A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Recruiting · NCT06528314 · 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 compensated cirrhosis due to NASH/MASH.
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
- 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
- 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 - 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 - Fountain Valley, 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 - Newport Beach, California, United States
- Akero Clinical Study Site - Orange, 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 Francisco, California, United States
- Akero Clinical Study Site - San Francisco, California, United States
- Akero Clinical Study Site - San Jose, California, United States
- Akero Clinical Study Site - Tarzana, 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 - Bradenton, Florida, United States
- Akero Clinical Study Site - Brandon, Florida, United States
- Akero Clinical Study Site - Cutler Bay, Florida, United States
- Akero Clinical Study Site - Daytona Beach, Florida, United States
- Akero Clinical Study Site - Doral, Florida, United States
- Akero Clinical Study Site - Fort Myers, Florida, United States
- Akero Clinical Study Site - Hialeah Gardens, Florida, United States
- Akero Clinical Study Site - Inverness, 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 - 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
- Akero Clinical Study Site - Naples, Florida, United States
- Akero Clinical Study Site - New Port Richey, Florida, United States
- Akero Clinical Study Site - Ocala, Florida, United States
- Akero Clinical Study Site - Orlando, Florida, United States
- Akero Clinical Study Site - Orlando, Florida, United States
- Akero Clinical Study Site - Pembroke Pines, Florida, United States
- Akero Clinical Study Site - Riverview, Florida, United States
- Akero Clinical Study Site - Sarasota, Florida, United States
- Akero Clinical Study Site - Temple Terrace, Florida, United States
Showing 60 of 331 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →