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

Last updated: November 7, 2024
Sponsor: 89bio, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Hepatic Fibrosis

Hyponatremia

Liver Disease

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).

  • At least 1 metabolic risk factor.

  • Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis [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 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

    Heidelberg, 3084
    Australia

    Active - Recruiting

  • 89bio Clinical Study Site

    Lodz, 91-363
    Poland

    Active - Recruiting

  • 89bio Clinical Study Site

    Homewood, Alabama 35209
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Flagstaff, Arizona 86001
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    North Little Rock, Arkansas 72117
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Camarillo, California 93012
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Canoga Park, California 91304
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Huntington Park, California 90255
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Poway, California 92064
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Rialto, California 92377
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Santa Ana, California 92704
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Hialeah Gardens, Florida 33016
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Lady Lake, Florida 32159
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Lehigh Acres, Florida 33936
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Miami, Florida 33176
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    New Port Richey, Florida 34653
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Ocala, Florida 34471
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Viera, Florida 32940
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Athens, Georgia 30607
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Lafayette, Louisiana 70503
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Glen Burnie, Maryland 21061
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Greenbelt, Maryland 20770
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Clinton Township, Michigan 48038
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Las Vegas, Nevada 89106
    United States

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  • 89bio Clinical Study Site

    Florham Park, New Jersey 07932
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Dayton, Ohio 45414
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Westlake, Ohio 44145
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Charleston, South Carolina 29425
    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

    Austin, Texas 78745
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Brownsville, Texas 78520
    United States

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  • 89bio Clinical Study Site

    Desoto, Texas 75115
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • 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

    Houston, Texas 77099
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Lubbock, Texas 79410
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Pearland, Texas 77584
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    San Antonio, Texas 78209
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Waco, Texas 76712
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Sandy, Utah 84092
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Richmond, Virginia 23229
    United States

    Active - Recruiting

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