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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,150
Administered by subcutaneous injection
Administered by subcutaneous injection
Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.
Measured by composite of protocol-specified clinical events
Time frame: 5 years
Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
Time frame: 96 Weeks
Change from baseline of non-invasive markers of liver fibrosis
ELF (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis)
Time frame: 96 Weeks, 5 Years
Change from baseline of non-invasive markers of liver fibrosis
Pro-C3 (ug/L)
Time frame: 96 Weeks, 5 Years
Change from baseline of non-invasive markers of liver fibrosis
Liver stiffness assessed by transient elastography (FibroScan®) (kPa)
Time frame: 96 Weeks, 5 Years
Change from baseline of markers of liver injury
ALT (U/L) and AST (U/L)
Time frame: 96 Weeks, 5 Years
Change from baseline of lipoproteins
Total cholesterol (mg/dL), Triglycerides (mg/dL), HDL-C (mg/dL), Non-HDL-C (mg/dL), and LDL-C (mg/dL)
Time frame: 96 Weeks, 5 Years
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Akero Clinical Study Site
Birmingham, Alabama, United States
RECRUITINGAkero Clinical Study Site
Dothan, Alabama, United States
RECRUITINGAkero Clinical Study Site
Chandler, Arizona, United States
RECRUITINGAkero Clinical Study Site
Flagstaff, Arizona, United States
ACTIVE_NOT_RECRUITINGAkero Clinical Study Site
Peoria, Arizona, United States
RECRUITINGAkero Clinical Study Site
Scottsdale, Arizona, United States
RECRUITINGAkero Clinical Study Site
Tucson, Arizona, United States
RECRUITINGAkero Clinical Study Site
Tucson, Arizona, United States
RECRUITINGAkero Clinical Study Site
Tucson, Arizona, United States
RECRUITINGAkero Clinical Study Site
Tucson, Arizona, United States
RECRUITING...and 312 more locations
Change from baseline of markers of insulin sensitivity and glycemic control
HbA1c (%)
Time frame: 96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control
C-Peptide (ng/mL)
Time frame: 96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control
Adiponectin (mg/L)
Time frame: 96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control
Insulin (mIU/L)
Time frame: 96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control
HOMA-IR (≥ 2.5 indicates insulin resistance)
Time frame: 96 Weeks, 5 Years
Change from baseline of body weight (kg)
Time frame: 96 Weeks, 5 Years
Safety and tolerability of EFX through the reporting of extent of exposure (weeks)
Time frame: From first dose through end of study (up to 5 Years)
Safety and tolerability of EFX through the reporting of adverse events (frequency of events)
Proportion of subjects reporting adverse events
Time frame: From first dose through end of study (up to 5 Years)
Safety and tolerability of EFX through the reporting of adverse events (severity of events)
Proportion of subjects reporting adverse events
Time frame: From first dose through end of study (up to 5 Years)
Number of participants with abnormal laboratory tests results, abnormal ECGs, abnormal ultrasounds, abnormal vital sign assessments
Time frame: From first dose through end of study (up to 5 years)
Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
Time frame: 5 Years
Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis
Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
Time frame: 96 Weeks
Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH
Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning)
Time frame: 96 Weeks
Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis
Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
Time frame: 96 Weeks