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
1,150
Administered by subcutaneous injection
Administered by subcutaneous injection
Time from randomization to first occurrence of disease progression as measured by composite of protocol-specified clinical events
Time frame: 5 years
Cohort 1 only: ≥ 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
Change from baseline of non-invasive markers of liver fibrosis
Pro-C3 (ug/L)
Time frame: 96 Weeks
Change from baseline of non-invasive markers of liver fibrosis
Liver stiffness assessed by transient elastography (FibroScan®) (kPa)
Time frame: 96 Weeks
Change from baseline of non-invasive markers of liver fibrosis
FAST score (varied on a scale from 0 to 1, with the patients being classified as having low \[\<0.35\], intermediate \[0.35-0.67\], or higher \[\>0.67\] probability of having significant inflammatory activity and fibrosis)
Time frame: 96 Weeks
Change from baseline of markers of liver injury
ALT (U/L) and AST (U/L)
Time frame: 96 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 298 more locations
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
Change from baseline of markers of insulin sensitivity and glycemic control
HbA1c (%)
Time frame: 96 Weeks
Change from baseline of markers of insulin sensitivity and glycemic control
C-Peptide (ng/mL)
Time frame: 96 Weeks
Change from baseline of markers of insulin sensitivity and glycemic control
Adiponectin (mg/L)
Time frame: 96 Weeks
Change from baseline of markers of insulin sensitivity and glycemic control
Insulin (mIU/L)
Time frame: 96 Weeks
Change from baseline of markers of insulin sensitivity and glycemic control
HOMA-IR (≥ 2.5 indicates insulin resistance)
Time frame: 96 Weeks
Change from baseline of body weight (kg)
Time frame: 96 Weeks
To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)
Time frame: 96 Weeks
To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)
Time frame: 96 Weeks
To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)
Time frame: 96 Weeks
Number of participants with abnormal laboratory tests results, abnormal ECGs, abnormal ultrasounds, abnormal vital sign assessments
Time frame: 96 Weeks
Cohort 1 only: ≥ 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: ≥ 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, 5 Years
Cohort 1 only: 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, 5 Years
Cohort 1 only: 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, 5 Years