Last updated 49 days ago
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
1650 patients around the world
Available in Puerto Rico, Spain, Argentina, United States
Akero Therapeutics, Inc
1650Patients around the world
This study is for people with
Fatty liver/nash
Nonalcoholic steatohepatitis
Steatohepatitis
Metabolic dysfunction-associated steatohepatitis - MASH
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetesFibroScan® measurement > 7.5 kPaELF score ≥ 7.7Biopsy-proven NASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 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)Lobular inflammation (scored 0 to 3)
- Other causes of liver disease based on medical history and/or liver histology and/or central laboratory resultsPresence of cirrhosis on liver biopsy (stage 4 fibrosis)Type 1 or uncontrolled Type 2 diabetes
SponsorAkero Therapeutics, Inc
Conditions
Nonalcoholic steatohepatitisMetabolic dysfunction-associated steatohepatitis - MASH
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06215716
