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

Last updated: March 13, 2025
Sponsor: Akero Therapeutics, Inc
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Disease

Scar Tissue

Treatment

Efruxifermin

Placebo

Clinical Study ID

NCT06215716
AK-US-001-0105
  • 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and non-pregnant, non-lactating females between 18 - 80 years of ageinclusive, 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 2diabetes.

  • Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 daysprior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liverdisease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each ofthe following NAS components:

  • Steatosis (scored 0 to 3),

  • Ballooning degeneration (scored 0 to 2), and

  • Lobular inflammation (scored 0 to 3).

Exclusion

Exclusion Criteria:

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

  • Presence of cirrhosis on liver biopsy (fibrosis stage 4).

  • Type 1 or uncontrolled Type 2 diabetes.

Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 1650
Treatment Group(s): 2
Primary Treatment: Efruxifermin
Phase: 3
Study Start date:
December 01, 2023
Estimated Completion Date:
November 30, 2032

Connect with a study center

  • Akero Clinical Study Site

    La Plata, Buenos Aires B1902AWL
    Argentina

    Active - Recruiting

  • Akero Clinical Study Site

    Ramos Mejia, Buenos Aires B1704ETD
    Argentina

    Active - Recruiting

  • Akero Clinical Study Site

    Buenos Aires, C1180AAX
    Argentina

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  • Akero Clinical Study Site

    Broadmeadow, New South Wales 2292
    Australia

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  • Akero Clinical Study Site

    Westmead, New South Wales 2145
    Australia

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  • Akero Clinical Study Site

    Adelaide, South Australia 5000
    Australia

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  • Akero Clinical Study Site

    Caulfield South, Victoria 3162
    Australia

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  • Akero Clinical Study Site

    Epping, Victoria 3076
    Australia

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  • Akero Clinical Study Site

    Heidelberg, Victoria 3084
    Australia

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  • Akero Clinical Study Site

    Melbourne, Victoria 3004
    Australia

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  • Akero Clinical Study Site

    Murdoch, Western Australia 6150
    Australia

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  • Akero Clinical Study Site

    Perth, Western Australia 6000
    Australia

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  • Akero Clinical Study Site

    Edmonton, Alberta T6G 2X8
    Canada

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  • Akero Clinical Study Site

    Hamilton, Ontario L8S 4K1
    Canada

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    Toronto, Ontario M6H 3M1
    Canada

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    Vaughan, Ontario L4L 4Y7
    Canada

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    Terrebonne, Quebec J7B6B7
    Canada

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    Nice Cedex 3, Alpes-Maritimes 06202
    France

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    Strasbourg, Bas-Rhin 67091
    France

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    Limoges Cedex, Haute-Vienne 87042
    France

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    Clichy, Hauts-de-Seine 92110
    France

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    Paris, Ile-de-France 75013
    France

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    Vandœuvre-lès-Nancy, Lorraine 54511
    France

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    Angers Cedex 9, Maine-et-Loire 49933
    France

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    Toulouse, Occitanie 31059
    France

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

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

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    Lyon, Rhone-Alpes 69008
    France

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    Versailles, Yvelines, Île-de-France 78000
    France

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    Würzburg, Bayern 97080
    Germany

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    Frankfurt am Main, Hessen 60590
    Germany

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    Mainz, Rheinland-Pfalz 55131
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    Leipzig, Saxony 04103
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    Lübeck, Schleswig-Holstein 23538
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    Berlin, 13353
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    Surat, Gujarat 395002
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    Dahegaon, Maharashtra 441108
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    Nagpur, Maharashtra 440010
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    Pune, Maharashtra 412201
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    Jaipur, Rajasthan 302001
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    Coimbatore, Tamil Nadu 641005
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    Hyderabad, Telangana 500 004
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    Varanasi, Uttar Pradesh 221005
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    Ramat Gan, Central District 5265601
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    Afula, Northern District 1834111
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    Nahariya, Northern District 22100
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    Nazareth, Northern District 1610001
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    Jerusalem, 9103102
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    Tel Aviv, 6423906
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    Rozzano, Milan 20089
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    Torino, Turin 10126
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    Modena, 41126
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    Seongnam-si, Gyeonggido [Kyonggi-do] 13520
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    Daegu, Gyeongsangbugdo [Kyongsangbuk-do] 42601
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    Bornova, Izmir 35100
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    Birmingham, England B15 2WB
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    Cambridge, England CB2 0QQ
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    Liverpool, England L9 7AL
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    Flagstaff, Arizona 86001
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    Mesa, Arizona 85213
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    Peoria, Arizona 85381
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    Tucson, Arizona 85712
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    Conway, Arkansas 72032
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    Jonesboro, Arkansas 72401
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    Little Rock, Arkansas 72205
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    North Little Rock, Arkansas 72117
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    Chula Vista, California 91910
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    Coronado, California 92118
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    Folsom, California 95630
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    Inglewood, California 90301
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    La Mesa, California 91942
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    Lancaster, California 93534
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    Long Beach, California 90815
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    Los Angeles, California 90057
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    Newport Beach, California 92663
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    Palm Springs, California 92262
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    Pasadena, California 91105
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    Redwood City, California 94063
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    San Diego, California 92161
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    New Haven, Connecticut 06520
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    Bradenton, Florida 34208
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    Brandon, Florida 33511
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    Fort Myers, Florida 33912
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    Gainesville, Florida 32610
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    Hialeah Gardens, Florida 33016
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    Inverness, Florida 34452
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    Jacksonville, Florida 32256
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    Lady Lake, Florida 32159
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    Lakewood Ranch, Florida 34211
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    Largo, Florida 33777
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    Maitland, Florida 32751
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    Miami, Florida 33136
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    South Bend, Indiana 46635
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    West Des Moines, Iowa 50265
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    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Richmond, Virginia 23235
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Suffolk, Virginia 23435
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • Akero Clinical Study Site

    Spokane, Washington 99218
    United States

    Active - Recruiting

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