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

Open to people ages 18-75

:

• 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.

:

• 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): 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
• International Normalized Ratio (INR) >1.3 unless due to therapeutic anticoagulants or laboratory error Further exclusion criteria apply.