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

Last updated: April 3, 2025
Sponsor: 89bio, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Hyponatremia

Liver Disease

Scar Tissue

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

    Buenos Aires, C1425BGH
    Argentina

    Active - Recruiting

  • 89bio Clinical Study Site

    Caba, C1430CKE
    Argentina

    Active - Recruiting

  • 89bio Clinical Study Site

    Capital Federal, C1280AEB
    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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  • 89bio Clinical Study Site

    Greenslopes, 04120
    Australia

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  • 89bio Clinical Study Site

    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
    Australia

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  • 89bio Clinical Study Site

    South Brisbane, 04101
    Australia

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  • 89bio Clinical Study Site

    Brussel, 01090
    Belgium

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  • 89bio Clinical Study Site

    Bruxelles, 01070
    Belgium

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  • 89bio Clinical Study Site

    Edegem, 02650
    Belgium

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  • 89bio Clinical Study Site

    Genk, 03600
    Belgium

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  • 89bio Clinical Study Site

    Gent, 09000
    Belgium

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    Roeselare, 08800
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    Gorna Oryahovitsa, 05100
    Bulgaria

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    Sofia, 01202
    Bulgaria

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    Stara Zagora, 06003
    Bulgaria

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    Vancouver, British Columbia V6Z2K5
    Canada

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    Winnipeg, Manitoba R3E 3P4
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    Ottawa, Ontario K1H 8L6
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    Toronto, Ontario M6H3M1
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    Amiens, 80054
    France

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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
    France

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    Paris, 75014
    France

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    Pessac CEDEX, 33604
    France

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    Strasbourg, 67091
    France

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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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    Frankfurt, 60590
    Germany

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    Freiburg, 79110
    Germany

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    Homburg, 66421
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    Münster, 48149
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    Hong Kong,
    Hong Kong

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    Shatin,
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    Budapest, 01088
    Hungary

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    Afula, 1834111
    Israel

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    Be'er Sheva, 8410101
    Israel

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    Haifa, 3109601
    Israel

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    Jerusalem, 9112001
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    Nahariyya, 2210001
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    Petach Tikva, 49100
    Israel

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    Tel Aviv, 69710
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    Tel HaShomer, 5265601
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    Bergamo, 24127
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    Foggia, 71121
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    Milano, 20162
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    Novara, 28100
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    Palermo, 90127
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    Roma, 00128
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    Rome, 00168
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    Rozzano, 20089
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    Torino, 10124
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    Bucheon, 14584
    Korea, Republic of

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    Busan, 49241
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    Daegu, 42415
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    Seoul, 03080
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    Amsterdam, 1081 HV
    Netherlands

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    Rotterdam, 3015GD
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    Utrecht, 3584 CX
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    Katowice, 40-752
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    Kraków, 31-501
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    Lodz, 91-363
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    Mysłowice, 41-400
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    Wrocław, 53-673
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    Almeria, 04009
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    Córdoba, 14004
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    Madrid, 28007
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    Pontevedra, 36071
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    Santander, 39008
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    Santiago De Compostela, 15706
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    Tainan, 00704
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    Bornova, Izmir 35040
    Turkey

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    Merkez, Rize 53020
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    Ankara, 06100
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    Istanbul, 34722
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  • 89bio Clinical Study Site

    London, SE5 9RS
    United Kingdom

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  • 89bio Clinical Study Site

    Plymouth, PL6 8DH
    United Kingdom

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  • 89bio Clinical Study Site

    Port Talbot, SA12 7BR
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  • 89bio Clinical Study Site

    Southampton, SO16 6YD
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  • 89bio Clinical Study Site

    Homewood, Alabama 35209
    United States

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  • 89bio Clinical Study Site

    Chandler, Arizona 85224
    United States

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  • 89bio Clinical Study Site

    Flagstaff, Arizona 86001
    United States

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  • 89bio Clinical Study Site

    Peoria, Arizona 85381
    United States

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  • 89bio Clinical Study Site

    Tucson, Arizona 85715
    United States

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  • 89bio Clinical Study Site

    Little Rock, Arkansas 72205
    United States

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  • 89bio Clinical Study Site

    North Little Rock, Arkansas 72117
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    Camarillo, California 93012
    United States

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    Canoga Park, California 91304
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    Coronado, California 92118
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    Fountain Valley, California 92708
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    Huntington Park, California 90255
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    Pasadena, California 91105
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    Poway, California 92064
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    Redwood City, California 94063
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    Rialto, California 92377
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    Santa Ana, California 92704
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  • 89bio Clinical Study Site

    Littleton, Colorado 80120
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  • 89bio Clinical Study Site

    Clermont, Florida 34711
    United States

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  • 89bio Clinical Study Site

    Fort Myers, Florida 33912
    United States

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  • 89bio Clinical Study Site

    Gainesville, Florida 32610
    United States

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  • 89bio Clinical Study Site

    Hialeah Gardens, Florida 33016
    United States

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  • 89bio Clinical Study Site

    Lady Lake, Florida 32159
    United States

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  • 89bio Clinical Study Site

    Lehigh Acres, Florida 33936
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  • 89bio Clinical Study Site

    Maitland, Florida 32751
    United States

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  • 89bio Clinical Study Site

    Miami, Florida 33176-1530
    United States

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  • 89bio Clinical Study Site

    New Port Richey, Florida 34653
    United States

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  • 89bio Clinical Study Site

    Ocala, Florida 34471
    United States

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  • 89bio Clinical Study Site

    Ocoee, Florida 34761
    United States

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  • 89bio Clinical Study Site

    Orlando, Florida 32825
    United States

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  • 89bio Clinical Study Site

    University Park, Florida 34201
    United States

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  • 89bio Clinical Study Site

    Viera, Florida 32940
    United States

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  • 89bio Clinical Study Site

    Winter Park, Florida 32789
    United States

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  • 89bio Clinical Study Site

    Athens, Georgia 30607
    United States

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  • 89bio Clinical Study Site

    Chicago, Illinois 60611
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  • 89bio Clinical Study Site

    Hammond, Indiana 46324
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  • 89bio Clinical Study Site

    New Albany, Indiana 47150
    United States

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  • 89bio Clinical Study Site

    Iowa City, Iowa 52242
    United States

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  • 89bio Clinical Study Site

    Topeka, Kansas 66606
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  • 89bio Clinical Study Site

    Lafayette, Louisiana 70503
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    Baltimore, Maryland 21202
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    Glen Burnie, Maryland 21061
    United States

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    Greenbelt, Maryland 20770
    United States

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    Burlington, Massachusetts 01805
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    Ann Arbor, Michigan 48109
    United States

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    Clinton Township, Michigan 48038
    United States

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    Wyoming, Michigan 49519
    United States

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    Ypsilanti, Michigan 48197
    United States

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  • 89bio Clinical Study Site

    Minneapolis, Minnesota 55413
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  • 89bio Clinical Study Site

    Rochester, Minnesota 55905
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  • 89bio Clinical Study Site

    Flowood, Mississippi 39232
    United States

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  • 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

    Site Not Available

  • 89bio Clinical Study Site

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    New York, New York 10016
    United States

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  • 89bio Clinical Study Site

    Asheville, North Carolina 28801
    United States

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  • 89bio Clinical Study Site

    Fayetteville, North Carolina 28304
    United States

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  • 89bio Clinical Study Site

    Greenville, North Carolina 27834
    United States

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  • 89bio Clinical Study Site

    Winston-Salem, North Carolina 27103
    United States

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  • 89bio Clinical Study Site

    Cincinnati, Ohio 45267
    United States

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  • 89bio Clinical Study Site

    Cleveland, Ohio 44106
    United States

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  • 89bio Clinical Study Site

    Columbus, Ohio 43210
    United States

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  • 89bio Clinical Study Site

    Dayton, Ohio 45414
    United States

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    Westlake, Ohio 44145
    United States

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  • 89bio Clinical Study Site

    Philadelphia, Pennsylvania 19148
    United States

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    East Greenwich, Rhode Island 02818
    United States

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  • 89bio Clinical Study Site

    Charleston, South Carolina 29425
    United States

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  • 89bio Clinical Study Site

    Columbia, South Carolina 29204
    United States

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  • 89bio Clinical Study Site

    Rapid City, South Dakota 57701
    United States

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  • 89bio Clinical Study Site

    Cordova, Tennessee 38018
    United States

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  • 89bio Clinical Study Site

    Hermitage, Tennessee 37076
    United States

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  • 89bio Clinical Study Site

    Nashville, Tennessee 37211
    United States

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  • 89bio Clinical Study Site

    Austin, Texas 78757-8059
    United States

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  • 89bio Clinical Study Site

    Brownsville, Texas 78520
    United States

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  • 89bio Clinical Study Site

    DeSoto, Texas 75115
    United States

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  • 89bio Clinical Study Site

    Edinburg, Texas 78539
    United States

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  • 89bio Clinical Study Site

    Farmers Branch, Texas 75234
    United States

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  • 89bio Clinical Study Site

    Fort Worth, Texas 76104
    United States

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    Harlingen, Texas 78550
    United States

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    Houston, Texas 77030
    United States

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    Lubbock, Texas 79410
    United States

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    Pearland, Texas 77584
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    San Antonio, Texas 78209
    United States

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    San Marcos, Texas 78666
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    Waco, Texas 76712
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    Sandy, Utah 84092
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    West Jordan, Utah 84088
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    Richmond, Virginia 23229
    United States

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    Seattle, Washington 98105
    United States

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