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

Inclusion criteria:

1. Male or female adults ≥18 years of age at the time of screening, and at least thelegal age of consent in countries where it is >18 years

2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)

3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosisdiagnosed according to modified Liver Forum criteria (Noureddin et al,Gastroenterology 2020;159:422-427).

4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5%or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained duringthe screening period or a historic MRI-PDFF or FibroScan® with CAP ≤12 weeks priorto randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF <5% or FibroScan® with CAP <288 dB/m is allowed). This inclusion criterion does notapply for participants with a recent (≤12 months prior to randomisation) liverbiopsy showing steatosis/steatohepatitis.

5. Further inclusion criteria apply.

Exclusion criteria:

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

2. Model of end-stage liver Disease (MELD) score >12 due to liver disease

3. History or current (i.e. at screening) hepatic decompensation event of any of thefollowing but not limited to:

• History of portal hypertension-related upper gastrointestinal (GI) bleeding

• Ascites

• Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria

4. 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 therapeuticanticoagulants

• Total bilirubin (TBL) >1.2x upper limit of normal (ULN) NOTE: Trialparticipants with Gilbert Syndrome are eligible with a TBL >1.2x ULN ifreticulocyte count is within normal limits, haemoglobin is within normal limitsunless due to chronic anaemia and unrelated to haemolysis, and direct bilirubinis <20% of TBL.

• Alkaline phosphatase >1.5x ULN

• Platelet count <100,000/µL (<100 GI/L)

5. History or evidence of other chronic liver diseases, such as primary biliarycholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlapsyndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetichaemochromatosis

6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg))

7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and apositive HCV ribonucleic acid (RNA))

8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN

9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined onthe basis of typical exposure and history

10. History of liver transplantation or listed for liver transplantation

11. History of transjugular intrahepatic portosystemic shunt (TIPS) or otherradiological/surgical procedure for portal hypertension treatment

12. Further exclusion criteria apply