RECRUITING

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

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Conditions

NASH - Nonalcoholic SteatohepatitisMASH - Metabolic Dysfunction-Associated Steatohepatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-04
Study Completion:2029-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06528314

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
  2. * Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
  1. * Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
  2. * Type 1 diabetes or unstable Type 2 diabetes
  3. * Any current or prior history of decompensated liver disease

Contacts and Locations

Study Contact

Akero Study Director
CONTACT
650-487-6488
AkeroSynchrony@akerotx.com

Study Locations (Sites)

Akero Clinical Study Site
Birmingham, Alabama, 35209
United States
Akero Clinical Study Site
Dothan, Alabama, 36301
United States
Akero Clinical Study Site
Chandler, Arizona, 85224
United States
Akero Clinical Study Site
Flagstaff, Arizona, 86001
United States
Akero Clinical Study Site
Peoria, Arizona, 85381
United States
Akero Clinical Study Site
Tucson, Arizona, 85712
United States
Akero Clinical Study Site
Tucson, Arizona, 85715
United States
Akero Clinical Study Site
Conway, Arkansas, 72032
United States
Akero Clinical Study Site
Jonesboro, Arkansas, 72401
United States
Akero Clinical Study Site
Little Rock, Arkansas, 72205
United States
Akero Clinical Study Site
North Little Rock, Arkansas, 72117
United States
Akero Clinical Study Site
Coronado, California, 92118
United States
Akero Clinical Study Site
Long Beach, California, 90815
United States
Akero Clinical Study Site
Pasadena, California, 91105
United States
Akero Clinical Study Site
Englewood, Colorado, 80113
United States
Akero Clinical Study Site
Bradenton, Florida, 34208
United States
Akero Clinical Study Site
Brandon, Florida, 33511
United States
Akero Clinical Study Site
Fort Myers, Florida, 33912
United States
Akero Clinical Study Site
Hialeah Gardens, Florida, 33016
United States
Akero Clinical Study Site
Lakewood Ranch, Florida, 34211
United States
Akero Clinical Study Site
Naples, Florida, 34102
United States
Akero Clinical Study Site
Ocala, Florida, 34471
United States
Akero Clinical Study Site
Orlando, Florida, 32806
United States
Akero Clinical Study Site
Pembroke Pines, Florida, 33027
United States
Akero Clinical Study Site
Sarasota, Florida, 34240
United States
Akero Clinical Study Site
Venice, Florida, 34285
United States
Akero Clinical Study Site
Viera, Florida, 32940
United States
Akero Clinical Study Site
Gainesville, Georgia, 30501
United States
Akero Clinical Study Site
Marietta, Georgia, 30060
United States
Akero Clinical Study Site
Snellville, Georgia, 30078
United States
Akero Clinical Study Site
South Bend, Indiana, 46635
United States
Akero Clinical Study Site
Topeka, Kansas, 66606
United States
Akero Clinical Study Site
Covington, Louisiana, 70433
United States
Akero Clinical Study Site
Houma, Louisiana, 70363
United States
Akero Clinical Study Site
Marrero, Louisiana, 70072
United States
Akero Clinical Study Site
Metairie, Louisiana, 70006
United States
Akero Clinical Study Site
Shreveport, Louisiana, 71105
United States
Akero Clinical Study Site
Baltimore, Maryland, 21202
United States
Akero Clinical Study Site
Dartmouth, Massachusetts, 02747
United States
Akero Clinical Study Site
Clinton Township, Michigan, 48038
United States
Akero Clinical Study Site
Columbia, Missouri, 65201
United States
Akero Clinical Study Site
Kansas City, Missouri, 64131
United States
Akero Clinical Study Site
Las Vegas, Nevada, 89106
United States
Akero Clinical Study Site
Jackson, New Jersey, 08527
United States
Akero Clinical Study Site
Sparta, New Jersey, 07871
United States
Akero Clinical Study Site
New York, New York, 10029
United States
Akero Clinical Study Site
Charlotte, North Carolina, 28204
United States
Akero Clinical Study Site
Charlotte, North Carolina, 28207
United States
Akero Clinical Study Site
Fayetteville, North Carolina, 28304
United States
Akero Clinical Study Site
Statesville, North Carolina, 28625
United States
Akero Clinical Study Site
Springboro, Ohio, 45066
United States
Akero Clinical Study Site
Westlake, Ohio, 44145
United States
Akero Clinical Study Site
Philadelphia, Pennsylvania, 19107
United States
Akero Clinical Study Site
Columbia, South Carolina, 29204
United States
Akero Clinical Study Site
Summerville, South Carolina, 29485
United States
Akero Clinical Study Site
Clarksville, Tennessee, 37040
United States
Akero Clinical Study Site
Hermitage, Tennessee, 37076
United States
Akero Clinical Study Site
Nashville, Tennessee, 37211
United States
Akero Clinical Study Site
Amarillo, Texas, 79106
United States
Akero Clinical Study Site
Austin, Texas, 78745
United States
Akero Clinical Study Site
Austin, Texas, 78757
United States
Akero Clinical Study Site
Brownsville, Texas, 78520
United States
Akero Clinical Study Site
Corpus Christi, Texas, 78404
United States
Akero Clinical Study Site
Dallas, Texas, 75203
United States
Akero Clinical Study Site
Dallas, Texas, 75234
United States
Akero Clinical Study Site
Dallas, Texas, 75246
United States
Akero Clinical Study Site
Dallas, Texas, 75390
United States
Akero Clinical Study Site
Denison, Texas, 75020
United States
Akero Clinical Study Site
Edinburg, Texas, 78539
United States
Akero Clinical Study Site
Edinburg, Texas, 78539
United States
Akero Clinical Study Site
Fort Worth, Texas, 76104
United States
Akero Clinical Study Site
Garland, Texas, 75044
United States
Akero Clinical Study Site
Houston, Texas, 77079
United States
Akero Clinical Study Site
San Antonio, Texas, 78222
United States
Akero Clinical Study Site
San Antonio, Texas, 78229
United States
Akero Clinical Study Site
San Antonio, Texas, 78229
United States
Akero Clinical Study Site
Sugar Land, Texas, 77478
United States
Akero Clinical Study Site
Waco, Texas, 76710
United States
Akero Clinical Study Site
Webster, Texas, 77598
United States
Akero Clinical Study Site
Wichita Falls, Texas, 76301
United States
Akero Clinical Study Site
Norfolk, Virginia, 23502
United States
Akero Clinical Study Site
Richmond, Virginia, 23236
United States
Akero Clinical Study Site
Richmond, Virginia, 23249
United States
Akero Clinical Study Site
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Akero Therapeutics, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-04
Study Completion Date2029-10

Study Record Updates

Study Start Date2024-09-04
Study Completion Date2029-10

Terms related to this study

Additional Relevant MeSH Terms

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