[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-alcoholic-fatty-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-alcoholic-fatty-liver-disease":38},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,69,0,25,[9,75,107,136,160,187,207,236,261,290,315,341,387,415,440,458,478,501,521,540,565,590,612,636,664],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100474891","inadvance-surveillance-prevention-and-interception-in-a-population-at-risk-for-cancer-100474891",false,"NCT05463796","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer","Inclusion Criteria:\n\n* Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type):\n\n  1-Hereditary risk for cancer including\n  * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes\n  * Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing)\n  * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)\n  * Hereditary Cancer Prediction Model-based elevated cancer risk\n  * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\\&N cancer for example), etc.\n* Exposed High Risk including\n\n  * Childhood cancer survivors with treatment exposures associated with increased risk of cancer\n  * Adult cancer survivors with treatment exposures associated with increased risk of cancer\n  * Documented high level exposure to group 1 IARC carcinogens\n  * Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \\>50, Smoking history of \\>15 pack years, First-degree relative history of lung cancer or COPD\n  * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis\n* Precursor Lesions including\n\n  * Breast: ductal\u002Flobular carcinoma in situ (CIS) and atypical hyperplasia\n  * GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia\u002Fadenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis\n  * GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia\u002Fcarcinoma in situ,\n  * Lung: Adenomatous hyperplasia\n  * H\\&N: high-risk oral precancerous diseases\n  * Skin: Class II melanocytic lesions. Squamous dysplasia\n  * Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas\n  * Thoracic: Lung nodules detected on screening CT that prompt further follow-up\n  * GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia\n  * Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others.\n* FAMILY MEMBERS or healthy individuals\n\nExclusion Criteria:\n\nThere are no exclusion criteria for the study.\n\nNote: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.",true,"ALL",{"count":20,"type":21},5000,"ESTIMATED","20 Years","OBSERVATIONAL","This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer.\n\n* The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.\n* The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"Cancer Risk","Cancer Predisposition Syndrome","Hereditary Cancer Prediction","Childhood Cancer Survivors","Adult Cancer Survivors","IARC Carcinogens","Smoking History","Lung Cancer","Ductal\u002FLobular Carcinoma","Barrett Esophagus","Pancreatic Precursor Lesions","Colonic Dysplasia\u002FAdenomata","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Steatohepatitis","Cirrhosis","High Grade Prostatic Epithelial Neoplasia","High-grade Bladder Urothelial Dysplasia\u002FCarcinoma in Situ","Adenomatous Hyperplasia","High-risk Oral Precancerous Diseases","Melanocytic Lesion, Adult","Hematologic Malignancy","Lung; Node","Serous Tubal Intraepithelial Carcinoma","Endometrial Intraepithelial Neoplasia","Cervical and Endocervical Carcinoma in Situ","Vulvar Intraepithelial Neoplasia","Nephrogenic Rests","Benign Bone Lesions With Risk of Malignant Degeneration","Giant Cell Tumor","Osteochondroma","Spitz Nevus",[58,59,60,61],"Hereditary Risk for Cancer","Childhood cancer survivors","Adult cancer survivors","Precursor Lesions","RECRUITING","2026-08-13",{"date":65,"type":66},"2026-08-17","ACTUAL",{"date":68,"type":66},"2023-04-25",{"date":70,"type":21},"2031-03-25",{"name":72,"class":73},"Dana-Farber Cancer Institute","OTHER",1,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100462716","phase-4-quantifying-hepatic-mitochondrial-fluxes-in-humans-100462716","NCT05305287","Quantifying Hepatic Mitochondrial Fluxes in Humans","Quantitation of Hepatic Mitochondrial Fluxes in Humans With Nonalcoholic Fatty Liver Disease (NAFLD)","T2D with NAFL\n\nInclusion Criteria:\n\n* Confirmed T2D based on OGTT (2 h glucose ≥200 mg\u002Fdl).\n* Treated with diet, metformin, and\u002For sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;\n* age = 18-80 years;\n* BMI = 25-40 kg\u002Fm2;\n* HbA1c = 7-10%; stable body weight (±4 pounds) over the preceding 3-months;\n* not taking any medication known to affect glucose metabolism other than antidiabetic medications.\n* Evidence of moderate\u002Fsevere fatty liver (steatosis; grade S2\u002FS3 on FibroScan corresponding to ≥10% fat on MRI-PDFF) and no\u002Fminimal hepatic fibrosis (grade F0\u002FF1 on FibroScan).\n\nExclusion Criteria:\n\n* Alcohol consumption \\>14 units\u002Fweek for women and \\>21 units\u002Fweek for men.\n* Liver cirrhosis (fibrosis stage 4).\n* Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected\u002Fproven liver cancer and any other liver disease other than NAFLD.\n* Type 1 diabetes and\u002For GAD positive subjects.\n* Subjects not drug naive or have been on metformin more than 3 months.\n* Presence of proliferative retinopathy.\n* Urine albumin excretion \\> 300 mg\u002Fday.\n* History of NY Class III-IV heart failure\n\nT2D with NASH\n\nInclusion Criteria:\n\n* Confirmed T2D based on OGTT (2 h glucose ≥200 mg\u002Fdl).\n* Treated with diet, metformin, and\u002For sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;\n* age = 18-80 years;\n* BMI = 25-40 kg\u002Fm2;\n* HbA1c = 7-10%;\n* stable body weight (±4 pounds) over the preceding 3-months;\n* not taking any medication known to affect glucose metabolism other than antidiabetic medications.\n* Evidence of moderate\u002Fsevere fatty liver (steatosis; grade S2\u002FS3 on FibroScan corresponding to ≥10% liver fat on MRI-PDFF) and moderate\u002Fsevere hepatic fibrosis (grade F2\u002FF3 on FibroScan).\n\nExclusion Criteria:\n\n* Alcohol consumption \\>14 units\u002Fweek for women and \\>21 units\u002Fweek for men.\n* Liver cirrhosis (fibrosis stage 4).\n* Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected\u002Fproven liver cancer and any other liver disease other than NAFLD.\n* Type 1 diabetes and\u002For GAD positive subjects.\n* Subjects not drug naive or have been on metformin more than 3 months.\n* Presence of proliferative retinopathy.\n* Urine albumin excretion \\> 300 mg\u002Fday.\n* History of NY Class III-IV heart failure","18 Years","80 Years",{"count":85,"type":21},60,"INTERVENTIONAL",[88],"PHASE4","In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D patients with NAFL and NASH before and after 16-weeks treatment with the insulin sensitizer pioglitazone",[38,91,92],"Type 2 Diabetes","Mitochondrial Metabolism Disorders",[94,95,96,97],"NAFLD","Mitochondria","Type 2 diabetes","Insulin resistance","2026-08-12",{"date":65,"type":66},{"date":101,"type":66},"2022-11-01",{"date":103,"type":21},"2027-03-31",{"name":105,"class":73},"The University of Texas Health Science Center at San Antonio",2,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":17,"sex":18,"minAge":82,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":86,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":74},"100353606","non-alcoholic-fatty-liver-disease-the-hepatic-response-to-oral-glucose-and-the-effect-of-semaglutide-nafld-heroes-100353606","NCT03884075","Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)","Non-Alcoholic Fatty Liver Disease, the Hepatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)","* INCLUSION CRITERIA:\n\n  1. Male or female Aged \\>= 18 years of age.\n  2. Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP \\>= 285 db\u002FM25) within 12 months.\n  3. Estimated average alcohol consumption \\\u003C 30 g\u002Fd for men or \\\u003C 20 g\u002Fd for women in the 6 months prior to enrollment and no binge-drinking behavior.\n  4. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nAdditional Inclusion Criteria for Treatment Phase\n\n1. Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on baseline admission liver biopsy.\n2. Liver fat content greater than or equal to 10% by 1H-MRS on initial admission.\n\nEXCLUSION CRITERIA:\n\n1. Pregnant or breast-feeding\n2. Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment \\> 18 months after treatment cessation. Patients receiving antiviral therapy are ineligible.\n3. HIV infection.\n4. Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis.\n5. Presence of definite or probable drug-induced liver injury. In the case of lipid-lowering, anti-hypertensive or anti-diabetic medications that are suspected to cause aminotransferase elevation, patients will be eligible if treatment is associated with stable enzyme levels for at least 6 months.\n6. Decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g\u002FdL, PT \\> 18 , albumin \\\u003C 3 g\u002FdL, MELD score \\> 12 (applicable only in patients without Gilbert s syndrome), or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis or liver transplant\n7. Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen\n8. Uncontrolled hypo- or hyperthyroidism.\n9. Thyroid nodules with ultrasonographic features suggestive of an increased risk of thyroid cancer per radiologist reporting (hypoechoic, microcalcifications, twinkling on B flow imaging, central vascularity, irregular margins, incomplete halo, nodule taller than wide and documented enlargement of a nodule), or nodules associated with an abnormal TSH (0.4 to 5 mU\u002FL).\n10. Active coronary artery disease, defined as persistent angina pectoris, reversible ischemia on cardiac stress test or imaging, or the presence of significant coronary artery disease on imaging or catheterization. Patients with coronary artery disease that was treated by angioplasty or bypass surgery may be eligible if they have no evidence of active disease \\>= 1 year after intervention, can safely stop antiplatelet and anticoagulant medications before the performance of invasive procedures, and have adequate ventricular function as assessed by echocardiography or cardiology consultation. These patients will require cardiology consultation and clearance prior to enrollment.\n11. Congestive heart failure.\n12. Chronic kidney disease, with creatinine clearance \\\u003C 60 ml\u002Fmin or eGFR \\\u003C 60\u002Fml\u002Fmin\u002Fm(2).\n13. Uncontrolled diabetes mellitus with HbA1c \\> 9% will exclude subjects. Patients with diabetes may be enrolled only if they have HbA1c \\\u003C=9%, have been on stable therapy with lifestyle and\u002For metformin for at least 3 months prior to enrollment, and are not foreseen to require change of antidiabetic medication or dose during the trial.\n14. Use of insulin, sulfonylurea agents, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists or DPP-4 inhibitors unless discontinued greater than or equal to 3 months before enrollment.\n15. Contraindication or inability to perform a liver biopsy.\n\n    1. Patients with coagulopathy (PT\u002FPTT values that are prolonged greater than or equal to 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\\\u003C 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude patients, unless they cannot be stopped safely for the performance of a liver biopsy.\n    2. Hemoglobin level \\\u003C 11 g\u002FdL\n16. Contraindications to MRI (heart pacemakers, unless MRI safe, insulin pumps, implanted hearing aids, neurostimulators, intracranial metal clips, metallic bodies in the eye, metal hip replacements, sutures, extreme anxiety or fear of small spaces.)\n17. History of gastric bypass or other bariatric surgery, partial or complete gastrectomy and known maldigestion or malabsorption.\n18. Treatment with orlistat.\n19. Patients with uncontrolled eating disorders including anorexia and bulimia nervosa.\n20. Patients with proliferative diabetic retinopathy.\n21. Use of medications or supplements to treat NAFLD (approved or unapproved) unless withdrawn greater than or equal to 3 months prior to enrollment or taken at a stable dose for greater than or equal to 6 months.\n22. Patients who had a liver biopsy performed less than or equal to 2 years before enrollment, unless they are willing to undergo all of the trial biopsies, knowing that these biopsies are purely for research and are not clinically indicated. This will be clearly documented in the patients charts prior to enrollment.\n23. Inability or unwillingness to receive subcutaneous injections.\n24. Known or suspected allergy to trial medication(s), excipients, or related products.\n25. Alcohol or substance abuse within the past 12 months.\n26. For women of childbearing potential, breast-feeding, pregnancy or inability or unwillingness to practice contraception for the duration of the study.\n27. Personal or first-degree family member with history of medullary thyroid carcinoma or subjects with known multiple endocrine neoplasia syndrome type 2 (MEN-2).\n28. Actively pursuing an intensive weight loss regiment, aimed at losing \\> 10% of current body weight, by following a different diet or exercise regimen over the study time period or recent (\\\u003C3 months) significant weight loss (\\>10%).\n29. The receipt of any investigational drug within 3 months prior to enrollment in this trial.\n30. Assessment by the principal investigator that the subject will be unlikely to complete the study procedures, or that enrollment puts the subject at a significant risk unspecified by the criteria above.\n\nINCLUSION CRITERIA for Healthy Volunteers (arm C)\n\n1. Male or female Aged greater than or equal to 18 years of age.\n2. No evidence of hepatic steatosis by imaging or histology.\n3. No history of known liver disease.\n4. Individuals on regular systemic medications may be considered eligible, and their eligibility will be determined by the principal investigator.\n5. BMI less than or equal to 25 kg\u002Fm2\n6. Non-diabetic.\n7. Normal transaminases (ALT less than or equal to 31 U\u002FL for men or less than or equal to 19 U\u002FL for women, and AST less than or equal to 30 U\u002FL).\n8. Fasting glucose less than or equal to 95 mg\u002FdL.\n9. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA for Healthy Volunteers (arm C)\n\n1. Pregnant or breastfeeding\n2. Excessive alcohol consumption, defined as an average alcohol consumption over \\> 1 drink per day over the past month\n3. Assessment by the principal investigator that the subject is unsuitable for participation in the study or that enrollment puts the subject at significant risk.","100 Years",{"count":116,"type":21},104,[118],"PHASE2","Background:\n\nIn non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help.\n\nObjective:\n\nTo find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide.\n\nEligibility:\n\nPeople with NAFLD and healthy volunteers ages 18 and older\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nImaging: A machine will take pictures of the participant s body.\n\nWithin 2-8 weeks of enrollment, participants will stay in the clinic for several days. This includes:\n\nBlood, urine, heart, and imaging tests\n\nFor NAFLD participants only: A needle-like device will remove a small biopsy of the liver and fatty tissue.\n\nParticipants will be alone in a special room for 5 hours. They will breathe through a tube under the nostrils. They will have blood drawn several times.\n\nThe baseline visit concludes participation for healthy volunteers but NAFLD participants will contine.\n\nAbout 6 weeks after discharge, participants will stay in the clinic again and repeat the tests. They will get their first semaglutide dose by injection.\n\nParticipants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits include blood tests.\n\nParticipants will inject semaglutide once a week at home.\n\nAt week 30, participants will stay in the clinic again and repeat the tests.\n\nParticipants will have a final visit 12 weeks after stopping treatment. This includes blood and urine tests.\n\n...",[121,38],"Non-Alcoholic Steatohepatitis",[123,124,125],"Non-Alcoholic Steatohepatitis (NASH)","Steatosis","Caloric Load","2026-08-07",{"date":128,"type":66},"2026-08-10",{"date":130,"type":66},"2019-07-24",{"date":132,"type":21},"2027-12-31",{"name":134,"class":135},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":17,"sex":18,"minAge":82,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":74},"100560002","harnessing-macrophage-lysosomal-lipid-metabolism-in-obesity-atm-100560002","NCT06571474","Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)","Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity-Associated Diseases","ATM","Inclusion Criteria :\n\n* age: ≥18 but ≤70 years\n* not pregnant or breastfeeding\n* weight stable and sedentary before enrollment\n* no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity \\[MAO\\]-Type 2 Diabetes group)\n* no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer)\n* participants must fulfil all of the following group-specific inclusion criteria below:\n\nLean group:\n\n* Body mass index (BMI) ≥18.5 but \\\u003C25.0 kg\u002Fm2\n* Intrahepatic triglyceride (IHTG) content \\\u003C5%\n* fasting blood glucose concentration: \\\u003C100 mg\u002Fdl\n* blood glucose concentration 2 h after a 75 g oral glucose challenge: \\\u003C140 mg\u002Fdl\n* Hemoglobin A1C (HbA1c) \\\u003C5.7 %\n\nMetabolically normal obesity (MNO) group:\n\n* BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2\n* IHTG content \\\u003C5%\n* fasting blood glucose concentration: \\\u003C100 mg\u002Fdl\n* blood glucose concentration 2 h after a 75 g oral glucose challenge: \\\u003C140 mg\u002Fdl\n* HbA1c \\\u003C5.7 %\n\nMetabolically abnormal obesity (MAO)-insulin resistance and non-alcoholic fatty liver disease (NAFLD) group:\n\n* BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2\n* IHTG content \\>7.5%\n* fasting blood glucose concentration: ≥100 but \\\u003C126 mg\u002Fdl\n* blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \\\u003C200 mg\u002Fdl\n* HbA1c: ≥5.7 but \\\u003C6.4 %\n\nMAO-type 2 diabetes group:\n\n* BMI ≥30.0 but \\\u003C45.0 kg\u002Fm2\n* clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \\>126 mg\u002Fdl or blood glucose concentration 2 h after a 75 g oral glucose challenge\\>200 mg\u002Fdl or HbA1c \\>6.4 % without medication if not diagnosed and medically treated for diabetes\n\nExclusion Criteria:\n\n\\- Individuals that do not meet all inclusion Criterion","70 Years",{"count":85,"type":21},"The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.\n\nBoth groups will have:\n\n* screening visit\n* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \\[MRI\\] and magnetic resonance spectroscopy \\[MRS\\] scans)\n* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies",[148,38,149,150],"Obesity","Diabetes Mellitus, Type 2","Healthy","2026-08-03",{"date":153,"type":66},"2026-08-06",{"date":155,"type":66},"2024-08-01",{"date":157,"type":21},"2028-03",{"name":159,"class":73},"Bettina Mittendorfer",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":17,"sex":18,"minAge":82,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":86,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"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","75 Years",{"count":170,"type":21},120,[88],"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.",[174,38,175,176,148],"Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Liver Fibrosis","2026-07-29",{"date":179,"type":66},"2026-07-31",{"date":181,"type":66},"2024-07-11",{"date":183,"type":21},"2029-12-31",{"name":185,"class":73},"The Cleveland Clinic",22,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":18,"minAge":194,"maxAge":82,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":74},"100300397","nonalcoholic-steatohepatitis-in-chinese-children-100300397","NCT03190538","Nonalcoholic Steatohepatitis in Chinese Children","Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up","Inclusion Criteria:\n\n* age 1-18 with biopsy-proven NAFLD\n* Alcohol consumption less than 20g\u002Fday and 10g\u002Fday for boys and girls respectively\n\nExclusion Criteria:\n\n* with viral hepatitis, e.g. HBV, HCV\n* with a1-anti-trypsin disease\n* with autoimmune hepatitis\n* with Wilson disease\n* with liver impaired by drugs","1 Year",{"count":196,"type":21},400,"Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality.\n\nA growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.",[38],"2026-07-28",{"date":177,"type":66},{"date":202,"type":66},"2017-05-01",{"date":204,"type":21},"2028-05-31",{"name":206,"class":73},"Humanity and Health Research Centre",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":168,"enrollmentInfo":215,"targetDuration":4,"studyType":86,"phases":217,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":235},"100609949","phase-3-a-pivotal-clinical-study-to-investigate-efimosfermin-alfa-in-participants-with-biopsy-confirmed-f2--or-f3-stage-mash-100609949","NCT07221227","A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)","ZENITH-1","Inclusion Criteria:\n\n1. Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures\n2. Age \\>=18 and \\\u003C=75 years at enrollment\n3. History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition\n4. Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \\>=4 confirmed by a central pathologist\n\nExclusion Criteria:\n\n1. Contraindication or ineligibility for percutaneous liver biopsy\n2. ALT or AST \\>=5 x upper limit of normal (ULN)\n3. Total bilirubin \\>=1.3 milligram per deciliter (mg\u002FdL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of \\>=1.3 mg\u002FdL and direct bilirubin is \\\u003C=20% of total bilirubin; otherwise, the individual will be excluded.\n4. Serum albumin \\\u003C=3.5 grams per deciliter (g\u002FdL)\n5. International normalized ratio (INR) \\>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.\n6. Alkaline phosphatase (ALP) \\>=2\\*ULN\n7. Platelet (PLT) count \\\u003C140,000 per (\u002F) cubic millimeter (mm\\^3); individuals with a PLT count between 110,000\u002Fmm\\^3 and 140,000\u002Fmm\\^3 may be enrolled after discussion with the Study Medical Monitor.\n8. Serum creatinine \\>=1.5 mg\u002FdL or creatinine clearance \\\u003C=60 milliliter (mL)\u002Fminute (min)\u002F1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation\n9. Alpha-fetoprotein \\>=20 nanogram per milliliter (ng\u002FmL)\n10. Glycated hemoglobin \\>=9.0%\n11. Model for End-Stage Liver Disease score \\>=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome)\n12. Phosphatidyl ethanol (PEth) \\>=80 ng\u002FmL at Screening\n13. Evidence of infection with any of the following:\n\n    1. Human immunodeficiency virus;\n    2. Hepatitis B virus (detectable HBsAg at Screening);\n    3. Hepatitis C virus (HCV);\n14. Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis or any history or evidence of cirrhosis on screening liver biopsy; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.\n15. Current or history of excessive alcohol intake for \\>=3 months within the 12-month period prior to Screening",{"count":216,"type":21},1200,[218],"PHASE3","The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.",[221],"Non-alcoholic Fatty Liver Disease",[223,224,221,213],"Efimosfermin Alfa","Metabolic Dysfunction-Associated Steatohepatitis","2026-07-24",{"date":227,"type":66},"2026-07-27",{"date":229,"type":66},"2025-10-24",{"date":231,"type":21},"2031-12-12",{"name":233,"class":234},"GlaxoSmithKline","INDUSTRY",91,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":168,"enrollmentInfo":244,"targetDuration":4,"studyType":86,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100609946","phase-3-a-clinical-study-to-investigate-the-safety-and-tolerability-of-efimosfermin-alfa-injection-in-participants-with-known-or-suspected-f2--or-f3-stage-mash-100609946","NCT07221188","A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)","ZENITH-2","Inclusion Criteria:\n\n* Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures\n* Age \\>=18 through \\\u003C=75 years at enrolment\n* History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition\n* History or presence of known or suspected MASH with evidence of fibrosis\n\nExclusion Criteria:\n\n* ALT or AST \\>=5 × upper limit of normal (ULN)\n* Total bilirubin (BILI) \\>=1.3 milligram per deciliter (mg\u002FdL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \\>=1.3 mg\u002FdL and direct BILI is \\\u003C=20% of total BILI; otherwise, the individual will be excluded.\n* Serum albumin \\\u003C=3.5 grams per deciliter (g\u002FdL)\n* International normalized ratio (INR) \\>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.\n* Alkaline phosphatase (ALP) \\>=2 × ULN\n* Platelet (PLT) count \\\u003C140 000 per (\u002F) cubic millimeter (mm\\^3); individuals with a PLT count between 110,000\u002Fmm\\^3 and 140,000\u002Fmm\\^3 may be enrolled after discussion with the Study Medical Monitor\n* Serum creatinine \\>=1.5 mg\u002FdL or creatinine clearance \\\u003C=60 milliliter (mL)\u002Fminute (min)\u002F1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.\n* Alpha-fetoprotein \\>=20 nanogram per milliliter (ng\u002FmL)\n* HbA1c \\>=9.0%\n* Model for End-Stage Liver Disease (MELD) 3.0 score \\>=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome)\n* Phosphatidylethanol (PEth) \\>=80 nanogram per milliliter (ng\u002FmL) at Screening\n* Known co-infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus; c. Hepatitis C virus (HCV); d. Hepatitis D virus; or e. Hepatitis E virus.\n* Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis, or any history or evidence of cirrhosis; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.\n* Current or history of excessive alcohol intake for \\>=3 months within the 12-month period prior to Screening",{"count":245,"type":21},1250,[218],"This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.",[221],[224,250,251,252,253,242],"efimosfermin alfa","Safety","Tolerability","Phase 3",{"date":227,"type":66},{"date":256,"type":66},"2025-12-12",{"date":258,"type":21},"2028-03-24",{"name":233,"class":234},53,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":280,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":74},"100642297","molecular-characterization-of-autoimmune-hepatitis-a-lipidomic-approach-100642297","NCT07644936","Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach","Molecular Characterization of Autoimmune Hepatitis Through Lipidomic Analysis and Extracellular Vesicle Profiling: A Controlled Pilot Clinical Study","AIH-LIPID","Inclusion Criteria:\n\nARM A:\n\n* Confirmed diagnosis of autoimmune hepatitis (AIH);\n* Adult age (≥18 years);\n* Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\"\n\nARM B:\n\nExclusion Criteria:\n\n* Confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD);\n* Adult age (≥18 years);\n* Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\"\n\nEsclusion Criteria:\n\n* Liver cirrhosis;\n* Active oncological diseases;\n* Viral hepatitis (HBV, HCV, HIV infection);\n* Severe medical conditions that may compromise study participation",{"count":270,"type":21},24,"This is a two-arm, prospective, controlled observational pilot clinical study aimed at characterizing the lipidomic profile and extracellular vesicles (EVs) of patients with autoimmune hepatitis (AIH) compared to patients with non-alcoholic fatty liver disease (NAFLD). A total of 24 adult outpatients will be enrolled at the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\". Blood samples will be collected by venipuncture to perform lipidomic analyses on red blood cell membranes and serum, and to isolate and characterize EVs. No intervention beyond standard clinical practice will be applied",[273,38],"Autoimmune Hepatitis",[275,276,277,278,279,94],"autoimmune hepatitis","lipidomic analysis","extracellular vesicles","fatty acids","biomarkers","NOT_YET_RECRUITING","2026-07-14",{"date":283,"type":66},"2026-07-15",{"date":285,"type":21},"2026-07-01",{"date":287,"type":21},"2028-07-01",{"name":289,"class":73},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":168,"enrollmentInfo":297,"targetDuration":4,"studyType":86,"phases":299,"briefSummary":300,"conditions":301,"keywords":302,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},"100586796","phase-2-a-study-of-efimosfermin-alfa-in-participants-with-biopsy-confirmed-cirrhosis-compensated-due-to-mash-100586796","NCT06920043","A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH","A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent form (ICF)\n* Age 18 through 75 years at enrollment\n* History or presence of 2 or more of the 5 components of metabolic syndrome\n* Liver biopsy confirmation of MASH consistent with stage F4 fibrosis\n* Other inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease\n* History of type 1 diabetes\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)\n* Other exclusion criteria may apply.",{"count":298,"type":21},42,[118],"The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.",[224,221],[303,304,305],"Fibroblast growth factor","Stage 4 fibrosis","Compensated Cirrhosis","2026-07-07",{"date":308,"type":66},"2026-07-08",{"date":310,"type":66},"2025-04-09",{"date":312,"type":21},"2028-07-10",{"name":233,"class":234},30,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":86,"phases":324,"briefSummary":326,"conditions":327,"keywords":331,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":337,"leadSponsor":339,"locationsCount":74},"100623974","phase-1-effect-of-insulin-lowering-on-lipogenesis-100623974","NCT07403604","Effect of Insulin Lowering on Lipogenesis","Human Models of Selective Insulin Resistance: Diazoxide, Part I","Inclusion Criteria:\n\n* Adults aged 18-65 years\n* Body mass index of 30-45 kg\u002Fm2\n* Able to understand written and spoken English and\u002For Spanish\n* Able to have pre-randomization screening labs drawn and study protocol initiated within 60 days of eligibility determination\n* Presence of uncomplicated metabolic dysfunction-associated steatotic liver disease (MASLD) by vibration-controlled transient elastography (VCTE)\n\n  * Steatosis score of S1-S3\n  * Fibrosis score of F0-F2 (Note that if VCTE result is available from within past 6 months, then do not have to repeat VCTE for study purposes)\n* Evidence of insulin resistance, represented by any or all of the following criteria:\n\n  * Meeting either of the American Diabetes Association's definitions for prediabetes or impaired fasting glucose (IFG) on screening labs:\n\n    * Prediabetes: Hemoglobin A1c 5.7-6.4%\n    * IFG: plasma glucose of 100-125 mg dL-1 after ≥ 8-h fast\n  * Homeostasis Model of Insulin Resistance (HOMA-IR) score ≥ 2.73\n* Fasting hyperinsulinemia (fasting insulin level ≥ 13 μU\u002FmL) on screening labs\n* Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.\n\nExclusion Criteria:\n\n* Unable to provide informed consent in English or Spanish\n* Concerns arising at screening visit (any of the following):\n\n  * Documented weight loss of ≥ 5.0% of baseline within the previous 3 months\n  * Abnormal blood pressure (including on treatment, if prescribed)\n\n    * Systolic blood pressure (SBP) \\\u003C 90 mm Hg or \\> 160 mm Hg, and\u002For\n    * Diastolic blood pressure (DBP) \\\u003C 60 mm Hg or \\> 100 mm Hg\n  * Resting heart rate \\\u003C 55 bpm or ≥ 110 bpm\n  * Abnormal screening electrocardiogram (or if on file, performed within previous 90 days)\n  * Laboratory evidence of diabetes mellitus:\n\n    * Hemoglobin A1c ≥ 6.5%, and\u002For\n    * Fasting plasma glucose ≥ 126 mg\u002FdL\n  * Positive qualitative serum β-human chorionic gonadotropin (β-hCG, i.e., pregnancy test) in women of childbearing potential\n  * Liver function abnormalities: transaminases (aspartate aminotransferase or alanine aminotransferase) \\> 3.0 x the upper limit of normal, and\u002For total bilirubin \\> 1.25 x the upper limit of normal\n  * Abnormal screening fasting triglycerides \\> 500 mg\u002FdL\n  * Abnormal screening serum electrolytes that are considered clinically significant according to the clinical judgment of the PI\n  * Creatinine equating to estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n  * Abnormal screening blood counts (any of the following):\n\n    * Hemoglobin \\\u003C 10 g\u002FdL\n    * White blood cell count below the lower limit of normal for sex\n    * Platelet count below the lower limit of normal for sex\n  * Uric acid level above the upper limit of normal\n* Reproductive concerns\n\n  * Women currently pregnant (tested by serum and\u002For urine β-hCG)\n  * Women currently breastfeeding\n* Concerns related to glucose metabolism\n\n  * History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):\n\n    * Hemoglobin A1c ≥ 6.5%\n    * Plasma glucose ≥ 126 mg\u002FdL after 8-h fast\n    * Plasma glucose of ≥ 200 mg\u002FdL at 2 h after ingestion of a 75-g glucose load\n    * Random plasma glucose ≥ 200 mg\u002FdL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state\n  * History of gestational diabetes mellitus within the previous 5 years\n  * Use of antidiabetic medications except metformin within the 90 days prior to screening\n  * Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n* Concerns related to lipid metabolism\n\n  * Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia\n  * Use of fibrates, prescription-strength omega-3 fatty acids, or high-dose niacin within the 90 days prior to screening:\n* Known, documented history (i.e., not to be newly screened\u002Ftested for study purposes), at the time of screening, of any of the following medical conditions:\n\n  * Pancreatic pathology, including but not limited to neoplasia, pancreatitis, pancreatectomy\n  * Cardiovascular disease (N.B. uncomplicated hypertension is not exclusionary)\n\n    * Atherosclerotic cardiovascular disease: stable or unstable angina, myocardial infarction, ischaemic or hemorrhagic stroke, or transient ischaemic attack, peripheral arterial disease (claudication), use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor), history of percutaneous coronary intervention\n    * Heart rhythm abnormalities\n    * Congestive heart failure of any New York Heart Association class\n    * Symptomatic valvular heart disease (e.g., aortic stenosis)\n    * Pulmonary hypertension\n  * Chronic kidney disease, Stage 3 or higher (estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F 1.73 m2), of any cause\n  * Chronic liver disease other than uncomplicated MASLD, including but not limited to:\n\n    * Advanced liver fibrosis, as determined by non-invasive testing, including fibrosis scores of F3-F4 on VCTE\n    * Cirrhosis of any etiology\n    * Autoimmune hepatitis or other rheumatologic disorder affecting the liver\n    * Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)\n    * Chronic liver infection (e.g., viral hepatitis, parasitic infestation)\n    * Hepatocellular carcinoma\n    * Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)\n  * Gout\n  * Chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n  * Malabsorptive conditions\n  * Active seizure disorder (including controlled with antiepileptic drugs)\n  * Psychiatric diseases that are or have been decompensated within 1 year of screening, and\u002For require use of antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine), monoamine oxidase inhibitors, tricyclic antidepressants, or lithium\n  * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency\n  * Other clinically significant endocrinopathies\n  * Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n  * Active malignancy, or hormonally active benign neoplasm, except allowances for non-melanoma skin cancer and differentiated thyroid cancer (Stage I only)\n  * Clinical concern for increased risk of volume overload or hypotension (SBP \\\u003C90 and\u002For DBP \\\u003C60 mm Hg), including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Clinical concern for increased risk of volume overload or hypotension (SBP \\\u003C90 and\u002For DBP \\\u003C60 mm Hg), including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Use of certain medications currently or within 90 d prior to screening:\n\n  * Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 90 d prior to screening, except allowances for:\n\n    * Statins for primary prevention of cardiovascular disease\n    * Use of drugs prescribed for indications other than the exclusionary diagnoses\u002Fpurposes listed above (e.g., non-hydantoin antiepileptic drugs used for non-seizure indications, angiotensin converting enzyme inhibitor\u002Fangiotensin receptor blocker used for uncomplicated hypertension rather than for congestive heart failure, etc.)\n    * Vasodilating drugs for any indication: hydralazine, nitrates, phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil), minoxidil (oral)\n    * Phenytoin or fosphenytoin for any indication\n    * Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 90 days; topical and inhaled formulations are permitted\n* History of certain weight-loss (bariatric) surgeries, including:\n\n  * Roux-en-Y gastric bypass\n  * Biliopancreatic diversion\n  * Restrictive procedures (lap band, sleeve gastrectomy) performed within past year\n* Clinical concern for alcohol overuse, including based on chart review and\u002For by participant's report of consuming more than 14 standard drinks per week for males or more than 7 standard drinks per week for females\n* Regular use of tobacco, either daily or an average of at least 1 cigarette per day, and\u002For nicotine vaping more than 1 day per week\n* Positive urine drug screen, except for lawfully prescribed medications or marijuana\u002Ftetrahydrocannabinol positivity, provided that the participant agrees not to use it during the same period that they will abstain from alcohol)\n* Atypical circadian rhythm, such as due to night shift work, within 30 days of screening or expected within 30 days of each treatment period\n* History of severe infection or ongoing febrile illness within 14 days of screening\n* Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n* Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations (including sulfa drugs), other biologics, intravenous (IV) infusion equipment, plastics, adhesive or silicone, history of infusion site reactions with IV administration of other medicines, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n* Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 5 half-lives of an investigational agent or biologic","65 Years",{"count":7,"type":21},[325],"PHASE1","The goal of this clinical trial is to compare a one-week course of diazoxide (2 mg\u002Fkg per dose x 14 doses) and placebo in people with obesity and insulin resistance (IR) with metabolic dysfunction-associated steatotic liver disease (MASLD). The main question it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects hepatic de novo lipogenesis, a major contributor to MASLD pathophysiology.\n\nParticipants will:\n\n* Take 14 doses of placebo over 7 days, followed 4-12 weeks later by either 14 doses of diazoxide (at 2 mg per kg of body weight per dose \\[mpk\\]) or another 14 doses of placebo, over 7 days\n* Take 18 doses of heavy (deuterated) water (50 mL each) over 7 days, twice\n* Have blood drawn and saliva collected after an overnight fast on four mornings over the course of the study\n* Undergo insulin suppression tests (IST) to assess the degree of insulin resistance at the end of each 1-week study period\n* Consume their total calculated daily caloric needs as divided into three meals per day\n\nResearchers will compare blood tests at the beginning and end of each 1-week study period in participants randomized (like the flip of a coin) to receive either placebo followed by diazoxide or placebo followed by placebo, to see how the drug treatment affects de novo lipogenesis, serum insulin, plasma glucose, and other serum lipid parameters (triglycerides, free fatty acids), among others.",[328,329,38,330,148],"Hyperinsulinemia","Insulin Resistance","Prediabetic State",[328,329,332,38,333],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Triglycerides",{"date":335,"type":66},"2026-07-06",{"date":285,"type":66},{"date":338,"type":21},"2029-09-30",{"name":340,"class":73},"Columbia University",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":86,"phases":350,"briefSummary":352,"conditions":353,"keywords":366,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":106},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751","NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist",{"count":349,"type":21},132,[351],"NA","Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[148,354,176,355,332,224,356,357,358,329,359,360,361,362,149,363,38,364,365],"Liver Diseases","Liver Fat","MASLD","MASH","Weight Loss","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","NASH With Fibrosis","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[367,368,369,370,371,372,373,374,375,376,175,377,123],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Non-Alcoholic Fatty Liver Disease (NAFLD)","2026-06-23",{"date":380,"type":66},"2026-06-25",{"date":382,"type":66},"2025-06-24",{"date":384,"type":21},"2028-06",{"name":386,"class":73},"Pichamol Jirapinyo, MD, MPH",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":394,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":74},"100507667","increased-risk-of-non-alcoholic-fatty-liver-disease-in-low-birth-weight-individuals-100507667","NCT05890365","Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals","Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.","Inclusion Criteria:\n\n* 250 healthy, men and women born with a low birth weight (birth weight (BW) \\\u003C10% of the population) and 50 born with a normal birth weight controls (BW between 50-90% of the population)\n* born at term (weeks 39-41)\n\nExclusion Criteria:\n\n* BMI\\>35 kg\u002Fm2\n* Disease\u002Fmedication known to affect primary outcome\n* Self-reported high physical activity level\n* Alcohol intake above general recommendations.\n* Metabolic\u002Fliver disease\n* Weight gain\u002Floss of \\>3 kg within the past 6 months","34 Years","49 Years",{"count":397,"type":21},300,"The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.",[38,400],"Low Birth Weight",[402,403,404,405],"Metabolic disease","Adipose tissue biology","Liver fat","Non-alcoholic fatty liver disease","2026-06-09",{"date":408,"type":66},"2026-06-11",{"date":410,"type":66},"2023-12-14",{"date":412,"type":21},"2026-12",{"name":414,"class":73},"Steno Diabetes Center Copenhagen",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":144,"enrollmentInfo":422,"targetDuration":4,"studyType":86,"phases":424,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100620509","phase-1-a-study-of-efimosfermin-alfa-in-adults-with-hepatic-impairment-100620509","NCT07358546","A Study of Efimosfermin Alfa in Adults With Hepatic Impairment","A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease","Inclusion Criteria:\n\n* Between 18 years and 70 years of age inclusive\n* Body Mass Index (BMI) within the range 23-40 kilogram per square meter (kg\u002Fm\\^2)\n* Male or female participants\n* Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must:\n\n  * Have a clinical diagnosis of liver cirrhosis in the participant's medical history corroborated by previous liver biopsy, medical imaging or compatible biochemical profile, and\n  * Be classed during Screening as one of the following Child-Pugh classes:\n\n    * Child-Pugh B: Score 7-9 or\n    * Child-Pugh C: Score 10-15\n* Chronic (greater than \\[\\>\\] 6 months) HI which is currently stable (no acute episodes of illness within the previous 1 month prior to Screening (Visit 1) due to deterioration in hepatic function). Participants must also remain stable throughout the Screening period. Assessment of the stability of the participant's hepatic function will be determined by the investigator.\n\nExclusion Criteria:\n\n* History of extrahepatic disorders possibly related to etiology of cirrhosis.\n* History of cryoglobulinemia.\n* Participants with Grade 3 ascites or refractory ascites.\n* Participants with refractory encephalopathy or significant central nervous system disease\n* History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and\u002For surgical procedures.\n* Other primary causes of liver disease. Steatotic liver disease must be the primary cause of liver disease.\n* Clinically significant abnormalities affecting physical health in medical history, or on physical examination, that could interfere with or for which treatment could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study.\n* Current, or history of known hepatocellular carcinoma (HCC).\n* Participants with transjugular intrahepatic portosystemic shunt (TIPS) placement.\n* Presence of hepatopulmonary or hepatorenal syndrome.\n* Presence of primarily cholestatic liver diseases.\n* Evidence of symptomatic or complicated cholecystitis.\n* History of pancreatic injury, pancreatitis, or other pancreatic disease.\n* History of liver transplantation, or active on the liver transplant waiting list.\n* Participants with signs of active infection\n* History of adrenal gland disease or using treatment that affects the hypothalamic-pituitary-adrenal axis.\n* History of significant bone disease such as osteoporosis\n* Psychosocial features that, in the opinion of the investigator, increase the likelihood of loss to follow-up.\n* History or presence of drug abuse.\n* Use of other investigational drugs at the time of screening, or within 5 half-lives or 30 days prior to study intervention, whichever was longer; or longer if required by local regulations\n* Have previously taken efimosfermin alfa\n* Participants with Alanine Aminotransferase (ALT) value \\>3 times (x) upper limit of normal (ULN)\n* Participants with Aspartate aminotransferase (AST) value \\>=300 Units\u002FLiter.\n* Participants with estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology \\[CKD-Epi\\] 2021) \\\u003C45 milliliter\u002Fminute\u002F1.73 square meter (mL\u002Fmin\u002F1.73m\\^2).\n* Average of triplicate QT interval corrected for heart rate using Fridericia formula (QTcF) \\>480 milliseconds (msec) (for male and female participants) at Screening\n* For participants in the MASH with alcohol category, significant risk of withdrawal symptoms.",{"count":423,"type":21},32,[325],"This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.",[221],[250,428,429,430,224,431],"Alcohol","Hepatic Impairment","Steatotic liver disease","Pharmacokinetics","2026-06-05",{"date":406,"type":66},{"date":435,"type":66},"2026-03-13",{"date":437,"type":21},"2027-10-13",{"name":233,"class":234},3,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":456,"locationsCount":74},"100373374","investigating-pathological-mechanisms-in-non-alcoholic-fatty-liver-disease-100373374","NCT04141592","Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease","Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed non-alcoholic Fatty liver disease (diagnosed clinically, radiologically or histologically)\n* If diabetic, Diagnosed with Type 2 Diabetes Mellitus\n\nOR\n\n• Healthy Control: no diagnosis of any liver condition including NAFLD\n\no NAFLD excluded by Fibroscan Controlled Attenuation Parameter (CAP) score of \\\u003C222 dB\u002Fm\n\nExclusion Criteria:\n\n* Unwilling or unable to give informed consent\n* Type 1 Diabetes Mellitus\n* Other form of liver disease (other than NAFLD)\n\n  o Viral hepatitis, Auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, Sarcoidosis, cystic fibrosis, sickle cell disease\n* Taking medication associated with liver dysfunction (except methotrexate)\n* Auto-immune disease which in the investigator's opinion may confound immune profiling\n* Concomitant immunosuppressive medications (except methotrexate, short course oral steroids or inhaled corticosteroids)\n* Currently pregnant\n* Any major organ transplant (excluding corneal or hair transplant)\n* Regular alcohol intake greater than 14 units a week for female participants and 21 units a week for male participants",{"count":448,"type":21},153,"To identify key characteristics of the tissue resident and peripherally circulating immune-phenotype in addition to blood markers, metabolic profile, faecal and oral microbiota in non-alcoholic fatty liver disease",[38],"2026-06-03",{"date":432,"type":66},{"date":454,"type":66},"2019-03-05",{"date":179,"type":21},{"name":457,"class":73},"Queen Mary University of London",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":168,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":476,"locationsCount":106},"100579101","identification-of-liver-fibrosis-biomarkers-100579101","NCT06819917","Identification of Liver Fibrosis Biomarkers","Prospective Sample Collection Study for Discovery and Evaluation of Novel Blood Based Biomarkers for Assessment of Hepatic Fibrosis","Inclusion Criteria:\n\n* Patients scheduled for biopsy (or F0-F2 patients that underwent biopsy within the last 6 months but at least 1 month ago) suspected of having hepatic fibrosis due to NAFLD (NAFL\u002FNASH) or patients with MASLD or MASH\n* Any FIB-4 value available\n* Any Fibroscan value available\n* Written and signed informed consent present\n* Patients aged ≥ 18 years to ≤ 75 years at the time of the blood draw\n* Body Mass Index (BMI) ≤ 45 kg\u002Fm²\n\nExclusion Criteria:\n\n* Vulnerable person: person deprived of liberty by a judicial or administrative decision and\u002For person under psychiatric care\n* Self-reported pregnancy or lactating females\n* Disease related to other etiologies, including alcoholic liver disease (alcoholic steatohepatitis), MetALD, specific etiology SLD (e.g. DILI or monogenic disease), cryptogenic SLD, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, human immunodeficiency virus, Wilson's disease, Hemochromatosis, alpha-1 antitrypsin deficiency\n* Any type of carcinoma, unless it is at least 5 years in remission\n* Prior liver transplant\n* Evidence of any other unstable or, untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric disorder. Medically controlled comorbidities can be allowed\n* Self-reported alcohol consumption greater 30 g\u002Fday (males) 20 g\u002Fday (females)\n* Recent myocardial infarction (within last 6 months)\n* Inability to have a liver biopsy, or provide blood sample in a fasted status\n* F0-F2 recalled patients with +\u002F- 5% change in weight between the biopsy and study inclusion",{"count":466,"type":21},575,"Chronic liver disease (CLD) is a major cause of global mortality and morbidity . CLD patients are at an increased risk of developing liver fibrosis (formation of scar tissue), cirrhosis and liver failure and are at significant risk to develop primary liver cancer. Non-alcoholic fatty liver disease (NAFLD) represents a major risk for CLD and it is becoming the most common chronic liver condition with an estimated 25% global prevalence. Progression to non-alcoholic steatohepatitis (NASH) occurs in approx. 1 of 5 NAFLD patients and due to the rapidly rising etiology of end-stage liver disease, is currently the second most common etiology of hepatocellular carcinoma (HCC) requiring liver transplantation. Liver biopsy, currently the gold-standard for grading disease activity and staging fibrosis, is invasive, costly and at risk for sampling error. Due to the number of patients diagnosed with fibrosis and since fibrosis stage is prognostic of mortality and drives patient management, it is important to develop noninvasive yet accurate diagnostic tools that can identify fibrosis stage. The purpose of this study is to obtain a panel of clinically well characterized blood specimens to identify novel biomarkers to be used as an aid in diagnosis to assess the stage of clinically significant hepatic fibrosis in patients with signs or symptoms of NAFLD (NAFL\u002FNASH). In addition, quantitative ultrasound (QUS) based approaches combined with artificial intelligence (AI) algorithms will be explored for assessing the stage of fibrosis.",[469,38,365],"Non-alcoholic Fatty Liver","2026-05-22",{"date":472,"type":66},"2026-05-27",{"date":474,"type":66},"2025-02-01",{"date":412,"type":21},{"name":477,"class":234},"Roche Diagnostics GmbH",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":484,"minAge":322,"maxAge":168,"enrollmentInfo":485,"targetDuration":4,"studyType":86,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":74},"100638743","additive-efficacy-of-physical-activity-program-in-hypthyroidism-elder-females-with-glaucoma-and-fatty-liver-issues-100638743","NCT07599241","Additive Efficacy of Physical Activity Program in Hypthyroidism Elder Females With Glaucoma and Fatty Liver Issues","Inclusion Criteria:\n\n* subclinical hypothrodism (significant form)\n* primary opened angle gaulcoma in both eyes with ocular hypertension in both eyes )(high-tension typed glaucoma)\n* fatty liver (non alcholic type)\n* elder females\n\nExclusion Criteria:\n\n* respiratory issues\n* cardiac issues\n* renal issues","FEMALE",{"count":486,"type":21},40,[351],"additive efficacy of physical activity program in hypthyroidism in elder females with glaucoma and fatty liver issues was not investigated",[490,38,491],"Subclinical hypothyroïdism","Primary Open Angle Glaucoma","2026-05-14",{"date":494,"type":66},"2026-05-20",{"date":496,"type":66},"2026-03-15",{"date":498,"type":21},"2026-12-15",{"name":500,"class":73},"Cairo University",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":322,"enrollmentInfo":508,"targetDuration":4,"studyType":86,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":280,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":4},"100636832","efficacy-safety-and-tolerability-of-cs0159-combined-with-semaglutide-in-mafld-patients-with-obesity-and-t2dm-100636832","NCT07570810","Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM","A Single -Center, Randomized, Double-blind, Placebo-controlled Proof of Exploratory Study Evaluating the Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM","Inclusion Criteria:\n\n* 1\\. Age≥18 and ≤65 years, male or female.\n* 2\\. MRI-PDFF ≥10% within 3 months prior to randomized.\n* 3\\. Diagnosis of T2DM.\n* 4\\. HbA1c: 7.0%-10.5%.\n* 5\\. FPG: 7.0-13.3 mmol\u002FL.\n* 6\\. BMI: 30-45 kg\u002Fm2.\n* 7\\. Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period.\n* 8\\. Willing to maintain consistent diet and exercise habits throughout the entire study, and adhere to the study protocol for timely administration of the study drug, and timely self-monitoring of blood glucose and recording.\n* 9\\. Can understand the research content, follow the research protocol, and voluntarily sign the ICF.\n\nExclusion Criteria:\n\n* 1\\. ALT≥2.5×ULN, AST≥2.5×ULN, TBil≥2×ULN, creatinine (Cr) ≥1.5×ULN and Serum creatinine clearance\\\u003C60 mL\u002Fmin, PLT\\\u003C100×10\\^9\u002FL, INR \\>1.3, ALB \\\u003C3.5 g\u002FdL.\n* 2\\. Use of glucose-lowering medication in the 3 months prior to randomization.\n* 3\\. Weight loss ≥ 5% in the 3 months prior to randomization or ≥10% in the 6 months prior to randomization or use of other weight-lowering drugs, corticosteroids, and etc.\n* 4\\. History of allergy to glucagon-like peptide-1 receptor agonists (GLP-1RA) medications, currently in an allergic state, having allergic conditions, or history of allergies to ≥2 substances.\n* 5\\. Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes.\n* 6\\. Subjects with a history of severe pruritus.\n* 7\\. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.\n* 8\\. Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history.\n* 9\\. History of acute or chronic pancreatitis.\n* 10\\. Subjects with Child-Pugh class B or C grade cirrhosis.\n* 11\\. HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive.\n* 12\\. Arrhythmias, male QTc≥450 ms, or female QTc≥470 ms. Or cardiovascular disease for which the researcher has assessed that participation in the trial is not appropriate.\n* 13\\. Diseases that interfere with the absorption, distribution, metabolism or excretion.\n* 14\\. Gastrointestinal diseases that affect food digestion and absorption.\n* 15\\. Use moderate or strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A4 enzyme) within the first 14 days of randomization and throughout the entire trial period.\n* 16\\. History of malignant tumors within the first 5 years of randomization.\n* 17\\. Serious hypoglycemic events occurring ≥ 3 times within 12 weeks prior to administration, or acute and severe metabolic disorder occurred within 12 weeks prior to administration.\n* 18\\. Drug abuse or alcohol abuse within the first 6 months of randomization.\n* 19\\. Poor blood pressure control.\n* 20\\. Mental illness, epilepsy.\n* 21\\. Patients with uncontrollable severe infectious diseases before randomization.\n* 22\\. Pregnant, planned pregnancy or breastfeeding.\n* 23\\. Participated in other clinical trials in the first three months of randomization.\n* 24\\. Any condition that in the judgement of the researcher precludes participation.",{"count":314,"type":21},[351],"This is an exploratory study evaluating CS0159 in combination with Semaglutide in metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).",[91,148,221],"2026-05-01",{"date":514,"type":66},"2026-05-06",{"date":516,"type":21},"2026-06-01",{"date":518,"type":21},"2026-12-31",{"name":520,"class":73},"Shanghai Jiao Tong University School of Medicine",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":322,"enrollmentInfo":527,"targetDuration":4,"studyType":86,"phases":529,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":74},"100582443","phase-2-evaluating-the-safety-and-efficacy-of-carbocisteine-in-the-treatment-of-nonalcoholic-fatty-liver-disease-patients-100582443","NCT06863376","Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients","Inclusion Criteria:\n\n* Either male or female adult patients (\\>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography\n\nExclusion Criteria:\n\n* Pregnant and\u002For lactating women\n* Excessive alcohol use (defined as an average alcohol intake \\> 30 g per day in men and \\> 20 g per day in women)\n* Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis.\n* patients suffering from chronic kidney disease, and hyper\u002Fhypoparathyroidism\n* Hypersensitivity to carbocistiene.",{"count":528,"type":21},46,[118],"Nonalcoholic fatty liver disease (NAFLD) is a global public health concern, and the leading cause of chronic liver disease, especially in developed countries. NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. Lifestyle interventions, including dietary modification and exercise, remain the cornerstone of NAFLD treatment. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven NASH and fibrosis.",[38],{"date":533,"type":66},"2026-05-04",{"date":535,"type":66},"2025-03-01",{"date":537,"type":21},"2027-04-20",{"name":539,"class":73},"Tanta University",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":194,"maxAge":547,"enrollmentInfo":548,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":106},"100531962","liver-steatosis-in-pediatric-cd-patients-100531962","NCT06206616","Liver Steatosis in Pediatric CD Patients","Liver Steatosis in Pediatric Celiac Disease Patients: Exploring the Epidemiological and Pathophysiological Features of an Underestimated Condition","Inclusion Criteria:\n\n* Age \\>1 and \\\u003C14 years\n* Celiac Disease diagnosis according European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria\n\nExclusion Criteria:\n\n* age \\\u003C1 and \\>14 years;\n* self-exclusion of gluten\u002Fwheat from the diet and refusal to reintroduce it, for diagnostic purposes, before entering the study;\n* bacterial and\u002For parasitic infections;\n* diagnosis of chronic inflammatory intestinal diseases and other organic pathologies affecting the digestive system (for example, serious liver diseases), nervous system diseases, immunological deficits and impairments that limit physical activity;\n* diagnosis of cancer\n* patients undergoing chemotherapy and\u002For radiotherapy.","14 Years",{"count":235,"type":21},"Celiac disease (CD) is an autoimmune enteropathy triggered by the intake of gluten, characterized by a genetic predisposition. Although, CD is often associated with malabsorption symptoms, a growing number of affected subjects are overweight or frankly obese. One of the conditions that is most frequently detected in pauci\u002Fasymptomatic subjects is an increase in transaminases, which often regresses completely after the start of GFD.\n\nMore recently, a specific liver disorder has shown a certain relevance in adult patients suffering from CD, so much so that the European Society for the Study of Coeliac Disease (ESsCD) has cited it among the possible comorbidities which should be screened in CD subjects: Non-Alcoholic Fatty Liver Disease (NAFLD).\n\nIn adults, a non-random association between CD and NAFLD has been demonstrated, showing a CD prevalence rate of 2-14% among patients with NAFLD. Few studies have focused on this same aspect in pediatric age, reporting contrasting data.\n\nSeveral factors have been advocated as putative responsible of association between CD and NAFLD: dietary imbalances, intestinal mucosa permeability impairment, alterations of the intestinal microbiota.\n\nThe objectives of this study are:\n\n1. define, retrospectively, the prevalence of NAFLD in a pediatric population affected by CD and study its possible association with GFD.\n2. define the possible role of the intestinal permeability alteration and\u002For the intestinal mucosa damage and\u002For the proinflammatory status in the development of NAFLD in children affected by CD.",[551,38],"Celiac Disease in Children",[553,38,554,555,556],"Celiac Disease","Intestinal Permeability","Inflammatory Cytokines","Children","2026-04-27",{"date":512,"type":66},{"date":560,"type":21},"2027-11-01",{"date":562,"type":21},"2028-09-30",{"name":564,"class":73},"University of Palermo",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":574,"conditions":575,"keywords":579,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":74},"100487136","chronic-hepatopathies-associated-with-alcohol-consumption-and-metabolic-syndrome-100487136","NCT05623150","CHronic Hepatopathies Associated With ALcohol Consumption aNd metAbolic Syndrome","CHALNA2","Inclusion Criteria:\n\n* Criteria common to all patients:\n\n  1. Affiliation to French social security.\n  2. Male or female ≥ 18 years of age\n  3. Patients able to receive and understand information about the research and to give written informed consent duly signed by the patient and the investigator (at the latest on the day of inclusion and before any examination necessary for the research).\n* Patients in the NAFLD group with HCC:\n\n  1. Alcohol consumption ≤ 30 g pure alcohol\u002Fd (or 210 g pure alcohol\u002Fweek) for men and ≤ 20 g pure alcohol\u002Fd (140 g pure alcohol\u002Fweek) for women.\n  2. Decision, less than 3 months old, of liver biopsy of the suspected HCC nodule and non-tumour liver tissue performed as a clinical routine.\n  3. No systemic treatment for HCC within 6 months prior to inclusion.\n* Patients in the NAFLD group without HCC:\n\n  1. Alcohol consumption ≤ 30 g pure alcohol\u002Fd (or 210 g pure alcohol\u002Fweek) for men and ≤ 20 g pure alcohol\u002Fd (140 g pure alcohol\u002Fweek) for women.\n  2. Decision of less than 3 months of a liver biopsy performed as a clinical routine. Biopsy will be motivated by liver function disturbance(s) and\u002For ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and\u002For fibrosis in some of these patients.\n* Patients in the alcohol-related liver disease group with HCC:\n\n  1. Alcohol consumption \\> 30 g pure alcohol\u002Fd (or 210 g pure alcohol\u002Fweek) for men and \\> 20 g pure alcohol\u002Fd (140 g pure alcohol\u002Fweek) or binge drinking\n  2. Decision within 3 months of liver biopsy of suspected HCC nodule and non-tumour liver tissue performed as part of clinical routine\n  3. No systemic treatment for HCC within 6 months prior to inclusion.\n* Patients in the alcohol-related liver disease group without HCC:\n\n  1. Alcohol consumption \\> 30 g pure alcohol\u002Fd (or 210 g pure alcohol\u002Fweek) for men and \\> 20 g pure alcohol\u002Fd (140 g pure alcohol\u002Fweek) or binge drinking\n  2. Decision of less than 3 months for a liver biopsy to be performed as a clinical routine. Biopsy will be motivated by liver balance disturbance(s) and\u002For ultrasound steatosis given the lack of validated non-invasive tests or the lack of accuracy (grey areas) of available non-invasive tests for the diagnosis of necro-inflammation and\u002For fibrosis in some of these patients.\n\nExclusion Criteria:\n\n1. Positive HIV serology\n2. Patients with detectable hepatitis C viral load\n3. Presence of Hbs antigen\n4. History of autoimmune hepatitis type 1 or 2, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, genetic haemochromatosis homozygous, alpha1 anti-trypsin deficiency\n5. Long-term use of methotrexate, corticosteroids, anti-Tumor Necrosis Factor cyclosporine, tacrolimus\n6. History of solid organ transplantation or bone marrow transplantation\n7. Cancerous disease in the process of being treated, except for skin cancer (excluding melanoma)\n8. Patients under legal protection or unable to express their consent,\n9. Pregnant or breastfeeding women",{"count":573,"type":21},710,"The aim is to determine the metabolic factors, host immune factors, and medical imaging data associated with the development of HepatoCellular Carcinoma (HCC) in patients with alcohol-related liver disease or dysmetabolic steatosis\u002FNon-Alcoholic SteatoHepatitis.\n\nThe investigators will include patients with and without cirrhosis in order to identify early molecular mechanisms involved in the development of HCC especially in non-cirrhotic patients.",[38,121,576,577,578],"Alcohol-related Liver Disease","Cirrhosis, Liver","Hepatocellular Carcinoma",[38,121,576,577,578],"2026-04-13",{"date":582,"type":66},"2026-04-16",{"date":584,"type":66},"2022-12-06",{"date":586,"type":21},"2032-03",{"name":588,"class":589},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":17,"sex":18,"minAge":82,"maxAge":144,"enrollmentInfo":596,"targetDuration":4,"studyType":86,"phases":597,"briefSummary":598,"conditions":599,"keywords":601,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":611,"locationsCount":74},"100543301","phase-1-human-models-of-selective-insulin-resistance-alpelisib-part-i-100543301","NCT06354088","Human Models of Selective Insulin Resistance: Alpelisib, Part I","Inclusion Criteria:\n\n1. Adults aged 18-70 years\n2. Able to understand written and spoken English and\u002For Spanish\n3. Body mass index of:\n\n   * For Group IS: BMI 18-25 kg\u002Fm2\n   * For Group IR: BMI 30-45 kg\u002Fm2\n4. Evidence of insulin sensitivity or insulin resistance:\n\n   * Insulin sensitive (for Group IS) defined as all of the following: (1) Fasting serum insulin ≤ 10 µIU\u002FmL, (2) Absence of dysglycemia (fasting plasma glucose \\\u003C 100 mg\u002FdL and hemoglobin A1c \\\u003C 5.7%), (3) Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score \\\u003C 2.5, and (4) Fibrosis-4 (FIB-4) score \\\u003C 1.3\n   * Insulin resistant (for Group IR) defined as fasting serum insulin ≥ 13 µIU\u002FmL plus at least one of the following: (1) Presence of prediabetic state (fasting plasma glucose 100-125 mg\u002FdL and\u002For hemoglobin A1c 5.7-6.4%), and\u002For HOMA-IR ≥ 2.5\n\nExclusion Criteria:\n\n1. Inability to provide informed consent in English or Spanish\n2. Concerns arising at screening visit:\n\n   * Abnormal vital signs: (1) Systolic blood pressure \\\u003C 90 mm Hg or \\> 160 mm Hg and\u002For (2) Diastolic blood pressure \\\u003C 55 mm Hg or \\> 100 mm Hg and\u002For (3) Abnormal resting heart rate \\\u003C 55 bpm (except at PI's discretion) or ≥ 110 bpm\n   * Abnormal screening serum electrolytes judged by the PI to be potentially clinically significant, including liver function abnormalities (either of the following): (1) Transaminases (AST or ALT) \\> 3.0 x the upper limit of normal and\u002For (2) Total bilirubin \\> 1.25 x the upper limit of normal\n   * Laboratory evidence of diabetes mellitus: (1) Hemoglobin A1c ≥ 6.5%, and\u002For (2) Fasting plasma glucose ≥ 126 mg\u002FdL\n3. Reproductive concerns i. Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential ii. Women currently pregnant iii. Women currently breastfeeding\n4. Concerns related to glucose metabolism\n\n   * History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes)\n   * History of gestational diabetes mellitus within the previous 5 years\n   * Use of most antidiabetic medications (other than metformin) within the 90 days prior to screening: thiazolidinediones, sulfonylureas, meglitinides, dipeptidyl peptidase-4 (DPP4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose cotransporter-2 (SGLT2) inhibitors, amylin mimetics, acarbose, insulin iv. Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n5. Concerns related to lipid metabolism\n\n   * Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia in the participant or a first-degree relative\n   * Use of certain lipid-lowering drugs within 14 d prior to screening visit: fibrates (e.g., fenofibrate, gemfibrozil), prescription-strength omega-3 fatty acids (e.g., icosapent ethyl), high-dose niacin (\\>100 mg daily)\n6. Known, documented history, at the time of screening, of any of the following medical conditions:\n\n   * Significant cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)\n   * Severe liver disease, including advanced fibrosis (e.g., fibrosis score F3-F4 by vibration-controlled transient elastography) and cirrhosis\n   * Psychiatric diseases causing functional impairment that: (1) Are or have been decompensated within 1 year of screening, and\u002For (2) Require use of anti-dopaminergic antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine)\n   * Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n   * Bleeding disorders, including due to anticoagulation, or significant anemia (see above)\n   * Active malignancy, or hormonally active benign neoplasm, except allowances for non-melanoma skin cancer and differentiated thyroid cancer (Stage I only)\n7. Clinical concern for increased risk of volume overload, including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n8. Use of oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 30 days; topical and inhaled formulations are permitted\n9. History of certain weight-loss (bariatric) surgery, including:\n\n   * Roux-en-Y gastric bypass\n   * Biliopancreatic diversion\n   * Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months\n10. Clinical concern for alcohol overuse based on chart review and\u002For by recruit's report of more than 14 standard drinks per week for males or more than 7 standard drinks per week for females\n11. Regular use of tobacco, either daily or an average of at least 1 cigarette per day, and\u002For nicotine vaping more than 1 day per week\n12. Clinical concern for use of illicit drugs other than marijuana or lawfully prescribed medications based on recruit's report, chart review, and point-of-care urine drug test at screening\n13. History of or ongoing febrile illness within 30 days of screening\n14. Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n15. Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations (including soy, cow dairy, or gluten), other biologics, venipuncture materials, plastics, adhesive or silicone, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n16. Dietary restrictions (e.g., vegan, kosher, halal) on gelatin present in overencapsulation\n17. Concurrent enrollment in another clinical study of any investigational drug\u002Fbiologic therapy within 6 months prior to screening or within 5 half-lives of an investigational agent or biologic, whichever is longer.\n\n    * Prior participation in other studies led by Dr. Cook (PI) is excluded from this prohibition according to his medical\u002Fscientific judgment.",{"count":423,"type":21},[325],"The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive \"tracer\" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.\n\nThe objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.",[329,330,600,38],"Overweight and Obesity",[97,328,38,602,603,604],"Hepatic steatosis","De novo lipogenesis","Glucose production","2026-04-06",{"date":607,"type":66},"2026-04-09",{"date":609,"type":66},"2024-04-24",{"date":518,"type":21},{"name":340,"class":73},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":86,"phases":621,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":280,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":631,"leadSponsor":633,"locationsCount":635},"100631213","impact-of-artificial-intelligence-algorithm-driven-versus-standard-lifestyle-intervention-in-non-alcoholic-fatty-liver-disease---a-multicenter-randomized-open-label-controlled-trial-100631213","NCT07497750","Impact of Artificial Intelligence Algorithm-driven Versus Standard Lifestyle Intervention in Non-Alcoholic Fatty Liver Disease - A Multicenter, Randomized, Open-label, Controlled Trial","S@VE-LIVER","Inclusion criteria:\n\n* Male or female aged 18 years or older;\n* Body mass index (BMI) between 25.0 and 45.0 kg\u002Fm² (including limit values);\n* Stable body weight for at least 3 months prior to inclusion (weight gain or loss \\\u003C 3%);\n* Medical history supporting the diagnosis of Non-alcoholic Fatty Liver Disease diagnosis (including available biology, imaging and\u002For histology data from the medical file);\n* Presence of significant liver steatosis attested by Fibroscan® Controlled Attenuation Parameter (CAP) value \\> 300 dB\u002Fm;\n* Absence of severe fibrosis attested by Fibroscan Vibration controlled Transient Elastography (VTE) value \\\u003C 8.5 kPa (corresponding to stage F0-F2);\n* Availability of a WIFI internet connection at patient home\n* Able to provide written informed consent and agree to comply with the study protocol;\n* Covered by a French National Health Insurance plan\n\nExclusion criteria:\n\n* History of liver disease other than NAFLD;\n* History of cirrhosis and\u002For liver cancer;\n* History of alcohol abuse and\u002For significant consumption in the past six months;\n* AST or ALT \\> 5 times the upper limit of normal;\n* History of diabetes mellitus with another etiological diagnosis than type 2 diabetes;\n* Type 2 diabetes with HbA1c ≥ 8% and\u002For requiring insulin therapy;\n* Type 2 diabetes with significant change in oral antidiabetic therapy in the last 3 months;\n* Type 2 diabetes with significant change in GLP-1RA therapy in the last 6 months;\n* History of bariatric surgery or bariatric surgery planned during the study period;\n* Use of medications affecting weight or energy intake\u002Fexpenditure in the last 3 months, including weight loss medications, corticosteroids, antipsychotic drugs or other medications according to investigator's opinion;\n* History of hypothyroidism with abnormal TSH value and\u002For adjustment of hormonal therapy in the last 3 months;\n* Severe chronic renal failure (eGFR\\\u003C30 ml\u002Fmin\u002F1.73 m2);\n* Severe cardiovascular disease, heart failure or any other medical condition not compatible with participation in the study according to investigator's opinion;\n* History of malignant tumor, unless considered to be in remission for 5 years or more;\n* Pregnant women or women planning to become pregnant;\n* Contra-indication to MRI examination or condition not allowing MRI to be carried out;\n* Persons participating in another research including a period of exclusion still in course\n* Patients who are unwilling or unable to give informed consent\n* Persons placed under judicial protection",{"count":620,"type":21},216,[351],"Now considered as a major public health challenge, non-alcoholic fatty liver disease (NAFLD) is rapidly rising as a major cause of end-stage liver disease. NAFLD encompasses a spectrum of conditions, ranging from steatosis, defined by excessive liver fat deposition, to Non-Alcoholic Steato-Hepatitis (NASH), an inflammatory and fibrotic stage which promotes severe complications such as cirrhosis and hepatocellular carcinoma.\n\nAlthough several drugs are currently under clinical development to limit inflammation and fibrosis processes, clinical evidence and previous studies support the role of lifestyle intervention (dietary modifications and exercise) as a cornerstone for NAFLD management. Indeed, insulin resistance is a key pathogenic trigger of the disease and patients with NAFLD are frequently obese and\u002For have type 2 diabetes. Therefore, lifestyle intervention should be implemented as early as possible in the disease course, from the first evidence of steatosis.\n\nDesigning lifestyle interventions with good efficacy and sustainability for patients with NAFLD, and with acceptable medico-economic costs, is thus urgently needed. However, the optimal way to implement such lifestyle modification programs remains unclear. Technological innovations in health-monitoring devices recently made it possible to propose disruptive lifestyle interventions, but the value of such strategies has not been addressed in NAFLD so far.",[624],"Non Alcoholic Fatty Liver Disease",[626,38],"artificial intelligence","2026-03-23",{"date":629,"type":66},"2026-03-27",{"date":516,"type":21},{"date":632,"type":21},"2030-12-31",{"name":634,"class":73},"University Hospital, Toulouse",9,{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":641,"acronym":642,"eligibilityCriteria":643,"healthyVolunteers":17,"sex":18,"minAge":644,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":647,"conditions":648,"keywords":652,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":74},"100555982","liver-gut-axis-study-through-identification-of-liver-disease-specific-microbiome-100555982","NCT06519162","Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome","Exploration of Liver-gut Axis Through Identification of Liver Disease-specific Microbiome","LGAS","Inclusion Criteria:\n\n* Adults aged 19 years and older diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, who have consented to participate in this study at Chungnam National University Hospital.\n* Adults aged 19 years and older, who are cohabitants of patients diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, and have consented to participate in this study at Chungnam National University Hospital.\n\nB. Exclusion\n\nExclusion Criteria:\n\n* Individuals under the age of 19.\n* Patients or guardians who do not consent to participate in the study","19 Years",{"count":646,"type":21},3000,"In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.",[273,649,38,650,651],"Primary Sclerosing Cholangitis","Liver Abscess","Primary Biliary Cirrhosis",[354,653,654],"Microbiota","Immune System","2026-03-19",{"date":657,"type":66},"2026-03-20",{"date":659,"type":66},"2024-07-08",{"date":661,"type":21},"2029-07-08",{"name":663,"class":73},"Chungnam National University Hospital",{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":671,"targetDuration":673,"studyType":23,"phases":4,"briefSummary":674,"conditions":675,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":106},"100495247","endoscopic-ultrasound-shear-wave-elastography-in-patients-with-non-alcoholic-fatty-liver-disease-100495247","NCT05728697","Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease","Endoscopic Ultrasound Shear Wave Elastography: A Novel Tool for Fibrosis Screening in Patient With Elevated Body Mass Index and Suspected Non-Alcoholic Fatty Liver Disease or Steatohepatitis","Inclusion Criteria:\n\n* Adults 18 years or older\n* Planned for clinically indicated endoscopic ultrasound with plan for follow up liver biopsy\n* Suspected or confirmed non alcoholic fatty liver disease prior to procedure\n* Body mass index \\>=25\n\nExclusion Criteria:\n\n* Inadequate liver biopsy sample",{"count":672,"type":21},150,"1 Week","The goal of this observation study is to assess whether endoscopic ultrasound shear wave elastography (EUS-SWE) may be a useful tool for liver fibrosis screening in patients with elevated body mass index and non alcoholic fatty liver disease as compared to other non-invasive screening modalities, which have traditionally had less accurate results in this population.\n\nThe main questions it aims to answer are:\n\n* Determine accuracy of EUS-SWE for liver fibrosis screening compared to other non-invasive scoring systems, such as the FIB-4 score and Fibroscan in patients with elevated body mass index\n* Establish optimal stiffness (kPa) cutoffs for liver fibrosis grading for EUS-SWE for this patient population in reference to the gold standard liver biopsy, as no standard cutoffs currently exist.\n\nParticipants will undergo routine endoscopic ultrasound as part of their standard clinical care and indication. Participants are consented for the procedure and undergoing the shear wave elastography. In addition to their standard ultrasound test, it takes on average an extra 2-3 minutes to perform the shear wave elastography. The procedure itself adds no additional risk to the patient and does not expose them to radiation.",[38,365,148],"2026-02-26",{"date":678,"type":66},"2026-03-02",{"date":680,"type":66},"2021-06-01",{"date":682,"type":21},"2027-01",{"name":684,"class":73},"Brigham and Women's Hospital"]