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RECRUITING
NCT05519475
PHASE2

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

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-02-09

Completion Date

2027-09-08

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

DRUG

ALN-HSD

Administered by subcutaneous injection (SC)

DRUG

Placebo

Administered by SC injection

Locations (71)

Arizona Liver Health

Chandler, Arizona, United States

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

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

Ark Clinical Research - Fountain Valley

Fountain Valley, 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

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 Liver Foundation

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