Ensayos clínicos

Inclusion Criteria

• Informed consent obtained before any trial-related activities, ie. any procedures carried out as part of the trial, including to determine suitability for the trial
• Male or female
• Age 18-75 years inclusive (for Japan age 20-75 years  inclusive) at the time of signing informed consent
• Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening
• A histological NAS equal or above 4 with a score of 1 or more in each sub-component of the score based on central pathologist evaluation
• NASH fibrosis stage 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation

Exclusion Criteria

• Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence as assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire), or narcotics use
• Diagnosis of type 1 diabetes according to medical records
• HbA1c above 9% at screening
• History or presence of pancreatitis (acute or chronic)
• Calcitonin equal or above 50 ng/L at screening
• Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • Family is defined as a first degree relative
• Body Mass Index (BMI) equal or below 25.0 or equal or above 45.0 kg/m^2 at the screening visit
• Pregnant, breast-feeding, intending to become pregnant, or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)