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A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk Factor

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
A Three-Part, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALN-PNP siRNA in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a PNPLA3 Genetic Risk Factor

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • Liver Diseases
  • Non-alcoholic Fatty Liver Disease
  • Nonalcoholic Fatty Liver Disease (NAFLD)
  • Nonalcoholic Steatohepatitis (NASH)
Clinical Trial Details
NCT number NCT06024408
Study type Interventional
Source Regeneron Pharmaceuticals
Contact Clinical Trials Administrator
Phone 844-734-6643
Email clinicaltrials@regeneron.com
Status Recruiting
Phase Phase 1
Start date May 21, 2024
Completion date September 14, 2025
View Details
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