A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)

Last updated: April 14, 2026
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

2

Condition

Hyponatremia

Hepatic Fibrosis

Treatment

BI 3802876

Placebo

Clinical Study ID

NCT07325526
1517-0002
1111-1313-8064
  • Ages 18-75
  • All Genders

Study Summary

This study is open to adults with a type of confirmed liver condition called compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH). The purpose of this study is to find out how well a study medicine called BI 3802876 is tolerated in people with this condition. The study looks at how different doses of BI 3802876 are handled by the body. BI 3802876 is being developed to improve liver health in people living with this liver condition.

Participants are put in 3 different dose groups randomly, which means by chance. Participants within a group get BI 3802876 or placebo. Placebo looks like BI 3802876 but does not contain any medicine. Participants have more than twice the chance of receiving BI 3802876 than placebo. The study medicine is given as an infusion into a vein.

Participants are in the study for about half a year. During this time, they visit the study site 12 times. At 2 visits, participants get the study medicine. Doctors collect information on any health problems and take blood samples to check how BI 3802876 is handled by the body. They compare results between the groups.

Eligibility Criteria

Inclusion

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:

  • Biopsy (collected during screening or ≤ 5 years* prior to screening) showing cirrhosis (fibrosis stage 4) with steatosis or steatohepatitis.

  • Biopsy (collected during screening or ≤ 5 years* prior to screening) showing cryptogenic cirrhosis.

  • Biopsy showing steatosis or steatohepatitis prior to screening without confirmation of fibrosis stage 4, or current or previous imaging showing steatosis with no liver histology available must meet either one of the following inclusion criteria at screening:

  1. Vibration-controlled transient elastography (VCTE) ≥ 15 kilopascals (kPa) plus 1 of the following, Magnetic Resonance Enterography (MRE) ≥4.2 kPa, platelet count <150,000/μL or imaging techniques (computed tomography (CT) scan and/or Magnetic Resonance Imaging (MRI) and/or Ultrasound) suggestive of cirrhosis.

  2. VCTE measurement ≥ 20 kPa

  3. Enhanced Liver Fibrosis (ELF) score ≥ 10.2 *If biopsy was collected > 365 days prior to screening either criteria a, b or c must be met Further inclusion criteria apply.

Exclusion Criteria :

  • Patients with clinically significant portal hypertension defined by any of the following:

  • VCTE ≥25 kPa if the platelets are ≥150,000/μL

  • VCTE ≥20 kPa if platelets are <150,000/μL

  • History of esophageal or gastric varices (Grade ≥1) on endoscopy

  • ELF score ≥11.3

  • 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.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: BI 3802876
Phase: 2
Study Start date:
February 27, 2026
Estimated Completion Date:
March 29, 2027

Connect with a study center

  • University of Alberta Hospital (University of Alberta)

    Edmonton, Alberta T6G 2XB
    Canada

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Southern California Research Center

    Coronado, California 92118
    United States

    Site Not Available

  • Velocity Clinical Research, San Diego

    La Mesa, California 91942
    United States

    Site Not Available

  • Orange County Research Center

    Lake Forest, California 92630
    United States

    Site Not Available

  • Kaiser Permanente - Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Site Not Available

  • Pfleger Liver Institute

    Los Angeles, California 90095
    United States

    Site Not Available

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Site Not Available

  • Velocity Clinical Research, San Diego

    San Diego, California 91942
    United States

    Site Not Available

  • Southern California Research Center

    Coronado 5339663, California 5332921 92118
    United States

    Site Not Available

  • Orange County Research Center

    Lake Forest 5364514, California 5332921 92630
    United States

    Site Not Available

  • Pfleger Liver Institute

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Catalina Research Institute, LLC

    Montclair 5374232, California 5332921 91763
    United States

    Site Not Available

  • Catalina Research Institute, LLC - Montclair

    Montclair 5374232, California 5332921 91763
    United States

    Site Not Available

  • Velocity Clinical Research, San Diego

    San Diego 5391811, California 5332921 91942
    United States

    Site Not Available

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Peak Gastroenterology Associates

    Colorado Springs 5417598, Colorado 5417618 80907
    United States

    Site Not Available

  • Schiff Center Liver Diseases

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Panax Clinical Research

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Covenant Metabolic Specialists, LLC - University Park

    University Park, Florida 34201
    United States

    Site Not Available

  • University of Miami

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Panax Clinical Research

    Miami Lakes 4164186, Florida 4155751 33014
    United States

    Site Not Available

  • Piedmont Healthcare-Atlanta

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Centricity Research Columbus Georgia Multispecialty

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Piedmont Healthcare-Atlanta

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Site Not Available

  • Centricity Research Columbus Georgia Multispecialty

    Columbus 4188985, Georgia 4197000 31904
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Mayo Clinic, Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic, Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Centricity Research - Morehead City

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Lucas Research, Inc.

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Centricity Research - Morehead City

    Morehead City 4480153, North Carolina 4482348 28557
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Nashville General Hospital

    Nashville, Tennessee 37209
    United States

    Site Not Available

  • Nashville General Hospital

    Nashville 4644585, Tennessee 4662168 37208
    United States

    Site Not Available

  • Texas Clinical Research Institute, LLC

    Arlington, Texas 76012
    United States

    Site Not Available

  • Epic Medical Research - Carrollton

    Carrollton, Texas 75006
    United States

    Site Not Available

  • The Liver Institute at Methodist Dallas

    Dallas, Texas 75203
    United States

    Site Not Available

  • Epic Medical Research - Fort Worth

    Fort Worth, Texas 76120
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Pioneer Research Solutions, Inc.

    Houston, Texas 77099
    United States

    Site Not Available

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Texas Clinical Research Institute, LLC

    Arlington 4671240, Texas 4736286 76012
    United States

    Site Not Available

  • Epic Medical Research - Carrollton

    Carrollton 4679195, Texas 4736286 75006
    United States

    Site Not Available

  • The Liver Institute at Methodist Dallas

    Dallas 4684888, Texas 4736286 75203
    United States

    Site Not Available

  • Epic Medical Research - Fort Worth

    Fort Worth 4691930, Texas 4736286 76120
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Pioneer Research Solutions, Inc.

    Houston 4699066, Texas 4736286 77099
    United States

    Site Not Available

  • American Research Corporation at the Texas Liver Institute

    San Antonio 4726206, Texas 4736286 78215
    United States

    Site Not Available

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