A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
NCT ID: NCT07325526
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2026-02-12
2027-03-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Placebo group
Placebo
Placebo
Dose group 1
BI 3802876
BI 3802876
Dose group 2
BI 3802876
BI 3802876
Dose group 3
BI 3802876
BI 3802876
Interventions
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BI 3802876
BI 3802876
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
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
Exclusion Criteria
* 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): patients with positive HCV ribonucleic acid (RNA). Patients treated for hepatitis C must have a negative RNA test at screening and be HCV RNA negative for at least 2 years prior to screening in order to be eligible for the trial.
* 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
18 Years
75 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Southern California Research Center
Coronado, California, United States
Orange County Research Center
Lake Forest, California, United States
Pfleger Liver Institute
Los Angeles, California, United States
Catalina Research Institute, LLC - Montclair
Montclair, California, United States
Velocity Clinical Research, San Diego
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
University of Miami
Miami, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Piedmont Healthcare-Atlanta
Atlanta, Georgia, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Centricity Research - Morehead City
Morehead City, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Nashville General Hospital
Nashville, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Epic Medical Research - Carrollton
Carrollton, Texas, United States
The Liver Institute at Methodist Dallas
Dallas, Texas, United States
Epic Medical Research - Fort Worth
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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1111-1313-8064
Identifier Type: REGISTRY
Identifier Source: secondary_id
1517-0002
Identifier Type: -
Identifier Source: org_study_id
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