ALN-PNP
DrugAdministered per the protocol
NCT Number: NCT05648214
This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug Administration (FDA) for any kind of treatment.
This study consists of 3 parts. Part A is focused on healthy participants. Parts B and C of the study are focused on participants who are known to have MASLD and a specific variant of the PNPLA3 gene.
The aim of the study is to see how safe, tolerable and effective the study drug is.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug (Parts A, B and C) * How much study drug (Parts A, B and C) and study drug metabolites (byproduct of the body breaking down the study drug) (Parts B and C) are in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) (Part A, B and C) * Explore impact of Japanese ethnicity on safety and PK (Pharmacokinetics, or study of what the body does to the drug) of single doses of ALN-PNP over time (Part A) * How the study drug works to change liver fat content in MASLD (Part B and C) * Better understanding of the study drug and MASLD (Part B and C)
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
California Clinical Trials Medical Group, Glendale, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Part A (Healthy Adults):
Part B and Part C (Participants with MASLD):
Key Exclusion Criteria:
Part A:
Part B and Part C:
NOTE: Other protocol defined inclusion / exclusion criteria apply
Administered per the protocol
Administered per the protocol
Time frame: Up to Day 337
Time frame: Up to Day 337
Time frame: Up to Day 337
Time frame: Up to Day 337
Time frame: Up to Day 337
Time frame: Baseline up to Day 169
Part A
Time frame: Baseline up to Day 169
Part A
Time frame: Baseline up to Day 337
Time frame: Baseline up to Day 337
Time frame: Baseline up to Day 253
Part B and Part C
Time frame: Baseline up to Day 337
Part B and Part C
Time frame: Baseline up to Day 337
Part B and Part C
Time frame: Baseline up to Day 337
Part B and Part C
Time frame: Baseline up to Day 337
Part B and Part C
Time frame: Baseline up to Day 337
Part C
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
A Three-Part, Phase 1/2a, Randomized, Double-blind, Placebo-Controlled, Single and Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of ALN-PNP, an siRNA Targeting PNPLA3, in Healthy Adults and Adult Participants With MASLD
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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