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 diagnosed according to modified Liver Forum criteria (Noureddin et al, Gastroenterology 2020;159:422-427).
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 or FibroScan® with CAP ≤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.
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.
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:
History of portal hypertension-related upper gastrointestinal (GI) bleeding.
Ascites.
Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria.
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.
Platelet count <100,000/µL (<100 GI/L).
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)).
Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA)).