RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Boehringer Ingelheim • ClinicalTrials.gov ID: NCT07325526

Registry updated: 2026-10-14

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Description

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.

Interventions

BI 3802876 (Drug)
BI 3802876
Placebo (Drug)
Placebo

Eligibility criteria

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.

Conditions

Liver Cirrhosis

Locations

Arizona Clinical Trials - Chandler — Chandler, Arizona, United States
Southern California Research Center — Coronado, California, United States
Velocity Clinical Research, San Diego — La Mesa, California, United States
Kaiser Permanente - Los Angeles Medical Center — Los Angeles, California, United States
Catalina Research Institute, LLC — Montclair, California, United States
Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
Schiff Center Liver Diseases — Miami, Florida, United States
Panax Clinical Research — Miami Lakes, Florida, United States
Covenant Metabolic Specialists, LLC - University Park — University Park, Florida, United States
Centricity Research Columbus Georgia Multispecialty — Columbus, Georgia, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
Mayo Clinic, Rochester — Rochester, Minnesota, United States
Columbia University Medical Center — New York, New York, United States
Lucas Research, Inc. — 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
Baylor Scott & White Research Institute — 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
University of Alberta Hospital (University of Alberta) — Edmonton, Alberta, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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