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A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

NCT06528314

RecruitingPhase 3

Sponsor: Akero Therapeutics, Inc

Conditions: NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis

Interventions: Efruxifermin, Placebo

Countries: United States, Argentina, Australia, Brazil, Canada, Chile, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (329)
  • Birmingham, Alabama, United States
  • Dothan, Alabama, United States
  • Chandler, Arizona, United States
  • Flagstaff, Arizona, United States
  • Peoria, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Conway, Arkansas, United States
  • Jonesboro, Arkansas, United States
  • Little Rock, Arkansas, United States
  • North Little Rock, Arkansas, United States
  • Coronado, California, United States
  • Escondido, California, United States
  • Folsom, California, United States
  • Fountain Valley, California, United States
  • Lancaster, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Newport Beach, California, United States
  • Orange, California, United States
  • Pasadena, California, United States
  • Redwood City, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • San Jose, California, United States
  • Tarzana, California, United States
  • + 299 more on CT.gov