A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Official Summary

The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.

Eligibility Requirements

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

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 700 participants

Study Arms

• EFX 50 mg (EXPERIMENTAL)
• Placebo (PLACEBO_COMPARATOR)
• EFX 50 mg (Open-Label Rollover) (EXPERIMENTAL)

Interventions

• DRUG: Efruxifermin — Administered by subcutaneous (SC) injection
• DRUG: Placebo — Administered by SC injection

Primary Outcomes

• Extent of exposure (52 Weeks)
• Number of participants with adverse events (52 Weeks)
• Number of participants with adverse events by severity (52 Weeks)
• Number of participants with clinically significant changes in clinical assessments (52 Weeks)

Secondary Outcomes

• Percentage of participants with reduction in enhanced liver fibrosis (ELF) score by ≥ 0.5 and reduction in liver stiffness measurement (LSM) by ≥ 30% (52 Weeks)
• Change from baseline in non-invasive marker ELF score (52 Weeks)
• Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3) (52 Weeks)
• Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP) (52 Weeks)
• Percentage of participants with a reduction in ELF score by ≥ 0.5 (52 Weeks)

Eligibility Criteria

Inclusion Criteria:

Main Study Only:

* Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
* 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
* Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD

Open-Label Rollover

* Prior participation in a previous Akero Phase 2 study

Exclusion Criteria:

* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis \[PBC\], primary sclerosing cholangitis \[PSC\], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
* Type 1 or unstable Type 2 diabetes

A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.

Other inclusion and exclusion criteria may apply.

Trial Locations

• Akero Clinical Study Site, Birmingham, 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, 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
• ...and 10 more locations

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