A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults with Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Condition studied

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Investigational medicinal product(s)

Every trial of Aln-Cideb across our registers →

Eligibility

Primary endpoint

Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)

Endpoint detail

Resolution of MASH with no worsening of Nonalcoholic Steatohepatitis-Clinical Research Network (NASH-CRN) fibrosis on liver biopsy, Percent change from baseline in liver fat by MRI-PDFF, Achievement of a ≥30% reduction in liver fat by MRI-PDFF, Achievement of ≤5% liver fat by MRI-PDFF, Percent change from baseline in liver fat by MRI-PDFF for each dose level of ALN-CIDEB, Improvement of NASH-CRN Fibrosis Stage (F) by ≥1 with no worsening of MASH, Occurrence and severity of Treatment-Emergent Adverse Events (TEAEs), Change from baseline in FibroScan Controlled Attenuation Parameter (CAP), Change from baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE), Change from baseline in Aspartate Aminotransferase (AST), Change from baseline in Alanine Aminotransferase (ALT), Change from baseline in Enhanced Liver Fibrosis (ELF), Change from baseline in PRO-C3, Change from baseline in ADAPT, Change from baseline in NIS2+, Percent change from baseline in liver fat by MRI-PDFF in genetic subpopulations