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

Status: Recruiting
Location: See all (71) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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-Clinical Research Network (CRN)

• NAS score ≥3, as defined in the protocol

• Meets genotype criteria for study enrollment, as defined in the protocol

• Has protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening

Locations
United States
Arizona
Arizona Liver Health
RECRUITING
Chandler
The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff
TERMINATED
Flagstaff
The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria
RECRUITING
Peoria
Adobe Clinical Research
RECRUITING
Tucson
Arizona Liver Health - Tucson
RECRUITING
Tucson
Del Sol Research Management, LLC
RECRUITING
Tucson
California
San Fernando Valley Health Institute
TERMINATED
Canoga Park
Velocity Clinical Research
TERMINATED
Chula Vista
Southern California Research Center
RECRUITING
Coronado
Ark Clinical Research - Fountain Valley
RECRUITING
Fountain Valley
Velocity Clinical Research
RECRUITING
Gardena
Velocity Clinical Research - Huntington Park
TERMINATED
Huntington Park
Om Research Llc
RECRUITING
Lancaster
Ark Clinical Research - Long Beach
RECRUITING
Long Beach
Velocity Clinical Research - Westlake
TERMINATED
Los Angeles
Clinnova Research Solutions
RECRUITING
Orange
Knowledge Research Center, St. Joseph's Medical Tower
RECRUITING
Orange
National Research Institute
RECRUITING
Panorama City
California Liver Research Institute
RECRUITING
Pasadena
Cadena Care Inst.
TERMINATED
Poway
Inland Empire Liver Foundation
RECRUITING
Rialto
Precision Research Institute - San Diego
TERMINATED
San Diego
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Florida
Synergy Healthcare, LLC
RECRUITING
Bradenton
Evolution Clinical Trials
RECRUITING
Hialeah Gardens
Health Awareness, inc.
RECRUITING
Jupiter
Genoma Research Group, Inc.
RECRUITING
Miami
IMIC, Inc
TERMINATED
Miami
Med Research of Florida, LLC
RECRUITING
Miami
Miami Clinical Research Center
TERMINATED
Miami
US Associates in Research, LLC
TERMINATED
Miami
Charter Research LLC - Orlando
RECRUITING
Orlando
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Deaconess Clinic - GI Specialty Center
RECRUITING
Newburgh
Louisiana
Tandem Clinical Research
RECRUITING
Metairie
Maryland
Mercy Medical Center
TERMINATED
Baltimore
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Mississippi
GI Associates
RECRUITING
Flowood
New York
Columbia University Irving Medical Center
RECRUITING
New York
Pennsylvania
Geisinger Medical Center
RECRUITING
Danville
Penn State Health Milton S. Hershey Medical Center
RECRUITING
Hershey
University of Pennsylvania - Perelman Center for Advanced Medicine
RECRUITING
Philadelphia
Texas
American Research Corporation
RECRUITING
Austin
Austin Clinical Research, LLC
SUSPENDED
Austin
Pinnacle Clinical Research - Austin
RECRUITING
Austin
South Texas Research Institute (STRI) - Brownsville
RECRUITING
Brownsville
Velocity Clinical Research - Austin
TERMINATED
Cedar Park
Methodist Dallas Medical Center
RECRUITING
Dallas
South Texas Research Institute (STRI) - Edinburg
RECRUITING
Edinburg
GI Alliance Research
RECRUITING
Fort Worth
Allure Health at Mt. Olympus Medical Research
TERMINATED
Friendswood
Advanced Medical Trials
RECRUITING
Georgetown
Pioneer Research Solutions, Inc.
RECRUITING
Houston
R & H Clinical Research, Inc.
TERMINATED
Katy
Great Lakes Research Institute
TERMINATED
Pharr
American Research Corporation at The Texas Liver Institute
RECRUITING
San Antonio
Pinnacle Clinical Research - San Antonio
RECRUITING
San Antonio
R & H Clinical Research
TERMINATED
Stafford
Utah
Intermountain Health
RECRUITING
Murray
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
Richmond Va Medical Center
RECRUITING
Richmond
Other Locations
Japan
JCHO Hokkaido Hospital
TERMINATED
Sapporo
Puerto Rico
Isis Clinical Research Center
TERMINATED
Guaynabo
Fundacion de Investigacion (FDI) Clinical Research
RECRUITING
San Juan
Klinical Investigations
TERMINATED
San Juan
Latin Clinical Trial Center
SUSPENDED
San Juan
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
TERMINATED
Daegu
Kyungpook National University Hospital
WITHDRAWN
Daegu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Hanyang University Seoul Hospital
RECRUITING
Seoul
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2023-02-09
Estimated Completion Date: 2027-09-08
Participants
Target number of participants: 90
Treatments
Experimental: ALN-HSD
Randomized 1:1
Placebo_comparator: Placebo
Randomized 1:1
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov