Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)

Exclusion Criteria

• •Known or suspected hypersensitivity to IMP or any of the excipients or to any component of the IMP formulation.
• •Previous participation in this trial. Participation is defined as randomised.
• •Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
• •History of multiple and/or severe allergies to drugs including contrast media or foods or a history of severe anaphylactic reaction.
• •Known non-MASH liver disease.
• •History or presence of cirrhosis (evidenced on imaging or by histology, or liver decompensation, including ascites, hepatic encephalopathy, or presence of esophageal varices).
• •Total body weight loss of \>5% within 6 months prior to screening.
• •If female, pregnancy or breast-feeding.
• •Women of childbearing potential who are not using a highly effective contraceptive method and whose male partner is not using a highly effective contraceptive method for the entire study duration and for at least 6 weeks after last dosing