A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

Last updated: May 7, 2025
Sponsor: 89bio, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Disease

Primary Biliary Cholangitis

Scar Tissue

Treatment

Placebo

Pegozafermin

Clinical Study ID

NCT06318169
BIO89-100-131
  • Ages 18-80
  • All Genders

Study Summary

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis [NASH]).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Males or non-pregnant females aged between 18 and 80 years (inclusive) at time ofsigning the informed consent form (ICF)

  • Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASHclinical research network (CRN) System and NAS ≥4, with a score of at least 1 ineach of steatosis, ballooning degeneration, and lobular inflammation or NAS <4and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of atleast 1 in steatosis. A historical biopsy must be within 6 months of screening visit (with additional requirements).

  • Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23kg/m^2 for Asian countries)

Exclusion

Key Exclusion Criteria:

  • Chronic liver diseases other than MASH/NASH

  • Evidence of cirrhosis on screening liver biopsy

  • Have type 1 diabetes or poorly controlled type 2 diabetes

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units perliter (U/L)

  • Participants taking vitamin E (>400 international units [IU]/day) or pioglitazonemust be on stable dose for at least 6 months prior to screening

Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 1050
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 13, 2024
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • 89bio Clinical Study Site

    Buenos Aires, C1425
    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, 1629
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  • 89bio Clinical Study Site

    Brisbane, Queensland 4120
    Australia

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    Herston, Queensland 4019
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    South Brisbane, Queensland 4101
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    Adelaide, South Australia 5000
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    Bedford Park, South Australia 5042
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    Clayton, Victoria 3168
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    Heidelberg, Victoria 3084
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    Perth, West Australia 6000
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    Fitzroy, 3065
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    Brussels, 1070
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    Edegem, 2650
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    Petah tikva, 4941492
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    Conway, Arkansas 72032
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    Hialeah Gardens, Florida 33016
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    Jacksonville, Florida 32256
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    Lady Lake, Florida 32159-8986
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    Lakewood Ranch, Florida 34211
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    Maitland, Florida 32751-7258
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    Ocoee, Florida 34761
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    Winter Park, Florida 32789
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    Athens, Georgia 30607
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    Dalton, Georgia 30720
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    Hammond, Indiana 46324
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    Greenbelt, Maryland 20770
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    Chesterfield, Michigan 48047
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    Rochester, Minnesota 55905
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    Flowood, Mississippi 39232
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    Las Vegas, Nevada 89106
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    Florham Park, New Jersey 07932
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    Warren, New Jersey 07059
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    Albuquerque, New Mexico 87109
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    Charlotte, North Carolina 28207
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    Durham, North Carolina 27710
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    Winston-Salem, North Carolina 27103
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    Dayton, Ohio 45414
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    Liberty Township, Ohio 45044
    United States

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    Springboro, Ohio 45066
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    Westlake, Ohio 44145
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    East Greenwich, Rhode Island 02818
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    Charleston, South Carolina 29425
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    Columbia, South Carolina 29204
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    Cordova, Tennessee 38018
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    Hermitage, Tennessee 37076
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    Austin, Texas 78757
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    Bellaire, Texas 77401
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    Brownsville, Texas 78520
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    Corpus Christi, Texas 78404
    United States

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    United States

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    Edinburg, Texas 78539
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    Farmers Branch, Texas 75234
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    Fort Sam Houston, Texas 78234
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    Fort Worth, Texas 76104
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    Garland, Texas 75044
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    Georgetown, Texas 78626
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    Houston, Texas 77099
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    San Antonio, Texas 78222
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    Ogden, Utah 84405
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