A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Official Summary

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 Requirements

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

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 2,150 participants

Study Arms

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

Interventions

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

Primary Outcomes

• Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc. (5 years)
• Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis (96 Weeks)

Secondary Outcomes

• Change from baseline of non-invasive markers of liver fibrosis (96 Weeks, 5 Years)
• Change from baseline of non-invasive markers of liver fibrosis (96 Weeks, 5 Years)
• Change from baseline of non-invasive markers of liver fibrosis (96 Weeks, 5 Years)
• Change from baseline of markers of liver injury (96 Weeks, 5 Years)
• Change from baseline of lipoproteins (96 Weeks, 5 Years)

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.

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, 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
• ...and 10 more locations

Contact Information

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

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