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A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

ConditionsNASH - Nonalcoholic SteatohepatitisMASH - Metabolic Dysfunction-Associated Steatohepatitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAkero Therapeutics, Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of >=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities

Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

Disqualifiers

Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results

Type 1 diabetes or unstable Type 2 diabetes

Any current or prior history of decompensated liver disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Efruxifermin

    Drug

    Administered by subcutaneous injection

  • Placebo

    Drug

    Administered by subcutaneous injection

Treatment groups

2,150 Participants
are divided into 2 treatment groups
Group A: EFX 50 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

Change from baseline of non-invasive markers of liver fibrosis

Pro-C3 (ug/L)

Time frame
96 Weeks, 5 Years
3

Change from baseline of non-invasive markers of liver fibrosis

Liver stiffness assessed by transient elastography (FibroScan®) (kPa)

Time frame
96 Weeks, 5 Years
4

Change from baseline of markers of liver injury

ALT (U/L) and AST (U/L)

Time frame
96 Weeks, 5 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akero Therapeutics, Inc

Lead sponsor

Source ClinicalTrials.gov
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