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. The aim of the study is to see how safe and tolerable the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How the study drug works to change liver fat content * How much study drug and study drug metabolites (byproducts of the body breaking down the study drug) are in the blood at different times
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Richmond Pharmacology Limited
London, Greater London, United Kingdom
RECRUITINGParexel International Early Phase Clinical Unit
Harrow, London, United Kingdom
RECRUITINGIncidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 48 Weeks
Severity of TEAEs
Time frame: Up to 48 Weeks
Change in liver fat fraction by magnetic resonance imaging proton density fat fraction (MRI-PDFF)
Time frame: Baseline up to 48 Weeks
Total concentration of ALN-CIDEB in plasma
Time frame: Up to 48 Weeks
Total concentration of potential major metabolite(s) in plasma
Time frame: Up to 48 Weeks
Urinary recovery of ALN-CIDEB as a proportion of the dose
Part A
Time frame: Up to 36 Weeks
Urinary recovery of potential major metabolite(s) as a proportion of the dose
Part A
Time frame: Up to 36 Weeks
Change in aspartate aminotransferase (AST)
Time frame: Baseline up to 48 Weeks
Change in alanine aminotransferase (ALT)
Time frame: Baseline up to 48 Weeks
Change in hepatic cell death-inducing DNA fragmentation factor alpha-like effector b (CIDEB) messenger RiboNucleic Acid (mRNA) level
Part B
Time frame: Baseline up to 36 Weeks
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