LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

Más betegség

• Model of end-stage liver Disease (MELD) score >12 due to liver disease
• History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:
  • Portal hypertension-related upper gastrointestinal (GI) bleeding
  • Ascites
  • Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
• History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
• Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
• Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
• Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
• History of liver transplantation or listed for liver transplantation
• History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment

Laborértékek

• Any of the following lab test result at screening
  • Albumin below <3.5 g/dL (<35.0 g/L)
  • International normalised ratio (INR) >1.3 unless due to therapeutic anticoagulants
  • Total bilirubin (TBL) >1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL >1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is <20% of TBL.
  • Alkaline phosphatase >1.5x ULN
  • PLT <100,000/µL (<100 GI/L)
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN

Életkor

• Current or history (<5 years) of significant alcohol consumption, defined as an average of >140 g/week in female patients and >210 g/week in male patients, for a period of >3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.

Egyéb

• Further exclusion criteria apply

• Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is >18 years
• Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
• Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
• Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF <5% or FibroScan® with CAP <288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
• Further inclusion criteria apply.