This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH. In 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. The study is looking at: * What side effects ALN-CIDEB might cause * How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring * 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Administered per the protocol
Administered per the protocol
Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)
Time frame: At week 26
Resolution of MASH with no worsening of Nonalcoholic Steatohepatitis-Clinical Research Network (NASH-CRN) fibrosis on liver biopsy
Time frame: At week 52
Percent change from baseline in liver fat by MRI-PDFF
Time frame: At week 52
Achievement of a ≥30% reduction in liver fat by MRI-PDFF
Time frame: At week 52
Achievement of ≤5% liver fat by MRI-PDFF
Time frame: At week 52
Percent change from baseline in liver fat by MRI-PDFF for each dose level of ALN-CIDEB
Time frame: Up to week 52
Improvement of NASH-CRN Fibrosis Stage (F) by ≥1 with no worsening of MASH
Time frame: At week 52
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to week 64
Severity of TEAEs
Time frame: Up to week 64
Change from baseline in FibroScan Controlled Attenuation Parameter (CAP)
Time frame: Through week 52
Change from baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)
Time frame: Through week 52
Change from baseline in Aspartate Aminotransferase (AST)
Time frame: Up to week 64
Change from baseline in Alanine Aminotransferase (ALT)
Time frame: Up to week 64
Change from baseline in Enhanced Liver Fibrosis (ELF)
Time frame: Through week 52
Change from baseline in PRO-C3
Time frame: Through week 52
Change from baseline in ADAPT
Time frame: Through week 52
Change from baseline in NIS2+
Time frame: Through week 52
Percent change from baseline in liver fat by MRI-PDFF in genetic subpopulations
Time frame: At week 52
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