Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Start Date
1/29/2026
Completion Date
2/1/2028
Summary
The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (\>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Larsucosterol
Placebo
Conditions
Locations
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama 35294
United States
University of South Alabama
Mobile, Alabama 36602
United States
Banner - University Medical Center, Phoenix, Arizona
Phoenix, Arizona 85006
United States
Mayo Clinic - Phoenix
Phoenix, Arizona 85054
United States
Southern California GI & Liver Centers - Coronado
Coronado, California 92118
United States
Scripps
La Jolla, California 92037
United States
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
UCLA Health - Ronald Reagan Medical Center
Los Angeles, California 90095
United States
Stanford Medicine - Clinical and Translational Research Unit - Redwood City
Redwood City, California 94063
United States
University of California at Davis Medical Center
Sacramento, California 95757
United States
Sutter Health
San Francisco, California 94109
United States
Yale School of Medicine
New Haven, Connecticut 06510
United States
Georgetown University Medical Center
Washington D.C., District of Columbia 20007
United States
Mayo Clinic
Jacksonville, Florida 32202
United States
Reliant Medical Research
Miami, Florida 33131
United States
University of Miami
Miami, Florida 33131
United States
AdventHealth Transplant Institute
Orlando, Florida 32804
United States
AdventHealth Medical Campus
Tampa, Florida 33602
United States
Tampa General Hospital
Tampa, Florida 33606
United States
Piedmont Atlanta Hospital - Piedmont Transplant Institute
Atlanta, Georgia 30309
United States
Augusta University
Augusta, Georgia 30901
United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois 60601
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
Loyola University Medical Center (LUMC)
Maywood, Illinois 60153
United States
Indiana Institute for Medical Research (Indiana VA)
Indianapolis, Indiana 46204
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United States
University of Kentucky -Chandler Medical Center
Lexington, Kentucky 40507
United States
Robley Rex VA Medical Center
Louisville, Kentucky 40206
United States
Tulane University Health Sciences Center - Tulane Avenue
New Orleans, Louisiana 70112
United States
Maine Medical Center - Bramhall Campus
Portland, Maine 04102-3134
United States
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
Baltimore, Maryland 21202
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Tufts Medical Center
Boston, Massachusetts 02108
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Boston University School of Medicine
Boston, Massachusetts 02118
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
UMass Chan Medical School
Worcester, Massachusetts 01655
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Henry Ford Hospital System
Detroit, Michigan 48202
United States
University of Minnesota Medical Center
Minneapolis, Minnesota 55414-2924
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64106
United States
University of Nevada Las Vegas
Las Vegas, Nevada 89101
United States
Virtua Medical Group (VMG) - Virtua Center for Liver Disease - Toms River
Camden, New Jersey 08102
United States
Rutgers University New Jersey Medical School
Newark, New Jersey 07103-2425
United States
University of New Mexico (UNM) Hospital
Albuquerque, New Mexico 87106-4713
United States
Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases
Manhasset, New York 11030
United States
Columbia University Medical Center (CUMC) - Presbyterian Hospital and Vanderbilt Clinic
New York, New York 10007
United States
NYU Langone Health
New York, New York 10016
United States
University of Rochester Medical Center
Rochester, New York 14604
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Levine Cancer Institute / Atrium Health
Charlotte, North Carolina 28204
United States
Duke University Hospital
Durham, North Carolina 27710
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Cleveland Clinic
Cleveland, Ohio 44114
United States
The Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio 43210
United States
Oregon Health & Science University
Portland, Oregon 97204
United States
Penn State Health, Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United States
VA Medical Center - Philadelphia
Philadelphia, Pennsylvania 19104-4551
United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania 19104
United States
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania 19107
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States
University of Pittsburgh
Pittsburgh, Pennsylvania 15222
United States
Ralph H. Johnson Department of Veterans Affairs Medical Center
Charleston, South Carolina 29401
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Galen Medical Group - Galen Hepatology
Chattanooga, Tennessee 37402
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37219
United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas 75203
United States
Baylor Scott White Research Institute - Dallas
Dallas, Texas 75246
United States
North Texas Gastroenterology
Denton, Texas 76201
United States
Baylor Scott & White All Saints Medical Center - Forth Worth
Fort Worth, Texas 76104
United States
Clinical Trial Network - Houston
Houston, Texas 77002
United States
Baylor College of Medicine (BCM) - Baylor Clinic
Houston, Texas 77030
United States
Methodist Healthcare - Methodist Hospital Specialty and Transplant
San Antonio, Texas 78205
United States
Baylor Scott White Research Institute - Temple
Temple, Texas 76501
United States
Intermountain Transplant Clinic
Murray, Utah 84107
United States
University of Utah Health - University of Utah
Salt Lake City, Utah 84132
United States
University of Virginia Health
Charlottesville, Virginia 22908
United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia 23226
United States
Richmond VA Medical Center
Richmond, Virginia 23249
United States
Swedish Medical Center
Seattle, Washington 98101
United States
UW Medicine-Harborview Medical Center
Seattle, Washington 98101
United States
Marshall Health
Huntington, West Virginia 25701
United States
University of Wisconsin-Madison
Madison, Wisconsin 53703
United States