Recruiting
Phase 3

Larsucosterol

Sponsor:

Bausch Health Americas, Inc.

Code:

NCT07428538

Conditions

Hepatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Larsucosterol

Placebo

Study Details

Brief 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.

Conditions

Hepatitis

Study ID

NCT07428538

Start date

Jan 29, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Larsucosterol 30 mg

Participants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.

placebo comparator: Placebo

Participants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.

Interventions

Larsucosterol

Larsucosterol intravenous infusion.

Placebo

Matching-placebo (sterile water for injection) intravenous infusion.

Primary outcome measure

  • Transplant Free Survival up to Day 90 [ Time Frame: Up to Day 90 ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham (UAB) Hospital

Recruiting

Birmingham, Alabama, United States, 35294

Banner - University Medical Center, Phoenix, Arizona

Recruiting

Phoenix, Arizona, United States, 85006

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

University of California at Davis Medical Center

Recruiting

Sacramento, California, United States, 95757

Sutter Health

Recruiting

San Francisco, California, United States, 94109

Piedmont Atlanta Hospital - Piedmont Transplant Institute

Recruiting

Atlanta, Georgia, United States, 30309

University of Iowa Hospitals & Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Tulane University Health Sciences Center - Tulane Avenue

Recruiting

New Orleans, Louisiana, United States, 70112

Mercy Medical Center - The Institute for Digestive Health and Liver Disease

Recruiting

Baltimore, Maryland, United States, 21202

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

University of New Mexico (UNM) Hospital

Recruiting

Albuquerque, New Mexico, United States, 87106-4713

Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases

Recruiting

Manhasset, New York, United States, 11030

The Ohio State University Wexner Medical Center (OSUWMC)

Recruiting

Columbus, Ohio, United States, 43210

Penn State Health, Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

The Liver Institute at Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Baylor College of Medicine (BCM) - Baylor Clinic

Recruiting

Houston, Texas, United States, 77030

Intermountain Transplant Clinic

Recruiting

Murray, Utah, United States, 84107

University of Virginia Health

Recruiting

Charlottesville, Virginia, United States, 22908

Bon Secours Liver Institute of Richmond

Recruiting

Richmond, Virginia, United States, 23226

Richmond VA Medical Center

Recruiting

Richmond, Virginia, United States, 23249

More Information

Sponsor

Bausch Health Americas, Inc.

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Alcoholic hepatitis
  • alcohol-associated liver disease (ALD)
  • Liver transplant (LT)
  • Alcohol-associated hepatitis (AH)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bausch Health Americas, Inc. on 2026-08-24.