[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643120":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":11,"responsibleParty":40,"collaborators":11,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":11,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":11},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"ALN-CIDEB Dose 1","EXPERIMENTAL",null,[13],"Drug: ALN-CIDEB",{"label":15,"type":10,"description":11,"interventionNames":16},"ALN-CIDEB Dose 2",[13],{"label":18,"type":19,"description":11,"interventionNames":20},"Placebo","PLACEBO_COMPARATOR",[21],"Drug: Placebo",[23,28],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","ALN-CIDEB","Administered per the protocol",[9,15],{"type":24,"name":18,"description":26,"armGroupLabels":29,"otherNames":11},[18],[31],{"name":32,"affiliation":5,"role":33},"Clinical Trial Management","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100643120","phase-2-study-to-evaluate-aln-cideb-in-adults-with-fibrotic-metabolic-dysfunction-associated-steatohepatitis-mash-100643120",false,"NCT07631637","Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Key Inclusion Criteria:\n\n1. A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers and clinical risk factors, including having a history of 1 or more elements of metabolic syndrome as described in the protocol\n2. Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol\n3. Has a FibroScan Aspartate aminotransferase (FAST) score \\>0.35 either at Screening Visit 1 or within approximately 3 months of Screening Visit 1 as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Known chronic liver disease other than Metabolic dysfunction-Associated steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol\n2. Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1\n3. History of liver transplantation, current placement on a liver transplant list, or MELD score \\>12\n4. Known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion and\u002For a score on the AUDIT questionnaire ≥8\n5. Prior current, or planned future use of a Glucagon-Like Peptide-1 (GLP-1) receptor agonist-based therapy or any medication approved for the treatment of MASH unless used at a generally stable dose and regimen since at least 3 months prior to Screening Visit 1 or the qualifying historical liver biopsy and throughout the screening period with no change to the dose or regimen anticipated during the treatment period as described in the protocol\n\nNOTE: Other Protocol-defined Inclusion\u002FExclusion Criteria Apply","ALL","18 Years","75 Years",{"count":53,"type":54},150,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH.\n\nIn this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver injury, and liver scarring. The study will compare ALN-CIDEB with placebo to understand how well ALN-CIDEB works to lower the amount of fat in the liver.\n\nThe study is looking at:\n\n* What side effects ALN-CIDEB might cause\n* How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring\n* How the body and the liver change after having ALN-CIDEB, which can help researchers understand why ALN-CIDEB works better for some people than others",[60],"Metabolic Dysfunction-Associated Steatohepatitis (MASH)",[62,63,64,65,66,67,68],"F2 or F3 MASH","Fibrotic MASH","Nonalcoholic Fatty Liver Disease (NAFLD)","Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)","Liver Inflammation","Liver Fibrosis","Cirrhosis","NOT_YET_RECRUITING","2026-06-01",{"date":72,"type":73},"2026-06-08","ACTUAL",{"date":75,"type":54},"2026-07-15",{"date":77,"type":54},"2029-02-06",{"name":5,"class":6}]