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NCT05519475 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH), sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT05519475: Recruiting Phase 2 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH), sponsored by Regeneron Pharmaceuticals.
NCT05519475 is a Phase 2 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 90 participants, below the 456-participant average among 5 other Metabolic Dysfunction-Associated Steatohepatitis (MASH) trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05519475, a Phase 2 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH), is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
Change in the continuous qFibrosis score measured by second harmonic generation/two-photon excitation microscopy
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 |
What NCT05519475 shows while recruiting
NCT05519475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 456-participant average among 5 other Metabolic Dysfunction-Associated Steatohepatitis (MASH) trials with a reported enrollment target (80% lower).
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.
NCT05519475 names 20 study sites across 2 states, led by California, Arizona.
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).
What interventions are being tested in trial NCT05519475?
The interventions under investigation include: Placebo (DRUG), ALN-HSD (DRUG).
Who is sponsoring clinical trial NCT05519475?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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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