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
213
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. No worsening of steatohepatitis was defined as no increase in score for any of the 3 components of NAS. The evaluation of the NAS endpoint was calculated using the following 3 categorical features: steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocellular ballooning \[0-2\]. NAS was derived as the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores.
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 and 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) 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 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 by 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
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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 96
Main: Change From Baseline in S-Pro-C3
Change from baseline in Serum Pro-C3 (N-terminal type III collagen propeptide), a biomarker of type III collagen formation reflecting fibrogenesis, measured in ug/L.
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score
ELF score is a composite serum biomarker score derived from HA, PIIINP, and TIMP-1 concentrations. Scores range approximately from 6 to 16, with higher scores indicating greater liver fibrosis severity.
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Liver Stiffness Assessed by Liver Elastography (kPa)
Change from baseline in liver stiffness assessed by liver elastography (kPa)
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), high-density lipoprotein (HDL-C) (mg/dL), non-HDL-C (mg/dL), and low-density lipoprotein (LDL-C) (mg/dL)
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in HbA1c (%)
Glycated hemoglobin (HbA1c), expressed as a percentage, reflects average blood glucose levels over approximately 2 to 3 months and is used as a measure of glycemic control
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in C-peptide (ug/L)
C-peptide reflects endogenous insulin secretion and pancreatic beta-cell function. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Adiponectin (mg/L)
Adiponectin is involved in glucose and lipid metabolism and is used as a marker of metabolic status. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Insulin (mIU/L)
Insulin reflects endogenous insulin levels measured after a period of fasting. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Time frame: Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in HOMA-IR
HOMA-IR has no fixed upper limit. Values near 1 are typically observed in individuals with normal insulin sensitivity, while progressively higher values indicate increasing insulin resistance. The clinical significance of a given value may vary depending on the population and assay methodology. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
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: Number of Participants With ADA Against EFX
Detect and measure ADA 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