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

RECRUITINGPhase 3Sponsored by Akero Therapeutics, Inc
Actively Recruiting
PhasePhase 3
SponsorAkero Therapeutics, Inc
Started2024-09-04
Est. completion2030-02
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations168 sites
View on ClinicalTrials.gov →

NCT06528314

Summary

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Other inclusion and exclusion criteria may apply.

Conditions3

Liver DiseaseMASH - Metabolic Dysfunction-Associated SteatohepatitisNASH - Nonalcoholic Steatohepatitis

Interventions1

Efruxifermin

Locations168 sites

Akero Clinical Study Site
Birmingham, Alabama, 35209
Akero Site 0129
Akero Clinical Study Site
Dothan, Alabama, 36301
Akero Site 0233
Akero Clinical Study Site
Chandler, Arizona, 85224
Akero Site 9106
Akero Clinical Study Site
Flagstaff, Arizona, 86001
Akero Clinical Study Site
Peoria, Arizona, 85381
Akero Site 9104

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