Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)

Inclusion Criteria:

• Aged greater than or equal to 18 years at the time of signing informed consent. InRepublic of Korea, subjects must be aged greater than or equal to 19 years. InJapan, subjects must be aged greater than or equal to 20 years. In Singapore,subjects must be aged greater than or equal to 21 years.

• Histological evidence of NASH based on a central pathologist evaluation of thebaseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtainedwithin 180 days prior to Visit 1.

• Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRNclassification based on a central pathologist evaluation of the baseline liverbiopsy.

• Histological non-alcoholic fatty liver disease (NAFLD) activity score (NAS) greaterthan or equal to 4 for subjects with F2/F3 or greater than or equal to 3 forsubjects with F4 based on a central pathologist evaluation of the baseline liverbiopsy. All subjects must have a score of 1 or more in steatosis, lobularinflammation and hepatocyte ballooning.

Exclusion Criteria:

• Documented causes of chronic liver disease other than NAFLD.

• Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any knownpresence of HCV RNA or HBsAg within 2 years of screening (V2A).

• Presence or history of ascites more than grade 1, variceal bleeding, hepaticencephalopathy, spontaneous bacterial peritonitis or liver transplantation at V2A.

• For subjects with F4, presence or history of gastro-oesophageal varices more than orequal to grade 2 at V3. An oesophagogastroduodenoscopy performed no more than 52weeks prior to V3 must be available at V3.

• Known or suspected excessive consumption of alcohol (more than 20 g/day for women ormore than 30 g/day for men) or alcohol dependence (assessed by the Alcohol UseDisorders Identification Test (AUDIT questionnaire)).

• Treatment with vitamin E (at doses more than or equal to 800 IU/day) or pioglitazoneor medications approved for the treatment of NASH which has not been at a stabledose in the opinion of the investigator in the period from 90 days prior to V2A. Inaddition, for subjects with a historical liver biopsy taken more than 90 days priorto V2A, treatment should be at a stable dose in the opinion of the investigator fromtime of biopsy until V2A.

• Treatment with GLP-1 RAs within 90 days prior to V2A. Subjects with a historicalliver biopsy taken more than 90 days prior to V2A are excluded if they receivetreatment with GLP-1 RAs from time of biopsy until V2A.

• Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-loweringmedication or weight loss medication not stable in the opinion of the investigatorin the period from 90 days prior to V2A. In addition, for subjects with a historicalliver biopsy taken more than 90 days prior to V2A, treatment should be at a stabledose in the opinion of the investigator from time of biopsy until V2A.