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

Recruiting Phase 3 Interventional Study
NASH - Nonalcoholic Steatohepatitis MASH - Metabolic Dysfunction-Associated Steatohepatitis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
2,150 (estimated)
Sponsor
Akero Therapeutics, Inc · Industry
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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.

Trial Locations
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Eligibility Criteria
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 ci…
Contacts

Akero Study Director

650-487-6488

AkeroSynchrony@akerotx.com

CONTACT