A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Recruiting · NCT06215716 · Interventional (participants receive a specific treatment) · Lead sponsor: Akero Therapeutics, Inc
View the official record on ClinicalTrials.gov →Interventions studied
EfruxiferminPlacebo
What this trial is about
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 diabetes.
- Cohort 1: Biopsy-proven NASH/MASH. 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), and
- Lobular inflammation (scored 0 to 3).
- Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \<4 may be enrolled and are not required to meet 1 point in each of the components of NAS.
Exclusion criteria
- Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
- Presence of cirrhosis on liver biopsy (fibrosis stage 4).
- Type 1 or uncontrolled Type 2 diabetes.
- ther inclusion and exclusion criteria may apply.
Where it is running
60 locations listed across 34 US states.
- 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 - 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 - Chula Vista, California, 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 - Inglewood, California, United States
- Akero Clinical Study Site - La Mesa, California, United States
- Akero Clinical Study Site - Lancaster, 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
- Akero Clinical Study Site - Los Angeles, California, United States
- Akero Clinical Study Site - Los Angeles, California, United States
- Akero Clinical Study Site - Newport Beach, California, United States
- Akero Clinical Study Site - Orange, California, United States
- Akero Clinical Study Site - Palm Springs, California, United States
- Akero Clinical Study Site - Pasadena, California, United States
- Akero Clinical Study Site - Redwood City, California, United States
- Akero Clinical Study Site - Sacramento, California, United States
- Akero Clinical Study Site - San Diego, California, United States
- Akero Clinical Study Site - San Diego, California, United States
- Akero Clinical Study Site - San Diego, California, United States
- Akero Clinical Study Site - San Francisco, California, United States
- Akero Clinical Study Site - San Francisco, California, United States
- Akero Clinical Study Site - Santa Maria, California, United States
- Akero Clinical Study Site - Aurora, Colorado, United States
- Akero Clinical Study Site - Colorado Springs, Colorado, United States
- Akero Clinical Study Site - Englewood, Colorado, United States
- Akero Clinical Study Site - New Haven, Connecticut, United States
- Akero Clinical Study Site - Washington D.C., District of Columbia, United States
- Akero Clinical Study Site - Washington D.C., District of Columbia, United States
- Akero Clinical Study Site - Bradenton, Florida, United States
- Akero Clinical Study Site - Brandon, Florida, United States
- Akero Clinical Study Site - Doral, Florida, United States
- Akero Clinical Study Site - Fort Myers, Florida, United States
- Akero Clinical Study Site - Gainesville, Florida, United States
- Akero Clinical Study Site - Hialeah Gardens, Florida, United States
- Akero Clinical Study Site - Inverness, Florida, United States
- Akero Clinical Study Site - Jacksonville, Florida, United States
- Akero Clinical Study Site - Lady Lake, Florida, United States
- Akero Clinical Study Site - Lakewood Rch, Florida, United States
- Akero Clinical Study Site - Largo, Florida, United States
- Akero Clinical Study Site - Lehigh Acres, Florida, United States
- Akero Clinical Study Site - Maitland, Florida, United States
- Akero Clinical Study Site - Margate, Florida, United States
- Akero Clinical Study Site - Miami, Florida, United States
- Akero Clinical Study Site - Miami, Florida, United States
- Akero Clinical Study Site - Miami Gardens, Florida, United States
Showing 60 of 356 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →