A Phase 3 interventional study of Efruxifermin and Placebo in NASH - Nonalcoholic Steatohepatitis and MASH - Metabolic Dysfunction-Associated Steatohepatitis, sponsored by Akero Therapeutics, Inc. Recruiting at 345 sites in 21 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Akero Therapeutics, Inc (part of Novo Nordisk A/S) · Phase 3, Interventional, and Treatment
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.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 2,150 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Akero Therapeutics, Inc is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
First submitted before Akero Therapeutics, Inc became part of Novo Nordisk A/S.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Efruxifermin
Drug: Placebo
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
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
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Showing the first 100 of 345 sites across 21 countries. Choose a country and city above to see the rest.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Efruxifermin
Non-alcoholic Fatty Liver Disease →