Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Akero Therapeutics, Inc
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
Main Study only: Body mass index (BMI) \> 25 kg/m\^2 (unless the patient has biopsy-proven NASH documented within the last 2 years).
Main Study only: Must have confirmation of ≥ 10% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
Main Study only: Biopsy-proven NASH. Must have had a liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
* Steatosis (scored 0 to 3),
* Ballooning degeneration (scored 0 to 2), and
* Lobular inflammation (scored 0 to 3)
Cohort C only: FibroScan® measurement \> 13.1 kPa.
Cohort C only: Cirrhosis due to NASH. Liver biopsy consistent with F4 fibrosis according to the NAS system, confirmed by the central or local reader.
You may not be if
Weight gain or loss \> 5% in the 3 months prior to randomization or \> 10% in the 6 months prior to screening.
