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
Start Date
2/9/2023
Completion Date
12/7/2028
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 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
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
ALN-HSD
Placebo
Conditions
Locations
Arizona Liver Health
Chandler, Arizona 85224
United States
The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff
Flagstaff, Arizona 86001
United States
The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria
Peoria, Arizona 85381
United States
Adobe Clinical Research
Tucson, Arizona 85712
United States
Arizona Liver Health - Tucson
Tucson, Arizona 85712
United States
Del Sol Research Management, LLC
Tucson, Arizona 85715
United States
San Fernando Valley Health Institute
Canoga Park, California 91304
United States
Velocity Clinical Research
Chula Vista, California 91911
United States
Southern California Research Center
Coronado, California 92118
United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California 92708
United States
Velocity Clinical Research
Gardena, California 90247
United States
Velocity Clinical Research - Huntington Park
Huntington Park, California 90255
United States
Om Research Llc
Lancaster, California 93534
United States
Ark Clinical Research - Long Beach
Long Beach, California 90815
United States
Velocity Clinical Research - Westlake
Los Angeles, California 90057
United States
Clinnova Research Solutions
Orange, California 92868
United States
Knowledge Research Center, St. Joseph's Medical Tower
Orange, California 92868
United States
National Research Institute
Panorama City, California 91402
United States
California Liver Research Institute
Pasadena, California 91105
United States
Cadena Care Inst.
Poway, California 92064
United States
Inland Empire Liver Foundation
Rialto, California 92377
United States
Precision Research Institute - San Diego
San Diego, California 92114
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
Synergy Healthcare LLC
Bradenton, Florida 34209
United States
Evolution Clinical Trials
Hialeah Gardens, Florida 33016
United States
Health Awareness, inc.
Jupiter, Florida 33458
United States
Miami Clinical Research
Miami, Florida 33155
United States
International Medical Investigational Centers (IMIC) Incorporated
Miami, Florida 33157
United States
Genoma Research Group, Inc.
Miami, Florida 33173
United States
US Associates in Research, LLC
Miami, Florida 33175
United States
Med Research of Florida, LLC
Miami, Florida 33186
United States
Charter Research LLC - Orlando
Orlando, Florida 32803
United States
Indiana University School of Medicine
Indianapolis, Indiana 46202
United States
Deaconess Clinic - GI Specialty Center
Newburgh, Indiana 47630
United States
Tandem Clinical Research
Metairie, Louisiana 70006
United States
Mercy Medical Center
Baltimore, Maryland 21202
United States
GI Associates
Flowood, Mississippi 39232
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United States
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United States
Austin Clinical Research, LLC
Austin, Texas 78745
United States
American Research Corporation
Austin, Texas 78757
United States
Pinnacle Clinical Research - Austin
Austin, Texas 78757
United States
South Texas Research Institute (STRI) - Brownsville
Brownsville, Texas 78520
United States
Velocity Clinical Research - Austin
Cedar Park, Texas 78613
United States
Methodist Dallas Medical Center
Dallas, Texas 75203
United States
South Texas Research Institute (STRI) - Edinburg
Edinburg, Texas 78539
United States
GI Alliance Research
Fort Worth, Texas 76104
United States
Allure Health at Mt. Olympus Medical Research
Friendswood, Texas 77546
United States
Advanced Medical Trials
Georgetown, Texas 78628
United States
Pioneer Research Solutions, Inc.
Houston, Texas 77099
United States
R & H Clinical Research, Inc.
Katy, Texas 77494
United States
Great Lakes Research Institute
Pharr, Texas 78577
United States
American Research Corporation at The Texas Liver Institute
San Antonio, Texas 78215
United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas 78229
United States
R & H Clinical Research
Stafford, Texas 77477
United States
Intermountain Health
Murray, Utah 84107
United States
University of Virginia Medical Center
Charlottesville, Virginia 22903
United States
Richmond Veterans Administration Medical Center
Richmond, Virginia 23249
United States
JCHO Hokkaido Hospital
Sapporo, Hokkaido 062-8618
Japan
Isis Clinical Research Center
Guaynabo, San Juan 00969
Puerto Rico
Klinical Investigations
San Juan, 00909
Puerto Rico
Latin Clinical Trial Center
San Juan, 00909
Puerto Rico
Fundacion de Investigacion (FDI) Clinical Research
San Juan, 00927
Puerto Rico
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Pusan National University Hospital
Busan, 49241
South Korea
Kyungpook National University Hospital
Daegu, 41944
South Korea
Keimyung University Dongsan Hospital
Daegu, 42601
South Korea
Hanyang University Seoul Hospital
Seoul, 04763
South Korea