A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Official Summary

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 Requirements

• Minimum Age: 18 Years
• Maximum Age: 80 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 1,650 participants

Study Arms

• EFX 28 mg (EXPERIMENTAL)
• EFX 50 mg (EXPERIMENTAL)
• Placebo (PLACEBO_COMPARATOR)

Interventions

• DRUG: Efruxifermin — Administered by subcutaneous injection
• DRUG: Placebo — Administered by subcutaneous injection

Primary Outcomes

• Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis (52 Weeks)
• Event-free survival (240 Weeks)

Secondary Outcomes

• Cohort 1 Only: Resolution of NASH/MASH and no worsening of fibrosis (52 Weeks)
• Cohort 1 Only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis (52 Weeks)
• Change from baseline of non-invasive markers of liver fibrosis (52 Weeks, 240 Weeks)
• Change from baseline of non-invasive markers of liver fibrosis (52 Weeks, 240 Weeks)
• Change from baseline of non-invasive markers of liver fibrosis (52 Weeks, 240 Weeks)

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).

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.

Trial Locations

• 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, Mesa, 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
• ...and 10 more locations

Contact Information

• Akero Study Director — CONTACT
  Phone: 650-487-6488
  Email: AkeroSynchrony@akerotx.com

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