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

Description

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.

Conditions

NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis

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Study Overview

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Study Details

Study overview

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.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrohosis Due to NASH/MASH

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

Condition
NASH - Nonalcoholic Steatohepatitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Akero Clinical Study Site, Birmingham, Alabama, United States, 35209

Dothan

Akero Clinical Study Site, Dothan, Alabama, United States, 36301

Chandler

Akero Clinical Study Site, Chandler, Arizona, United States, 85224

Flagstaff

Akero Clinical Study Site, Flagstaff, Arizona, United States, 86001

Peoria

Akero Clinical Study Site, Peoria, Arizona, United States, 85381

Tucson

Akero Clinical Study Site, Tucson, Arizona, United States, 85712

Tucson

Akero Clinical Study Site, Tucson, Arizona, United States, 85715

Conway

Akero Clinical Study Site, Conway, Arkansas, United States, 72032

Jonesboro

Akero Clinical Study Site, Jonesboro, Arkansas, United States, 72401

Little Rock

Akero Clinical Study Site, Little Rock, Arkansas, United States, 72205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
  • * Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Akero Therapeutics, Inc,

Study Record Dates

2029-10