RECRUITING

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

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Conditions

NASH with FibrosisMASH with Fibrosis

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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 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.

Official Title

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

Quick Facts

Study Start:2023-12-01
Study Completion:2032-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06215716

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. * Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
  2. * 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.
  3. * 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:
  4. * Steatosis (scored 0 to 3),
  5. * Ballooning degeneration (scored 0 to 2), and
  6. * Lobular inflammation (scored 0 to 3).
  1. * Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
  2. * Presence of cirrhosis on liver biopsy (fibrosis stage 4).
  3. * Type 1 or uncontrolled Type 2 diabetes.

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
Chandler, Arizona, 85224
United States
Akero Clinical Study Site
Flagstaff, Arizona, 86001
United States
Akero Clinical Study Site
Mesa, Arizona, 85213
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, 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
Chula Vista, California, 91910
United States
Akero Clinical Study Site
Coronado, California, 92118
United States
Akero Clinical Study Site
Inglewood, California, 90301
United States
Akero Clinical Study Site
La Mesa, California, 91942
United States
Akero Clinical Study Site
Lancaster, California, 93534
United States
Akero Clinical Study Site
Long Beach, California, 90815
United States
Akero Clinical Study Site
Los Angeles, California, 90036
United States
Akero Clinical Study Site
Los Angeles, California, 90057
United States
Akero Clinical Study Site
Newport Beach, California, 92663
United States
Akero Clinical Study Site
Palm Springs, California, 92262
United States
Akero Clinical Study Site
Pasadena, California, 91105
United States
Akero Clinical Study Site
San Diego, California, 92120
United States
Akero Clinical Study Site
San Diego, California, 92123
United States
Akero Clinical Study Site
San Diego, California, 92161
United States
Akero Clinical Study Site
San Francisco, California, 94115
United States
Akero Clinical Study Site
Santa Maria, California, 93458
United States
Akero Clinical Study Site
Englewood, Colorado, 80113
United States
Akero Clinical Study Site
New Haven, Connecticut, 06520
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
Gainesville, Florida, 32610
United States
Akero Clinical Study Site
Hialeah Gardens, Florida, 33016
United States
Akero Clinical Study Site
Inverness, Florida, 34452
United States
Akero Clinical Study Site
Jacksonville, Florida, 32256
United States
Akero Clinical Study Site
Lady Lake, Florida, 32159
United States
Akero Clinical Study Site
Lakewood Ranch, Florida, 34211
United States
Akero Clinical Study Site
Largo, Florida, 33777
United States
Akero Clinical Study Site
Maitland, Florida, 32751
United States
Akero Clinical Study Site
Miami Lakes, Florida, 33016
United States
Akero Clinical Study Site
Miami, Florida, 33136
United States
Akero Clinical Study Site
Naples, Florida, 34102
United States
Akero Clinical Study Site
Ocala, Florida, 34471
United States
Akero Clinical Study Site
Port Orange, Florida, 32127
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
West Palm Beach, Florida, 33401
United States
Akero Clinical Study Site
Winter Park, Florida, 32789
United States
Akero Clinical Study Site
Winter Park, Florida, 32792
United States
Akero Clinical Study Site
Columbus, Georgia, 31904
United States
Akero Clinical Study Site
Gainesville, Georgia, 30501
United States
Akero Clinical Study Site
Marietta, Georgia, 30060
United States
Akero Clinical Study Site
South Bend, Indiana, 46635
United States
Akero Clinical Study Site
West Des Moines, Iowa, 50265
United States
Akero Clinical Study Site
Topeka, Kansas, 66606
United States
Akero Clinical Study Site
Wichita, Kansas, 67205
United States
Akero Clinical Study Site
Louisville, Kentucky, 40202
United States
Akero Clinical Study Site
Bastrop, Louisiana, 71220
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
Marrero, Louisiana, 70072
United States
Akero Clinical Study Site
Metairie, Louisiana, 70006
United States
Akero Clinical Study Site
New Orleans, Louisiana, 70112
United States
Akero Clinical Study Site
New Orleans, Louisiana, 70121
United States
Akero Clinical Study Site
Shreveport, Louisiana, 71105
United States
Akero Clinical Study Site
Baltimore, Maryland, 21202
United States
Akero Clinical Study Site
Glen Burnie, Maryland, 21061
United States
Akero Clinical Study Site
Greenbelt, Maryland, 20770
United States
Akero Clinical Study Site
Dartmouth, Massachusetts, 02747
United States
Akero Clinical Study Site
Southfield, Michigan, 48075
United States
Akero Clinical Study Site
Wyoming, Michigan, 49519
United States
Akero Clinical Study Site
Ypsilanti, Michigan, 48197
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
Las Vegas, Nevada, 89109
United States
Akero Clinical Study Site
Reno, Nevada, 89511
United States
Akero Clinical Study Site
Florham Park, New Jersey, 07932
United States
Akero Clinical Study Site
Somers Point, New Jersey, 08244
United States
Akero Clinical Study Site
Sparta, New Jersey, 07871
United States
Akero Clinical Study Site
Santa Fe, New Mexico, 87505
United States
Akero Clinical Study Site
New York, New York, 10016
United States
Akero Clinical Study Site
New York, New York, 10021
United States
Akero Clinical Study Site
New York, New York, 10029
United States
Akero Clinical Study Site
New York, New York, 10033
United States
Akero Clinical Study Site
Chapel Hill, North Carolina, 27514
United States
Akero Clinical Study Site
Charlotte, North Carolina, 28204
United States
Akero Clinical Study Site
Fayetteville, North Carolina, 28303
United States
Akero Clinical Study Site
Morehead City, North Carolina, 28557
United States
Akero Clinical Study Site
New Bern, North Carolina, 28562
United States
Akero Clinical Study Site
Raleigh, North Carolina, 27612
United States
Akero Clinical Study Site
Statesville, North Carolina, 28625
United States
Akero Clinical Study Site
Columbus, Ohio, 43213
United States
Akero Clinical Study Site
Dayton, Ohio, 45414
United States
Akero Clinical Study Site
Springboro, Ohio, 45066
United States
Akero Clinical Study Site
Westlake, Ohio, 44145
United States
Akero Clinical Study Site
Medford, Oregon, 97504
United States
Akero Clinical Study Site
Philadelphia, Pennsylvania, 19104
United States
Akero Clinical Study Site
Philadelphia, Pennsylvania, 19107
United States
Akero Clinical Study Site
Pittsburgh, Pennsylvania, 15213
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
Chattanooga, Tennessee, 37421
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
Bellaire, Texas, 77401
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, 75230
United States
Akero Clinical Study Site
Dallas, Texas, 75234
United States
Akero Clinical Study Site
Dallas, Texas, 75390
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
Houston, Texas, 77030
United States
Akero Clinical Study Site
Houston, Texas, 77079
United States
Akero Clinical Study Site
Houston, Texas, 77084
United States
Akero Clinical Study Site
Lewisville, Texas, 75057
United States
Akero Clinical Study Site
McAllen, Texas, 78504
United States
Akero Clinical Study Site
San Antonio, Texas, 78209
United States
Akero Clinical Study Site
San Antonio, Texas, 78215
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
San Antonio, Texas, 78240
United States
Akero Clinical Study Site
San Antonio, Texas, 78258
United States
Akero Clinical Study Site
San Marcos, Texas, 78666-7502
United States
Akero Clinical Study Site
San Marcos, Texas, 78666
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
Ogden, Utah, 84405
United States
Akero Clinical Study Site
Salt Lake City, Utah, 84117
United States
Akero Clinical Study Site
Sandy, Utah, 84092
United States
Akero Clinical Study Site
South Ogden, Utah, 84405
United States
Akero Clinical Study Site
Falls church, Virginia, 22042-3300
United States
Akero Clinical Study Site
Newport News, Virginia, 23602
United States
Akero Clinical Study Site
Norfolk, Virginia, 23502
United States
Akero Clinical Study Site
Richmond, Virginia, 23226
United States
Akero Clinical Study Site
Richmond, Virginia, 23235
United States
Akero Clinical Study Site
Richmond, Virginia, 23249
United States
Akero Clinical Study Site
Richmond, Virginia, 23298
United States
Akero Clinical Study Site
Roanoke, Virginia, 24014
United States
Akero Clinical Study Site
Suffolk, Virginia, 23435
United States
Akero Clinical Study Site
Seattle, Washington, 98105
United States
Akero Clinical Study Site
Spokane, Washington, 99218
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 Date2023-12-01
Study Completion Date2032-11

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2032-11

Terms related to this study

Additional Relevant MeSH Terms

  • NASH with Fibrosis
  • MASH with Fibrosis