancreatitis within 1 year prior to screening, history of pancreatic surgery; or symptomatic gallbladder disease within 1 year prior to screening (e.g., choledocholithiasis, multiple gallstones, etc., except those who underwent cholecystectomy or stone removal);\n4. Personal or family history (first-degree relatives-parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);\n5. History of severe psychiatric disorders, including but not limited to depression, suicidal tendencies or attempts, schizophrenia, bipolar disorder, etc.;\n6. Clinically significant active cardiovascular\u002Fcerebrovascular disease within 6 months prior to screening, defined as: ① Myocardial infarction (MI) or unstable angina; ② Cardiac-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention); ③Congestive heart failure (New York Heart Association \\[NYHA\\] Class III-IV) (see Appendix 3); ④ Cerebrovascular accident (except old lacunar infarction), including but not limited to stroke\u002Ftransient ischemic attack; ⑤ Other cardiovascular or cerebrovascular diseases deemed unsuitable for trial participation by the investigator;\n7. Retinal diseases requiring urgent treatment at screening (including but not limited to retinal vascular disorders, retinal inflammation, retinal detachment, retinal degeneration, etc.), as assessed by the investigator;\n8. History of severe hypoglycemic coma or frequent hypoglycemia (≥1 episode\u002Fweek) within 2 months prior to enrollment (defined as fingertip or venous blood glucose \\\u003C3.9 mmol\u002FL for T2DM subjects or \\\u003C2.8 mmol\u002FL for non-T2DM subjects);\n9. Gastroparesis or other gastrointestinal motility disorders (e.g., pyloric obstruction, intestinal obstruction, etc.), uncontrolled gastroesophageal reflux disease, or gastrointestinal conditions deemed by the investigator to increase drug-related risks (e.g., severe active ulcers, inflammatory bowel disease, acute gastroenteritis, symptomatic chronic gastritis, functional gastrointestinal disorders, intestinal tuberculosis, etc.);\n10. Major surgery, severe trauma, or severe infection within 1 month prior to screening, deemed unsuitable for participation by the investigator;\n11. History of malignancy (except adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer post-radical therapy, ductal carcinoma in situ of the breast post-radical therapy, and papillary thyroid carcinoma post-radical therapy);\n12. Concurrent diseases deemed by the investigator to affect subject safety, efficacy evaluation, or compliance, e.g., neurological, endocrine, psychiatric, etc. ; 4.Laboratory abnormalities at screening meeting any of the following criteria:\n\n1\\) Hepatic or renal impairment, based on each hospital laboratory's reference values, serum ALT and\u002For AST \\>5× upper limit of normal (ULN); serum total bilirubin ≥1.5×ULN; estimated glomerular filtration rate (eGFR) \\\u003C60 mL·min-1·1.73m-2. (calculated using CKD-EPI formula see Appendix 4) ; 2) Alkaline phosphatase (ALP) \\>2.0×ULN; 3) Platelet count \\\u003C 100 × 10⁹\u002FL; 4) Serum calcitonin ≥ 50 pg\u002FmL (i.e., 50 ng\u002FL); 5) Serum amylase or lipase \\> 2.0× ULN; 6) International normalized ratio (INR) \\>1.2×ULN at screening; 7) Albumin \\\u003C 3.5 g\u002FdL (35.0 g\u002FL). 8) Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg at screening), subjects may be re-screened after 1 month of initiating or adjusting antihypertensive therapy; 9) Unstable thyroid dysfunction requiring medication adjustment at screening, or clinically significant abnormal thyroid function test results necessitating treatment initiation; 10) Subjects with clinically significant ECG abnormalities at screening, including: a) Second- or third-degree atrioventricular block; b) Long QT syndrome, QTcF \\>470 ms for females or \\>450 ms for males (QTcF = QT\u002F(RR\\^0.33) ); c) Wolff-Parkinson-White syndrome; or d) Other severe arrhythmias requiring treatment; 11) Abnormal physical examination, vital signs, or laboratory results deemed clinically significant by the investigator, potentially posing major risks or interfering with efficacy, safety, or PK evaluations; 5.Contraindications to liver biopsy at screening, as assessed by the investigator:(1) Hepatic hemangioma or hepatic alveolar echinococcosis;(2) Extrahepatic obstructive jaundice;(3) Significant bleeding tendency, severe thrombocytopenia, or coagulation disorders;(4) Coma or uncooperative due to other conditions;(5) Infection at the puncture site; 6.Positive for hepatitis B surface antigen, positive for hepatitis B core antibody (except those with positive anti-HBc but hepatitis B virus deoxyribonucleic acid \\[HBV-DNA\\] below the lower limit of the reference range), positive for hepatitis C virus antibody with hepatitis C virus ribonucleic acid (HCV-RNA) above the upper limit of the reference range (subjects with a history of HCV infection may be enrolled if HCV PCR has been negative for more than 3 years), positive for human immunodeficiency virus antibody, or positive for syphilis antibody (except cured syphilis) will be excluded; 7.Blood loss or donation \\> 400 mL within 3 months prior to screening, receipt of blood\u002Fcomponent transfusions; or concurrent hemoglobinopathy, hemolytic anemia, or sickle-cell disease.\n\n8.MRI contraindications, including but not limited to severe claustrophobia, large tattoos, inner ear implants, pacemakers or other implantable rhythm management devices, MRI-incompatible intracranial aneurysm clips, or other non-MRI-compatible metal implants (e.g., insulin pumps, hip replacements); 9.Participation in other clinical trial within 3 months prior to screening or 5 half-lives of the investigational drug (whichever is longer)(except for screening-only or non-interventional studies): 10.Excessive alcohol consumption within 12 months prior to screening, defined as \\>210 g\u002Fweek (male) or \\>140 g\u002Fweek (female) of ethanol (alcohol) for \\>3 months. Ethanol intake \\[g\\] = volume \\[mL\\] × alcohol percentage × 0.8); 11.Lactating or pregnant females; 12.Intolerance to venipuncture or history of needle\u002Fphobia; 13.Other conditions deemed unsuitable for trial participation by the investigator.",{"count":288,"type":20},156,[117],"This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of UBT251 in MASH subjects. Subjects will be randomly assigned to UBT251 2mg-dose, 4mg-dose，6mg-dose and placebo groups. The entire trial cycle includes a 6-week screening period, a 48-week double-blind treatment period, and a 4-week follow-up period.",[120],"2025-11-19",{"date":294,"type":32},"2025-11-20",{"date":296,"type":32},"2025-09-30",{"date":298,"type":20},"2027-08-31",{"name":300,"class":39},"The United Bio-Technology (Hengqin) Co., Ltd.",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":21,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":76},"100588158","phase-2-a-study-of-ibi362-in-participants-with-metabolic-dysfunction-associated-steatohepatitis-mash-100588158","NCT06937749","A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)","A Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy and Safety of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* Must be willing to participate in the study and provide written informed consent.\n* Male or female, age 18 years or older at the time of signing informed consent\n* Body mass Index (BMI) ≥25 kg\u002Fm²\n* Diagnosis of Metabolic dysfunction-associated steatohepatitis (MASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in steatosis, inflammation and ballooning each) and fibrosis stage F2 or F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 3 months prior to screening\n\nExclusion Criteria:\n\n1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs\n2. HbA1c\\>10%\n3. History or current other forms of chronic liver disease other than MASH\n4. Patients with positive Hepatitis B surface antigen (HBsAg). Patients with positive HBcAb will be eligible only when HBV DNA test negative at screening\n5. patients with HCV antibody positive.\n6. Patients with HIV antibody positive or syphilis specific antibodies positive (patients with non-specific antibody turned negative will be eligible)\n7. Model for End-stage Liver Disease(MELD) \\>12 or Child-Turcotte-Pugh(CTP) \\>6",{"count":309,"type":20},165,[117],"This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.",[120],"2025-11-17",{"date":294,"type":32},{"date":316,"type":32},"2025-07-01",{"date":318,"type":20},"2027-07-22",{"name":320,"class":39},"Innovent Biologics (Suzhou) Co. Ltd.",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":328,"targetDuration":4,"studyType":330,"phases":4,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":232},"100607412","patients-perspectives-on-metabolic-dysfunction-associated-steatohepatitis-a-qualitative-study-100607412","NCT07188220","Patients' Perspectives on Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study","Perspectives on the Multidisciplinary Approach to Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study With Patients From the MASH-Cardiovascular Programme at Hospital de Sant Pau i la Santa Creu, Barcelona","Inclusion Criteria:\n\n* Patients who voluntarily agree to participate in the MASH-Cardiovascular Programme.\n* Patients followed in the outpatient hepatology\u002Fgastroenterology clinic at Hospital de Sant Pau with a diagnosis of MASH and fibrosis stage F2-F4.\n* Patients aged between 18 and 75 years.\n* Patients with a BMI ≥ 27 kg\u002Fm².\n* Patients who consent to participate in the study-specific interviews.\n\nExclusion Criteria:\n\n* Patients who do not agree to participate in the study-specific interviews.\n* Patients meeting exclusion criteria of the MASH-Cardiovascular Programme:\n* Patients with decompensated liver cirrhosis.\n* Patients who are vegetarians or have dietary habits\u002Fpreferences that prevent adherence to standard-of-care nutritional guidelines.\n* Patients with moderate-to-severe alcohol consumption (\\>20 g\u002Fday for women and \\>40 g\u002Fday for men).\n* Patients with an eGFR \\\u003C 30 mL\u002Fmin.\n* Patients with malnutrition.\n* Patients with type 1 diabetes or other forms of diabetes.\n* Patients who are candidates for bariatric surgery.\n* Patients with active malignancy.\n* Patients with advanced or unstable heart failure.\n* Patients with eating disorders or severe psychiatric illness.\n* Patients currently enrolled in another clinical trial.\n* Pregnant women or women planning to become pregnant.",{"count":329,"type":20},25,"OBSERVATIONAL","The aim of this qualitative study is to explore and identify the expectations, perceptions, attitudes, needs, and knowledge related to the management of metabolic dysfunction-associated steatohepatitis (MASH) in patients diagnosed with this condition, before and after their participation in the MASH-Cardiovascular Programme at Hospital de la Santa Creu i Sant Pau, Barcelona.\n\nThe main research question is:\n\nWhat expectations, attitudes, needs, and perceptions do patients with MASH participating in the MASH-Cardiovascular Programme exhibit before and after the intervention?\n\nParticipants will undergo two semi-structured interviews: one prior to, and one following, their involvement in the MASH-Cardiovascular Programme at Hospital de Sant Pau i la Santa Creu, Barcelona.",[26],[334,202,201,335,336],"Qualitative","Perceptions","Semi-structured interviews","2025-09-16",{"date":339,"type":32},"2025-09-23",{"date":341,"type":32},"2025-06-03",{"date":343,"type":20},"2028-01-20",{"name":345,"class":75},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":21,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":362,"leadSponsor":364,"locationsCount":76},"100594222","phase-1-to-evaluate-the-tolerability-pharmacokinetics-and-pharmacodynamics-of-imm-h014-in-patients-with-mash-100594222","NCT07016633","To Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 in Patients With MASH","A Phase Ib\u002FIIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 Consecutive Multiple Treatment for 12 Weeks in Adult Patients With MASH","Inclusion Criteria:\n\n1. Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the experiment;\n2. Voluntarily comply with the experimental requirements and conduct follow-up visits on designated dates, demonstrating good adherence to the protocol; And voluntarily maintain the original lifestyle (diet and exercise habits) during the study period without changing.\n3. Participants (including partners) agree to take effective contraceptive measures throughout the study period until 6 months after discontinuation of medication;\n4. Male and female patients aged 18 to 65 years old (including 18 and 65 years old);\n5. If suffering from hypertension, blood pressure should be stabilized at 160\u002F100mmHg or below under monotherapy control;\n6. If the patient has type 2 diabetes, the patient must have not taken any medicine, or has received metformin, sulfonylurea or α - glycosidase inhibitor treatment, and the dose should be stable for at least 3 months;\n7. The presence of hepatic steatosis accompanied by at least one of the following cardiovascular metabolic risk factors (guidelines for the prevention and treatment of metabolism related (non-alcoholic) fatty liver disease 2024).\n\n   BMI ≥ 24.0 kg\u002Fm2, or waist circumference ≥ 90cm (male) and 85cm (female), or excessive body fat content and percentage.\n\n   Arterial blood pressure ≥ 130\u002F85 mmHg, or under treatment with antihypertensive drugs.\n\n   Fasting blood glucose ≥ 6 1mmol \u002FL, Or blood glucose level ≥ 7 2 hours after glucose load 8 mmol\u002FL or HbA1c ≥ 5.7%, or history of type 2 diabetes, or HOMA-IR ≥ 2.5.\n\n   Fasting serum TG ≥ 1.70 mmol\u002FL, or currently receiving lipid-lowering medication treatment.\n\n   Serum high-density lipoprotein ≤ 1 0 mmol\u002FL (male) and 1 3 mmol\u002FL (female), or currently being treated with lipid-lowering drugs.\n8. Screening period ALT ≥ ULN. Or histological evidence of NASH (NAS score ≥ 4, with inflammation and ballooning at least 1 point each, fibrosis level ≤ F3, scoring criteria in Appendix 6) obtained through liver pathological biopsy within the 6 months prior to screening or during the screening period, and no treatment or weight loss within 6 months (weight change\\\u003C5% within 6 months);\n9. MRI-PDFF ≥ 10% within 28 days prior to enrollment.\n\nExclusion Criteria:\n\n1. Excessive alcohol consumption for three consecutive months or more within the year prior to screening (men consume an average of over 30 grams of ethanol per day, equivalent to 3.75 units of alcohol, and women consume over 20 grams, equivalent to 2.5 units of alcohol: 1 unit=285 mL of beer, 25 mL of spirits, or 100 mL of wine);\n2. Individuals with allergies (to multiple drugs or foods);\n3. Donate blood or experience significant blood loss (\\>450 mL) within the first three months of screening;\n4. Individuals with a history of weight loss surgery or those who are planning to undergo weight loss surgery recently;\n5. History of liver transplantation surgery or planned liver transplantation;\n6. Suffering from any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;\n7. Liver biopsy indicates cirrhosis or previous clinical diagnosis of cirrhosis;\n8. Patients with type 1 diabetes;\n9. Uncontrolled type 2 diabetes patients (HbA1c ≥ 8.0%);\n10. Other clinically significant diseases (including but not limited to respiratory system, circulatory system, digestive system, endocrine system, rheumatic and immune system, nervous system, hematological system diseases, and psychiatric\u002Fpsychological diseases) that are found to be unstable or untreated before screening;\n11. History of swallowing difficulties or any gastrointestinal diseases or surgeries that affect drug absorption;\n12. Existence of any of the following diseases or medical histories: unstable angina, myocardial infarction, percutaneous coronary intervention (allowing diagnostic angiography), coronary artery bypass surgery, heart failure, transient ischemic attack, cerebrovascular accident, etc;\n13. Currently taking medications that may cause steatosis\u002Fsteatohepatitis (including amiodarone, methotrexate, steroid hormones, tetracycline, tamoxifen, valproic acid, etc.);\n14. Newly taken or irregularly taken hypoglycemic drugs (excluding metformin, sulfonylureas, or alpha glucosidase inhibitors), hepatoprotective drugs (including but not limited to reduced glutathione, glucuronide, glycyrrhetinic acid preparations, ursodeoxycholic acid, niacinamide, biphenyl diesters, liver protection tablets, silibinin, etc.), and lipid-lowering drugs (including but not limited to fibrates, statins, niacin, colexamine, etc.) within 90 days before enrollment;\n15. Currently receiving treatment with anti TNF - α drugs such as adalimumab, etanercept, etc;\n16. 28 days prior to screening or during the study period, any drugs that alter liver enzyme activity CYP3A4, including strong inhibitors and inducers that affect liver metabolic enzymes, are planned to be taken concurrently;\n17. Individuals who have consumed a special diet (including dragon fruit, mango, grapefruit, etc.) or engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. within 2 weeks prior to enrollment;\n18. Individuals who have participated in clinical trials of other drugs within 3 months prior to medication use;\n19. Abnormal electrocardiogram with clinical significance, QTcF\\>450ms;\n20. Suspected liver and gallbladder diseases with other causes based on medical history and laboratory tests, including but not limited to: hepatitis B or C virus infection, chronic alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's liver disease, alpha and alpha antitrypsin deficiency, liver cancer, significant liver dysfunction (ALT or AST ≥ 5 × ULN or TBIL ≥ 1.5 × ULN), etc;\n21. Positive for HIV infection;\n22. Kidney disease or renal dysfunction with clinical significance, blood creatinine\\>1.5 × ULN, eGFR\\\u003C60 mL\u002Fmin\u002F1.73m2 \\[calculation formula: eGFR=186 × Scr-1.154 × Age-0.203 × (0.742 female)\\], etc;\n23. Platelet count\\\u003C100 × 109\u002FL;\n24. Confirmation of positive and clinically significant anti nuclear antibody (ANA);\n25. TSH abnormality with clinical significance;\n26. Pregnant and lactating women or those with positive serum pregnancy tests;\n27. Patients with contraindications to MRI scanning;\n28. Have taken any alcoholic products within 24 hours prior to taking the study medication;\n29. Consumed chocolate, any caffeinated or xanthine rich food or beverage 24 hours prior to taking the study drug;\n30. Acute illness occurs from the screening stage to the study medication;\n31. Individuals who have tested positive in urine drug screening or have a history of drug abuse or use of drugs within the past five years.","65 Years",{"count":51,"type":20},[116,117],"This study will evaluate the tolerability, pharmacokinetics, and pharmacodynamics of consecutive Multiple treatment for 12 weeks（84 Days） in Adult Patients with Metabolic Dysfunction-Associated Steatohepatitis. Participants will receive either IMM-H014 or placebo.",[57],"2025-06-10",{"date":360,"type":32},"2025-06-13",{"date":358,"type":20},{"date":363,"type":20},"2027-12-01",{"name":365,"class":39},"Changchun Intellicrown Pharmaceutical Co. LTD",{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":330,"phases":4,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":387,"leadSponsor":389,"locationsCount":391},"100577234","clinical-classification-of-mafld-based-liver-biopsy-100577234","NCT06795646","Clinical Classification of MAFLD Based Liver Biopsy","Clinical Classification and Prediction System of MAFLD Based on Liver Biopsy","Inclusion Criteria:\n\n* Ultrasound confirmation of fatty liver and the presence of at least one of the following metabolic cardiovascular risk factors:\n\n  1. BMI ≥ 24 kg\u002Fm² or waist circumference ≥ 90 cm (men) and 85 cm (women) or excessive body fat content and body fat percentage.\n  2. Fasting blood glucose ≥ 6.1 mmol\u002FL or 2-hour post-load blood glucose ≥ 7.8 mmol\u002FL or HbA1c ≥ 5.7% or history of Type 2 Diabetes Mellitus (T2DM) or Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) ≥ 2.5.\n  3. Fasting serum triglycerides ≥ 1.70 mmol\u002FL or currently receiving lipid-lowering drug therapy.\n  4. Serum high-density lipoprotein cholesterol (HDL-C) ≤ 1.0 mmol\u002FL (men) and 1.3 mmol\u002FL (women) or currently receiving lipid-lowering drug therapy.\n  5. Blood pressure ≥ 130\u002F85 mmHg or currently receiving antihypertensive drug therapy.\n* histology of liver-biopsy\n\nExclusion Criteria:\n\n* Excessive Alcohol Consumption: Individuals who consume alcohol equivalent to ≥30 grams of ethanol per day for males, or ≥20 grams of ethanol per day for females, or those with missing alcohol consumption information.\n* Viral Hepatitis Markers: Individuals who are positive for hepatitis B surface antigen (HBsAg), positive for hepatitis C virus (HCV) antibodies, or have missing information regarding these markers.\n* History of Serious Medical Conditions: Individuals with a history of malignant tumors, cardiovascular diseases, chronic kidney disease, decompensated liver cirrhosis (manifested by ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc.), or those who have undergone liver transplantation.",{"count":374,"type":20},2000,"Metabolic dysfunction-associated Fatty Liver Disease (MAFLD), also known as Non-Alcoholic Fatty Liver Disease (NAFLD), is the most common chronic progressive liver disease in China. It is closely related to the high incidence of cardiovascular-renal-metabolic syndrome and both liver and non-liver malignancies, posing a serious threat to public health. However, the diagnostic criteria for MAFLD are not unified globally, and the classification and staging still rely on liver biopsy for pathological assessment. The characteristics, mechanisms, and predictive indicators of liver and extrahepatic disease outcomes in MAFLD patients are not yet clear.\n\nThe severe form of MAFLD, metabolic dysfunction-associated steatohepatitis (MASH), has been a hot and challenging area of research for non-invasive tests (NITs). However, serum markers, imaging examinations, and novel markers under development cannot replace liver biopsy for the diagnosis of MASH. Clinically, the disease outcomes of MAFLD mainly depend on metabolic cardiovascular risk factors and fibrosis staging. Both liver biopsy and NIT-diagnosed advanced fibrosis and cirrhosis can predict liver-related events and all-cause mortality risks in MAFLD patients. Artificial intelligence and machine learning methods can improve the consistency of pathologists in diagnosing MASH and fibrosis. The Agile score, which combines gender, T2DM status, AST\u002FALT ratio, platelet count, and liver stiffness measurement (LSM), can improve the diagnostic efficacy of advanced fibrosis and cirrhosis in MAFLD patients and the efficiency of predicting liver-related events. However, the predictive effect of fibrosis staging and its changes on liver cancer needs to be improved. There is a lack of high-quality research on early warning indicators for the incidence of CVD, chronic kidney disease, and non-liver malignancies in MAFLD patients. It is necessary to explore the role of conventional indicators such as low-density lipoprotein cholesterol, lipoprotein(a), uric acid, and high-sensitivity C-reactive protein, as well as multi-omics parameters, in the classification, staging, and risk prediction of MAFLD.\n\nMAFLD is an increasingly serious public health issue associated with a higher risk of liver-related events, cardiovascular-renal-metabolic syndrome, and malignancies. The prevalence of MAFLD in China is high, but the rate of standardized management is low. Even patients with the same classification and staging often have different clinical characteristics and outcomes. There is currently a lack of a clinical classification and early warning system for MAFLD that combines metabolic cardiovascular risk factors and NITs for different outcome risks.",[377,120],"Metabolic Dysfunction Associated Steatotic Liver Disease",[379,201,380,381,382],"MAFLD","liver-biopsy","classification","prediction model","2025-02-08",{"date":385,"type":32},"2025-02-12",{"date":383,"type":20},{"date":388,"type":20},"2038-12-31",{"name":390,"class":75},"Beijing Friendship Hospital",6]