BI 3802876 for Compensated Liver Cirrhosis due to MASH
This study is for adults aged 18 to 75 with compensated liver cirrhosis (scarring of the liver that is stable) caused by MASH (Metabolic Dysfunction-Associated Steatohepatitis), a type of fatty liver disease. The main goal is to see how well a medicine called BI 3802876 is tolerated and handled by your body. Participants will be randomly assigned to receive either BI 3802876 or a placebo (a substance with no medicine) in different doses. You have more than twice the chance of receiving BI 3802876 than the placebo. The study will track any side effects (Adverse Events) for up to 134 days. The study is currently unclear on its recruitment status and plans to enroll 29 people.
- Study design
- This is an interventional study with 29 planned participants. Participants will be randomly assigned to one of three dose groups, receiving either BI 3802876 or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for the occurrence of any Adverse Events (AEs) for up to 134 days.
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NCT07325526
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
Recruiting
PHASE2Ages 18–75InterventionalTreatmentBoehringer Ingelheim
~29 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:BI 3802876Placebo
At a glance
Recruiting sites
13 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of any Adverse Events (AEs)
Measured over up to 134 days
Conditions
Where it's being run
27 sites across 15 statesTexas8
California4
Florida3
Arizona1
Colorado1
Georgia1
Iowa1
Kansas1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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
What this trial measures
- Occurrence of any Adverse Events (AEs)up to 134 days