Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
At least 1 metabolic risk factor.
Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis [NASH] Clinical Research Network (CRN) system) with compensated cirrhosis.
Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and <50.0 kilograms (kg)/meters squared (m^2).
Liver disorder other than MASH.
History or evidence of hepatic decompensation.
History or evidence of hepatocellular carcinoma.
Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
Participants taking vitamin E (>400 international units [IU]/day) must be on stable dose for at least 6 months prior to screening.
Sites
PCR Cuautitlán Izcalli
Recruiting
Nicolás Bravo E1-3, 703Generalísimo José María Morelos y Pavón, Manzana 007, Generalísimo José María Morelos y Pavón, 54769 Cuautitlán Izcalli, Méx., Mexico