A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

Last updated: June 2, 2026
Sponsor: 89bio, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Ulcers

Gastrointestinal Diseases And Disorders

Primary Biliary Cholangitis

Treatment

Pegozafermin

Placebo

Clinical Study ID

NCT06419374
BIO89-100-132
  • Ages 18-75
  • All Genders

Study Summary

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Males or non-pregnant females aged between 18 and 75 years (inclusive) at time ofsigning the informed consent form (ICF).

  • Participants must have type 2 diabetes mellitus diagnosed at least 3 months beforescreening or at least 2 metabolic risk factors.

  • Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN)system) with compensated cirrhosis.

  • Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and <50.0kilograms (kg)/meters squared (m^2).

Exclusion

Key Exclusion Criteria:

  • Liver disorder other than MASH.

  • History or evidence of hepatic decompensation.

  • History or evidence of hepatocellular carcinoma.

  • Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.

  • ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).

  • Participants taking vitamin E (>400 international units [IU]/day) must be on stabledose for at least 6 months prior to screening.

Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Total Participants: 762
Treatment Group(s): 2
Primary Treatment: Pegozafermin
Phase: 3
Study Start date:
May 24, 2024
Estimated Completion Date:
August 31, 2031

Connect with a study center

  • 89bio Clinical Study Site

    Buenos Aires, C1125ABE
    Argentina

    Active - Recruiting

  • 89bio Clinical Study Site

    Buenos Aires 3435910, C1199ABB
    Argentina

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  • 89bio Clinical Study Site

    CABA, C1430CKE
    Argentina

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  • 89bio Clinical Study Site

    Capital Federal, C1280AEB
    Argentina

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  • 89bio Clinical Study Site

    Pilar, B1629AHJ
    Argentina

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  • 89bio Clinical Study Site

    Adelaide, SA 5000
    Australia

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  • 89bio Clinical Study Site

    Fitzroy, 03065
    Australia

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    Greenslopes, 04120
    Australia

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    Heidelberg, 3084
    Australia

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  • 89bio Clinical Study Site

    Herston, Qld 4029
    Australia

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  • 89bio Clinical Study Site

    Murdoch, 06150
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    Perth, 06000
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    South Brisbane, 04101
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    Brussels, 01070
    Belgium

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    Brussels 2800866, 1200
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    Edegem, 02650
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    Genk, 03600
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    Ghent, 09000
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    Roeselare, 08800
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    Barretos, 14784-400
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    Botucatu, 18618-687
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    Goiânia, 74605-050
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    Porto Alegre, 90035-903
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    Vancouver, British Columbia V5Z 1M9
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    Vancouver 6173331, British Columbia 5909050 V6Z2K5
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    Amiens, 80054
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    Dijon, 21000
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    Limoges, 87000
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    Lyon, 69004
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    Montpellier, 34295
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    Nice, 06202
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    Paris, 75012
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    Paris 2988507, 75013
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    Pessac, 33604
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    Strasbourg, 67091
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    Toulouse, 31400
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    Vandœuvre-lès-Nancy, 54500
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    Villejuif, 94800
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    Vénissieux, 69694
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    Chemnitz, 9116
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    Frankfurt, 60590
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    Freiburg im Breisgau, 79110
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    Hanover, 30625
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    Krakow, 31-501
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    Warsaw 756135, 04-501
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    Singapore, 529889
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    Singapore 1880252, 119074
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    Bucheon-si, 14584
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    Daegu, 700-712
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    Daegu 1835329, 42415
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    Incheon, 22332
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    Seoul, 07895
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    Seoul 1835848, 03080
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    Almería, 04009
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    Badalona, 08916
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    Barcelona, 08003
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    Barcelona 3128760, 08003
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    Córdoba, 14004
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    Madrid, 28007
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    Málaga, 29010
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    Pontevedra, 36071
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    Santander, 39008
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    Santiago de Compostela, 15706
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    Zaragoza, 50009
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    Merkez, Rize 53020
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    Ankara, 06100
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    Istanbul, 34010
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    Merkez, Rize Province 53020
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    Bornova, İzmir 35040
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    Istanbul 745044, 34010
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    Aberdeen, AB25 2ZN
    United Kingdom

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    Ann Arbor, Michigan 48109
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    Active - Recruiting

  • 89bio Clinical Study Site

    New York 5128581, New York 5128638 10033
    United States

    Site Not Available

  • 89bio Clinical Study Site

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Fayetteville, North Carolina 28304
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • 89bio Clinical Study Site

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Akron, Ohio 44320
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Dayton, Ohio 45414
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Liberty Township, Ohio 45044
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Westlake, Ohio 44145
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Philadelphia, Pennsylvania 19148
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Columbia, South Carolina 29204
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Cordova, Tennessee 38018
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Hermitage, Tennessee 37076
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Nashville, Tennessee 37211
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Austin, Texas 78745
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Brownsville, Texas 78520
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Edinburg, Texas 78539
    United States

    Site Not Available

  • 89bio Clinical Study Site

    Farmers Branch, Texas 75234
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Harlingen, Texas 78550
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Lewisville, Texas 75067
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Pearland, Texas 77584
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    San Antonio, Texas 78229-5069
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    San Marcos, Texas 78666
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Waco, Texas 76712
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Austin 4671654, Texas 4736286 78757-8059
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Houston 4699066, Texas 4736286 77074
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    San Antonio 4726206, Texas 4736286 78229-4801
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Waco 4739526, Texas 4736286 76710
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Sandy City, Utah 84092
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    West Jordan, Utah 84088
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Richmond 4781708, Virginia 6254928 23236
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Seattle, Washington 98101
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Seattle 5809844, Washington 5815135 98105
    United States

    Active - Recruiting

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