This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
Who can participate
Inclusion Criteria:
* Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of \>=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities
* Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
Exclusion Criteria:
* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
* Type 1 diabetes or unstable Type 2 diabetes
* Any current or prior history of decompensated liver disease
Other inclusion and exclusion criteria may apply.
Interventions
Efruxifermin
DRUG
Placebo
DRUG
Locations
318
Argentina (7)
Akero Clinical Study Site
Buenos Aires , Buenos Aires
Akero Clinical Study Site
Buenos Aires , Distrito Federal
ACTIVE_NOT_RECRUITING
Akero Clinical Study Site
Ciudad Autónoma de Buenos Aires , Buenos Aires
Akero Clinical Study Site
Ciudad Autónoma de Buenos Aires , Buenos Aires
Akero Clinical Study Site
La Plata , Buenos Aires
Akero Clinical Study Site
Ramos Mejía , Buenos Aires
Akero Clinical Study Site
Rosario , Sante Fe
Australia (14)
Akero Clinical Study Site
Adelaide , South Australia
Akero Clinical Study Site
Box Hill , Victoria
Akero Clinical Study Site
Broadmeadow , New South Wales
Akero Clinical Study Site
Clayton , Victoria
Akero Clinical Study Site
Epping , Victoria
Akero Clinical Study Site
Heidelberg , Victoria
Akero Clinical Study Site
Herston , Queensland
Akero Clinical Study Site
Kingswood , New South Wales
Akero Clinical Study Site
Liverpool , New South Wales
Akero Clinical Study Site
Melbourne , Victoria
Akero Clinical Study Site
Murdoch , Western Australia
Akero Clinical Study Site
Nedlands , Western Australia
Akero Clinical Study Site
Perth , Western Australia
Akero Clinical Study Site
Westmead , New South Wales
Brazil (4)
Akero Clinical Study Site
Belo Horizonte , Minas Gerais
Akero Clinical Study Site
Brasília , Federal District
ACTIVE_NOT_RECRUITING
Akero Clinical Study Site
Goiânia , Goiás
Akero Clinical Study Site
Porto Alegre , Rio Grande do Sul
Canada (6)
Akero Clinical Study Site
Edmonton , Alberta
Akero Clinical Study Site
Montreal , Quebec
Akero Clinical Study Site
Terrebonne , Quebec
Akero Clinical Study Site
Toronto , Ontario
Akero Clinical Study Site
Toronto , Ontario
Akero Clinical Study Site
Vaughan , Ontario
Chile (5)
Akero Clinical Study Site
La Serena , Coquimbo Region
Akero Clinical Study Site
Las Condes , Santiago Metropolitan
Akero Clinical Study Site
Santiago , Santiago Metropolitan
Akero Clinical Study Site
Santiago , Santiago Metropolitan
Akero Clinical Study Site
Santiago , Santiago Metropolitan
ACTIVE_NOT_RECRUITING
France (14)
Akero Clinical Study Site
Angers , Maine-et-Loire
Akero Clinical Study Site
Clichy , Hauts-de-Seine
Akero Clinical Study Site
Créteil , Val-de-Marne
Akero Clinical Study Site
Le Chesnay , Île-de-France Region
Akero Clinical Study Site
Lille , Hauts-de-France
Akero Clinical Study Site
Limoges , Haute-Vienne
Akero Clinical Study Site
Lyon , Rhône
Akero Clinical Study Site
Marseille , Provence-Alpes-Côte d'Azur Region
Akero Clinical Study Site
Montpellier Cedex 5 , Provence-Alpes-Côte d'Azur Region