This study is researching an experimental drug called ALN-PNP. This study is focused on participants who are known to have nonalcoholic fatty liver disease (NAFLD), and a specific variant of the patatin-like phospholipase domain containing 3 (PNPLA3) gene. The aim of this study is to see how safe, tolerable, and effective the study drug is. This 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 in NAFLD * How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in your blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) * Better understanding of the study drug and NAFLD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
Chungbuk National University Hospital
Cheongju-si, Chungcheong Buk-do, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 253 days
Severity of TEAEs
Time frame: Up to 253 days
Change in liver fat fraction by magnetic resonance imaging proton density fat fraction (MRI-PDFF) in participants with NAFLD
Time frame: Baseline up to 253 days
Change in low-density lipoprotein cholesterol (LDL-C) in participants with NAFLD
Time frame: Baseline up to 253 days
Change in high-density lipoprotein cholesterol (HDL-C) in participants with NAFLD
Time frame: Baseline up to 253 days
Change in triglycerides (TG) in participants with NAFLD
Time frame: Baseline up to 253 days
Change in lipoprotein a (Lp(a)) in participants with NAFLD
Time frame: Baseline up to 253 days
Change in apolipoprotein A1 (ApoA1) in participants with NAFLD
Time frame: Baseline up to 253 days
Change in apolipoprotein B (ApoB) in participants with NAFLD
Time frame: Baseline up to 253 days
Concentration of ALN-PNP and potential major metabolite(s) in plasma over time
Time frame: Up to 253 days
Incidence of anti-drug antibodies (ADAs) to ALN-PNP
Time frame: Up to 253 days
Titer of anti-drug antibodies (ADAs) to ALN-PNP
Time frame: Up to 253 days
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