[{"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":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,71,0,25,[9,48,103,133,161,192,211,232,256,278,297,324,351,373,396,420,441,468,491,519,540,559,597,627,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100353606","phase-2-non-alcoholic-fatty-liver-disease-the-hepatic-response-to-oral-glucose-and-the-effect-of-semaglutide-nafld-heroes-100353606",false,"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.",true,"ALL","18 Years","100 Years",{"count":22,"type":23},104,"ESTIMATED","INTERVENTIONAL",[26],"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...",[29,30],"Non-Alcoholic Steatohepatitis","Non-Alcoholic Fatty Liver Disease",[32,33,34],"Non-Alcoholic Steatohepatitis (NASH)","Steatosis","Caloric Load","RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2019-07-24",{"date":43,"type":23},"2026-10-02",{"name":45,"class":46},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":79,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"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":56,"type":23},132,[58],"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.",[61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,30,77,78],"Obesity","Liver Diseases","Liver Fibrosis","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[80,81,82,83,84,85,86,87,88,89,90,91,32],"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)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","2026-06-23",{"date":94,"type":39},"2026-06-25",{"date":96,"type":39},"2025-06-24",{"date":98,"type":23},"2028-06",{"name":100,"class":101},"Pichamol Jirapinyo, MD, MPH","OTHER",2,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":129,"leadSponsor":131,"locationsCount":47},"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":112,"type":23},24,"OBSERVATIONAL","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",[116,30],"Autoimmune Hepatitis",[118,119,120,121,122,123],"autoimmune hepatitis","lipidomic analysis","extracellular vesicles","fatty acids","biomarkers","NAFLD","NOT_YET_RECRUITING","2026-06-15",{"date":127,"type":39},"2026-06-16",{"date":38,"type":23},{"date":130,"type":23},"2028-07-01",{"name":132,"class":101},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis",{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":18,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":47},"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":143,"type":23},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.",[30,146],"Low Birth Weight",[148,149,150,151],"Metabolic disease","Adipose tissue biology","Liver fat","Non-alcoholic fatty liver disease","2026-06-09",{"date":154,"type":39},"2026-06-11",{"date":156,"type":39},"2023-12-14",{"date":158,"type":23},"2026-12",{"name":160,"class":101},"Steno Diabetes Center Copenhagen",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":191},"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.","70 Years",{"count":170,"type":23},32,[172],"PHASE1","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.",[175],"Non-alcoholic Fatty Liver Disease",[177,178,179,180,66,181],"efimosfermin alfa","Alcohol","Hepatic Impairment","Steatotic liver disease","Pharmacokinetics","2026-06-05",{"date":152,"type":39},{"date":185,"type":39},"2026-03-13",{"date":187,"type":23},"2027-10-13",{"name":189,"class":190},"GlaxoSmithKline","INDUSTRY",3,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":47},"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":200,"type":23},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",[30],"2026-06-03",{"date":182,"type":39},{"date":206,"type":39},"2019-03-05",{"date":208,"type":23},"2026-07-31",{"name":210,"class":101},"Queen Mary University of London",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":230,"locationsCount":102},"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","75 Years",{"count":220,"type":23},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.",[223,30,78],"Non-alcoholic Fatty Liver","2026-05-22",{"date":226,"type":39},"2026-05-27",{"date":228,"type":39},"2025-02-01",{"date":158,"type":23},{"name":231,"class":190},"Roche Diagnostics GmbH",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":238,"minAge":239,"maxAge":218,"enrollmentInfo":240,"targetDuration":4,"studyType":24,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":47},"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","65 Years",{"count":241,"type":23},40,[58],"additive efficacy of physical activity program in hypthyroidism in elder females with glaucoma and fatty liver issues was not investigated",[245,30,246],"Subclinical hypothyroïdism","Primary Open Angle Glaucoma","2026-05-14",{"date":249,"type":39},"2026-05-20",{"date":251,"type":39},"2026-03-15",{"date":253,"type":23},"2026-12-15",{"name":255,"class":101},"Cairo University",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":239,"enrollmentInfo":263,"targetDuration":4,"studyType":24,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"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":264,"type":23},30,[58],"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).",[268,61,175],"Type 2 Diabetes","2026-05-01",{"date":271,"type":39},"2026-05-06",{"date":273,"type":23},"2026-06-01",{"date":275,"type":23},"2026-12-31",{"name":277,"class":101},"Shanghai Jiao Tong University School of Medicine",{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":239,"enrollmentInfo":284,"targetDuration":4,"studyType":24,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":47},"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":285,"type":23},46,[26],"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.",[30],{"date":290,"type":39},"2026-05-04",{"date":292,"type":39},"2025-03-01",{"date":294,"type":23},"2027-04-20",{"name":296,"class":101},"Tanta University",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":304,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":102},"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.","1 Year","14 Years",{"count":307,"type":23},91,"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.",[310,30],"Celiac Disease in Children",[312,30,313,314,315],"Celiac Disease","Intestinal Permeability","Inflammatory Cytokines","Children","2026-04-27",{"date":269,"type":39},{"date":319,"type":23},"2027-11-01",{"date":321,"type":23},"2028-09-30",{"name":323,"class":101},"University of Palermo",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":218,"enrollmentInfo":332,"targetDuration":4,"studyType":24,"phases":334,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":350},"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":333,"type":23},1250,[335],"PHASE3","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.",[175],[66,177,339,340,341,330],"Safety","Tolerability","Phase 3","2026-04-13",{"date":344,"type":39},"2026-04-16",{"date":346,"type":39},"2025-12-12",{"date":348,"type":23},"2028-03-24",{"name":189,"class":190},43,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":218,"enrollmentInfo":359,"targetDuration":4,"studyType":24,"phases":361,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":372},"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":360,"type":23},1200,[335],"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.",[175],[365,66,175,357],"Efimosfermin Alfa",{"date":344,"type":39},{"date":368,"type":39},"2025-10-24",{"date":370,"type":23},"2031-12-12",{"name":189,"class":190},49,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":382,"conditions":383,"keywords":387,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":47},"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":381,"type":23},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.",[30,29,384,385,386],"Alcohol-related Liver Disease","Cirrhosis, Liver","Hepatocellular Carcinoma",[30,29,384,385,386],{"date":344,"type":39},{"date":390,"type":39},"2022-12-06",{"date":392,"type":23},"2032-03",{"name":394,"class":395},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":239,"enrollmentInfo":403,"targetDuration":4,"studyType":24,"phases":404,"briefSummary":405,"conditions":406,"keywords":409,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":47},"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",{"count":7,"type":23},[172],"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.",[407,70,30,408,61],"Hyperinsulinemia","Prediabetic State",[407,70,65,30,410],"Triglycerides","2026-04-06",{"date":413,"type":39},"2026-04-09",{"date":415,"type":23},"2026-05-31",{"date":417,"type":23},"2029-09-30",{"name":419,"class":101},"Columbia University",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":168,"enrollmentInfo":426,"targetDuration":4,"studyType":24,"phases":427,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":440,"locationsCount":47},"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":170,"type":23},[172],"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.",[70,408,430,30],"Overweight and Obesity",[432,407,30,433,434,435],"Insulin resistance","Hepatic steatosis","De novo lipogenesis","Glucose production",{"date":413,"type":39},{"date":438,"type":39},"2024-04-24",{"date":275,"type":23},{"name":419,"class":101},{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":448,"enrollmentInfo":449,"targetDuration":4,"studyType":24,"phases":450,"briefSummary":451,"conditions":452,"keywords":453,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":47},"100618713","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-immunogenicity-of-efimosfermin-alfa-administered-as-a-single-dose-to-healthy-participants-of-chinese-japanese-and-whiteeuropean-ancestry-100618713","NCT07335198","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White\u002FEuropean Ancestry","A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White\u002FEuropean Ancestry","Inclusion Criteria:\n\nParticipants who are generally healthy as determined by medical evaluation\n\n* Body weight at least 50.0 Kilogram (kg) for male participants or at least 45.0 kg for female participants\n* Body mass index (BMI) within the range of 18.0 to 28.0 kilograms per square meter (kg\u002Fm\\^2) (inclusive)\n* Male and female participants\n* Participants of Chinese ancestry are eligible if born in mainland China, Hong Kong, or Taiwan, and have lived outside China, Hong Kong, or Taiwan for less than 10 years at the time of screening.\n* Participants of Japanese ancestry are eligible if born in Japan and Descendant of 2 ethnic Japanese parents and 4 ethnic Japanese grandparents; and. have lived outside Japan for less than 10 years at the time of screening.\n* Participants of White\u002FEuropean ancestry are eligible if self-identified as being of White\u002FEuropean ancestry, (i.e., from the original peoples of Europe) irrespective of current place of residence; and.\n* Descendant of 2 parents and 4 grandparents of White\u002FEuropean ancestry (that is \\[i.e.\\], from the original peoples of Europe) irrespective of place of birth or current place of residence.\n\nExclusion Criteria:\n\n* History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.\n* Current or chronic history of liver or biliary disease with the exception of Gilbert's syndrome or asymptomatic gallstones.\n* History of pancreatic injury, pancreatitis or other pancreatic disease; history of Type one Diabetes Mellitus (T1DM) or positive glutamic acid decarboxylase auto-antibodies, or major Type two Diabetes Mellitus (T2DM) complications including severe gastroparesis and autonomic neuropathy.\n* Abnormal blood pressure (defined as systolic Blood Pressure (BP) more than equal (\\>=)140 millimeters of mercury (mmHg) or diastolic BP \\>=90 mmHg) measured based on the average of triplicate BP readings).\n* History of metabolic bone disorders including osteoporosis, osteopenia, or osteomalacia.\n* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.\n* Alanine transaminase (ALT) more than (\\>)1.5 \\* upper limit of normal (ULN).\n* Total bilirubin \\>1.5 \\* ULN\n* Known bleeding disorder.\n* History of immunodeficiency diseases, including a positive test result for human immunodeficiency virus (HIV).\n* Corrected QT Interval using Fridericia's Formula. (QTcF) \\>=450 millisecond (msec)(male) or \\>=470 msec (female) at Screening Visit based on the average of triplicate ECGs.\n* Use of statins, other lipid lowering medications or hypertension medications unless on a stable dose for at least 3 months.\n* Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever was longer; or longer if required by local regulations.\n* Participants who have received native FGF21 or a FGF21 analog at any time in the past.\n* Intended use of over the counter (OTC) or prescription medication (including herbal medications) within 7 days prior to dosing and for the duration of study participation.\n* Live vaccine within 14 days prior to dosing and non-live vaccines for 7 days prior study dosing.\n* Current enrolment or participation in another clinical trial within the last 30 days before signing consent of current study.\n* Presence of hepatitis B surface antigen (HBsAg) or hepatitis C antibody at screening or within 3 months prior to the first dose of study intervention\n* A positive pre-study drug\u002Falcohol screen","55 Years",{"count":264,"type":23},[172],"This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White\u002FEuropean ancestry.",[175],[454,455,456,457,458,459,181,339],"Efimosfermin alfa","Placebo","First time in Asia","Chinese","Japanese","White\u002FEuropeans","2026-03-24",{"date":462,"type":39},"2026-03-27",{"date":464,"type":39},"2026-03-05",{"date":466,"type":23},"2026-08-17",{"name":189,"class":190},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":24,"phases":477,"briefSummary":478,"conditions":479,"keywords":481,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":486,"leadSponsor":488,"locationsCount":490},"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":476,"type":23},216,[58],"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.",[480],"Non Alcoholic Fatty Liver Disease",[482,30],"artificial intelligence","2026-03-23",{"date":462,"type":39},{"date":273,"type":23},{"date":487,"type":23},"2030-12-31",{"name":489,"class":101},"University Hospital, Toulouse",9,{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":17,"sex":18,"minAge":499,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":502,"conditions":503,"keywords":507,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":47},"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":501,"type":23},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.",[116,504,30,505,506],"Primary Sclerosing Cholangitis","Liver Abscess","Primary Biliary Cirrhosis",[62,508,509],"Microbiota","Immune System","2026-03-19",{"date":512,"type":39},"2026-03-20",{"date":514,"type":39},"2024-07-08",{"date":516,"type":23},"2029-07-08",{"name":518,"class":101},"Chungnam National University Hospital",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":526,"targetDuration":528,"studyType":113,"phases":4,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":102},"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":527,"type":23},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.",[30,78,61],"2026-02-26",{"date":533,"type":39},"2026-03-02",{"date":535,"type":39},"2021-06-01",{"date":537,"type":23},"2027-01",{"name":539,"class":101},"Brigham and Women's Hospital",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":239,"enrollmentInfo":547,"targetDuration":4,"studyType":24,"phases":548,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":557,"locationsCount":47},"100464816","diet-and-meal-timing-in-patients-with-metabolic-dysfunction-associated-steatoic-liver-disease-100464816","NCT05332613","Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease","Diet and Meal Timing in Patients With Metabolic Dysfunction Associated Steatoic Liver Disease: A Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 and \\\u003C 65 years old\n* Must provide signed written informed consent and agree to comply with the study protocol\n* BMI \\>25 kg\u002Fm²\n* Baseline liver fat content of at least 10% as measured by MRI-PDFF\n\nExclusion Criteria:\n\n* Unclear etiology of liver disease\n* Competing etiologies for hepatic steatosis\n* Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:\n* Positive hepatitis B surface antigen\n* Positive hepatitis C virus RNA\n* Suspicion of drug-induced liver disease\n* Alcoholic liver disease\n* Autoimmune hepatitis\n* Wilson's disease\n* Hemochromatosis\n* Primary biliary cholangitis or primary sclerosing cholangitis\n* Known or suspected hepatocellular carcinoma\n* Current or recent history (\\\u003C5 years) of significant alcohol consumption. For men, significant consumption is defined as \\>30g of alcohol per day. For women, it is defined as \\>20g of alcohol per day.\n* Compensated and decompensated cirrhosis (clinical and\u002For histologic evidence of cirrhosis). NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system are excluded.\n* Reduction in weight by ≥ 5% within the prior 90 days\n* Current fasting for ≥ 12 hours per day on the majority of days each week\n* Pregnant females\n* Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain\n* Inability to perform MRI-PDFF and\u002For study as defined below\n* Inability to medically perform prolonged fasting (i.e. insulin regimen)",{"count":241,"type":23},[58],"This study will assess the impact of time-restricted eating (8 hours of eating each day) with standard of care lifestyle recommendations (hypocaloric, Mediterranean diet and 30 minutes of exercise on at least 5 days\u002Fweek) on the degree of fat in the liver as measured by magnetic resonance imaging.",[30],"2026-02-25",{"date":553,"type":39},"2026-02-27",{"date":555,"type":39},"2022-04-27",{"date":487,"type":23},{"name":558,"class":101},"Weill Medical College of Cornell University",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":239,"enrollmentInfo":567,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":569,"conditions":570,"keywords":578,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":47},"100517290","comorbidities-resolution-after-mgb-surgery-and-change-in-body-composition-100517290","NCT06015620","Comorbidities Resolution After MGB Surgery and Change in Body Composition","CoMOrbidities Resolution After Mini-GAstric Bypass Surgery for Morbid Obesity and Change in BOdy Composition: A Prospective Cohort Study (MOGAMBO Study)","MOGAMBO","Inclusion Criteria:\n\n* All patients undergoing laparoscopic MGB surgery for morbid obesity and it's associated comorbidities\n\nExclusion Criteria:\n\n* Patients not giving consent for the study\n* All patients who were undergoing a redo-procedure for recurrence were excluded from the study",{"count":568,"type":23},35,"This observational study aims to learn about the correlation between the improving comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in body composition in morbidly obese patients. The main questions it aims to answer are:\n\nTo study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition.\n\nOther objectives are:\n\n* Changes in the parameters of the metabolic syndrome after surgery\n* Changes in the cardiovascular risk biomarkers after metabolic surgery\n* Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits.\n\nType of Study: An observational study in which participants with morbid obesity will undergo mini-gastric bypass surgery as per routine protocol. No separate experimental interventions will be done in the study for the participants.",[571,572,573,574,575,576,30,577],"Morbid Obesity","Type2diabetes","Sleep Apnea","Hypothyroidism","Hypertension","Lipid Disorder","Chronic Venous Hypertension With Ulcer",[579,580,581,582,583,584,585,586,587],"morbid obesity","OSA","mini gastric bypass","metabolic surgery","polysomnography","metabolic syndrome","DEXA scan","bioelectrical impedance","body composition","2026-02-16",{"date":590,"type":39},"2026-02-18",{"date":592,"type":39},"2023-09-01",{"date":594,"type":23},"2027-03-30",{"name":596,"class":101},"All India Institute of Medical Sciences, Bhubaneswar",{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":606,"conditions":607,"keywords":613,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":47},"100415541","constitution-of-a-biological-collection-to-establish-preclinical-translational-models-for-the-study-of-tumors-and-chronic-liver-diseases-100415541","NCT04690972","\"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases\".","LivMOD","Inclusion Criteria:\n\n1. Patients\n\n   * diagnosed with chronic liver disease (viral or not)\n   * diagnosed with at least one liver nodule for which a biopsy is planned as part of the care\n   * for hepatobiliary surgery planned as part of care\n   * for locoregional treatment for HCC is indicated\n2. Patients able to receive and understand information relating to the study and give their written informed consent\n3. Patients affiliated to the French social security system\n\nExclusion Criteria:\n\n1. Minor patients\n2. Patients under legal protection,\n3. Patients subject to legal protection or unable to express their consent,\n4. Patients in a situation of social fragility,\n5. Pregnant or breastfeeding woman,\n6. No signing of informed consent.",{"count":605,"type":23},800,"Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies.",[608,609,30,29,610,611,612],"Chronic Liver Disease and Cirrhosis","Liver Cancer","Viral Hepatitis B","Viral Hepatitis C","Viral Hepatitis D",[614,615,616,617,618],"Liver disease","Ex vivo models","Single cell","Biomarkers","Spheroïds","2026-02-10",{"date":621,"type":39},"2026-02-12",{"date":623,"type":39},"2021-01-14",{"date":625,"type":23},"2029-09-02",{"name":394,"class":395},{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":239,"enrollmentInfo":634,"targetDuration":4,"studyType":24,"phases":636,"briefSummary":638,"conditions":639,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":47},"100624284","early-phase-1-a-randomized-double-blind-single-center-phase-iiia-study-of-xtyw007-tablets-in-subjects-100624284","NCT07407634","A Randomized, Double-blind, Single-center Phase I\u002FIIa Study of XTYW007 Tablets in Subjects.","Evaluation of XTYW007 in Healthy Subjects and Healthy Subjects With Elevated LDL-C:A Randomized, Double-Blind, Single-Center Phase I\u002FIIa Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect Following Single and Multiple Doses","Inclusion Criteria:\n\n1. Subjects voluntarily sign the informed consent before the trial, and fully understand the content, process and possible adverse effects of the trial;\n2. They are able to complete the study according to the requirements of the trial protocol;\n3. Subjects (including partners) are willing to have no pregnancy plan and voluntarily use effective contraceptive measures within 6 months from screening to the last dose of study drug;\n4. Male and female subjects between the ages of 18 and 65 (including borderline values);\n5. Male subjects weighing not less than 50 kg and female subjects weighing not less than 45 kg. Body mass index (BMI) = weight (kg)\u002F height 2 (m2), BMI within the range of 18-28 kg\u002Fm2 (including the threshold value);\n6. During screening, for single-dose studies, fasting low-density lipoprotein cholesterol (LDL-C): 80 mg\u002FdL \\\u003C LDL-C \\\u003C 120 mg\u002FdL (2.06 mmol\u002FL \\~ 3.1 mmol\u002FL); for multiple-dose studies, fasting low-density lipoprotein cholesterol (LDL-C) \\> 110 mg\u002FdL (2.85 mmol\u002FL);\n7. Physical examination and vital signs are normal or abnormal without clinical significance.\n\nExclusion Criteria:\n\n1. Individuals with allergic constitution (allergic to multiple drugs and foods) or intolerance to β-blockers;\n2. History of thyroid-related diseases and\u002For thyroid function abnormalities during the screening phase that are clinically significant;\n3. Individuals who smoked more than 5 cigarettes per day in the 3 months prior to the trial;\n4. History of drug abuse and\u002For alcoholism (consuming 14 units of alcohol per week: 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine);\n5. Blood donation or significant blood loss (\\>450 mL) within 3 months prior to taking the study drug;\n6. Use of any prescription drugs, over-the-counter drugs, vitamins, herbal products, or alcohol within 14 days before taking the study drug;\n7. Consumption of special foods (such as grapefruit, mango, dragon fruit, grape juice, orange juice, etc., rich in flavonoids or coumarins) within 2 weeks before taking the study drug, or engaging in intense exercise, or other factors affecting drug absorption, distribution, metabolism, or excretion;\n8. Significant changes in diet or exercise habits recently;\n9. Use of the study drug or participation in a drug clinical trial within 3 months before taking the study drug;\n10. Difficulty swallowing or any gastrointestinal diseases affecting drug absorption within 6 months prior to the study;\n11. Any disease that increases bleeding risk, such as hemorrhoids, acute gastritis, or gastroduodenal ulcer;\n12. Clinically significant ECG abnormalities; QTcF \\> 470 ms (QTcF = QT\u002F(RR)\\^0.33);\n13. Female subjects who are breastfeeding during the screening or trial phase, planning pregnancy in the near future, or have positive serum pregnancy results;\n14. Abnormal clinical laboratory test results with clinical significance, or other clinical findings within 12 months prior to screening that are clinically significant, including but not limited to diseases of the gastrointestinal tract, kidney, liver, nervous system, hematopoietic system, endocrine system, tumors, lungs, immune system, mental health, or cardiovascular and cerebrovascular systems;\n15. Any positive result for hepatitis B surface antigen, hepatitis C antibody\u002Fcore antigen, HIV antigen\u002Fantibody, or syphilis treponema antibody during screening;\n16. Occurrence of acute illness or concomitant medication use from the screening phase to the start of study medication;\n17. Consumption of chocolate, any caffeine-containing or xanthine-containing foods or beverages within 24 hours before taking the study drug;\n18. Serum creatinine clearance ≤ 70 mL\u002Fmin \\[calculation formula: Ccr: (140 - age) × weight (kg) \u002F (0.818 × Scr) (μmol\u002FL), ×0.85 for females\\];\n19. Subjects with special dietary requirements who cannot consume the complete study meal or who do not agree to adhere to water intake regimen and position restrictions during the trial;\n20. Subjects whom the investigator considers to have other factors that make them unsuitable for participation in this trial.",{"count":635,"type":23},94,[637],"EARLY_PHASE1","Aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of XTYW007 in healthy subjects and healthy subjects with elevated LDL-C, as well as studying the effects of food on the pharmacokinetics and metabolic transformation of XTYW007, and preliminarily assessing the pharmacodynamics of XTYW007.",[30],"2026-02-09",{"date":621,"type":39},{"date":643,"type":23},"2026-03-25",{"date":645,"type":23},"2027-05-27",{"name":647,"class":101},"Xi'an Xintong Pharmaceutical Research Co.,Ltd.",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":652,"acronym":653,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":656,"conditions":657,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":47},"100413654","integrated-diagnostics-for-early-diagnosis-of-liver-disease-100413654","NCT04666402","Integrated Diagnostics for Early Diagnosis of Liver Disease","ID LIVER","Inclusion Criteria:\n\n* All patients referred to Community Liver Assessment Clinic.\n* Male or female \\> 18 years of age.\n* Females will be non-pregnant and non-lactating.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnancy\u002Fbreast-feeding. Women of childbearing potential (not \\>2 years post- menopausal and\u002For not surgically sterilised) must have a negative blood serum pregnancy test.\n* Isolated bilirubinaemia.\n* Known pre-existing liver disease.\n* Acutely unwell.\n* Suspected malignancy.",{"count":360,"type":23},"This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.",[30,78,658,659],"Alcoholic Liver Disease","Liver Fibroses","2026-02-05",{"date":640,"type":39},{"date":663,"type":39},"2020-10-21",{"date":665,"type":23},"2027-03-31",{"name":667,"class":395},"Manchester University NHS Foundation Trust"]