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NCT05519475RecruitingPhase 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 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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
15 Aug 2022
Start date
9 Feb 2023
Primary completion date
27 Apr 2028
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT05519475

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From 9 Feb 2023 to the primary completion date, 27 Apr 2028
  • 71 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Bariatric surgery within approximately 5 years prior to or planned during the study period
  • Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)
    • Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Other illness

  • Evidence of other forms of known chronic liver disease, as defined in the protocol
  • Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol
  • History of Type 1 diabetes

Who the study is looking for

  • Adult male or female ≥18 years (or country's legal age of adulthood)
  • A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN
  • NAS score ≥3, as defined in the protocol
  • Meets genotype criteria for study enrollment, as defined in the protocol
  • Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (71)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
JCHO Hokkaido Hospital
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SapporoJapanTerminated
Pusan National University Hospital
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BusanSouth KoreaTerminated
Kyungpook National University Hospital
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DaeguSouth KoreaTerminated
Keimyung University Dongsan Hospital
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DaeguSouth KoreaTerminated
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaTerminated
Hanyang University Seoul Hospital
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SeoulSouth KoreaTerminated
Isis Clinical Research Center
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GuaynaboPuerto RicoTerminated
Klinical Investigations
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San JuanPuerto RicoTerminated
Fundacion de Investigacion (FDI) Clinical Research
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San JuanPuerto RicoRecruiting
Latin Clinical Trial Center
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San JuanPuerto RicoTerminated
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesRecruiting
Pinnacle Clinical Research - Austin
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AustinUnited StatesRecruiting
American Research Corporation
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AustinUnited StatesRecruiting
Austin Clinical Research, LLC
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AustinUnited StatesTerminated
Mercy Medical Center
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BaltimoreUnited StatesTerminated
Synergy Healthcare LLC
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BradentonUnited StatesTerminated
South Texas Research Institute (STRI) - Brownsville
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BrownsvilleUnited StatesTerminated
San Fernando Valley Health Institute
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Canoga ParkUnited StatesTerminated
Velocity Clinical Research - Austin
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Cedar ParkUnited StatesTerminated
University of Virginia Medical Center
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CharlottesvilleUnited StatesRecruiting
Velocity Clinical Research
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Chula VistaUnited StatesTerminated
Southern California Research Center
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CoronadoUnited StatesRecruiting
Methodist Dallas Medical Center
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DallasUnited StatesRecruiting
Geisinger Medical Center
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DanvilleUnited StatesRecruiting
South Texas Research Institute (STRI) - Edinburg
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EdinburgUnited StatesTerminated
The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff
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FlagstaffUnited StatesTerminated
GI Associates
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FlowoodUnited StatesRecruiting
GI Alliance Research
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Fort WorthUnited StatesRecruiting
Allure Health at Mt. Olympus Medical Research
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FriendswoodUnited StatesTerminated
Velocity Clinical Research
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GardenaUnited StatesTerminated
Advanced Medical Trials
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GeorgetownUnited StatesRecruiting
Penn State Health Milton S. Hershey Medical Center
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HersheyUnited StatesRecruiting
Evolution Clinical Trials
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Hialeah GardensUnited StatesRecruiting
Pioneer Research Solutions, Inc.
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HoustonUnited StatesRecruiting
Velocity Clinical Research-Huntington Park
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Huntington ParkUnited StatesTerminated
Indiana University School of Medicine
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IndianapolisUnited StatesRecruiting
Health Awareness, Inc
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JupiterUnited StatesRecruiting
R&H Clinical Research, Inc.
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KatyUnited StatesTerminated
Om Research LLC
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LancasterUnited StatesRecruiting
Ark Clinical Research - Long Beach
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Long BeachUnited StatesTerminated
Ark Clinical Research, LLC
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Long BeachUnited StatesTerminated
Velocity Clinical Research, Westlake
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Los AngelesUnited StatesTerminated
Tandem Clinical Research
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MetairieUnited StatesRecruiting
International Medical Investigational Centers (IMIC) Incorporated
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MiamiUnited StatesTerminated
Med Research of Florida, LLC
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MiamiUnited StatesRecruiting
Genoma Research Group, Inc.
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MiamiUnited StatesRecruiting
Miami Clinical Research
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MiamiUnited StatesTerminated
US Associates in Research, LLC
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MiamiUnited StatesTerminated
Intermountain Health
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MurrayUnited StatesTerminated
Deaconess Clinic - GI Specialty Center
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NewburghUnited StatesTerminated
Columbia University Irving Medical Center
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New YorkUnited StatesRecruiting
Knowledge Research Center, St. Joseph's Medical Tower
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OrangeUnited StatesRecruiting
Clinnova Research Solutions
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OrangeUnited StatesRecruiting
Charter Research LLC - Orlando
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OrlandoUnited StatesRecruiting
National Research Institute
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Panorama CityUnited StatesTerminated
California Liver Research Institute
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PasadenaUnited StatesRecruiting
The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria
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PeoriaUnited StatesRecruiting
Great Lakes Research Institute
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PharrUnited StatesTerminated
University of Pennsylvania - Perelman Center for Advanced Medicine
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PhiladelphiaUnited StatesRecruiting
Cadena Care Inst.
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PowayUnited StatesTerminated
Inland Empire Clinical Trials
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RialtoUnited StatesRecruiting
Richmond Veterans Administration Medical Center
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RichmondUnited StatesRecruiting
Pinnacle Clinical Research - San Antonio
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San AntonioUnited StatesRecruiting
American Research Corporation at the Texas Liver Institute
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San AntonioUnited StatesRecruiting
Precision Research Institute - San Diego
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San DiegoUnited StatesTerminated
R & H Clinical Research
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StaffordUnited StatesTerminated
Washington University School of Medicine
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St LouisUnited StatesRecruiting
The Institute for Liver Health II LLC dba Arizona Liver Health
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TucsonUnited StatesRecruiting
Arizona Liver Health - Tucson
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TucsonUnited StatesRecruiting
Del Sol Research Management, LLC
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TucsonUnited StatesRecruiting
Adobe Clinical Research
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TucsonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.