Clinical Trials Directory

Trials / Completed

CompletedNCT06024408

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Regeneron Pharmaceuticals · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGALN-PNPPart A: Administered as single subcutaneous (SC) injection on day 1 Part B and Part C: Administered SC every 12 weeks (Q12W x2)
DRUGPlaceboPart A: Administered as single SC injection on day 1 Part B and Part C: Administered SC every 12 weeks (Q12W x2)

Timeline

Start date
2024-05-21
Primary completion
2025-07-07
Completion
2025-07-07
First posted
2023-09-06
Last updated
2025-07-31

Locations

5 sites across 1 country: South Korea

Regulatory

Source: ClinicalTrials.gov record NCT06024408. Inclusion in this directory is not an endorsement.