ALN-PNP
DrugPart A: Administered as single subcutaneous (SC) injection on day 1 Part B and Part C: Administered SC every 12 weeks (Q12W x2)
NCT Number: NCT06024408
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
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Chungbuk National University Hospital, Cheongju-si, Chungcheong Buk-do, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion Criteria apply
Part A: Administered as single subcutaneous (SC) injection on day 1 Part B and Part C: Administered SC every 12 weeks (Q12W x2)
Part A: Administered as single SC injection on day 1 Part B and Part C: Administered SC every 12 weeks (Q12W x2)
Time frame: Up to 253 days
Time frame: Up to 253 days
Time frame: Baseline up to 253 days
Time frame: Baseline up to 253 days
Time frame: Baseline up to 253 days
Time frame: Baseline up to 253 days
Time frame: Baseline up to 253 days
Time frame: Baseline up to 253 days
Time frame: Baseline up to 253 days
Time frame: Up to 253 days
Time frame: Up to 253 days
Time frame: Up to 253 days
Regeneron Pharmaceuticals
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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