A Study Evaluating Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Description

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Conditions

NASH with Fibrosis, MASH with Fibrosis

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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 non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

A Study Evaluating Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Condition
NASH with Fibrosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

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

Chandler

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

Flagstaff

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

Mesa

Akero Clinical Study Site, Mesa, Arizona, United States, 85213

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, 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

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

  • * Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
  • * Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
  • * Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
  • * Steatosis (scored 0 to 3),
  • * Ballooning degeneration (scored 0 to 2), and
  • * Lobular inflammation (scored 0 to 3).
  • * Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
  • * Presence of cirrhosis on liver biopsy (fibrosis stage 4).
  • * Type 1 or uncontrolled Type 2 diabetes.

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

2032-11