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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05519475

Public ClinicalTrials.gov record NCT05519475. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of siRNA Gene Silencing for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Participants With Genetic Risk Factors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 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

Study identification

NCT ID
NCT05519475
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
120 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 8, 2023
Primary completion
Apr 26, 2028
Completion
Dec 6, 2028
Last update posted
Jul 7, 2026

2023 – 2028

United States locations

U.S. sites
61
U.S. states
14
U.S. cities
51
Facility City State ZIP Site status
Arizona Liver Health Chandler Arizona 85224 Recruiting
The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff Flagstaff Arizona 86001 Terminated
The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria Peoria Arizona 85381 Recruiting
Adobe Clinical Research Tucson Arizona 85712 Recruiting
Arizona Liver Health - Tucson Tucson Arizona 85712 Recruiting
Del Sol Research Management, LLC Tucson Arizona 85715 Recruiting
San Fernando Valley Health Institute Canoga Park California 91304 Terminated
Velocity Clinical Research Chula Vista California 91911 Terminated
Southern California Research Center Coronado California 92118 Recruiting
Ark Clinical Research - Fountain Valley Fountain Valley California 92708 Recruiting
Velocity Clinical Research Gardena California 90247 Terminated
Velocity Clinical Research - Huntington Park Huntington Park California 90255 Terminated
Om Research Llc Lancaster California 93534 Recruiting
Ark Clinical Research - Long Beach Long Beach California 90815 Recruiting
Velocity Clinical Research - Westlake Los Angeles California 90057 Terminated
Clinnova Research Solutions Orange California 92868 Recruiting
Knowledge Research Center, St. Joseph's Medical Tower Orange California 92868 Recruiting
National Research Institute Panorama City California 91402 Terminated
California Liver Research Institute Pasadena California 91105 Recruiting
Cadena Care Inst. Poway California 92064 Terminated
Inland Empire Liver Foundation Rialto California 92377 Recruiting
Precision Research Institute - San Diego San Diego California 92114 Terminated
University of Colorado Anschutz Medical Campus Aurora Colorado 80045 Recruiting
Synergy Healthcare LLC Bradenton Florida 34209 Terminated
Evolution Clinical Trials Hialeah Gardens Florida 33016 Recruiting
Health Awareness, inc. Jupiter Florida 33458 Recruiting
Miami Clinical Research Miami Florida 33155 Terminated
International Medical Investigational Centers (IMIC) Incorporated Miami Florida 33157 Terminated
Genoma Research Group, Inc. Miami Florida 33173 Recruiting
US Associates in Research, LLC Miami Florida 33175 Terminated
Med Research of Florida, LLC Miami Florida 33186 Recruiting
Charter Research LLC - Orlando Orlando Florida 32803 Recruiting
Indiana University School of Medicine Indianapolis Indiana 46202 Recruiting
Deaconess Clinic - GI Specialty Center Newburgh Indiana 47630 Terminated
Tandem Clinical Research Metairie Louisiana 70006 Recruiting
Mercy Medical Center Baltimore Maryland 21202 Terminated
GI Associates Flowood Mississippi 39232 Recruiting
Washington University School of Medicine St Louis Missouri 63110 Recruiting
Columbia University Irving Medical Center New York New York 10032 Recruiting
Geisinger Medical Center Danville Pennsylvania 17822 Recruiting
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania 17033 Recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine Philadelphia Pennsylvania 19104 Recruiting
Austin Clinical Research, LLC Austin Texas 78745 Terminated
American Research Corporation Austin Texas 78757 Recruiting
Pinnacle Clinical Research - Austin Austin Texas 78757 Recruiting
South Texas Research Institute (STRI) - Brownsville Brownsville Texas 78520 Terminated
Velocity Clinical Research - Austin Cedar Park Texas 78613 Terminated
Methodist Dallas Medical Center Dallas Texas 75203 Recruiting
South Texas Research Institute (STRI) - Edinburg Edinburg Texas 78539 Terminated
GI Alliance Research Fort Worth Texas 76104 Recruiting
Allure Health at Mt. Olympus Medical Research Friendswood Texas 77546 Terminated
Advanced Medical Trials Georgetown Texas 78628 Recruiting
Pioneer Research Solutions, Inc. Houston Texas 77099 Recruiting
R & H Clinical Research, Inc. Katy Texas 77494 Terminated
Great Lakes Research Institute Pharr Texas 78577 Terminated
American Research Corporation at The Texas Liver Institute San Antonio Texas 78215 Recruiting
Pinnacle Clinical Research - San Antonio San Antonio Texas 78229 Recruiting
R & H Clinical Research Stafford Texas 77477 Terminated
Intermountain Health Murray Utah 84107 Terminated
University of Virginia Medical Center Charlottesville Virginia 22903 Recruiting
Richmond Veterans Administration Medical Center Richmond Virginia 23249 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05519475, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 7, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05519475 live on ClinicalTrials.gov.

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