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

Last updated: May 1, 2025
Sponsor: Akero Therapeutics, Inc
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Disease

Treatment

Placebo

Efruxifermin

Clinical Study ID

NCT06528314
AK-US-001-0106
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

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

Exclusion

Exclusion Criteria:

  • Other causes of liver disease based on medical history and/or liver histology and/orcentral laboratory results

  • Type 1 diabetes or unstable Type 2 diabetes

  • Any current or prior history of decompensated liver disease

Other inclusion and exclusion criteria may apply

Study Design

Total Participants: 1150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 04, 2024
Estimated Completion Date:
October 31, 2029

Connect with a study center

  • Akero Clinical Study Site

    La Plata, Buenos Aires B1902AWL
    Argentina

    Active - Recruiting

  • Akero Clinical Study Site

    Broadmeadow, New South Wales 2292
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Liverpool, New South Wales 1871
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Herston, Queensland 4029
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Epping, Victoria 3076
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

  • Akero Clinical Study Site

    Edmonton, Alberta T6G 2X8
    Canada

    Active - Recruiting

  • Akero Clinical Study Site

    Toronto, Ontario M6H 3M1
    Canada

    Active - Recruiting

  • Akero Clinical Study Site

    Vaughan, Ontario L4L 4Y7
    Canada

    Active - Recruiting

  • Akero Clinical Study Site

    Santiago, Región Metropolitana De Santiago 8330109
    Chile

    Active - Recruiting

  • Akero Clinical Study Site

    Clichy, Hauts-de-Seine 92118
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Paris, Ile-de-France 75013
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Vandœuvre-lès-Nancy, Lorraine 54511
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Angers Cedex 9, Maine-et-Loire 49933
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Toulouse, Occitanie 31059
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Montpellier Cedex 5, Provence Alpes Cote d'Azur 34295
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Marseille Cedex 08, Provence-Alpes-Côte d'Azur 13008
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Nice Cedex 3, Provence-Alpes-Côte d'Azur 06202
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Lyon, Rhône 69004
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Le Chesnay, Île-de-France 78150
    France

    Active - Recruiting

  • Akero Clinical Study Site

    Frankfurt am Main, Hessen 60590
    Germany

    Active - Recruiting

  • Akero Clinical Study Site

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Akero Clinical Study Site

    Lübeck, Schleswig-Holstein 23538
    Germany

    Active - Recruiting

  • Akero Clinical Study Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Akero Clinical Study Site

    New Delhi, Delhi 110 070
    India

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  • Akero Clinical Study Site

    Surat, Gujarat 395002
    India

    Active - Recruiting

  • Akero Clinical Study Site

    Vadodara, Gujarat 390007
    India

    Active - Recruiting

  • Akero Clinical Study Site

    Mysore, Karnataka 570001
    India

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  • Akero Clinical Study Site

    Thiruvananthapuram, Kerala 695011
    India

    Active - Recruiting

  • Akero Clinical Study Site

    Mumbai, Maharashtra 400008
    India

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  • Akero Clinical Study Site

    Nagpur, Maharashtra 440010
    India

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  • Akero Clinical Study Site

    Pune, Maharashtra 412201
    India

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  • Akero Clinical Study Site

    Ludhiana, Punjab 141002
    India

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  • Akero Clinical Study Site

    Jaipur, Rajasthan 302001
    India

    Active - Recruiting

  • Akero Clinical Study Site

    Hyderabad, Telangana 500 004
    India

    Active - Recruiting

  • Akero Clinical Study Site

    Varanasi, Uttar Pradesh 221005
    India

    Active - Recruiting

  • Akero Clinical Study Site

    Rishikesh, Uttaranchal 249203
    India

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  • Akero Clinical Study Site

    Kolkata, West Bengal 700073
    India

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  • Akero Clinical Study Site

    Haifa, Haifa District 3436212
    Israel

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  • Akero Clinical Study Site

    Nahariya, Northern District 22100
    Israel

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  • Akero Clinical Study Site

    Jerusalem, 9103102
    Israel

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  • Akero Clinical Study Site

    Tel Aviv, 6423906
    Israel

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  • Akero Clinical Study Site

    Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi] 41944
    Korea, Republic of

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  • Akero Clinical Study Site

    Incheon, Gyeonggi-do 22332
    Korea, Republic of

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  • Akero Clinical Study Site

    Seoul, Seoul Teugbyeolsi 04763
    Korea, Republic of

    Active - Recruiting

  • Akero Clinical Study Site

    Manatí, 00674
    Puerto Rico

    Active - Recruiting

  • Akero Clinical Study Site

    Mayagüez, 00680
    Puerto Rico

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  • Akero Clinical Study Site

    San Juan, 00927
    Puerto Rico

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  • Akero Clinical Study Site

    Sabadell, Barcelona 08208
    Spain

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  • Akero Clinical Study Site

    Santander, Cantabria 39008
    Spain

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  • Akero Clinical Study Site

    Majadahonda, Madrid 28222
    Spain

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  • Akero Clinical Study Site

    Barcelona, 08035
    Spain

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  • Akero Clinical Study Site

    Madrid, 28027
    Spain

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  • Akero Clinical Study Site

    Valencia, 46010
    Spain

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  • Akero Clinical Study Site

    Lugano, Ticino 6900
    Switzerland

    Active - Recruiting

  • Akero Clinical Study Site

    Bern, 3010
    Switzerland

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  • Akero Clinical Study Site

    Sankt Gallen, 9007
    Switzerland

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  • Akero Clinical Study Site

    Zürich, 8091
    Switzerland

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  • Akero Clinical Study Site

    Birmingham, Alabama 35209
    United States

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  • Akero Clinical Study Site

    Dothan, Alabama 36301
    United States

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  • Akero Clinical Study Site

    Chandler, Arizona 85224
    United States

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  • Akero Clinical Study Site

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • Akero Clinical Study Site

    Peoria, Arizona 85381
    United States

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  • Akero Clinical Study Site

    Tucson, Arizona 85712
    United States

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  • Akero Clinical Study Site

    Conway, Arkansas 72032
    United States

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  • Akero Clinical Study Site

    Jonesboro, Arkansas 72401
    United States

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  • Akero Clinical Study Site

    Little Rock, Arkansas 72205
    United States

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  • Akero Clinical Study Site

    North Little Rock, Arkansas 72117
    United States

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  • Akero Clinical Study Site

    Coronado, California 92118
    United States

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  • Akero Clinical Study Site

    Escondido, California 92025
    United States

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  • Akero Clinical Study Site

    Folsom, California 95630
    United States

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  • Akero Clinical Study Site

    Long Beach, California 90815
    United States

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  • Akero Clinical Study Site

    Newport Beach, California 92663
    United States

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  • Akero Clinical Study Site

    Orange, California 92868
    United States

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  • Akero Clinical Study Site

    Pasadena, California 91105
    United States

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  • Akero Clinical Study Site

    San Francisco, California 94115
    United States

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  • Akero Clinical Study Site

    Aurora, Colorado 80045
    United States

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  • Akero Clinical Study Site

    Colorado Springs, Colorado 80907
    United States

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  • Akero Clinical Study Site

    Englewood, Colorado 80113
    United States

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  • Akero Clinical Study Site

    Bradenton, Florida 34208
    United States

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  • Akero Clinical Study Site

    Brandon, Florida 33511
    United States

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  • Akero Clinical Study Site

    Cutler Bay, Florida 33189
    United States

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  • Akero Clinical Study Site

    Doral, Florida 33126
    United States

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  • Akero Clinical Study Site

    Fort Myers, Florida 33912
    United States

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  • Akero Clinical Study Site

    Hialeah Gardens, Florida 33016
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Inverness, Florida 34452
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Lakewood Ranch, Florida 34211
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Lehigh Acres, Florida 33936
    United States

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  • Akero Clinical Study Site

    Margate, Florida 33063
    United States

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  • Akero Clinical Study Site

    Miami, Florida 33136
    United States

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  • Akero Clinical Study Site

    Miami Gardens, Florida 33014
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Naples, Florida 34102
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    New Port Richey, Florida 34653
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Ocala, Florida 34471
    United States

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  • Akero Clinical Study Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Akero Clinical Study Site

    Pembroke Pines, Florida 33027
    United States

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  • Akero Clinical Study Site

    Sarasota, Florida 34240
    United States

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  • Akero Clinical Study Site

    Temple Terrace, Florida 33617
    United States

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  • Akero Clinical Study Site

    Venice, Florida 34285
    United States

    Site Not Available

  • Akero Clinical Study Site

    Viera, Florida 32940
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Zephyrhills, Florida 33542
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Marietta, Georgia 30060
    United States

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  • Akero Clinical Study Site

    Snellville, Georgia 30078
    United States

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  • Akero Clinical Study Site

    Chicago, Illinois 60611
    United States

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  • Akero Clinical Study Site

    Hammond, Indiana 46324
    United States

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  • Akero Clinical Study Site

    South Bend, Indiana 46635
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Bastrop, Louisiana 71220
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Houma, Louisiana 70363
    United States

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  • Akero Clinical Study Site

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Shreveport, Louisiana 71105
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Akero Clinical Study Site

    South Dartmouth, Massachusetts 02747
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • Akero Clinical Study Site

    Southfield, Michigan 48075
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Kansas City, Missouri 64131
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Jackson, New Jersey 08527
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Somers Point, New Jersey 08244
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Sparta, New Jersey 07871
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    New York, New York 10029
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Chapel Hill, North Carolina 27516
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Fayetteville, North Carolina 28304
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Raleigh, North Carolina 27612
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Statesville, North Carolina 28625
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Springboro, Ohio 45066
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Westlake, Ohio 44145
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Columbia, South Carolina 29204
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Summerville, South Carolina 29485
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Clarksville, Tennessee 37040
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Hermitage, Tennessee 37076
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Nashville, Tennessee 37211
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Brownsville, Texas 78520
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Corpus Christi, Texas 78404
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Dallas, Texas 75234
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Denison, Texas 75020
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Fort Sam Houston, Texas 78234
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Garland, Texas 75044
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Pharr, Texas 78577
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    San Antonio, Texas 78222
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Waco, Texas 76712
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Wichita Falls, Texas 76301
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Richmond, Virginia 23284
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Seattle, Washington 98105
    United States

    Active - Recruiting

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