[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nonalcoholic-steatohepatitis-nash\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nonalcoholic-steatohepatitis-nash":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,70,99,124],{"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":14,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100635513","phase-1-evaluating-the-pharmacokinetics-and-safety-of-miricorilant-100635513",false,"NCT07553663","Evaluating the Pharmacokinetics and Safety of Miricorilant","A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* Evidence of presumed MASH with either FibroScan liver stiffness measurement ≥ 8 kPa and controlled attenuation parameter (CAP) ≥ 280 dB\u002Fm OR historical biopsy within 12 months of screening that meets the following criteria:\n\n  1. Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 3 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis score of F1 OR\n  2. NAS ≥ 2 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F2 or 3.\n* Aspartate aminotransferase (AST) \\> 17 U\u002FL for women and AST \\> 20 U\u002FL for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of Screening.\n* Presence of at least 1 of the following metabolic conditions that increase the risk of MASH:\n\n  1. Diagnosis of type 2 diabetes OR\n  2. Presence of 2 or more components of metabolic syndrome:\n\n     * Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or treatment for elevated blood glucose\n     * Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension\n     * Serum triglycerides ≥ 150 mg\u002FdL (1.7 mmol\u002FL) or drug treatment for elevated triglycerides\n     * Serum high-density lipoprotein (HDL) cholesterol \\\u003C 40 mg\u002FdL (1 mmol\u002FL) in men and \\\u003C 50 mg\u002FdL (1.3 mmol\u002FL) in women or drug treatment for low HDL\n     * Overweight or obese (body mass index \\[BMI\\] ≥ 25 kg\u002Fm2 \\[BMI ≥ 23 kg\u002Fm2 in Asians\\]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (men ≥ 90 cm \\[35.4 in\\]; women ≥ 80 cm \\[31.5 in\\] in Asians).\n\nExclusion Criteria:\n\n* Women who are pregnant, planning to become pregnant, or are lactating.\n* Have a BMI \\\u003C 18 kg\u002Fm2 or \\> 45 kg\u002Fm2.\n* Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire\n* Have had liver transplantation or plan to have liver transplantation during the study.\n* Have type 1 diabetes.\n* Have poorly controlled type 2 diabetes with a glycated hemoglobin (HbA1c)\n\n  * 9.5%.\n* Have any other chronic liver disease\n* History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation\n* Have hepatic decompensation\n\nOther exclusion criteria may apply","ALL","18 Years","75 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1",[26,27,28,29],"Nonalcoholic Steatohepatitis (NASH)","Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis","Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","Non-alcoholic Fatty Liver Disease (NAFLD)",[31,26,32,33],"Nonalcoholic Fatty Liver Disease (NAFLD)","Metabolic dysfunction-Associated Steatohepatitis (MASH)","Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)","RECRUITING","2026-05-21",{"date":37,"type":38},"2026-05-26","ACTUAL",{"date":40,"type":38},"2026-04-30",{"date":42,"type":21},"2026-10-30",{"name":44,"class":45},"Corcept Therapeutics","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100588891","phase-1-evaluation-of-miricorilant-on-liver-fat-in-patients-with-masld-100588891","NCT06947304","Evaluation of Miricorilant on Liver Fat in Patients With MASLD","A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* AST \\> 17 U\u002FL for women and AST \\> 20 U\u002FL for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of screening showing one of the following:\n\n  1. NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research Network (CRN) fibrosis score of F0 OR\n  2. NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR\n  3. NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3\n* MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.\n* Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH:\n\n  a. Diagnosis of type 2 diabetes managed with diet alone or diet and metformin (metformin dose must be stable for at least 1 month prior to screening) OR b. Presence of 3 or more components of metabolic syndrome: i. Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or treatment for elevated blood glucose with metformin ii. Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension iii. Serum TG ≥ 150 mg\u002FdL (1.7 mmol\u002FL) iv. Serum high-density lipoprotein cholesterol (HDL) \\\u003C 40 mg\u002FdL (1 mmol\u002FL) in men and \\\u003C 50 mg\u002FdL (1.3 mmol\u002FL) in women or drug treatment for low HDL v. Having overweight or obesity (body mass index \\[BMI\\] ≥ 25 kg\u002Fm2 \\[BMI\n  * 23 kg\u002Fm2 in Asians\\]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (men ≥ 90 cm \\[35.4 in\\]; women ≥ 80 cm \\[31.5 in\\] in Asians).\n\nOther inclusion criteria may apply\n\nExclusion Criteria:\n\n* Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months.\n* Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer.\n* Women who are pregnant, planning to become pregnant, or lactating.\n* BMI \\\u003C 18 kg\u002Fm² or \\> 45 kg\u002Fm².\n* Significant alcohol consumption exceeding 20 g\u002Fday for women or 30 g\u002Fday for men within 1 year prior to screening.\n* Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids.\n* Known or suspected cirrhosis or signs of hepatic decompensation.\n* Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease.\n* History of myocardial infarction, unstable angina, or stroke within 3 months prior to screening.\n* Uncontrolled hypertension (systolic \\> 160 mm Hg or diastolic \\> 100 mm Hg).\n* Current use of medications prohibited due to potential drug-drug interactions with study treatment.\n* Contraindications to magnetic resonance imaging (MRI).\n\nOther exclusion criteria may apply",{"count":55,"type":21},8,[24],"A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)",[26,59,60,29],"Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)",[31,26,32,33],"2026-02-09",{"date":64,"type":38},"2026-02-11",{"date":66,"type":38},"2025-08-22",{"date":68,"type":21},"2026-05",{"name":44,"class":45},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100503995","phase-2-study-of-adi-peg-20-versus-placebo-in-subjects-with-nash-100503995","NCT05842512","Study of ADI-PEG 20 Versus Placebo in Subjects With NASH","A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of ADI-PEG 20 or Placebo in Subjects With Nonalcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n1. Males and non-lactating, pregnancy test negative females between 18 - 80 years of age with biopsy proven F1 - F4 (compensated cirrhosis, Child-Pugh A, score ≤6) NASH. Limit F1 fibrosis to ≤ 20% of total subject population.\n2. Willingness to use appropriate contraceptive measures throughout study treatment and for 90 days thereafter (see Appendix A).\n3. Body mass index (BMI) \\> 23 kg\u002Fm2\n4. Must have confirmation of ≥ 5 % liver fat content on MRI-PDFF at screening.\n5. Biopsy-proven NASH confirmed by a central pathologist. Must have had a liver biopsy either during the screening period or a historical biopsy conducted within the last 6 months prior to pre-screening with fibrosis stage 1 to 4 (F score, F1-F4) 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   1. Steatosis (scored 0 to 3),\n   2. Ballooning degeneration (scored 0 to 2), and\n   3. Lobular inflammation (scored 0 to 3).\n6. Must have no evidence of worsening of ALT and AST (within 50%) measurements within 2 months prior to screening (-8 weeks) visits.\n7. Screening laboratory parameters, as determined by the central laboratory:\n\n   1. Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin, as calculated by the Cockcroft- Gault equation;\n   2. HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted);\n   3. Hemoglobin ≥ 11 g\u002FdL;\n   4. INR ≤ 1.3, unless due to therapeutic anticoagulation;\n   5. Direct bilirubin ≤ 0.5 mg\u002FdL;\n   6. Total bilirubin ≤ 1.3 x upper limit of normal (ULN), unless due to an alternate etiology such as Gilbert's syndrome or hemolytic anemia;\n   7. Creatinine kinase \\\u003C 3 x ULN;\n   8. Platelet count ≥ 150,000\u002FμL;\n   9. Serum triglyceride level ≤ 500 mg\u002FdL;\n   10. ALT \\\u003C 6 x ULN;\n   11. AST \\\u003C 6 x ULN;\n   12. ALP \\\u003C 2 x ULN.\n8. FibroScan® measurement \\> 7.0 kPa and \\\u003C 20.0 kPa.\n9. Subjects on non-insulin dependent diabetic, weight loss, or lipid-modifying medication(s) must be on stable dose(s) for at least 3 months prior to the diagnostic liver biopsy through randomization.\n10. Subjects on vitamin E and pioglitazone must maintain a stable dosage before the diagnostic liver biopsy and during the study period.\n\nExclusion Criteria:\n\n1. Weight gain or loss \\> 5% in the 3 months prior to randomization or \\> 10% in the 6 months prior to screening.\n2. Type 1 and insulin-dependent Type 2 diabetes.\n3. Poorly controlled hypertension (blood pressure \\[BP\\] \\> 160\u002F100 mmHg).\n4. Prior history of decompensated liver disease including ascites, hepatic encephalopathy (HE), or variceal bleeding.\n5. Chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen \\[HBsAg\\] positive.\n6. Chronic hepatitis C virus (HCV) infection (HCV antibody \\[Ab\\] and HCV ribonucleic acid \\[RNA\\] positive). Subjects cured of HCV infection less than 1 year prior (based on date of RNA polymerase chain reaction \\[PCR\\] negative confirmation following conclusion of treatment) to the screening visit are not eligible.\n7. Prior or planned (during the study period) bariatric surgery (e.g., gastroplasty, roux-en-Y gastric bypass), surgery reversal or removal of intragastric balloon \\> 2 years prior to enrollment would be eligible.\n8. Other causes of liver disease based on medical history and\u002For centralized review of liver histology, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis \\[PBC\\], primary sclerosing cholangitis \\[PSC\\], autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment.\n9. History of liver transplantation.\n10. Subjects with primary cancer, including co-existent second malignancy, with the exception of primary solid tumor with no known active disease present in the opinion of the Investigator which will not affect subject outcome in the setting of current diagnosis.\n11. Alcohol intake above an average limit of 2 drinks per day for women and 3 drinks per day for men. An alcoholic drink is defined as 12 ounces of regular beer, which is usually about 5% alcohol, 5 ounces of wine, which is typically about 12% alcohol, and 1.5 ounces of distilled spirits, which is about 40% alcohol.\n12. Human immunodeficiency virus (HIV) infection.\n13. Unstable cardiovascular disease in the 6 months prior to screening.\n14. Life expectancy less than 2 years.\n15. Use of any investigational medication within 30 days or within 5 half-lives of the investigational medication, whichever is longer, prior to screening and throughout the study is prohibited.\n16. Subjects with a history of (12 months prior to baseline) or current use of prescription drugs associated with liver steatosis (e.g., methotrexate, amiodarone, high-dose estrogen, tamoxifen, systemic steroids, anabolic steroids, valproic acid) should be excluded. However, subjects currently using silymarin should maintain their current dosage throughout the trial period.\n17. Contraindication of magnetic resonance imaging. These include but are not limited to devices or metal foreign bodies, such as Pacemaker, defibrillator or wires other than sternal wires, metallic foreign body in the eye, \"triggerfish\" contact lens, gastric reflux device, and insulin pumps.\n18. MELD score \\>12\n19. Subjects with esophageal or gastric varices with recent bleeding episodes (within 1 year).","80 Years",{"count":79,"type":21},60,[81],"PHASE2","Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH",[26],[26,85,86,87,88],"Arginine","Arginine Deiminase","ADI-PEG 20","Pegargiminase","2025-09-18",{"date":91,"type":38},"2025-09-23",{"date":93,"type":38},"2023-09-13",{"date":95,"type":21},"2028-01-31",{"name":97,"class":45},"Polaris Group",10,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":16,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":46},"100532687","phase-1-to-evaluate-the-safety-tolerability-pharmacokinetics-and-food-effects-of-imm-h014-in-healthy-subjects-100532687","NCT06216041","To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects","A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMM-H014 Sand the Effects of Food on Pharmacokinetics in Healthy Subjects","Inclusion Criteria:\n\n1. Subjects can voluntarily participate in the clinical trial, sign informed consent before the trial, fully understand the trial content, process and possible adverse events, and complete the study in accordance with the requirements of the trial protocol;\n2. Subjects can use effective contraceptive methods, such as abstinence, condoms, IUD use, and dual barrier method (such as condom plus diaphragm), within 6 months from the beginning of screening to the last trial drug administration;\n3. 18-45 years of age, male and female (including 18 and 45 years);\n4. Male weight ≥50kg, female weight ≥45kg; Body mass index (BMI) in the range of 18-28 kg\u002Fm2 (including the cut-off value); 5）Vital signs and physical examination with normal or abnormal has no clinical significance.\n\nExclusion Criteria:\n\n1. Clinical history of drug allergy or specific allergic diseases (asthma, urticaria), or known or suspected allergic history to experimental drugs and related excipients;\n2. Subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health products within 2 weeks before screening;\n3. Clinical laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, virology examination, thyroid function), abdominal color Doppler ultrasound (liver, gallbladder, spleen, pancreas, kidneys, adrenal gland), chest radiography and other abnormalities with clinical significance; Or other clinically significant diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) within 6 months before screening;\n4. Subjects who ate diets (including grapefruit or grapefruit products, pitaya, mango, etc.) that may affect drug metabolism within 7 days before screening, or had strenuous exercise, or the researchers thought that there were other dieters that affected drug metabolism, absorption, distribution, metabolism and excretion;\n5. A family history of a first-degree relative (i.e., biological parent, sibling, or child) with a risk factor for tip torsional ventricular tachycardia, or a family history of short QT syndrome, long QT syndrome, sudden unexplained death in youth (less than\u002Fetc. 40 years old), or sudden infant death syndrome;\n6. Subjects who suffer from hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia which are abnormal and clinically significant by the investigator;\n7. Presence of clinically significant abnormalities in ECG or QTcF\\>450ms (corrected according to Frederica formula, the calculation method is QTCF = Qt\u002F(RR 0.33));\n8. Creatinine clearance rate \\\u003C 90mL\u002Fmin (Creatinine clearance calculation Cockcroft-Gault formula: CrCl = \\[(140 - age) by weight (kg)\\] \u002F \\[0.814 x Scr (umol\u002FL)\\] or CrCl = (140 - age) by weight (kg) \u002F 72 x Scr (mg\u002FdL), women need to according to the formula calculation results by 0.85);\n9. Suffering from chronic or active gastrointestinal diseases, such as esophageal diseases, acute gastritis, gastric and duodenal ulcers, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery, which investigators believe is still clinically relevant;\n10. Subjects who had undergone major surgery (excluding diagnostic surgery) in the six months prior to screening, or who will undergo surgery during the study period, or who had undergone surgery that the investigator determines will affect drug absorption, distribution, metabolism, or excretion;\n11. Participants who had participated in other clinical trials within 3 months prior to screening (participants can be enrolled if they withdraw from the study before administration of the investigational drug, that is, they have not received the drug);\n12. Blood donation or significant blood loss (\\> 450ml) within 3 months prior to screening;\n13. Had a history of alcohol abuse (drinking an average of 14 units of alcohol per week in the 3 months prior to screening (1 unit =360 mL beer or 45mL liquor with 40% alcohol or 150 ml wine), or could not abstinence during the test period, or had a positive alcohol breath test;\n14. Smoking more than 5 cigarettes per day in the 3 months before screening;\n15. Have a history of drug or drug abuse or urine drug abuse screening positive;\n16. Subjects who have special requirements for diet and cannot accept a unified diet;\n17. Have dysphagia;\n18. Female subjects are lactating or have positive serological pregnancy results.\n19. Acute illness or concomitant medication occurred between the screening stage and the administration of the investigational drug;\n20. Ingested chocolate, any food or drink containing caffeine or rich in xanthines within 24 hours before first taking the experimental drug;\n21. Subjects who taken any alcohol-containing product or a positive alcohol breath test in the 24 hours prior to the use of the study drug;\n22. The investigator believes that the subjects are not suitable to participate in the clinical study for other reasons.",true,"45 Years",{"count":109,"type":21},138,[24],"This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either IMM-H014 or placebo.",[26],[114],"Adverse Event","2025-04-09",{"date":117,"type":38},"2025-04-11",{"date":119,"type":38},"2023-12-06",{"date":121,"type":21},"2025-08-01",{"name":123,"class":45},"Changchun Intellicrown Pharmaceutical Co. LTD",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":106,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":133,"phases":4,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":46},"100329687","quantitative-ultrasound-techniques-for-diagnosis-of-nonalcoholic-steatohepatitis-100329687","NCT03572465","Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis","QUS in NASH","Inclusion Criteria:\n\n* Are at least 18 years old at screening;\n* Able to comprehend and willingness to provide voluntary consent;\n* Understand French or English;\n* NAFLD\u002FNASH subjects:\n\n  * Have a suspected or known NAFLD or NASH;\n  * Must undergo a liver biopsy as part of their clinical standard of care\n* Non-NAFLD volunteers:\n\n  * Do not have a suspected or known NAFLD or NASH\n\nExclusion Criteria:\n\n* Are pregnant or trying to become pregnant;\n* Have a weight or girth preventing them from entering the MR magnet bore;\n* Are unable to understand or unwilling to provide written informed consent for this study;\n* Non-NAFLD volunteers:\n\n  * Have risk factors for developing liver steatosis (type 2 diabetes mellitus, alcohol consumption \\>60g of alcohol per day, lipogenic medication and body mass index \\>25 kg\u002Fm2);\n  * Have a liver steatosis (defined as MRI-proton density fat fraction \\\u003C5%);\n* NAFLD\u002FNASH subjects:\n\n  * Have other causes of chronic liver disease;\n  * Have a liver transplant",{"count":132,"type":21},102,"OBSERVATIONAL","Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH). If left untreated, NASH can evolve to cirrhosis, the late stage of fibrosis. Once cirrhosis is established, patients are at increased risk of developing gastrointestinal bleeding, liver cancer and liver failure that may require transplantation. A liver biopsy is currently needed to diagnose the severity of fatty liver disease but this is usually not indicated in asymptomatic patients. This procedure requires the insertion of a needle inside the liver to remove a small piece of tissue for examination under microscope. Liver biopsy is an invasive procedure with a small risk of major complications such as bleeding in 0.5% of cases. It is also affected by sub-optimal sampling leading to diagnostic errors\n\nUltrasound is optimum for screening patients with or without symptoms because it is a safe and widely available technology to scan the whole liver. Members of our team have developed Advanced ultrasound techniques that provide unique information not possible with state-of-the-art techniques. Unlike liver biopsy, these techniques would be applicable even in asymptomatic patients because it is non-invasive. This research proposal proposes a novel approach for diagnosis of NASH and will be the first study to measure individual components of NASH (fat, inflammation and fibrosis) with quantitative ultrasound (QUS) scores. This study is timely because NASH is the second leading cause of liver transplantation in North America and is predicted to become the leading indication in the near future.",[31,26],[137,138,139,140,141,142,143],"Chronic liver disease","Fibrosis","Elastography","Ultrasound","Magnetic resonance elastography","Diagnostic performance","Sensitivity and specificity","2025-03-14",{"date":146,"type":38},"2025-03-18",{"date":148,"type":38},"2019-10-23",{"date":150,"type":21},"2026-02-28",{"name":152,"class":153},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER"]