Clinical Trials

Inclusion Criteria:

- Age above or equal to 18 years at the time of signing informed consent.

- Histological evidence of NASH based on a central pathologist evaluation of the
baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained
within 180 days prior to the screening visit (V1).

- Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN
(Clinical Research Network) classification based on a central pathologist evaluation
of the baseline liver biopsy.

- A histological NAS (Non-alcoholic fatty liver disease Activity Score) above or equal
to 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte
ballooning based on a central pathologist evaluation of the baseline liver biopsy.

Exclusion Criteria:

- Documented causes of chronic liver disease other than non-alcoholic fatty liver
disease (NAFLD)

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

- Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous
bacterial peritonitis or liver transplantation at randomisation.

- Known or suspected excessive consumption of alcohol (greater than 20 g/day for women
or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use
Disorders Identification Test (AUDIT questionnaire)).

- Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or
pioglitazone or medications approved for treatment of NASH which has not been at a
stable dose in the period from 90 days prior to the screening visit (V2A). In
addition, for subjects with historical liver biopsies taken more than 90 days prior to
screening, treatment should be at a stable dose in from time of biopsy until
screening.

- Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit
(V2A). In addition, for subjects with historical liver biopsies taken more than 90
days prior to screening, any treatment with GLP-1 RAs from time of biopsy until
screening (V2A).

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/15/23. Questions regarding updates should be directed to the study team contact.