Clinical Research Directory

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 or without 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/or FIB-4 score ≥ 1.3. 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