Can this IV drug help avoid liver transplants in heavy drinkers?

NCT ID NCT07428538

Disease control Sponsor: Bausch Health Americas, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This Phase 3 trial tests an experimental drug called larsucosterol in 350 people with severe alcohol-associated hepatitis. The goal is to see if the drug helps patients survive for 90 days without needing a liver transplant. Participants receive either the drug or a placebo by IV, and researchers track survival, hospital stays, and overall health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: larsucosterol (also called DUR928 or DV928), given as an intravenous infusion
What this could lead to: If it works, this could provide a new treatment to help people with severe alcohol-related hepatitis survive without needing a liver transplant.
What could go wrong: This is a late-stage trial, but the condition is very serious and hard to treat. The drug may not improve survival or could have side effects. Results are still pending.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria- A participant will be eligible for inclusion in this study if he/she meets all the following criteria: 1. Able to provide written informed consent (either from participant or participant's legally acceptable representative). 2. Onset of jaundice within 8 weeks before hospital admission. 3. Average daily consumption of greater than (\>) 40 (females) or \>60 (males) grams alcohol for 6 months or longer, with less than (\<) 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made and documented by the site Investigator. 4. The determination of AH will be based on typical serum chemistry (as determined by local laboratory): 1. Serum total bilirubin \>3.0 milligrams per deciliter (mg/dL) (required at randomization) 2. ALT \<400 international unit per Liter (IU/L) (required at randomization) 3. 50 \<AST \<400 IU/L 4. AST \<400 IU/L (required at randomization) 5. AST \>50 IU/L (at any time since current hospital admission or leading to this current hospitalization) 6. AST/ALT \>1.5 (at any time since current hospital admission or leading to this current hospitalization) 5. Maddrey discriminant function (MDF) \>=32, assuming a control prothrombin time of 12 seconds. NOTE: If a local laboratory's control time differs from 12 seconds, then the local laboratory's control time should be used. If control time is not stated or is stated as a range, the control time should be calculated by the formula prothrombin time/INR. 6. Original Model for End-stage Liver Disease (MELD; not MELD-Na) score: 21-30 (inclusive). 7. Male or female participants 18 years of age or older. 8. Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the 90-day portion of the study. Acceptable methods that may be used are abstinence, birth control pills ("The Pill") or patch, diaphragm, IUD (coil), vaginal ring, condom, surgical sterilization or progestin implant or injection, or sexual activity limited to a sterile (e.g., vasectomized) male partner. 9. Male participants must agree to use a medically acceptable method of contraception/birth control and refrain from sperm donation throughout the 90-day portion of the study. 10. Participants must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists. 11. Participants must be dosed within 9 calendar days (216 hours) of hospital admission inclusive of time spent in other hospital(s) Exclusion Criteria- A participant will be excluded from the study if he or she meets any of the following criteria: 1. Participants using systemic corticosteroids for current AH before enrollment or having a history of using systemic corticosteroids for more than 8 days in the last 30 days prior to screening. NOTE: Inhaled, topical, or local corticosteroid injections are permitted NOTE: A participant who has a confirmed diagnosis of hypoadrenalism and is taking a physiological replacement dose of hydrocortisone (or equivalent) is permitted to take part in the trial 2. Participants experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens. 3. Active infection (such as spontaneous bacterial peritonitis \[SBP\], urinary tract infection \[UTI\], cellulitis, pneumonia, bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection). 1. Participants who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor. 2. Participants with bacterial infections may be enrolled provided they remain in the enrollment window and the infection is adequately treated. For example, participants with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP. 3. Participants with systemic fungal infection of any kind cannot be considered for this trial. 4. Serum creatinine \>2.5 mg/dL. 5. Participants undergoing continuous veno-venous hemodialysis (CVVH). 6. Gastrointestinal bleeding not controlled by local therapy (i.e., band ligation or injection sclerotherapy). Participant who are at high risk of rebleeding or likely in need of TIPS insertion should be excluded. 7. TIPS insertion or variceal embolization within the last 4 weeks. 8. Known portal vein occlusion. 9. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy. 10. Liver biopsy (if carried out) with findings not compatible with AH. NOTE: A post-dose liver biopsy that is not compatible with AH will not be considered a protocol deviation. 11. Stage \>=3 hepatic encephalopathy by West Haven criteria. 12. Participants with medical conditions that are expected to pose a high risk of short-term (less than or equal to \[\<=\] 90 days) mortality unrelated to alcohol-associated hepatitis, or that may confound assessment of 90-day survival in the Investigator's judgement. Examples include, but are not limited to: 1. Severe concomitant cardiopulmonary disease (e.g., New York Heart Association \[NYHA\] Class III or IV heart failure) 2. Clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia, unmanaged atrial fibrillation, QTc \>=500 msec, or high-grade AV block) 3. Ventilator-dependent respiratory failure, or Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Stage III or IV chronic obstructive pulmonary disease \[COPD\]) 4. End-stage renal disease requiring chronic, ongoing dialysis 5. Severe uncontrolled endocrine or metabolic disorders 6. Severe psychiatric illness likely to interfere with study participation 7. Hypotension/shock as defined by the North American Consortium for the study of End-stage Liver Disease (NACSELD) criteria (i.e., Mean Arterial Pressure \[MAP\] \<60 millimeter of mercury (mmHg), despite adequate fluid resuscitation and cardiac output) 13. Other concomitant cause(s) of liver disease as a result of: 1. Autoimmune liver disease 2. Ischemic hepatitis 3. Wilson disease or alpha 1 antitrypsin deficiency 4. Vascular liver disease (e.g., Budd-Chiari) 5. Drug induced liver disease 6. Surface antigen positive hepatitis B (HBsAg+). NOTE: Participants with isolated core antibody (anti-HBc) or who are on stable antiviral medication with known viral suppression are not excluded, but appropriate HBV prophylaxis should be considered if steroid dosing \>4 weeks is anticipated. 7. Acute hepatitis A (if test performed per SOC) 8. Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. NOTE: participants with stable chronic HCV or successfully treated HCV are not excluded 9. Acute hepatitis E (if test performed per SOC) 10. Acute cytomegalovirus (CMV) viral hepatitis (if test performed per SOC) 14. Any known active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas). 15. Existing or intended pregnancy or breast feeding. 16. Participation in another interventional clinical trial within 30 days of Screening. 17. History of organ transplantation other than corneal transplant. 18. Underlying disease that, in the opinion of the site Investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug. 19. Participant listed for liver transplant (LT) prior to study drug administration. 20. Concern of participant's willingness and ability to be compliant with the schedule of protocol assessments, per the Investigator's judgement.

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Conditions

The condition(s) this trial relates to.

alcoholic hepatitis hepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

85 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AdventHealth Medical Campus
NOT_YET_RECRUITING

Tampa, Florida, 33602, United States
AdventHealth Transplant Institute
NOT_YET_RECRUITING

Orlando, Florida, 32804, United States
Augusta University
NOT_YET_RECRUITING

Augusta, Georgia, 30901, United States
Banner - University Medical Center, Phoenix, Arizona
RECRUITING

Phoenix, Arizona, 85006, United States
Baylor College of Medicine (BCM) - Baylor Clinic
RECRUITING

Houston, Texas, 77030, United States
Baylor Scott & White All Saints Medical Center - Fort Worth
NOT_YET_RECRUITING

Fort Worth, Texas, 76104, United States
Baylor Scott White Research Institute - Dallas
NOT_YET_RECRUITING

Dallas, Texas, 75246, United States
Baylor Scott White Research Institute - Temple
NOT_YET_RECRUITING

Temple, Texas, 76501, United States
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING

Boston, Massachusetts, 02215, United States
Bon Secours Liver Institute of Richmond
RECRUITING

Richmond, Virginia, 23226, United States
Boston University School of Medicine
NOT_YET_RECRUITING

Boston, Massachusetts, 02118, United States
Cedars Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Cleveland Clinic
NOT_YET_RECRUITING

Cleveland, Ohio, 44114, United States
Clinical Trial Network - Houston
NOT_YET_RECRUITING

Houston, Texas, 77002, United States
Columbia University Medical Center (CUMC) - Presbyterian Hospital and Vanderbilt Clinic
NOT_YET_RECRUITING

New York, New York, 10007, United States
Duke University Hospital
NOT_YET_RECRUITING

Durham, North Carolina, 27710, United States
Einstein Medical Center Philadelphia
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Galen Medical Group - Galen Hepatology
NOT_YET_RECRUITING

Chattanooga, Tennessee, 37402, United States
Georgetown University Medical Center
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20007, United States
Henry Ford Hospital System
NOT_YET_RECRUITING

Detroit, Michigan, 48202, United States
Indiana Institute for Medical Research (Indiana VA)
NOT_YET_RECRUITING

Indianapolis, Indiana, 46204, United States
Intermountain Transplant Clinic
RECRUITING

Murray, Utah, 84107, United States
Johns Hopkins Hospital
NOT_YET_RECRUITING

Baltimore, Maryland, 21287, United States
Levine Cancer Institute / Atrium Health
NOT_YET_RECRUITING

Charlotte, North Carolina, 28204, United States
Loyola University Medical Center (LUMC)
NOT_YET_RECRUITING

Maywood, Illinois, 60153, United States
Maine Medical Center - Bramhall Campus
NOT_YET_RECRUITING

Portland, Maine, 04102-3134, United States
Marshall Health
NOT_YET_RECRUITING

Huntington, West Virginia, 25701, United States
Massachusetts General Hospital
NOT_YET_RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
NOT_YET_RECRUITING

Jacksonville, Florida, 32202, United States
Mayo Clinic - Phoenix
NOT_YET_RECRUITING

Phoenix, Arizona, 85054, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
RECRUITING

Baltimore, Maryland, 21202, United States
Methodist Healthcare - Methodist Hospital Specialty and Transplant
NOT_YET_RECRUITING

San Antonio, Texas, 78205, United States
Montefiore Medical Center
NOT_YET_RECRUITING

The Bronx, New York, 10467, United States
NYU Langone Health
NOT_YET_RECRUITING

New York, New York, 10016, United States
North Texas Gastroenterology
NOT_YET_RECRUITING

Denton, Texas, 76201, United States
Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases
RECRUITING

Manhasset, New York, 11030, United States
Northwestern University - Feinberg School of Medicine
NOT_YET_RECRUITING

Chicago, Illinois, 60601, United States
Oregon Health & Science University
NOT_YET_RECRUITING

Portland, Oregon, 97204, United States
Penn State Health, Milton S. Hershey Medical Center
RECRUITING

Hershey, Pennsylvania, 17033, United States
Piedmont Atlanta Hospital - Piedmont Transplant Institute
RECRUITING

Atlanta, Georgia, 30309, United States
Ralph H. Johnson Department of Veterans Affairs Medical Center
NOT_YET_RECRUITING

Charleston, South Carolina, 29401, United States
Reliant Medical Research
NOT_YET_RECRUITING

Miami, Florida, 33131, United States
Richmond VA Medical Center
RECRUITING

Richmond, Virginia, 23249, United States
Robley Rex VA Medical Center
NOT_YET_RECRUITING

Louisville, Kentucky, 40206, United States
Rush University Medical Center
NOT_YET_RECRUITING

Chicago, Illinois, 60612, United States
Rutgers University New Jersey Medical School
NOT_YET_RECRUITING

Newark, New Jersey, 07103-2425, United States
Saint Luke's Hospital of Kansas City
NOT_YET_RECRUITING

Kansas City, Missouri, 64106, United States
Scripps
NOT_YET_RECRUITING

La Jolla, California, 92037, United States
Southern California GI & Liver Centers - Coronado
WITHDRAWN

Coronado, California, 92118, United States
Stanford Medicine - Clinical and Translational Research Unit - Redwood City
NOT_YET_RECRUITING

Redwood City, California, 94063, United States
Sutter Health
RECRUITING

San Francisco, California, 94109, United States
Swedish Medical Center
NOT_YET_RECRUITING

Seattle, Washington, 98101, United States
Tampa General Hospital
NOT_YET_RECRUITING

Tampa, Florida, 33606, United States
Temple University Hospital
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19140, United States
The Liver Institute at Methodist Dallas Medical Center
RECRUITING

Dallas, Texas, 75203, United States
The Ohio State University Wexner Medical Center (OSUWMC)
RECRUITING

Columbus, Ohio, 43210, United States
Thomas Jefferson University Hospital
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Tufts Medical Center
NOT_YET_RECRUITING

Boston, Massachusetts, 02108, United States
Tulane University Health Sciences Center - Tulane Avenue
RECRUITING

New Orleans, Louisiana, 70112, United States
UCLA Health - Ronald Reagan Medical Center
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
UMass Chan Medical School
NOT_YET_RECRUITING

Worcester, Massachusetts, 01655, United States
UW Medicine-Harborview Medical Center
NOT_YET_RECRUITING

Seattle, Washington, 98101, United States
University Hospitals Cleveland Medical Center
NOT_YET_RECRUITING

Cleveland, Ohio, 44106, United States
University of Alabama at Birmingham (UAB) Hospital
RECRUITING

Birmingham, Alabama, 35294, United States
University of California at Davis Medical Center
RECRUITING

Sacramento, California, 95757, United States
University of Iowa Hospitals & Clinics
RECRUITING

Iowa City, Iowa, 52242, United States
University of Kentucky -Chandler Medical Center
NOT_YET_RECRUITING

Lexington, Kentucky, 40507, United States
University of Miami
NOT_YET_RECRUITING

Miami, Florida, 33131, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Minnesota Medical Center
NOT_YET_RECRUITING

Minneapolis, Minnesota, 55414-2924, United States
University of Nevada Las Vegas
NOT_YET_RECRUITING

Las Vegas, Nevada, 89101, United States
University of New Mexico (UNM) Hospital
RECRUITING

Albuquerque, New Mexico, 87106-4713, United States
University of North Carolina (UNC Hospitals)
NOT_YET_RECRUITING

Chapel Hill, North Carolina, 27514, United States
University of Pennsylvania Hospital
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15222, United States
University of Rochester Medical Center
NOT_YET_RECRUITING

Rochester, New York, 14604, United States
University of South Alabama
NOT_YET_RECRUITING

Mobile, Alabama, 36602, United States
University of Utah Health - University of Utah
NOT_YET_RECRUITING

Salt Lake City, Utah, 84132, United States
University of Virginia Health
RECRUITING

Charlottesville, Virginia, 22908, United States
University of Wisconsin-Madison
NOT_YET_RECRUITING

Madison, Wisconsin, 53703, United States
VA Medical Center - Philadelphia
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19104-4551, United States
Vanderbilt University Medical Center
NOT_YET_RECRUITING

Nashville, Tennessee, 37219, United States
Virginia Mason Medical Center (VMMC) - Seattle
NOT_YET_RECRUITING

Seattle, Washington, 98101, United States
Virtua Medical Group (VMG) - Virtua Center for Liver Disease - Toms River
NOT_YET_RECRUITING

Camden, New Jersey, 08102, United States
Yale School of Medicine
NOT_YET_RECRUITING

New Haven, Connecticut, 06510, United States

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