[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659215":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":11,"studyPopulation":11,"armGroups":54,"interventions":82,"overallOfficials":11,"centralContacts":92,"locations":11,"responsibleParty":98,"collaborators":11,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":11,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":11,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":121,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":11},{"fullName":5,"class":6},"Arrowhead Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percent Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF) at Week 48",null,"Baseline, Week 48",[14,17,19,21,23,26,29,32,35,37,39,41,43],{"measure":15,"description":11,"timeFrame":16},"Percentage of Participants With Resolution of Steatohepatitis and No Worsening of Liver Fibrosis (Histology)","Week 48",{"measure":18,"description":11,"timeFrame":16},"Percentage of Participants With Improvement in Liver Fibrosis by ≥1 Stage and No Worsening of Steatohepatitis (Histology)",{"measure":20,"description":11,"timeFrame":12},"Change From Baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) Total Score and Individual Subscores (Steatosis, Hepatocyte Ballooning, and Lobular Inflammation) at Week 48",{"measure":22,"description":11,"timeFrame":12},"Change From Baseline in Fibrosis Stage (Histology) at Week 48",{"measure":24,"description":11,"timeFrame":25},"Number of Participants With Treatment-emergent Adverse Events (TEAEs)","Baseline up to Week 48",{"measure":27,"description":11,"timeFrame":28},"Change From Baseline in LFC by MRI-PDFF at Week 24","Baseline, Week 24",{"measure":30,"description":11,"timeFrame":31},"Percentage of Participants With >30%, >50%, and >70% Reduction in LFC From Baseline by MRI-PDFF at Week 24 and Week 48","Week 24 and Week 48",{"measure":33,"description":11,"timeFrame":34},"Change From Baseline Through Week 48 in Body Weight","Baseline through Week 48",{"measure":36,"description":11,"timeFrame":34},"Change From Baseline Through Week 48 in Body Composition (Total Adipose Tissue [TAT], Visceral Adipose Tissue [VAT] Volume, and Total Lean Tissue [TLT]), by Whole-body Magnetic Resonance Imaging (WB-MRI)",{"measure":38,"description":11,"timeFrame":34},"Change From Baseline Through Week 48 in Serum Activin E Protein",{"measure":40,"description":11,"timeFrame":34},"Change From Baseline in Markers of Hepatic Steatosis at Week 48",{"measure":42,"description":11,"timeFrame":34},"Change From Baseline in Markers of Inflammation at Week 48",{"measure":44,"description":11,"timeFrame":34},"Change From Baseline in Markers of Fibrosis at Week 48",{"allocation":46,"interventionModel":47,"interventionModelDescription":11,"primaryPurpose":48,"observationalModel":11,"timePerspective":11,"maskingInfo":49},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":50,"maskingDescription":11,"whoMasked":51},"DOUBLE",[52,53],"PARTICIPANT","INVESTIGATOR",[55,61,67,71,74,78],{"label":56,"type":57,"description":58,"interventionNames":59},"ARO-INHBE Low Dose","EXPERIMENTAL","Participants will receive ARO-INHBE at a low dose on Days 1, 85, 169, and 253.",[60],"Drug: ARO-INHBE",{"label":62,"type":63,"description":64,"interventionNames":65},"Placebo for ARO-INHBE Low Dose","PLACEBO_COMPARATOR","Participants will receive placebo on Days 1, 85, 169, and 253.",[66],"Drug: Placebo",{"label":68,"type":57,"description":69,"interventionNames":70},"ARO-INHBE High Dose (Schedule 1)","Participants will receive ARO-INHBE at a high dose on Days 1, 85, 169, and 253.",[60],{"label":72,"type":63,"description":64,"interventionNames":73},"Placebo for ARO-INHBE High Dose (Schedule 1)",[66],{"label":75,"type":57,"description":76,"interventionNames":77},"ARO-INHBE High Dose (Schedule 2)","Participants will receive ARO-INHBE at a high dose on Days 1, 85, and 169.",[60],{"label":79,"type":57,"description":80,"interventionNames":81},"Placebo for ARO-INHBE High Dose (Schedule 2)","Participants will receive placebo on Days 1, 85, and 169.",[66],[83,88],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":11},"DRUG","ARO-INHBE","Subcutaneous (SC) injection",[68,75,56],{"type":84,"name":89,"description":90,"armGroupLabels":91,"otherNames":11},"Placebo","SC injection",[72,79,62],[93],{"name":94,"role":95,"phone":96,"phoneExt":11,"email":97},"Medical Monitor","CONTACT","626-304-3400","AROINHBE@arrowheadpharma.com",{"type":99,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659215","phase-2-a-trial-to-evaluate-the-efficacy-and-safety-of-aro-inhbe-in-adults-with-metabolic-dysfunction-associated-steatohepatitis-100659215",false,"NCT07859813","A Trial to Evaluate the Efficacy and Safety of ARO-INHBE in Adults With Metabolic Dysfunction-Associated Steatohepatitis","A Phase 2, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ARO-INHBE in Adults With Metabolic Dysfunction-Associated Steatohepatitis With or Without Type 2 Diabetes Mellitus","Key Inclusion Criteria:\n\n* BMI between 30.0 to 50.0 kilograms (kg)\u002Fsquare meter (m\\^2) (inclusive) with body weight ≤159 kg at Screening\n* Stable body weight\n* Participants on background glucagon-like peptide-1 (GLP-1) (or GLP-1\u002Fglucose-dependent insulinotropic polypeptide \\[GIP\\]) therapy must be on a stable dose for ≥6 months\n* Participants not on GLP-1 (or GLP-1\u002FGIP) therapy must be treatment naïve or off therapy for ≥6 months.\n\nKey Exclusion Criteria:\n\n* Clinical or laboratory signs of decompensated liver disease, history of esophageal varices, ascites, or hepatic encephalopathy, or history of cirrhosis on biopsy performed prior to Screening.\n* History or evidence of hepatic disease of non-metabolic dysfunction-associated steatotic liver disease (MASLD) etiology (viral hepatitis, alcoholic liver disease, primary biliary cholangitis \\[PBC\\], primary sclerosing cholangitis \\[PSC\\], Wilson's disease, alpha-1 antitrypsin \\[A1AT\\] deficiency, hemochromatosis, or autoimmune hepatitis).\n* Type 1 diabetes mellitus (T1DM) or uncontrolled Type 2 diabetes mellitus (T2DM).\n* Use of non-GLP-1 receptor medications known to cause weight loss within 3 months prior to Screening.\n* Use of medications associated with weight gain (for example, tricyclic antidepressants, mirtazapine, paroxetine, atypical antipsychotics) unless on a stable dose ≥3 months prior to Screening with anticipated continuation on this dose throughout the trial.\n* Clinically significant end-organ disease.\n* Major surgery within 90 days of Screening.\n* Use of hepatocyte-targeted ribonucleic acid interference (RNAi) therapies within 6 months of Screening.\n* Insulin use within 6 months of Screening (except short-term peri-procedural\u002Finpatient use).\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","70 Years",{"count":111,"type":112},252,"ESTIMATED","INTERVENTIONAL",[115],"PHASE2","This study is designed to evaluate the safety and efficacy of ARO-INHBE in adults with suspected metabolic dysfunction-associated steatohepatitis (MASH).",[118],"Metabolic Dysfunction-Associated Steatohepatitis",[120],"MASH","NOT_YET_RECRUITING","2026-09-30",{"date":124,"type":125},"2026-10-06","ACTUAL",{"date":127,"type":112},"2026-09",{"date":129,"type":112},"2029-10",{"name":5,"class":6}]