New drug hopes to tackle MASH cirrhosis

NCT ID NCT07325526

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 10 times

Summary

This study tests a new medicine called BI 3802876 in adults with compensated cirrhosis caused by MASH (a type of fatty liver disease). The main goal is to see if the drug is safe and how the body handles it. Participants receive either the drug or a placebo as an infusion, and are followed for about six months with 12 clinic visits.

What this could mean

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

Active substance: BI 3802876 (a drug given as an infusion into a vein)
What this could lead to: If successful, this could point toward a treatment to improve liver health in people with MASH-related cirrhosis.
What could go wrong: This is an early Phase 2 trial with only 29 participants, so results may not apply to everyone. The drug may cause side effects or fail to show benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Started

Feb 2026

Expected to finish

Aug 2027

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 to 75 years

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: * Male or female adults ≥18 to ≤75 years of age at the time of screening, and at least the legal age of consent in countries where it is \> 18 years * Patients meeting criteria for Child-Pugh category A without history of previous decompensation event * Compensated Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis diagnosed by 1 of the following: * The most recent liver biopsy (≤ 5 years prior to randomisation) showing cirrhosis with steatohepatitis. There is no evidence for a competing aetiology. * Historical biopsy (≤ 5 years prior to randomisation) showed steatohepatitis with F1 to F3 fibrosis, but now with cirrhosis either by NITs or biopsy. There is no evidence of competing aetiology. If there is a current biopsy (≤ 6 months prior to randomisation), and it does not show evidence of steatosis or steatohepatitis, there is at least 1 coexisting or history of metabolic comorbidity. * The most recent liver biopsy (≤ 5 years prior to randomisation) showing cirrhosis with steatosis. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or type 2 diabetes mellitus (T2DM). There is no evidence for a competing aetiology. * Historical biopsy (≤ 5 years prior to randomisation) showed steatosis, but now with cirrhosis, either by NITs or biopsy. If there is a current biopsy (≤ 6 months prior to randomisation), and it does not show evidence of steatosis or steatohepatitis, there are at least 2 coexisting or history of metabolic comorbidities including obesity and/or T2DM. There is no evidence of competing aetiology. * Trial participant with cirrhosis with current or previous imaging showing evidence of steatosis (by liver ultrasound or CT scan or FibroScan® with CAP ≥288 dB/m or MRI-PDFF ≥5%). There is no liver histology available. There are at least 2 coexisting or history of metabolic comorbidities, including obesity and/or T2DM. There is no evidence of competing aetiology. * Cryptogenic cirrhosis' (either by NITs or biopsy; not to exceed 20% of trial participants) without current or previous evidence of steatosis by imaging or steatosis/steatohepatitis by histology. There are at least 2 coexisting or history of metabolic comorbidities, including obesity and/or T2DM. There is no evidence of competing aetiology. Further inclusion criteria apply. Exclusion Criteria: * Patients with clinically significant signs of advanced portal hypertension defined by any of the following: * VCTE ≥30 kPa * VCTE ≥25 kPa if the platelets are ≥150,000/μL * History of esophageal or gastric varices (Grade ≥1) on endoscopy * Hepatic venous pressure gradient (HVPG) ≥10 mmHg * Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis \[PBC\], primary sclerosing cholangitis \[PSC\], autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1- antitryspin deficiency * Chronic viral hepatitis parameters that would be considered exclusionary for the participation in this trial are (hepatitis B and C testing will be done at screening visit): * Hepatitis B virus (HBV): Past or present hepatitis B infection, including a positive hepatitis B surface antigen (HBsAg) and/or detectable HBV Deoxyribonucleic Acid (DNA). * Hepatitis C virus (HCV): Past or present hepatitis C infection, including positive hepatitis C antibodies and/or detectable HCV ribonucleic acid (RNA). * History of liver transplantation or patients listed for liver transplantation * Suspicion, confirmed diagnosis, or history of Hepatocellular Carcinoma (HCC) * Present or past evidence of decompensating events of liver cirrhosis * Model for End-Stage Liver Disease (MELD) score \> 12, unless due to therapeutic anti-coagulation * History of significant alcohol consumption (defined as intake of \> 210 g/week in males and \> 140 g/week in females on average over a consecutive period of more than 3 months) within 1 year prior to screening * International Normalized Ratio (INR) \>1.3 unless due to therapeutic anticoagulants or laboratory error Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver cirrhosis, familial metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

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

Liver cirrhosis

How to take part

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

The places running it

27 sites in 2 countries. 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

American Research Corporation at the Texas Liver Institute
RECRUITING

San Antonio, Texas, 78215, United States
Arizona Clinical Trials - Chandler
NOT_YET_RECRUITING

Chandler, Arizona, 85225, United States
Baylor Scott & White Research Institute
NOT_YET_RECRUITING

Dallas, Texas, 75246, United States
Catalina Research Institute, LLC
RECRUITING

Montclair, California, 91763, United States
Centricity Research Columbus Georgia Multispecialty
RECRUITING

Columbus, Georgia, 31904, United States
Columbia University Medical Center
NOT_YET_RECRUITING

New York, New York, 10032, United States
Covenant Metabolic Specialists, LLC - University Park
RECRUITING

University Park, Florida, 34201, United States
Epic Medical Research - Carrollton
RECRUITING

Carrollton, Texas, 75006, United States
Epic Medical Research - Fort Worth
RECRUITING

Fort Worth, Texas, 76120, United States
Houston Methodist Hospital
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
Johns Hopkins Hospital
NOT_YET_RECRUITING

Baltimore, Maryland, 21287, United States
Kaiser Permanente - Los Angeles Medical Center
NOT_YET_RECRUITING

Los Angeles, California, 90027, United States
Lucas Research, Inc.
RECRUITING

Morehead City, North Carolina, 28557, United States
Mayo Clinic, Rochester
NOT_YET_RECRUITING

Rochester, Minnesota, 55905, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Nashville General Hospital
RECRUITING

Nashville, Tennessee, 37209, United States
Panax Clinical Research
RECRUITING

Miami Lakes, Florida, 33014, United States
Peak Gastroenterology Associates
RECRUITING

Colorado Springs, Colorado, 80907, United States
Pioneer Research Solutions, Inc.
RECRUITING

Houston, Texas, 77099, United States
Schiff Center Liver Diseases
NOT_YET_RECRUITING

Miami, Florida, 33136, United States
Southern California Research Center
RECRUITING

Coronado, California, 92118, United States
Texas Clinical Research Institute, LLC
NOT_YET_RECRUITING

Arlington, Texas, 76012, United States
The Liver Institute at Methodist Dallas
NOT_YET_RECRUITING

Dallas, Texas, 75203, United States
University of Alberta Hospital (University of Alberta)
NOT_YET_RECRUITING

Edmonton, Alberta, T6G 2XB, Canada
University of Iowa Hospitals and Clinics
NOT_YET_RECRUITING

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
NOT_YET_RECRUITING

Kansas City, Kansas, 66160, United States
Velocity Clinical Research, San Diego
NOT_YET_RECRUITING

La Mesa, California, 91942, United States

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