This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
182
Main: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36.
Time frame: Week 36
Main: Resolution of NASH assessed by the NASH CRN system
Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) as determined by the NASH CRN criteria at Week 36 and Week 96
Time frame: Week 36, Week 96
Main: Fibrosis improvement with no worsening of NASH assessed by the NASH CRN system
Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) and ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
Time frame: Week 36, Week 96
Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 96
Time frame: Week 96
Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
Time frame: Week 36, Week 96
Main: Change from baseline in non-invasive markers of fibrosis
Change from baseline in ELF score, Pro-C3 (ug/L),and liver stiffness assessed by liver elastography (kPa, CAP)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Akero Clinical Study Site
Chandler, Arizona, United States
Akero Clinical Study Site
Glendale, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
Akero Clinical Study Site
North Little Rock, Arkansas, United States
Akero Clinical Study Site
Fresno, California, United States
Akero Clinical Study Site
Long Beach, California, United States
Akero Clinical Study Site
Los Angeles, California, United States
Akero Clinical Study Site
Pasadena, California, United States
Akero Clinical Study Site
Englewood, Colorado, United States
...and 39 more locations
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change from baseline in lipoproteins
Change from baseline in Triglycerides (mg/dL), total cholesterol (mg/dL), HDL-C (mg/dL), non-HDL-C (mg/dL), and LDL-C (mg/dL)
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change from baseline of markers in insulin sensitivity and glycemic control
Change from baseline in HbA1c (%), C-peptide (ug/L), adiponectin (mg/L), insulin (mIU/L), and HOMA-IR
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change from baseline in body weight
Change from baseline in body weight (kg)
Time frame: Week 36, Week 48, Week 96
Main: To assess the immunogenicity of EFX
Detect and measure ADA, including NAb, against EFX
Time frame: Through Week 96
Main: To assess the safety and tolerability of EFX
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory tests, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Time frame: Through Week 96
Cohort D: To assess the safety and tolerability of EFX compared to placebo when added to an existing GLP-1R agonist in subjects with type 2 diabetes and liver fibrosis due to NASH
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory assessments, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Time frame: Through Week 12