A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Part of paid clinical trials in Glendale, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05648214
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Healthy Volunteers
  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • ALN-PNP — DRUG
    Administered per the protocol
  • Placebo (PB) — DRUG
    Administered per the protocol

Study Details

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)

Key Dates

Start date
Dec 27, 2022
Status verified
Apr 2026
Primary completion
Aug 10, 2027
Completion
Aug 10, 2027

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Cohorts
  • Experimental: Part A: Optional Cohort
  • Experimental: Part A: JPN Cohorts
  • Experimental: Part B: Cohorts
  • Experimental: Part C: Cohorts

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 337 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
California Clinical Trials Medical GroupGlendaleCalifornia91206-
Velocity Clinical researchLos AngelesCalifornia90057-
Genoma Research Group, IncMiamiFlorida33173-
Med Research of Florida, LLCMiamiFlorida33186-
Tandem Clinical ResearchMarreroLouisiana70072-
Pioneer Research SolutionsHoustonTexas77099-

Find similar trials in Glendale, CA

By research site
California Clinical Trials Medical Group· Glendale, CAVelocity Clinical research· Los Angeles, CAGenoma Research Group, Inc· Miami, FLMed Research of Florida, LLC· Miami, FLTandem Clinical Research· Marrero, LAPioneer Research Solutions· Houston, TX

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