[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580385":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":72,"collaborators":24,"id":74,"slug":24,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":24,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":24,"studyType":86,"phases":87,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A","EXPERIMENTAL","Randomized per the protocol",[13,14],"Drug: ALN-CIDEB","Drug: Placebo",{"label":16,"type":10,"description":11,"interventionNames":17},"Part B",[13,14],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","ALN-CIDEB","Administered per the protocol",[9,16],null,{"type":20,"name":26,"description":22,"armGroupLabels":27,"otherNames":24},"Placebo",[9,16],[29],{"name":30,"affiliation":5,"role":31},"Clinical Trial Management","STUDY_DIRECTOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[39,52,63],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":24},"Arizona Liver Health","RECRUITING","Chandler","Arizona","85225","United States",{"type":47,"coordinates":48},"Point",[49,50],-111.84125,33.30616,{"lat":50,"lon":49},{"facility":53,"status":41,"city":54,"state":55,"zip":56,"country":57,"cosmosGeoPoint":58,"geoPoint":62,"contacts":24},"Richmond Pharmacology Limited","London","Greater London","SE1 1YR","United Kingdom",{"type":47,"coordinates":59},[60,61],-0.12574,51.50853,{"lat":61,"lon":60},{"facility":64,"status":41,"city":65,"state":54,"zip":66,"country":57,"cosmosGeoPoint":67,"geoPoint":71,"contacts":24},"Parexel International Early Phase Clinical Unit","Harrow","HA1 3UJ",{"type":47,"coordinates":68},[69,70],-0.33208,51.57835,{"lat":70,"lon":69},{"type":73,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100580385",false,"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.","ALL","18 Years","65 Years",{"count":84,"type":85},132,"ESTIMATED","INTERVENTIONAL",[88,89],"PHASE1","PHASE2","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",[92,93],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis",[95,96,97],"Obese","MASLD","MASH","2026-04-22",{"date":100,"type":101},"2026-04-27","ACTUAL",{"date":103,"type":101},"2025-04-28",{"date":105,"type":85},"2027-05-15",{"name":5,"class":6},3]