RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT05519475

Registry updated: 2026-10-08

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Description

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

Interventions

ALN-HSD (Drug)
Administered per the protocol
Placebo (Drug)
Administered per the protocol

Eligibility criteria

Key Inclusion Criteria: 1. Adult male or female ≥18 years (or country's legal age of adulthood) 2. A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN 3. NAS score ≥3, as defined in the protocol 4. Meets genotype criteria for study enrollment, as defined in the protocol 5. Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening Key Exclusion Criteria: 1. Evidence of other forms of known chronic liver disease, as defined in the protocol 2. Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol 3. History of Type 1 diabetes 4. Bariatric surgery within approximately 5 years prior to or planned during the study period 5. 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

Conditions

Metabolic Dysfunction-Associated SteatoHepatitis (MASH)

Locations

The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff — Flagstaff, Arizona, United States
The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria — Peoria, Arizona, United States
Adobe Clinical Research — Tucson, Arizona, United States
Arizona Liver Health - Tucson — Tucson, Arizona, United States
The Institute for Liver Health II LLC dba Arizona Liver Health — Tucson, Arizona, United States
Del Sol Research Management, LLC — Tucson, Arizona, United States
San Fernando Valley Health Institute — Canoga Park, California, United States
Velocity Clinical Research — Chula Vista, California, United States
Southern California Research Center — Coronado, California, United States
Velocity Clinical Research — Gardena, California, United States
Velocity Clinical Research - Huntington Park — Huntington Park, California, United States
Om Research Llc — Lancaster, California, United States
Ark Clinical Research - Long Beach — Long Beach, California, United States
Ark Clinical Research, LLC — Long Beach, California, United States
Velocity Clinical Research - Westlake — Los Angeles, California, United States
Clinnova Research Solutions — Orange, California, United States
Knowledge Research Center, St. Joseph's Medical Tower — Orange, California, United States
National Research Institute — Panorama City, California, United States
California Liver Research Institute — Pasadena, California, United States
Cadena Care Inst. — Poway, California, United States
Inland Empire Clinical Trials — Rialto, California, United States
Precision Research Institute - San Diego — San Diego, California, United States
University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
Synergy Healthcare LLC — Bradenton, Florida, United States
Evolution Clinical Trials — Hialeah Gardens, Florida, United States
Health Awareness, inc. — Jupiter, Florida, United States
Miami Clinical Research — Miami, Florida, United States
International Medical Investigational Centers (IMIC) Incorporated — Miami, Florida, United States
Genoma Research Group, Inc. — Miami, Florida, United States
US Associates in Research, LLC — Miami, Florida, United States
Med Research of Florida, LLC — Miami, Florida, United States
Charter Research LLC - Orlando — Orlando, Florida, United States
Indiana University School of Medicine — Indianapolis, Indiana, United States
Deaconess Clinic - GI Specialty Center — Newburgh, Indiana, United States
Tandem Clinical Research — Metairie, Louisiana, United States
Mercy Medical Center — Baltimore, Maryland, United States
GI Associates — Flowood, Mississippi, United States
Washington University School of Medicine — St Louis, Missouri, United States
Columbia University Irving Medical Center — New York, New York, United States
Geisinger Medical Center — Danville, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
University of Pennsylvania - Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
Austin Clinical Research, LLC — Austin, Texas, United States
American Research Corporation — Austin, Texas, United States
Pinnacle Clinical Research - Austin — Austin, Texas, United States
South Texas Research Institute (STRI) - Brownsville — Brownsville, Texas, United States
Velocity Clinical Research - Austin — Cedar Park, Texas, United States
Methodist Dallas Medical Center — Dallas, Texas, United States
South Texas Research Institute (STRI) - Edinburg — Edinburg, Texas, United States
GI Alliance Research — Fort Worth, Texas, United States
Allure Health at Mt. Olympus Medical Research — Friendswood, Texas, United States
Advanced Medical Trials — Georgetown, Texas, United States
Pioneer Research Solutions, Inc. — Houston, Texas, United States
R & H Clinical Research, Inc. — Katy, Texas, United States
Great Lakes Research Institute — Pharr, Texas, United States
American Research Corporation at The Texas Liver Institute — San Antonio, Texas, United States
Pinnacle Clinical Research - San Antonio — San Antonio, Texas, United States
R & H Clinical Research — Stafford, Texas, United States
Intermountain Health — Murray, Utah, United States
University of Virginia Medical Center — Charlottesville, Virginia, United States
Richmond Veterans Administration Medical Center — Richmond, Virginia, United States
JCHO Hokkaido Hospital — Sapporo, Hokkaido, Japan
Isis Clinical Research Center — Guaynabo, San Juan, Puerto Rico
Klinical Investigations — San Juan, Puerto Rico
Latin Clinical Trial Center — San Juan, Puerto Rico
Fundacion de Investigacion (FDI) Clinical Research — San Juan, Puerto Rico
Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Hospital — Busan, South Korea
Kyungpook National University Hospital — Daegu, South Korea
Keimyung University Dongsan Hospital — Daegu, South Korea
Hanyang University Seoul Hospital — Seoul, South Korea

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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