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

Korábbi kezelés

• 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

Más betegség

• 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)
• Model for End-Stage Liver Disease (MELD) score > 12, unless due to therapeutic anti-coagulation

Laborértékek

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

Egyéb

• Present or past evidence of decompensating events of liver cirrhosis

• 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.