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

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

Phase

3

Condition

Ulcers

Liver Disease

Gastrointestinal Diseases And Disorders

Treatment

Pegozafermin

Placebo

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 compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

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 with fibrosis stage F2 or F3

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

Exclusion

Key Exclusion Criteria:

  • Chronic liver diseases other than MASH

  • 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: 1350
Treatment Group(s): 2
Primary Treatment: Pegozafermin
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, 1181
    Argentina

    Active - Recruiting

  • 89bio Clinical Study Site

    Buenos Aires 3435910, 1181
    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
    Argentina

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  • 89bio Clinical Study Site

    Brisbane, Queensland 4120
    Australia

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  • 89bio Clinical Study Site

    Herston, Queensland 4019
    Australia

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  • 89bio Clinical Study Site

    South Brisbane, Queensland 4101
    Australia

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  • 89bio Clinical Study Site

    Adelaide, South Australia 5000
    Australia

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  • 89bio Clinical Study Site

    Bedford Park, South Australia 5042
    Australia

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  • 89bio Clinical Study Site

    Clayton, Victoria 3168
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    Heidelberg, Victoria 3084
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    Perth, Western Australia 6000
    Australia

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  • 89bio Clinical Study Site

    Fitzroy, 3065
    Australia

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    Murdoch, 6150
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    Graz, 8036
    Austria

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    Innsbruck, 6020
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    Klagenfurt, 9020
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    Sankt Pölten, 3100
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    Wels, 4600
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    Brussels, 1020
    Belgium

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    Brussels 2800866, 1020
    Belgium

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    Edegem, 2650
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    Genk, 3600
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    Ghent, 9000
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    Jette, 1090
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    Gorna Oryahovitsa, 5100
    Bulgaria

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    Stara Zagora, 6003
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    Calgary, Alberta T2N 4Z6
    Canada

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    Vancouver, British Columbia V6Z2K5
    Canada

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    Vancouver 6173331, British Columbia 5909050 V5Z 1M9
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    Winnipeg, Manitoba R3T 2N2
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    London, Ontario N6A 5A5
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    Ottawa, Ontario K1H8L6
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    Toronto, Ontario M5G2C4
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    Vaughan, Ontario L4L 4Y7
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    Toronto 6167865, Ontario 6093943 M5G2C4
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    Brno, 625 00
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    Ostrava, 708 52
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    Pilsen, 30100
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    Amiens, 80080
    France

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    Angers, 49933
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    Bordeaux, 33604
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    Lille, 59000
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    Limoges, 87042
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    Lyon, 69004
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    Montpellier, 34090
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    Nantes, 44093
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    Nice, 06200
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    Paris, 75013
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    Paris 2988507, 75014
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    Pierre-Bénite, 69310
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    Strasbourg, 67000
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    Toulouse, 31076
    France

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    Toulouse 2972315, 31076
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    Vandœuvre-lès-Nancy, 54500
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    Villejuif, 94800
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    Vénissieux, 69200
    France

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    Batumi, 6010
    Georgia

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    Batumi 615532, 6010
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    Tbilisi, 0159
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    Tbilisi, 0159
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    Tbilisi 611717, 0159
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    Chemnitz, 09116
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    Freiburg im Breisgau, 79106
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    Hong Kong, 0000
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    Shatin, 0000
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    Guwahati, Assam 701032
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    Afula, 1834111
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    Beersheba, 8410500
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    Haifa, 3109601
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    Tel Aviv, 6971014
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    Tel Aviv 293397, 6971014
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    Bergamo, 24127
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    Milan 3173435, 20089
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    Naples, 80131
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    Novara, 28100
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    Palermo, 90127
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    Roma, 00128
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    Rome, 169
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    Rome 3169070, 00136
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    Torino, 10126
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    Maebashi, Gunma 371-0821
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    Sapporo 2128295, Hokkaido 2130037 065-0012
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    Yokohama, Kanagawa 236-004
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    Ehime, 798-8510
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    Fukuoka, 814-0180
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    Gifu, 500-8323
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    Kumamoto, 862-0971
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    Nagano, 381-0006
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    Okayama, 700-8558
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    Osaka, 545-0051
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    Osaka 1853909, 545-0051
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    Saga, 849-0937
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    Sapporo, 062-0921
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    Seoul, 03080
    Korea, Republic of

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    Chihuahua City, 31217
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    Cuautitlán Izcalli, 54769
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    Jalisco, 44130
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    Mexico City, 06700
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    Mexico City 3530597, 03330
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    Morelos, 62270
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    Nuevo León, 64310
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    Yucatán, 97070
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    Rotterdam, South Holland 3015C
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    Amsterdam, 1081HV
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    Utrecht, 3584CX
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    Katowice, 40-752
    Poland

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    Krakow, 31-501
    Poland

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    Lodz, 91-363
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    Lodz 3093133, 90-302
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    Mysłowice, 41-400
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    Warsaw, 04-501
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    Warsaw 756135, 02-172
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    Warszawa, 00-215
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    Wroclaw, 53-673
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    Manati, 00674
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    Mayagüez, 00680
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    San Juan, 00927
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    Singapore, 308433
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    Cape Town, 7530
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    Johannesburg, 2196
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    Worcester, 6850
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    Busan, 49241
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    Daegu, 42415
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    Gyeonggi-do, 16247
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    Seoul, 02447
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    Seoul 1835848, 07985
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    Barcelona, 08916
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    Taipei, 100225
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    Adana, 1370
    Turkey (Türkiye)

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    Ankara, 06800
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    Ankara 323786, 06800
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    Bursa, 16110
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    Center, 53020
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    Istanbul, 34899
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    Flagstaff, Arizona 86001
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    Tucson, Arizona 85712
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    Victorville, California 92395
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    Brandon, Florida 33511
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    Jupiter, Florida 33458
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    Active - Recruiting

  • 89bio Clinical Study Site

    Lady Lake 4161118, Florida 4155751 32159-8986
    United States

    Terminated

  • 89bio Clinical Study Site

    Maitland 4163220, Florida 4155751 32751-7497
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Athens, Georgia 30607
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Dalton, Georgia 30720
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Hammond, Indiana 46324
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    South Bend, Indiana 46635
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Houma, Louisiana 70360
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    West Monroe, Louisiana 71291
    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

    Burlington, Massachusetts 01805
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Chesterfield, Michigan 48047
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Maplewood, Minnesota 55109
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    St Louis, Missouri 63123
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Florham Park, New Jersey 07932
    United States

    Terminated

  • 89bio Clinical Study Site

    Freehold, New Jersey 07728
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Warren Township, New Jersey 07059
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Carmel, New York 10512
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    New York, New York 10021
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    New York 5128581, New York 5128638 10033
    United States

    Terminated

  • 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

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Raleigh, North Carolina 27612
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • 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

    Cleveland, Ohio 44106
    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

    Lima, Ohio 45801
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Springboro, Ohio 45066
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Westlake, Ohio 44145
    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

    Chattanooga, Tennessee 37421
    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

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Brownsville, Texas 78520
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Corpus Christi, Texas 78404
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Denton, Texas 76201
    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 Sam Houston, Texas 78234
    United States

    Terminated

  • 89bio Clinical Study Site

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Garland, Texas 75044
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Georgetown, Texas 78626
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Katy, Texas 77494
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Stafford, Texas 77477
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Tomball, Texas 77584
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Waco, Texas 76710
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Austin 4671654, Texas 4736286 78745
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Georgetown 4693342, Texas 4736286 78628
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    San Antonio 4726206, Texas 4736286 78215
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Waco 4739526, Texas 4736286 76301
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Ogden, Utah 84405
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Richmond, Virginia 23229
    United States

    Terminated

  • 89bio Clinical Study Site

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Richmond 4781708, Virginia 6254928 23298
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Seattle, Washington 98101
    United States

    Active - Recruiting

  • 89bio Clinical Study Site

    Seattle 5809844, Washington 5815135 98101
    United States

    Active - Recruiting

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