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A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition
NCT05519475 · View on ClinicalTrials.gov ↗
Study Summary
This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have metabolic dysfunction-associated steatohepatitis (MASH). MASH is a form of metabolic dysfunction-associated steatotic liver disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring side effects related to MASH. The study is looking at several other research questions, including: * How ALN-HSD works to improve liver function and lessen MASH-related inflammation in the liver * What side effects may happen from receiving the study drug * How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times * Better understanding of the study drug and MASH
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALN-HSD
Study Locations (20)
California
- San Fernando Valley Health Institute — Canoga Park
- Velocity Clinical Research — Chula Vista
- Southern California Research Center — Coronado
- Ark Clinical Research - Fountain Valley — Fountain Valley
- Velocity Clinical Research — Gardena
- Velocity Clinical Research - Huntington Park — Huntington Park
- Om Research Llc — Lancaster
- Ark Clinical Research - Long Beach — Long Beach
- Velocity Clinical Research - Westlake — Los Angeles
- Clinnova Research Solutions — Orange
- Knowledge Research Center, St. Joseph's Medical Tower — Orange
- National Research Institute — Panorama City
- California Liver Research Institute — Pasadena
- Cadena Care Inst. — Poway
Arizona
- Arizona Liver Health — Chandler
- The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff — Flagstaff
- The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria — Peoria
- Adobe Clinical Research — Tucson
- Arizona Liver Health - Tucson — Tucson
- Del Sol Research Management, LLC — Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-02-09 |
| Est. Completion | 2027-09-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05519475
The ClinicalTrials.gov registry entry for NCT05519475 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metabolic Dysfunction-associated Steatohepatitis (MASH) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05519475 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05519475 about?
NCT05519475 is a clinical study titled "A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition". This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have metabolic dysfunction-associated steatohepatitis (MASH). MASH is a form of metabolic dysfunction-associated steatotic liver disease (MASLD). MASH occurs when fa...
What is the current status of trial NCT05519475?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2023-02-09. Estimated completion is 2027-09-08.
What conditions does trial NCT05519475 study?
This clinical trial studies the following conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05519475?
The interventions under investigation include: Placebo (DRUG), ALN-HSD (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05519475?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05519475 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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