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

Inclusion Criteria:

• Signed and dated informed consent obtained before any trial-related activities

• Male or female subject.

• Age between 18 and 75 years, both inclusive.

• Overweight or obesity (body mass index BMI ≥ 25.0 kg/m2 and ≤ 45.0 kg/m2) with orwithout type 2 diabetes mellitus (T2DM with an HbA1c ≤ 9.5%).

• eGFR ≥ 30 and < 90 (mL/min/1.73 m²).

• Presumed mild to higher liver fibrosis as shown by a FIBROTEST score ≥ 0.28 and/orFIB-4 score ≥ 1.3.

Exclusion Criteria:

• Known or suspected hypersensitivity to IMP or any of the excipients or to anycomponent 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 orfoods or a history of severe anaphylactic reaction.

• Known non-MASH liver disease.

• History or presence of cirrhosis (evidenced on imaging or by histology, or liverdecompensation, including ascites, hepatic encephalopathy, or presence of esophagealvarices).

• 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 contraceptivemethod and whose male partner is not using a highly effective contraceptive methodfor the entire study duration and for at least 6 weeks after last dosing