LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

Exclusion Criteria

• •1. Any of the following liver laboratory test abnormalities at screening:
• •* Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)
• •* Platelet count \<140 000/mm\^3 (\<140 GI/L)
• •* Alkaline phosphatase \>2x upper limit of normal (ULN)
• •* Abnormal synthetic liver function as defined by screening central laboratory evaluation:
• •* Albumin below \<3.5 g/dL (35.0 g/L)
• •* OR International normalised ratio (INR) of prothrombin time \>1.3
• •* OR total serum bilirubin concentration ≥1.5x ULN
• •2. Any history or evidence of acute or chronic liver disease other than MASH
• •3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
• •4. History of or current diagnosis of hepatocellular carcinoma
• •5. History of or planned liver transplant
• •6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
• •7. History of portal hypertension or presence of decompensated liver disease