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

Inclusion criteria:

1. Male or female participants ≥18 years (or who are of legal age in countries wherethat is greater than 18 years) of age at time of consent

2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD) activity score [NAS] ≥4, with at least 1 point in inflammation and ballooning each) and fibrosis stageF2-F3 proven by a biopsy conducted during the screening period or by a historicalbiopsy conducted within the last 6 months prior to randomisation

3. Stable body weight defined as less than 5% self-reported change in body weight 3months prior to the screening or during the period between the historical biopsy andrandomisation, if a historical biopsy is used

4. Be willing to maintain a stable diet and physical activity levels throughout theentire trial

5. Further inclusion criteria apply

Exclusion criteria:

1. Any of the following liver laboratory test abnormalities at screening:

• Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit ofnormal (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 laboratoryevaluation:

• Albumin below <3.5 g/dL (35.0 g/L)

• OR International normalised ratio (INR) of prothrombin time >1.3 (unlessparticipant is on anticoagulants)

• OR total serum bilirubin concentration ≥1.5x ULN (participants with adocumented history of Gilbert's syndrome can be enrolled if the directbilirubin is within normal reference range)

2. Any history or evidence of acute or chronic liver disease other than MASH

3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screeningor 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 suitablehistorical biopsy is unavailable for central review), or during trial conduct.

7. History of portal hypertension or presence of decompensated liver disease (includinghepatic encephalopathy, variceal bleeding, ascites, and spontaneous bacterialperitonitis)

8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease.

9. Treatment with any medication for the indication obesity within 3 months beforescreening biopsy or historical biopsy time point

10. History of either chronic or acute pancreatitis or elevation of serum lipase oramylase >2x ULN as measured by the central laboratory at screening

11. Major surgery (in the opinion of the investigator) performed within 3 months priorto screening or planned during the trial

12. Further exclusion criteria apply