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A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

NCT06215716

RecruitingPhase 3

Sponsor: Akero Therapeutics, Inc

Conditions: NASH With Fibrosis, MASH With Fibrosis

Interventions: Efruxifermin, Placebo

Countries: United States, Argentina, Australia, Canada, France, Germany, India, Israel

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Other inclusion and exclusion criteria may apply.

Locations (356)

Birmingham, Alabama, United States
Dothan, Alabama, United States
Chandler, Arizona, United States
Flagstaff, Arizona, United States
Peoria, 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
Chula Vista, California, United States
Coronado, California, United States
Escondido, California, United States
Folsom, California, United States
Inglewood, California, United States
La Mesa, California, United States
Lancaster, California, United States
Lancaster, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Orange, California, United States
Palm Springs, California, United States
Pasadena, California, United States
Redwood City, California, United States
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