[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-dysfunction-associated-steatohepatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-dysfunction-associated-steatohepatitis":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,40,83,113,142,164,189,222,248,271,291,339,364,384,410],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100564690","liverage---cirrhosis-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-cirrhosis-100564690",false,"NCT06632457","LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Cirrhosis","A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction Associated Steatohepatitis (NASH\u002FMASH) Cirrhosis","Inclusion criteria:\n\n1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \\>18 years\n2. Body mass index (BMI) ≥27 kg\u002Fm2(≥25 kg\u002Fm2 for Asian trial participants)\n3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.\n4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB\u002Fm, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \\\u003C5% or FibroScan® with CAP \\\u003C288 dB\u002Fm is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis\u002Fsteatohepatitis.\n5. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Current or history (\\\u003C5 years) of significant alcohol consumption, defined as an average of \\>140 g\u002Fweek in female patients and \\>210 g\u002Fweek in male patients, for a period of \\>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.\n2. Model of end-stage liver Disease (MELD) score \\>12 due to liver disease\n3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:\n\n   * Portal hypertension-related upper gastrointestinal (GI) bleeding\n   * Ascites\n   * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria\n4. Any of the following lab test result at screening\n\n   * Albumin below \\\u003C3.5 g\u002FdL (\\\u003C35.0 g\u002FL)\n   * International normalised ratio (INR) \\>1.3 unless due to therapeutic anticoagulants\n   * Total bilirubin (TBL) \\>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \\>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \\\u003C20% of TBL.\n   * Alkaline phosphatase \\>1.5x ULN\n   * PLT \\\u003C100,000\u002FµL (\\\u003C100 GI\u002FL)\n5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis\n6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection\n7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))\n8. Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\>5x ULN\n9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history\n10. History of liver transplantation or listed for liver transplantation\n11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological\u002Fsurgical procedure for portal hypertension treatment\n12. Further exclusion criteria apply","ALL","18 Years",{"count":19,"type":20},1590,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study is open to adults who are at least 18 years old and have:\n\n* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or\n* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)\n* BMI of 27 kg\u002Fm2 or more or\n* 25 kg\u002Fm2 or more if the participant is Asian.\n\nPeople with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.\n\nParticipants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.",[26],"Metabolic Dysfunction Associated Steatohepatitis","RECRUITING","2026-08-20",{"date":30,"type":31},"2026-08-21","ACTUAL",{"date":33,"type":31},"2024-11-12",{"date":35,"type":20},"2029-06-05",{"name":37,"class":38},"Boehringer Ingelheim","INDUSTRY",445,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100651335","metabolic-flux-analysis-in-metabolic-dysfunction-associated-steatotic-liver-disease-100651335","NCT07760909","Metabolic Flux Analysis in Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Flux Analysis in MASLD","MASLD","Inclusion Criteria:\n\n* Scheduled and clinically cleared for protocol-eligible bariatric surgery at Vanderbilt University Medical Center.\n* BMI ≥40 kg\u002Fm², or BMI \\>35 kg\u002Fm² with at least one obesity-associated comorbidity, such as type 2 diabetes, cardiovascular disease, hypertension, hyperlipidemia, obstructive sleep apnea, MASLD, osteoarthritis, or polycystic ovarian syndrome.\n* Able and willing to complete study procedures, including informed consent, questionnaires, blood draws, MRI\u002FMRE imaging, stable isotope tracer infusion, and research tissue collection during planned bariatric surgery.\n* Able to provide informed consent in English.\n\nExclusion Criteria:\n\n* Contraindication to MRI\u002FMRE, including implanted cardiac defibrillator, pacemaker, or other MRI-incompatible implanted device.\n* Prior gastric or intestinal surgery, pancreatic surgery, or other prior surgery that, in the judgment of the study team or bariatric surgeon, would interfere with study procedures or outcome interpretation.\n* Active cancer or ongoing cancer treatment.\n* Presence or history of HIV infection.\n* Alcohol use above study-defined limits: more than 14 alcoholic drinks per week for men or more than 7 alcoholic drinks per week for women, or illicit drug use that would interfere with safe participation or interpretation of study results.\n* Anemia or other hematologic condition that would increase risk from study blood collection.\n* Abnormal ECG or clinically significant cardiovascular finding that would increase risk from study procedures.\n* Impaired renal function or other clinically significant condition that would increase risk from study participation.\n* Known Wilson's disease, alpha-1 antitrypsin deficiency, hemochromatosis, or other non-MASLD chronic liver disease that would confound interpretation of study outcomes.\n* Any medical, surgical, or safety condition that, in the judgment of the PI, clinical co-investigator, CRC staff, anesthesia team, or bariatric surgeon, would make participation unsafe or interfere with completion of study procedures.","21 Years","70 Years",{"count":51,"type":20},20,[53],"NA","This prospective, single-center pilot study will evaluate metabolic flux dysregulation in adults with obesity and suspected or confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) who are scheduled for protocol-eligible bariatric surgery at Vanderbilt University Medical Center. Participants will undergo research assessments before surgery, during the planned bariatric surgery encounter, and approximately 6 months after surgery. The study uses non-radioactive stable isotope tracer infusions, serial blood sampling, abdominal MRI\u002FMRE, and research tissue specimens collected only during clinically planned bariatric surgery to quantify hepatic and extrahepatic metabolic fluxes. The primary objective is to determine how hepatic citric acid cycle flux and related metabolic pathways change after bariatric surgery and how these metabolic measures relate to liver fat, liver stiffness, and biopsy-graded MASLD\u002FMASH severity.",[56,57,58,59],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","Obesity","Bariatric Surgery",[46,61,62,63,64,65,66,67,68,69,70,71],"MASH","metabolic flux analysis","stable isotope tracer","bariatric surgery","Roux-en-Y gastric bypass","sleeve gastrectomy","liver fat","magnetic resonance elastography","citric acid cycle","gluconeogenesis","free fatty acid turnover","NOT_YET_RECRUITING","2026-08-07",{"date":75,"type":31},"2026-08-12",{"date":77,"type":20},"2026-10-01",{"date":79,"type":20},"2060-01-01",{"name":81,"class":82},"Vanderbilt University Medical Center","OTHER",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100615094","phase-2-a-study-of-a-thyroid-hormone-receptor-beta-isoform-thr-agonist-and-an-semicarbazide-sensitive-amine-oxidase-ssao-inhibitor-alone-and-in-combination-in-adults-with-presumed-metabolic-dysfunction-associated-steatohepatitis-mash-100615094","NCT07288138","A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of a THRβ Agonist (ECC4703), an SSAO Inhibitor (ECC0509), and Their Combination in Adults With Presumed MASH","Inclusion Criteria:\n\n1. Adults between 18 and 75 years of age, inclusive, who can provide written informed consent and comply with study procedures.\n2. Diagnosis of presumed MASH based on: liver biopsy within 180 days prior to screening showing an NAFLD activity score (NAS) of ≥3 and a fibrosis score (F) of F1-3 OR FibroScan® CAP \\>280 dB\u002Fm at screening with presence of metabolic risk factors.\n3. Evidence of hepatic steatosis confirmed by FibroScan® LSM \\> 7 kPa and \\\u003C 20 kPa and MRI-PDFF \\>8% at screening.\n4. BMI \\>25 kg\u002Fm\\^2 to \\\u003C50 kg\u002Fm\\^2 (non-Asian); BMI ≥23.0 to \\\u003C50.0 kg\u002Fm\\^2 (Asian).\n5. ALT ≥60 U\u002FL at the first screening visit and stability of ALT and AST levels during the screening period.\n6. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m\\^2 (Chronic Kidney Disease Epidemiology Collaboration, \\[CKD-EPI\\]).\n7. Stable body weight (no \\>5% change) for at least 6 months prior to screening.\n8. Willing to comply with contraception requirements (as applicable to males and females of childbearing potential).\n9. In the opinion of the investigator, able to participate safely and complete required MRI\u002Fbiomarker assessments.\n\nExclusion Criteria:\n\n1. Chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)\u002FMASH, including alcoholic liver disease, autoimmune hepatitis, cholestatic disease, genetic liver diseases, or drug-induced liver injury.\n2. Presence of cirrhosis on liver histology according to the assessment of the central reader, and\u002For cross-sectional imaging evidence consistent with cirrhosis and\u002For portal hypertension (e.g, nodular liver contour; portosystemic collaterals, ascites, splenomegaly; known presence or history of esophageal varices; and\u002For elastography evidence consistent with cirrhosis).\n3. ALT and\u002For AST \\>5× Upper Limit of Normal (ULN) or ALP \\>2×ULN at screening.\n4. Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders.\n5. Type 1 diabetes, HbA1c \\>9.5%, or unstable type 2 diabetes requiring medication changes within 90 days.\n6. Use of medications that affect liver fat or fibrosis (e.g., Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) not on a stable dose, pioglitazone, obeticholic acid, high-dose vitamin E, hepatotoxic drugs) within protocol-specified washout periods.\n7. Significant alcohol use within 1 year prior to screening.\n8. Recent cardiovascular events, including myocardial infraction (MI), stroke, unstable angina, heart failure (New York heart association \\[NYHA III-IV\\]), or uncontrolled arrhythmia.\n9. Current or recent serious psychiatric illness, including psychosis, active suicidal ideation, or suicide attempt within 5 years.\n10. Pregnancy, breastfeeding, or conditions that increase risk or interfere with study procedures, including MRI contraindications or other investigator-determined safety concerns.","75 Years",{"count":92,"type":20},160,[94],"PHASE2","The primary objective of this trial is to evaluate the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and high dose), and their combination on hepatic fat reduction as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 12.",[97],"Metabolic Dysfunction-associated Steatohepatitis",[99,100,101,102],"Liver Disease","Nonalcoholic Steatohepatitis","ECC0509","ECC4703","2026-08-04",{"date":105,"type":31},"2026-08-06",{"date":107,"type":31},"2025-12-15",{"date":109,"type":20},"2027-09-29",{"name":111,"class":38},"Eccogene",63,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100647219","phase-3-a-study-to-investigate-safety-and-efficacy-of-efimosfermin-compared-with-placebo-in-adult-participants-with-compensated-cirrhosis-due-to-metabolic-dysfunction-associated-steatohepatitis-mash-100647219","NCT07704892","A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 3, Two-part, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis (Stage F4 Fibrosis) Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-2)","NEBULA-2","Inclusion Criteria:\n\n* Participants aged between 18 and 75 years at enrolment.\n* Participants with history or presence of at least two components of metabolic syndrome.\n* Liver biopsy consistent with cirrhosis (fibrosis stage 4).\n\nExclusion Criteria:\n\n* Participants with other chronic liver diseases.\n* Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.\n* Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications.\n* History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.\n* A recent history or planned surgical procedures or medications intended to produce significant weight loss.\n* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \\>= 5 times upper limit normal (ULN).\n* Current or history of excessive alcohol intake",{"count":122,"type":20},380,[23],"This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.",[97],[127,128,129,130,131],"Cirrhosis","Efimosfermin","Fibrosis","Metabolic dysfunction-associated","Steatohepatitis","2026-08-03",{"date":134,"type":31},"2026-08-05",{"date":136,"type":31},"2026-07-22",{"date":138,"type":20},"2033-12-08",{"name":140,"class":38},"GlaxoSmithKline",2,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100645475","phase-3-a-pivotal-clinical-study-to-investigate-the-safety-and-efficacy-of-efimosfermin-compared-with-placebo-in-adult-participants-with-compensated-cirrhosis-due-to-metabolic-dysfunction-associated-steatohepatitis-mash-100645475","NCT07701993","A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)","NEBULA-1","Inclusion Criteria:\n\n* Participants aged between 18 and 75 years at enrollment.\n* Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.\n* Participants with history or presence of at least two components of metabolic syndrome.\n\nExclusion Criteria:\n\n* Participants with other chronic liver diseases.\n* Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.\n* Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes complications.\n* Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.\n* Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.\n* Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>=5 times upper limit normal (ULN).\n* Participants with current or history of excessive alcohol intake.",{"count":151,"type":20},1740,[23],"This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.",[97],[156,130,157,129,127],"Efimosfermin alfa","steatohepatitis",{"date":134,"type":31},{"date":136,"type":31},{"date":161,"type":20},"2033-08-24",{"name":140,"class":38},1,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":171,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100511906","phase-1-a-study-of-ini-822-in-healthy-volunteers-and-participants-with-metabolic-dysfunction-associated-steatohepatitis-mash-or-presumed-mash-100511906","NCT05945537","A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH","A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n1. Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 30 days after their last dose of IP or 5 half-lives, whichever is longer. Females with same-sex partners (abstinent from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day -1. Women not of childbearing potential must be postmenopausal for ≥ 12 months (postmenopausal status is to be confirmed through testing of follicle stimulating hormone \\[FSH\\] levels ≥ 40 IU\u002FL at Screening for amenorrhoeic female participants). Females must not donate ova from the first dose of IP until at least 30 days after the last dose of IP.\n2. Males must be surgically sterile (\\> 30 days since vasectomy \\[documented evidence\\] with no viable sperm), or, if engaged in sexual relations with a WOCBP, they must use a condom and either his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method must be used from Day -1 until at least 30 days after the last dose of IP. Males with same-sex partners (abstinent from penile-vaginal intercourse) or abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least 30 days after the last dose of IP.\n3. Able and willing to attend the necessary visits to the study site.\n4. Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.\n5. Normal renal function (estimated glomerular filtration rate \\> 60 mL\u002Fmin using Cockcroft-Gault) at Screening and Day -1 Visits.\n\n   For Parts A and B, D, and F only:\n6. Clinical laboratory values within normal range at Screening and Day -1 and Day 7 (Part D), as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or designee. Any laboratory values \\> upper limit of normal (ULN) at Screening should be discussed with the Sponsor, independent MM, or Investigator for approval prior to inclusion. Repeat testing at Screening is acceptable for out-of-range values following approval by the Investigator or designee. Inclusion of participants with laboratory values \\> ULN at Day -1 and Day 7 (Part D) will be at the Investigator's discretion.\n7. In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination at Screening and\u002For before the first administration of IP, at the discretion of the Investigator or designee.\n8. Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg\u002Fm2 with a maximum body weight of 120 kg.\n9. 18 to 55 years of age (inclusive at the time of informed consent).\n10. Able and willing to refrain from use of tobacco and other nicotine-containing products while at the study site and through the study treatment period.\n\nFor Part C only:\n\n11.18 to 65 years of age (inclusive at the time of informed consent).\n\n12\\. A diagnosis of MASH confirmed by 1 or more of the following:\n\n1. Historical liver biopsy consistent with MASH (presence of Grade 1 steatosis, hepatocellular ballooning, and lobular inflammation) according to the non-alcoholic fatty liver disease (MAFLD) activity score.\n2. F0-3 fibrosis according to the MASH Clinical Research Network classification within 1 year of Screening.\n3. A clinical diagnosis of MASH, and the presence of any component of the metabolic syndrome (obesity, dyslipidemia, hypertension, elevated fasting glucose, or type 2 diabetes).\n4. FibroScan-aspartate aminotransferase (FAST) score more than equal to 0.35.\n\n   13\\. Alanine aminotransferase (ALT) \\> 1.00 × ULN at 2 separate time points in the past 6 months. At least 1 time point must be at Screening and the values must be at least 2 weeks apart. Patients with ALT values \\\u003C1.00 × ULN may be included in the study on a case-by-case basis after approval by the Sponsor.\n\n   14\\. Fibrosis-4 (FIB-4) score ≤ 2.67, controlled attenuation parameter (CAP) score by FibroScan® ≥ 280 Db\u002Fm, and liver stiffness measurement (LSM) by FibroScan® ≤ 14 kPa.\n\n   15\\. No documented weight loss \\> 5% in the 6 months preceding Screening.\n\n   16\\. If on glucagon-like peptide 1 (GLP1) agonists, sodium-glucose co-transporter 2 (SGLT2) inhibitors, or vitamin E (dose \\> 400 IU\u002Fday), then should have been on a stable dose for at least 3 months.\n\n   17\\. Platelet count \\> 150,000 and albumin ≥ 35 g\u002FL.\n\n   18\\. BMI Greater than equals to 18.0 and ≤ 40.0 kg\u002Fm2\n\nFor Part E only:\n\n19\\. 18 to 70 years of age (inclusive at the time of informed consent).\n\n20\\. A diagnosis of MASH confirmed by 1 or more of the following:\n\n1. Historical liver biopsy within 1 year of Screening, consistent with MASH (presence of Grade 1 steatosis, hepatocellular ballooning, and lobular inflammation) according to the non-alcoholic fatty liver disease (MAFLD) activity score.\n2. F0-3 fibrosis according to the MASH Clinical Research Network classification within 1 year of Screening.\n3. FibroScan-aspartate aminotransferase (FAST) score ≥ 0.36 and AST ≥ 24.\n\n   21\\. FIB-4 score ≤ 3.25, CAP score by FibroScan® ≥ 280 Db\u002Fm, and LSM by FibroScan® ≤ 15 kPa.\n\n   22\\. No documented weight loss \\> 5% in the 6 months prior to first IP administration.\n\n   23\\. If on GLP1 agonists, SGLT2 inhibitors, or vitamin E (dose ≥ 400 IU\u002Fday), then should have been on a stable dose for at least 3 months prior to first IP administration.\n\n   24\\. Platelet count ≥ 150,000 and albumin ≥ 35 g\u002FL at Screening and Day -1 Visits.\n\n   25\\. BMI ≥ 18.0 and ≤ 45.0 kg\u002Fm2.\n\nExclusion Criteria:\n\nA participant who meets any of the following exclusion criteria must be excluded from the study:\n\n1. An underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.\n2. Blood donation or significant blood loss (\\> 500 mL) within 60 days prior to the first administration of IP.\n3. Plasma donation within 7 days prior to the first administration of IP.\n4. Fever (body temperature \\> 37.7°C) or symptomatic viral or bacterial infection within 2 weeks prior to Day 1.\n5. Dysphagia that would limit ability to swallow IP.\n6. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents. The excipients in the IP are: Hydroxypropyl methylcellulose Acetate Succinate (HPMCAS), Microcrystalline Cellulose, Micronized Poloxamer 407 (polyoxyethylene oxide), Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate, and Hydroxypropylmethylcellulose capsules containing Titanium Oxide.\n7. Abnormalities in physical examination at Screening and Day -1 which are deemed clinically significant by the Investigator or designee.\n8. Abnormal electrocardiogram (ECG) measurements at Screening (an average of 3 readings) and Day -1 (single reading) that are considered by the Investigator or designee to be clinically significant, including corrected QT interval with Fridericia's correction (QTcF) \\> 450 msec (males) or \\> 470 msec (females).\n9. Unstable vital sign(s) or the following values seen at Screening or prior to dosing following 5 minutes of resting in the semi-supine position (an abnormal value may be repeated once, separated by at least 5 minutes, with both values documented). If there is a known medical reason for the abnormality, the timepoint may be repeated on a separate day:\n\n   1. Systolic blood pressure \\\u003C 90 mmHg or \\> 160 mmHg OR\n   2. Diastolic blood pressure \\\u003C 50 mmHg or \\> 95 mmHg OR\n   3. Pulse rate \\\u003C 45 beats per minute (bpm) or \\> 100 bpm.\n10. Presence of other clinically significant causes of active liver disease including genetic, autoimmune, viral, and alcoholic liver disease.\n11. Cirrhosis of the liver as defined by:\n\n    1. A prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding OR\n    2. F4 on previous liver biopsy OR\n    3. Historical evidence of cirrhosis on liver imaging.\n12. History of major hospitalization or major surgery within 6 months prior to first IP administration. Sites are encouraged to confirm with the Sponsor or MM if there are any questions on what would be considered major hospitalization or major surgery.\n13. Infections requiring parenteral antibiotics within 6 months prior to first IP administration.\n14. Vaccination with a live vaccine within 4 weeks prior to the first administration of IP.\n15. Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 4 months prior to first IP administration or 5-half-lives, whichever is longer.\n16. Positive blood screen for active infections including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at Screening.\n17. History of substance abuse or dependency or history of recreational intravenous drug use over the last 12 months (by self-declaration).\n18. Use of any IP or investigational medical device within 30 days for small molecules (or 5 half-lives of the IP if longer than 30 days) or 90 days for biologics prior to first IP administration.\n19. Anything that the Investigator considers would jeopardise the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.\n20. Bariatric surgery.\n21. Cardiovascular disease including heart failure with reduced left ventricular ejection fraction, atrial fibrillation requiring anticoagulation, or any other cardiovascular illness that, in the opinion of the Investigator, warrants exclusion from the study.\n\n    For Parts A and B , D, and F only:\n22. Use of (or anticipated use of) any prescription drugs (other than hormonal contraception; oral contraceptive pills \\[OCPs\\], long-acting implantable hormones, injectable hormones, or an intrauterine device \\[IUD\\]), any known drugs or supplements that are moderate or strong inhibitors\u002Finducers of cytochrome P450 (CYP) enzymes, over-the-counter (OTC) medication, herbal remedies, supplements or vitamins within 48 hours of IP administration and during the course of the study without prior approval of the Investigator and independent MM. Simple analgesia (paracetamol \\\u003C 2 g\u002Fday) may be permitted at the discretion of the Investigator.\n23. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, haematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity, as determined by the Investigator.\n24. History of or suspected malignancy. Participants with basal or squamous cell carcinoma of the skin or carcinoma in situ that has been successfully treated could be included at the discretion of the Investigator or designee.\n25. Positive toxicology screening panel (urine test including methamphetamine, opiates, cocaine, tetrahydrocannabinol, phencyclidine, benzodiazepines, barbiturates, methadone, tricyclic antidepressants and amphetamine), or alcohol breath test at Screening, Day -1, or Day 7 (Part D).\n26. History of alcohol use disorder (within 9 months prior to Screening by self-declaration) or habitual consumption of significant amounts of alcohol (by self-declaration), defined as \\> 10 standard drinks per week or \\> 4 standard drinks on any single day (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit, or a 150 mL glass of wine). Participants who are unable to abstain from alcohol 72 hours prior to Screening and Day -1 visits and until study completion are to be excluded.\n\n    For Part C only:\n27. ALT ≥ 5 × ULN; AST\\>ALT. If ALT ≤ ULN, then AST may be greater than the ALT if it is also ≤ ULN.\n28. Use of (or anticipated use of) any known drugs or supplements that are moderate or strong inhibitors\u002Finducers of CYP enzymes or any drugs that are substrates of CYP2C9 with a narrow therapeutic index (e.g., warfarin or other coumarin based anticoagulants, phenytoin, celecoxib, glimepiride, tolbutamide or phenobarbital or other drugs metabolised by CYP2C9) or any oral drugs that are significantly metabolised by CYP3A4 (e.g., alfentanil, apixaban, avanafil, buspirone, cyclosporine, dihydroergotamine, ergotamine, fentanyl, oxybutinin, losartan, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, pimozide, quinidine, sildenafil, simvastatin, sirolimus, tadalafil, tamsulosin, tacrolimus and zopiclone), during the course of the study. Prescription medications for stable medical condition may be allowable if the Investigator considers they will not interfere with the study; the independent MM may be contacted to discuss any particular medications.\n29. Participants with uncontrolled medical conditions; the independent MM may be contacted for discussion.\n30. History of significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack within 6 months prior to the first dose of IP.\n31. Uncontrolled diabetes mellitus (haemoglobin A1c \\[HbA1c\\] \\> 9.0% at Screening).\n32. Malignancy within the last 5 years; basal or squamous cell carcinoma of the skin or carcinoma in situ that has been successfully treated could be included at the discretion of Investigator or designee.\n33. History or presence of a condition associated with significant immunosuppression.\n34. Positive toxicology screening panel (urine test including Methamphetamine, Opiates, Cocaine, tetrahydrocannabinol, Phencyclidine, Benzodiazepines, Barbiturates, Methadone, tricyclic antidepressants, and Amphetamine) at Screening or Day -1. A positive toxicology screening that is explained by a prescribed medication is allowable.\n35. History of alcohol use disorder (within 9 months prior to Screening by self-declaration) or habitual consumption of significant amounts of alcohol (by self-declaration), defined as \\> 10 standard drinks per week or \\> 4 standard drinks in a day (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit, or a 150 mL glass of wine). Participants who are unable to abstain from alcohol 72 hours prior to Screening and Day -1 visits are to be excluded. Participants unable to consume 10 standard drinks or fewer in a week or 2 standard drinks in a day or fewer during the study are to be excluded.\n\n    For Part E only:\n36. ALT ≥ 5 × ULN; AST\\>ALT at Screening and Day -1 Visits.\n37. Use of (or anticipated use of) any known drugs or supplements that are moderate or strong inhibitors\u002Finducers of CYP enzymes or any drugs that are substrates of CYP2C9 with a narrow therapeutic index (e.g., warfarin or other coumarin-based anticoagulants, phenytoin, celecoxib, glimepiride, tolbutamide or phenobarbital or other drugs metabolized by CYP2C9) or any oral drugs that are significantly metabolised by CYP3A4 (e.g., alfentanil, apixaban, avanafil, buspirone, cyclosporine, dihydroergotamine, ergotamine, fentanyl, oxybutynin, losartan, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, pimozide, quinidine, sildenafil, simvastatin, sirolimus, tadalafil, tamsulosin, tacrolimus, and zopiclone), during the course of the study. Prescription medications for stable medical condition may be allowable if the Investigator considers they will not interfere with the study; the independent MM may be contacted to discuss any particular medications.\n38. Participants with uncontrolled medical conditions; the independent MM may be contacted for discussion.\n39. History of significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke, or transient ischaemic attack within 6 months prior to the first dose of IP.\n40. Uncontrolled diabetes mellitus (haemoglobin A1c \\[HbA1c \\> 9.0% \\[76 mmol\u002Fmol\\] at Screening).\n41. Malignancy within the last 5 years prior to IP administration; basal or squamous cell carcinoma of the skin or carcinoma in situ that has been successfully treated could be included at the discretion of Investigator or designee.\n42. History or presence of a condition associated with significant immunosuppression. Sites are encouraged to confirm with the Sponsor or MM if there are any questions on what would be considered significant immunosuppression.\n43. Positive toxicology screening panel (urine test including methamphetamine, opiates, cocaine, tetrahydrocannabinol, phencyclidine, benzodiazepines, barbiturates, methadone, tricyclic antidepressants, and amphetamine), at Screening or Day -1. A positive toxicology screening that is explained by a prescribed medication is allowable.\n44. History of alcohol use disorder (within 9 months prior to Screening by self-declaration) or habitual consumption of significant amounts of alcohol (by self-declaration), defined as \\> 10 standard drinks per week or \\> 4 standard drinks in a day (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit, or a 150 mL glass of wine) or presence of circulating phosphatidyl ethanol (PEth) levels \\>35 ng\u002FmL at Screening. Participants who are unable to abstain from alcohol 72 hours prior to Screening and Day -1 Visits are to be excluded. Participants unable to consume 10 standard drinks or fewer in a week or 2 standard drinks in a day or fewer during the study are to be excluded.\n\nNote: Sites may determine full eligibility and randomize after Day -1 assessments and eligibility review. Any assessments completed prior to dosing on Day 1 should be reviewed by an Investigator prior to the first dose.",true,{"count":173,"type":20},168,[175],"PHASE1","This Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A, B, D and F and in participants with a history of MASH or presumed MASH in Part C and in participants with MASH in E.",[57],[179],"Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH","2026-07-30",{"date":132,"type":31},{"date":183,"type":31},"2023-09-08",{"date":185,"type":20},"2026-10-31",{"name":187,"class":38},"Inipharm Australia Pty Ltd",11,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100647990","phase-2-pre-hepatectomy-rehabilitation-in-obese-masld-complicated-living-liver-donors-with-mazdutide-prime-100647990","NCT07718126","Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)","Short-term Mazdutide Plus Lifestyle Intervention Versus Placebo for Pre-hepatectomy Prehabilitation in Living Liver Donors With MASLD: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial","PRIME","Inclusion Criteria:\n\n* Age between 18 and 60 years old at the time of signing the informed consent form.\n* Overweight, defined as Body Mass Index (BMI) ≥ 24 kg\u002Fm².\n* Diagnosed with MASLD by non-invasive means (conventional ultrasound, FibroScan®, or MRI), with a Controlled Attenuation Parameter (CAP) ≥ 268 dB\u002Fm via FibroScan®.\n* Histologically confirmed MASLD without any liver fibrosis, presenting a NAS ≥ 3, including a steatosis subscore ≥ 2 (subscores for hepatocyte ballooning and lobular inflammation are not limited).\n* Meets ethical and legal regulations, voluntarily donates a portion of the liver, and the corresponding potential liver transplant recipient must be a spouse or a direct or collateral blood relative within three generations.\n* Understands all procedures and follow-up requirements of the study, participates voluntarily, and signs the written informed consent form in person.\n\nExclusion Criteria:\n\n* Liver biopsy indicates complication with any degree of liver fibrosis.\n* Failure to diagnose overweight or MASLD by non-invasive means, including BMI \\\u003C 24 kg\u002Fm² and\u002For CAP \\\u003C 268 dB\u002Fm.\n* Histological evaluation shows a total NAS \\\u003C 3 and\u002For a steatosis subscore \\\u003C 2.\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN) at screening, and\u002For ALT or AST levels increase by more than 1 fold compared to baseline during screening, which is considered clinically significant by the investigator.\n* Total bilirubin (TBil) \\> 25.6 μmol\u002FL (1.5 mg\u002FdL), and\u002For alkaline phosphatase (ALP) \\> 2 × ULN, and\u002For International Normalized Ratio (INR) \\> 1.35 at screening.\n* Platelet count \\\u003C 150,000\u002FμL at screening, unless considered by the investigator to reflect the patient's daily baseline level and portal hypertension is absent.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m² based on the CKD-EPI formula at screening.\n* Glycated hemoglobin (HbA1c) \\> 9.5% at screening.\n* Unstable weight, defined as self-reported weight change \\> 5% within 90 days prior to screening up to the time of screening.\n* Presence of other clearly defined etiologies causing chronic liver disease (non-NAFLD), including positive HBsAg, positive anti-HIV, or positive HCV RNA at screening, or a known history of HCV RNA or HBsAg positivity within 2 years prior to screening.\n* Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatocellular carcinoma, or liver transplantation at screening and randomization.\n* Presence or history of malignant tumors within 5 years (except basal cell carcinoma, squamous cell skin cancer, and any carcinoma in situ).\n* Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).\n* History of acute pancreatitis within 180 days prior to screening, or a history of chronic pancreatitis.\n* Presence or history of gastroparesis, severe gastroesophageal reflux disease, or prior bariatric surgery at screening and randomization.\n* History or presence of type 1 diabetes.\n* Occurrence of myocardial infarction, stroke, NYHA class IV heart failure, hospitalization due to unstable angina, or transient ischemic attack within 90 days prior to screening or during the screening-to-randomization window.\n* Type 2 diabetes accompanied by uncontrolled and potentially unstable diabetic retinopathy or maculopathy.\n* History of severe depression, suicidal ideation, or recent suicide attempts.\n* Known or suspected allergy to the active ingredients or any excipients of the study drug.\n* Females who are pregnant, lactating, planning a pregnancy, or of childbearing potential but not utilizing highly effective contraceptive methods.\n* Participation in any approved or unapproved investigational drug clinical trial within 180 days prior to screening (defined as exposure to the investigational drug and inclusive of any post-treatment follow-up period).\n* Prior participation in this trial (defined as having already undergone randomization).\n* Known or suspected excessive alcohol consumption (females \\> 20g\u002Fday, males \\> 30g\u002Fday) or presence of alcohol dependence.\n* Use of any GLP-1 receptor agonist (GLP-1RA) within 90 days prior to screening.\n* Receipt of glucose-lowering drugs (except GLP-1RA), lipid-lowering drugs, or weight-loss drugs considered by the investigator to be at unstable doses within 90 days prior to screening.\n* Any condition considered by the investigator to render the participant unsuitable for liver donation, or diseases\u002Fconditions that may compromise participant safety, pose safety hazards from substantial weight loss, or affect compliance with the protocol.\n* The recipient designated to receive the liver graft is not a spouse or a direct or collateral blood relative within three generations, or the donation violates ethical, moral, legal, or regulatory codes.","60 Years",{"count":199,"type":20},60,[94,23],"The purpose of this study is to evaluate the efficacy and safety of a short-term (12-week) prehabilitation strategy combining mazdutide (a novel GLP-1\u002FGCG receptor dual agonist) with lifestyle optimization, compared to lifestyle optimization alone, in potential living liver transplantation donors with metabolic dysfunction-associated steatohepatitis (MASLD).\n\nOverweight or obese individuals who intend to donate a portion of their liver but are temporarily disqualified due to hepatic steatosis will be recruited across multiple clinical centers. Participants will be randomly assigned in a 1:1 ratio to either the experimental group (mazdutide subcutaneous injection once weekly plus standardized lifestyle counseling) or the control group (placebo subcutaneous injection once weekly plus standardized lifestyle counseling).\n\nThe primary objective is to determine whether the short-term addition of mazdutide can significantly increase the proportion of donors achieving histological resolution of hepatic steatosis without the worsening of fibrosis within 12 weeks. The study ultimately aims to provide high-quality evidence for a rapid, safe, and effective surgical prehabilitation protocol to expand the living donor pool and optimize perioperative outcomes for both donors and recipients.",[57,203,204],"Hepatic Steatosis","Living Liver Donors",[206,207,208,209,46,210,211],"Mazdutide","GLP-1\u002FGCG receptor dual agonist","Living Donor Liver Transplantation","Prehabilitation","Organ Donation","Preoperative Weight Loss","2026-07-16",{"date":214,"type":31},"2026-07-21",{"date":216,"type":20},"2026-09-01",{"date":218,"type":20},"2028-08-31",{"name":220,"class":82},"West China Hospital",3,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},"100586796","phase-2-a-study-of-efimosfermin-alfa-in-participants-with-biopsy-confirmed-cirrhosis-compensated-due-to-mash-100586796","NCT06920043","A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH","A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent form (ICF)\n* Age 18 through 75 years at enrollment\n* History or presence of 2 or more of the 5 components of metabolic syndrome\n* Liver biopsy confirmation of MASH consistent with stage F4 fibrosis\n* Other inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease\n* History of type 1 diabetes\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)\n* Other exclusion criteria may apply.",{"count":230,"type":20},42,[94],"The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.",[57,234],"Non-alcoholic Fatty Liver Disease",[236,237,238],"Fibroblast growth factor","Stage 4 fibrosis","Compensated Cirrhosis","2026-07-07",{"date":241,"type":31},"2026-07-08",{"date":243,"type":31},"2025-04-09",{"date":245,"type":20},"2028-07-10",{"name":140,"class":38},30,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100580385","phase-1-a-study-to-evaluate-aln-cideb-in-adult-participants-with-metabolic-dysfunction-associated-steatotic-liver-disease-or-with-metabolic-dysfunction-associated-steatohepatitis-masldmash-100580385","NCT06836609","A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD\u002FMASH)","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Two Doses of ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Key Inclusion Criteria:\n\n1. Part A: 18 to 55 years at Screening Visit 1 with MASLD, at Screening Visit 1 Part B: 18 to 65 years at Screening Visit 1 with a diagnosis of MASH, at Screening Visit 1\n2. Body Mass Index (BMI) ≥30 kg\u002Fm2 and ≤40 kg\u002Fm2 at Screening Visit 1\n3. Controlled-Attenuation Parameter (CAP) ≥285 dB\u002Fm by FibroScan during screening as described in the protocol\n4. Liver fat content ≥8.5% by MRI-PDFF during screening\n5. If on anti-hypertensive and\u002For lipid lowering medications and\u002For glucose lowering medications, must be on generally stable dose(s) for at least 12 weeks prior to screening and no changes to the dose(s) are anticipated during the study\n6. Part B: A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers (eg, evidence of fatty liver on imaging and elevated liver enzymes) and clinical risk factors, including having a history of 2 or more elements of metabolic syndrome, as defined in the protocol\n7. Part B: Screening percutaneous liver biopsy NAFLD Activity Score (NAS) ≥3 and fibrosis stage, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Known historical or current diagnosis of portal hypertension or cirrhosis based on clinical assessment, imaging, and\u002For liver biopsy\n2. Known historical or current diagnosis of other forms of chronic liver disease, as defined in the protocol\n3. Prior or current suspected or known drug-induced liver injury within 1 year prior to screening\n4. History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score \\>12\n5. Contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions, or other contraindications for MRI\n6. Liver stiffness measurement, laboratory parameter assessment, estimated Glomerular Filtration Rate (GFR), and evidence of uncontrolled hypertension, as defined in the protocol\n7. Evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B Virus (HBV) infection, or Hepatitis C Virus (HCV) infection during screening, as described in the protocol\n8. History of Type 1 Diabetes\n9. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, within approximately 5 years prior to randomization or planned during the study period\n\nNOTE: Other protocol-defined inclusion\u002Fexclusion criteria apply.","65 Years",{"count":257,"type":20},132,[175,94],"This study is researching an experimental drug called ALN-CIDEB, also referred to as \"study drug\". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B). MASLD and MASH are long-lasting liver conditions caused by having too much fat in the liver.\n\nThe aim of the study is to see how safe and tolerable the study drug is.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How the study drug works to change liver fat content\n* How much study drug and study drug metabolites (byproducts of the body breaking down the study drug) are in the blood at different times",[56,57],[262,46,61],"Obese",{"date":241,"type":31},{"date":265,"type":31},"2025-04-28",{"date":267,"type":20},"2027-05-15",{"name":269,"class":38},"Regeneron Pharmaceuticals",4,{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":171,"sex":16,"minAge":17,"maxAge":255,"enrollmentInfo":278,"targetDuration":4,"studyType":21,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":163},"100560304","phase-1-a-study-to-test-how-well-different-doses-of-bi-3804379-are-tolerated-by-healthy-people-and-patients-with-metabolic-dysfunction-associated-steatohepatitis-mash-100560304","NCT06575400","A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People and Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Rising Subcutaneous Doses of BI 3804379 in Healthy Male and Female Participants and in Stable Patients With Advanced Fibrosis Due to MASH","Inclusion criteria for Part A and Part B:\n\n1. Healthy male or female (of non-child-bearing potential) participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests\n2. Age of 18 to 65 years (inclusive)\n3. Body mass index (BMI) of 18.5 to 30.0 kg\u002Fm2 (inclusive)\n4. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply\n\nInclusion criteria for Part C:\n\n1\\. Male or female patients with advanced liver fibrosis due to MASH, aged between 18 and 70 years (inclusive) Further inclusion criteria apply\n\nExclusion criteria for Part A and Part B:\n\n1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.\n2. Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm).\n3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.\n4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.\n\nFurther exclusion criteria apply\n\nExclusion criteria for Part C:\n\n1. Type 1 diabetes or uncontrolled type 2 diabetes (e.g., hemoglobin A1C (HbA1c) ≥10%, recent major treatment changes, or severe hypoglycemia).\n2. Significant weight loss (≥10%) between diagnosis and screening.\n3. Relevant surgery after diagnosis or planned during the study period.\n4. Evidence of clinically significant or unstable disease increasing risk to the participant.\n5. Severe renal impairment (estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n6. Uncontrolled hypertension or significant cardiovascular disease (e.g., recent myocardial infarction, stroke, or heart failure New York Heart Association (NYHA) class III\u002FIV).\n7. Clinically relevant ECG abnormalities, including QT interval corrected for heart rate (QTc) prolongation or risk factors for Torsade de Pointes.\n8. Participation in another clinical trial or exposure to an investigational drug within 60 days prior to study treatment.\n\nFurther exclusion criteria apply",{"count":279,"type":20},124,[175],"The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female participants and in stable patients with advanced liver fibrosis due to MASH following administration of single rising doses and administration of multiple rising doses.",[283,97],"Healthy","2026-07-06",{"date":239,"type":31},{"date":287,"type":31},"2024-09-12",{"date":289,"type":20},"2028-03-20",{"name":37,"class":38},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":316,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":141},"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":257,"type":20},[53],"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.",[58,302,303,304,56,57,46,61,305,306,307,308,309,310,311,312,313,314,315],"Liver Diseases","Liver Fibrosis","Liver Fat","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[317,318,319,320,321,322,323,324,325,326,327,328,329],"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)","Non-Alcoholic Steatohepatitis (NASH)","2026-06-23",{"date":332,"type":31},"2026-06-25",{"date":334,"type":31},"2025-06-24",{"date":336,"type":20},"2028-06",{"name":338,"class":82},"Pichamol Jirapinyo, MD, MPH",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":21,"phases":349,"briefSummary":350,"conditions":351,"keywords":352,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":270},"100628501","phase-1-safety-tolerability-and-pharmacokineticpharmacodynamicpkpd-profile-of-act500-in-metabolic-dysfunction-associated-steatotic-liver-diseasemasld-100628501","NCT07462455","Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic(PK\u002FPD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)","A Multicenter, Open-label, Multiple-dose Escalation Phase Ⅰb Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic Profile of ACT500 in Participants With Metabolic Dysfunction-associated Steatotic Liver Disease","Inclusion Criteria:\n\n* The participant fully understands the purpose, nature, methods, and possible adverse reactions of the study, voluntarily participates in this study, and has signed the informed consent form.\n* Male or female participants aged between 18 and 69 years (inclusive of 18 and 69 years) at the time of signing the informed consent form.\n* Liver fat content (LFC) ≥10% as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during the screening period.\n* Liver stiffness measurement (LSM) assessed by FibroScan during the screening period meets the criteria of 8 kPa ≤ LSM ≤ 15 kPa, OR a liver biopsy pathological result of F2\u002FF3 fibrosis within 6 months prior to screening.\n* Serum alanine aminotransferase (ALT) levels meeting 2×ULN ≤ ALT ≤ 5×ULN at screening.\n* Presence of at least one of the following metabolic risk factors:\n\n  1. BMI ≥ 24.0 kg\u002Fm\\^2, or waist circumference ≥ 90 cm (males) and ≥ 85 cm (females);\n  2. Presence of prediabetes: fasting blood glucose ≥ 6.1 mmol\u002FL, or glycated hemoglobin (HbA1c) ≥ 5.7%;\n  3. History of type 2 diabetes mellitus;\n  4. Fasting serum triglycerides (TG) ≥ 1.70 mmol\u002FL but \\\u003C 5.6 mmol\u002FL;\n  5. Fasting serum high-density lipoprotein cholesterol (HDL-C) ≤ 1.0 mmol\u002FL (males) and ≤ 1.3 mmol\u002FL (females), OR currently receiving a stable dose of lipid-lowering medication;\n  6. Systolic blood pressure (SBP) ≥ 130 mmHg or diastolic blood pressure (DBP) ≥ 85 mmHg, while simultaneously meeting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg, OR currently receiving a stable dose of antihypertensive medication and meeting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg.\n* Both male and female participants must agree to use appropriate contraceptive methods, as follows:\n\n  1. For male participants: Agreement to use reliable contraceptive measures and refrain from sperm donation from signing the informed consent form until 3 months after the last dose.\n  2. For female participants: Female participants of non-childbearing potential; OR female participants of childbearing potential who are not pregnant or breastfeeding, have a negative serum pregnancy test at screening and within 1 day prior to the first dose, and agree to use reliable contraceptive measures and refrain from egg donation from signing the informed consent form until 3 months after the last dose.\n\nExclusion Criteria:\n\n* \\[1\\] Combined with other liver diseases, including but not limited to hepatitis B, hepatitis C, drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, suspected or confirmed hepatocellular carcinoma, etc.\n\n  \\[2\\] Have a history of or currently have other malignancies, liver cirrhosis (including confirmed or suspected liver cirrhosis by imaging examination, or liver cirrhosis confirmed by liver biopsy), or have evidence of decompensated liver disease (such as ascites, esophageal and gastric variceal bleeding, or hepatic encephalopathy, etc.), or have a history of liver transplantation.\n\n  \\[3\\] Have a history of or current symptoms of severe cardiovascular and cerebrovascular diseases, including but not limited to uncontrolled or severe arrhythmias (ventricular fibrillation, atrial fibrillation, etc.), myocardial infarction, coronary heart disease, etc.\n\n  \\[4\\] Have a history of persistent, clinically significant respiratory, neurological, gastrointestinal, immunological, hematological, or psychiatric diseases, which, in the investigator's judgment, would pose additional risk to the participant.\n\n  \\[5\\] Have type 1 diabetes or uncontrolled type 2 diabetes (fasting blood glucose \\>9 mmol\u002FL within 3 months prior to screening, or HbA1c \\>9.5% at screening), or are diabetic patients using glucose-lowering medications other than metformin.\n\n  \\[6\\] Have an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m² at screening or a history of severe renal impairment.\n\n  \\[7\\] Have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia; or have hemoglobin \\\u003C105 g\u002FL for female participants or \\\u003C115 g\u002FL for male participants at screening; or any other condition known to interfere with hemoglobin measurement as judged by the investigator.\n\n  \\[8\\] Have any of the following laboratory abnormalities at screening: alkaline phosphatase (ALP) \\> 2 × upper limit of normal (ULN), serum total bilirubin (TBIL) \\> 1.5 × ULN, or international normalized ratio (INR) \\> 1.3.\n\n  \\[9\\] Have had a body weight change (increase or decrease) of \\>5% within 3 months prior to screening, or have undergone dieting, bariatric surgery, or used medications approved for weight loss indications.\n\n  \\[10\\] Have a history of major trauma or surgery within 3 months prior to screening, or plan to undergo surgery during the study period.\n\n  \\[11\\] Have a history of excessive alcohol consumption for 3 consecutive months or more within 1 year prior to screening, defined as a weekly ethanol intake of ≥210 g for males and ≥140 g for females; or have a history of drug abuse\u002Fdependence or a history of illicit drug inhalation\u002Finjection within 1 year prior to screening.\n\n  \\[12\\] Have used medications that may have a therapeutic effect on MASLD\u002FMASH (e.g., GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors, FGF21 analogs, resmetirom, etc.) or medications that may cause MASLD\u002FMASH (e.g., amiodarone, methotrexate, tetracyclines, tamoxifen, estrogens at doses greater than hormone replacement therapy, anabolic steroids, valproic acid, other known hepatotoxic drugs, etc.) within 3 months prior to screening, or other medications that the investigator considers may affect the trial.\n\n  \\[13\\] Have participated in another drug clinical trial within 3 months prior to screening.\n\n  \\[14\\] Have a positive test for any of the following at screening: human immunodeficiency virus antibody (HIV-Ab) or Treponema pallidum antibody.\n\n  \\[15\\] Have a known allergy to the excipients of ACT500 or to drugs with a similar chemical structure to ACT500, or have other drug allergies that, in the investigator's judgment, preclude participation in the study.\n\n  \\[16\\] Have any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study, or are unable to participate in the trial due to the participant's own reasons after signing the informed consent form (ICF).","69 Years",{"count":348,"type":20},24,[175],"This study is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The trial plans to enroll approximately 24 MASLD participants across four dose cohorts, each consisting of 6 participants who will receive oral ACT500 once daily.",[97],[97,353,354],"ACT500","NM6606","2026-03-15",{"date":357,"type":31},"2026-03-17",{"date":359,"type":20},"2026-03-31",{"date":361,"type":20},"2027-04-30",{"name":363,"class":38},"Xiamen Amoytop Biotech Co., Ltd.",{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":171,"sex":16,"minAge":17,"maxAge":255,"enrollmentInfo":371,"targetDuration":4,"studyType":21,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":163},"100618627","phase-1-ecc4703-food-effect-and-relative-bioavailability-study-in-healthy-adult-participants-100618627","NCT07334080","ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants","A Phase I, Open-Label, Randomized, Single-Dose, Crossover Study to Evaluate Food Effect and Relative Bioavailability of ECC4703 Formulations (F0, F1, F2, and F3) in Healthy Adults","Inclusion Criteria:\n\n* Healthy male and female participants\n* Age of 18 to 65 years\n* BMI of 18.0 to 32.0 kg\u002Fm2 with a minimum body weight of 50.0 kg (110 lb) for males and 45.0 kg (99 lb) for females.\n* Female participants of childbearing potential must have negative serum pregnancy test at screening and a negative serum or urine pregnancy test prior to the first dose of study drug; use at least 1 highly effective method of contraception (e.g., hormonal contraception, intrauterine device, bilateral tubal occlusion, or vasectomized partner with confirmed success) during the study and for at least 90 days after the last dose of study drug; and refrain from egg donation or fertility treatments during the same period.\n* Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence\n* Male participants agree to use contraception, or agree to practice true abstinence\n* Not taking any medication within 14 days (or at least 5 half-lives whichever is longer) prior to Day 1 dosing, with the exception of stable-dose contraception, stable-dose hormonal replacement therapy, paracetamol at up to 2 g\u002Fday; or other medication, which in the opinion of the investigator and sponsor will not interfere with study assessments.\n* No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, clinical laboratory evaluations, concomitant medications, or medical\u002Fpsychiatric history\n* Able to understand and sign and date informed consent\n\nExclusion Criteria:\n\n* Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 90 days after the study.\n* Concomitant participation in any investigational study of any nature\n* Blood loss of ≥470 mL for non-physiological reasons (i.e., trauma, blood collection, blood donation) within 3 months prior to the first dose of study drug, plasma donation within 2 weeks prior to the first dose, platelet donation within 6 weeks prior to the first dose, or plans to donate blood during this study or within 1 month after the last dose of study drug.\n* Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems\n* Significant allergic reaction to active ingredients or excipients of the study drug\n* Regularly uses tobacco or nicotine products, including e-cigarettes (\\>5 times per week) or has stopped using regular tobacco or nicotine products within the past 2 months.\n* Unwilling to abstain from alcohol-containing products and\u002For xanthine\u002Fcaffeine-containing products, including any food and beverages, within 48 hours prior to admission to the CRU on Day -1.\n* Unwilling to abstain from grapefruit, grapefruit juice, and Seville oranges from 7 days prior to check-in on Day -1 until after their final follow-up visit.\n* Unable to refrain from the use of any over-the-counter medications, prescription medications, nutritional supplements, or herbal medicines during the study, except for stable-dose contraception, stable-dose hormonal replacement therapy, paracetamol at up to 2 g\u002Fday; or other medication, which in the opinion of the investigator and sponsor will not interfere with study assessments.\n* Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.\n* Has had clinically significant interventional therapies and\u002For hospitalization (surgery, paracentesis, etc.) within 6 months prior to the study, or plans to have any surgeries during the duration of the study.",{"count":372,"type":20},72,[175],"This is a Phase I, open-label, randomized, single-dose, 2-part study designed to evaluate the food effect and relative bioavailability of ECC4703 in healthy adult participants.",[57],"2026-01-14",{"date":378,"type":31},"2026-01-16",{"date":380,"type":20},"2026-01-10",{"date":382,"type":20},"2026-05",{"name":111,"class":38},{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":394,"phases":4,"briefSummary":395,"conditions":396,"keywords":399,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":141},"100582875","study-of-the-link-between-mash--metabolic-dysfunction-associated-steatohepatitis-and-mams-mitochondria-associated-membranes--alteration-in-patients-undergoing-bariatric-surgery---mamba-100582875","NCT06868992","Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA","Study of the Link Between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) Alteration in Patients Undergoing Bariatric Surgery - MAMBA","MAMBA","* Inclusion Criteria \\* :\n\n  * Female or male adult patients\n  * Patient who has benefited from a pluridisciplinary evaluation (medical, surgical, psychiatric), with a favorable opinion for a sleeve gastrectomy or a gastric bypass.\n  * Patient with an indication Indication for intraoperative liver biopsy due to suspected MASH\n  * Patient who agrees to be included in the study and who signs the informed consent form,\n  * Patient affiliated to a healthcare insurance plan.\n* Exclusion Criteria \\* :\n\n  * Patient presenting Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).\n  * Patient presenting previous or current infection with Hepatitis C\n  * Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.\n  * Patient presenting Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.\n  * Patient presenting Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.\n  * Patient presenting Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.\n  * Patient presenting Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y\u002FH63D.\n  * Patient presenting Drug-induced liver disease as defined on the basis of typical exposure and history.\n  * Patient presenting Bile duct obstruction as shown by imaging studies.\n  * History of ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, methotrexate, amiodarone or tetracycline in the previous 6 months.\n  * Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices\n  * Consommation régulière et\u002Fou excessive d'alcool (plus de 30g\u002Fj pour les hommes et plus de 15 g\u002Fj pour les femmes) sur une période de plus de 2 ans au cours des 10 dernières années.\n  * History of known HIV infection\n  * History of type 1 diabetes\n  * Pregnant women or breastfeeding mothers\\*.\n  * Minor patient\n  * Patient deprived of liberty,\n  * Patients under psychiatric care\n  * Patients admitted to a health or social care establishment for purposes other than research\n  * Mentally unbalanced patients, under supervision or guardianship,\n  * Patients not affiliated to a social security scheme or benefiting from a similar scheme\n  * Patient who does not understand French\u002F is unable to give consent,\n  * Patient already included in a trial who may interfere with the study","99 Years",{"count":51,"type":20},"OBSERVATIONAL","The main research hypothesis is that alterations in the communication between the endoplasmic reticulum (ER) and the mitochondria at contact sites called mitochondria-associated membranes (MAMs) occurs in different hepatic cell types of patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD) and is involved in the progression towards MASH and could also influence the process of improvement of MASH.\n\nThis study aims to investigate the link between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) in liver cells and peripheral blood mononuclear cells (PBMCs) in patients undergoing bariatric surgery. The primary objective is to analyze MAMs alterations in hepatocytes in MASH patients compared to non-MASH patients. Secondary objectives include evaluating the correlation between MAMs in PBMCs and liver cells and assessing MAMs changes post-bariatric surgery.",[56,57,397,398],"Sleeve Gastrectomy","Gastric Bypass Surgery",[61,46,400,59,401],"Mitochondria-Associated Membranes (MAMs)","Hepatic Fibrosis",{"date":403,"type":31},"2026-01-15",{"date":405,"type":31},"2025-04-15",{"date":407,"type":20},"2028-03",{"name":409,"class":82},"Hospices Civils de Lyon",{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":418,"targetDuration":420,"studyType":394,"phases":4,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":163},"100578608","prognostic-factors-for-hcc-and-liver-transplantation-in-patients-with-masldmash-100578608","NCT06813508","Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD\u002FMASH","Prognostic Factors for the Development of Hepatocellular Carcinoma (HCC) and Indications for Liver Transplantation in Patients With Metabolic Liver Diseases (MASLD\u002FMASH): The BOMASH Study","BOMASH","Inclusion Criteria:\n\n* All patients with a diagnosis of MASLD, established according to the most recent published guidelines (EASL, EASD, EASO)\n* Age ≥18 years\n\nInclusion Criteria for Biological Sample Collection:\n\n* Patients requiring liver biopsy for diagnostic purposes, as indicated by the most recent published guidelines (EASL, EASD, EASO)\n\nExclusion Criteria:\n\n* No exclusion criteria.",{"count":419,"type":20},1000,"6 Months","The BOMASH study is a single-center, prospective\u002Fretrospective observational study without pharmacological interventions. It will include all patients diagnosed with Metabolic-Associated Steatotic Liver Disease (MASLD\u002FMASH), whether newly diagnosed or previously identified at the center during follow-up or as part of routine diagnostic and therapeutic care.\n\nThe aim of the study is to identify predictive factors related to the prognosis of patients with metabolic liver disease (MASLD\u002FMASH). Specifically, the study seeks to uncover biomarkers that can identify individuals at risk of requiring a liver transplant or developing HCC.",[56,423,57,424],"Hepatocellular Carcinoma","Liver Transplant","2025-02-03",{"date":427,"type":31},"2025-02-07",{"date":429,"type":31},"2024-11-20",{"date":431,"type":20},"2044-11-20",{"name":433,"class":82},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]