RECRUITINGPhase 3INTERVENTIONAL
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
- Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
* 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
Treatments Being Tested
DRUG
Efruxifermin
Administered by subcutaneous injection
DRUG
Placebo
Administered by subcutaneous injection
Locations (20)
Akero Clinical Study Site
Birmingham, Alabama, United States
Akero Clinical Study Site
Dothan, Alabama, United States
Akero Clinical Study Site
Chandler, Arizona, United States
Akero Clinical Study Site
Flagstaff, Arizona, United States
Akero Clinical Study Site
Peoria, Arizona, United States
Akero Clinical Study Site
Scottsdale, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
Conway, Arkansas, United States
Akero Clinical Study Site
Jonesboro, Arkansas, United States
Akero Clinical Study Site
Little Rock, Arkansas, United States
Akero Clinical Study Site
North Little Rock, Arkansas, United States
Akero Clinical Study Site
Coronado, California, United States
Akero Clinical Study Site
Escondido, California, United States
Akero Clinical Study Site
Folsom, California, United States
Akero Clinical Study Site
Lancaster, California, United States
Akero Clinical Study Site
Long Beach, California, United States
Akero Clinical Study Site
Los Angeles, California, United States