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

June 2, 2026 updated by: 89bio, Inc.

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

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.

Study Overview

Status

Recruiting

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1350

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ENLIGHTEN clinical trial
Phone Number: 1-415-432-9270
Email: enlighten@89bio.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1061
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Buenos Aires, Argentina, 1125
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      89bio Clinical Study Site
  - Buenos Aires, Argentina, C1425
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      89bio Clinical Study Site
  - Buenos Aires, Argentina, 1181
    - Recruiting
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      89bio Clinical Study Site
  - Buenos Aires, Argentina, C1012AAR
    - Terminated
    - 89bio Clinical Study Site
  - Caba, Argentina, C1430CKE
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      89bio Clinical Study Site
  - Capital Federal, Argentina, C1280AEB
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      89bio Clinical Study Site
  - Pilar, Argentina, 1629
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Australia
- - Fitzroy, Australia, 3065
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  - Murdoch, Australia, 6150
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- Queensland
  - Brisbane, Queensland, Australia, 4120
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      89bio Clinical Study Site
  - Herston, Queensland, Australia, 4019
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      89bio Clinical Study Site
  - South Brisbane, Queensland, Australia, 4101
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- South Australia
  - Adelaide, South Australia, Australia, 5000
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      89bio Clinical Study Site
  - Bedford Park, South Australia, Australia, 5042
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- Victoria
  - Clayton, Victoria, Australia, 3168
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  - Heidelberg, Victoria, Australia, 3084
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- Western Australia
  - Perth, Western Australia, Australia, 6000
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Austria
- - Graz, Austria, 8036
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  - Innsbruck, Austria, 6020
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  - Klagenfurt, Austria, 9020
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  - Sankt Pölten, Austria, 3100
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  - Wels, Austria, 4600
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Belgium
- - Brussels, Belgium, 1020
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  - Brussels, Belgium, 1070
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  - Edegem, Belgium, 2650
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  - Genk, Belgium, 3600
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  - Ghent, Belgium, 9000
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  - Jette, Belgium, 1090
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Bulgaria
- - Gorna Oryahovitsa, Bulgaria, 5100
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  - Sofia, Bulgaria, 1431
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      89bio Clinical Study Site
  - Sofia, Bulgaria, 1407
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      89bio Clinical Study Site
  - Sofia, Bulgaria, 1202
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      89bio Clinical Study Site
  - Stara Zagora, Bulgaria, 6003
    - Terminated
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Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
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- British Columbia
  - Vancouver, British Columbia, Canada, V6Z2K5
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  - Vancouver, British Columbia, Canada, V5Z 1M9
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- Manitoba
  - Winnipeg, Manitoba, Canada, R3T 2N2
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- Ontario
  - London, Ontario, Canada, N6A 5A5
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  - Ottawa, Ontario, Canada, K1H8L6
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      89bio Clinical Study Site
  - Toronto, Ontario, Canada, M6H 3M1
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      89bio Clinical Study Site
  - Toronto, Ontario, Canada, M5G2C4
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      89bio Clinical Study Site
  - Vaughan, Ontario, Canada, L4L 4Y7
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Czechia
- - Brno, Czechia, 625 00
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      89bio Clinical Study Site
  - Ostrava, Czechia, 708 52
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      89bio Clinical Study Site
  - Pilsen, Czechia, 30100
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France
- - Amiens, France, 80080
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      89bio Clinical Study Site
  - Angers, France, 49933
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  - Bordeaux, France, 33604
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  - Lille, France, 59000
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  - Limoges, France, 87042
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  - Lyon, France, 69004
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  - Montpellier, France, 34090
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  - Nantes, France, 44093
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      89bio Clinical Study Site
  - Nice, France, 06200
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      89bio Clinical Study Site
  - Paris, France, 75013
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  - Paris, France, 75012
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  - Paris, France, 75014
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      89bio Clinical Study Site
  - Pierre-Bénite, France, 69310
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  - Strasbourg, France, 67000
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  - Toulouse, France, 31076
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  - Toulouse, France
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  - Vandœuvre-lès-Nancy, France, 54500
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      89bio Clinical Study Site
  - Villejuif, France, 94800
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      89bio Clinical Study Site
  - Vénissieux, France, 69200
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Georgia
- - Batumi, Georgia, 6000
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      89bio Clinical Study Site
  - Batumi, Georgia, 6010
    - Terminated
    - 89bio Clinical Study Site
  - Tbilisi, Georgia, 0177
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      89bio Clinical Study Site
  - Tbilisi, Georgia, 0159
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      89bio Clinical Study Site
  - Tbilisi, Georgia, 0159
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Germany
- - Chemnitz, Germany, 09116
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      89bio Clinical Study Site
  - Frankfurt am Main, Germany, 60596
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  - Freiburg im Breisgau, Germany, 79106
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      89bio Clinical Study Site
  - Hanover, Germany, 30625
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  - Homburg, Germany, 66421
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      89bio Clinical Study Site
  - Münster, Germany, 48149
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Hong Kong
- - Hong Kong, Hong Kong, 0000
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  - Shatin, Hong Kong, 0000
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India
- - Bhubaneswar, India, 751024
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  - Gujrāt, India, 360001
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  - Nagpur, India, 440012
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  - Wardha, India, 442004
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- Assam
  - Guwahati, Assam, India, 701032
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- Uttar Pradesh
  - Allahābād, Uttar Pradesh, India, 211002
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- West Bengal
  - Kolkata, West Bengal, India, 700150
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Israel
- - Afula, Israel, 1834111
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  - Beersheba, Israel, 8410500
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      89bio Clinical Study Site
  - Haifa, Israel, 3109601
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      89bio Clinical Study Site
  - Haifa, Israel, 3436212
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  - Jerusalem, Israel
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      89bio Clinical Study Site
  - Nahariya, Israel, 2210001
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      89bio Clinical Study Site
  - Petah Tikva, Israel, 4941492
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  - Ramat Gan, Israel, 52621
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  - Tel Aviv, Israel
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      89bio Clinical Study Site
  - Tel Aviv, Israel, 6971014
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Italy
- - Bergamo, Italy, 24127
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      89bio Clinical Study Site
  - Milan, Italy, 20152
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  - Milan, Italy, 20089
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      89bio Clinical Study Site
  - Milan, Italy, 20162
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  - Modena, Italy, 41126
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  - Naples, Italy, 80131
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  - Novara, Italy, 28100
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  - Palermo, Italy, 90127
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  - Roma, Italy, 00128
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  - Rome, Italy, 00136
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  - Rome, Italy, 169
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  - Torino, Italy, 10126
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Japan
- - Ehime, Japan, 798-8510
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  - Ehime, Japan, 791-0295
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  - Fukuoka, Japan, 814-0180
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  - Gifu, Japan, 500-8323
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  - Kumamoto, Japan, 862-0971
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  - Nagano, Japan, 381-0006
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  - Okayama, Japan, 700-8558
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      89bio Clinical Study Site
  - Osaka, Japan, 545-0051
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      89bio Clinical Study Site
  - Osaka, Japan, 564-0013
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      89bio Clinical Study Site
  - Saga, Japan, 849-0937
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      89bio Clinical Study Site
  - Sapporo, Japan, 062-0921
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- Gunma
  - Maebashi, Gunma, Japan, 371-0821
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- Hokkaido
  - Sapporo, Hokkaido, Japan, 065-0012
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- Iwate
  - Hizume, Iwate, Japan, 028-3695
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- Kanagawa
  - Kawasaki, Kanagawa, Japan, 215-0026
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  - Yokohama, Kanagawa, Japan, 236-004
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Mexico
- - Chihuahua City, Mexico, 31217
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  - Cuautitlán Izcalli, Mexico, 54769
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  - Jalisco, Mexico, 44130
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  - Mexico City, Mexico, 03330
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  - Mexico City, Mexico, 06700
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  - Morelos, Mexico, 62270
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  - Nuevo León, Mexico, 64310
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  - Yucatán, Mexico, 97070
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Netherlands
- - Amsterdam, Netherlands, 1081HV
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  - Utrecht, Netherlands, 3584CX
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- South Holland
  - Rotterdam, South Holland, Netherlands, 3015C
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Poland
- - Katowice, Poland, 40-752
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  - Krakow, Poland, 31-501
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  - Lodz, Poland, 91-363
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      89bio Clinical Study Site
  - Lodz, Poland, 90-302
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  - Mysłowice, Poland, 41-400
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      89bio Clinical Study Site
  - Warsaw, Poland, 02-172
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      89bio Clinical Study Site
  - Warsaw, Poland, 04-501
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  - Warsaw, Poland, 00-215
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      89bio Clinical Study Site
  - Wroclaw, Poland, 53-673
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Puerto Rico
- - Manati, Puerto Rico, 00674
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  - Mayagüez, Puerto Rico, 00680
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  - San Juan, Puerto Rico, 00927
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Singapore
- - Singapore, Singapore, 169856
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  - Singapore, Singapore, 308433
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      89bio Clinical Study Site
  - Singapore, Singapore, 529889
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      89bio Clinical Study Site
  - Singapore, Singapore, 119228
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South Africa
- - Cape Town, South Africa, 7530
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  - Johannesburg, South Africa, 2196
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      89bio Clinical Study Site
  - Worcester, South Africa, 6850
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South Korea
- - Busan, South Korea, 49241
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      89bio Clinical Study Site
  - Daegu, South Korea, 42415
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  - Gyeonggi-do, South Korea, 16247
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      89bio Clinical Study Site
  - Incheon, South Korea, 22332
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      89bio Clinical Study Site
  - Seoul, South Korea, 03080
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      89bio Clinical Study Site
  - Seoul, South Korea, 06591
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      89bio Clinical Study Site
  - Seoul, South Korea, 07061
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      89bio Clinical Study Site
  - Seoul, South Korea, 02447
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      89bio Clinical Study Site
  - Seoul, South Korea, 07985
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      89bio Clinical Study Site
  - Seoul, South Korea, 08308
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Spain
- - Barcelona, Spain, 08041
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      89bio Clinical Study Site
  - Barcelona, Spain, 08036
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      89bio Clinical Study Site
  - Barcelona, Spain, 08003
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      89bio Clinical Study Site
  - Barcelona, Spain, 08035
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      89bio Clinical Study Site
  - Barcelona, Spain, 08916
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      89bio Clinical Study Site
  - Córdoba, Spain, 14004
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      89bio Clinical Study Site
  - Madrid, Spain, 28007
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      89bio Clinical Study Site
  - Majadahonda, Spain, 28222
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      89bio Clinical Study Site
  - Málaga, Spain, 29010
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  - Pontevedra, Spain, 36071
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      89bio Clinical Study Site
  - Santander, Spain, 39008
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      89bio Clinical Study Site
  - Santiago de Compostela, Spain, 15706
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    - Contact:
      
      89bio Clinical Study Site
  - Seville, Spain, 41013
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
Taiwan
- - Chiayi City, Taiwan, 60002
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Kaohsiung City, Taiwan, 807
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Taipei, Taiwan, 100225
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 1370
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Ankara, Turkey (Türkiye), 06230
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Ankara, Turkey (Türkiye), 06800
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Bursa, Turkey (Türkiye), 16110
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Center, Turkey (Türkiye), 53020
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Fatih, Turkey (Türkiye), 34093
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Gaziantep, Turkey (Türkiye), 27410
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Istanbul, Turkey (Türkiye), 34010
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Istanbul, Turkey (Türkiye), 34899
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Izmir, Turkey (Türkiye), 35360
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Sarıçam, Turkey (Türkiye), 01790
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Umraniye, Turkey (Türkiye), 34764
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
United Kingdom
- - Bristol, United Kingdom, BS6 6LT
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Glasgow, United Kingdom, G514TY
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Hull, United Kingdom, HU3 2JZ
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - London, United Kingdom, E1
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - London, United Kingdom, SE5 9RS
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - London, United Kingdom, NW32QG
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - London, United Kingdom, W2 1NY
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - London, United Kingdom, E13 8SL
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Oxford, United Kingdom, OX3 9DU
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Portsmouth, United Kingdom, PO6 3LY
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Preston, United Kingdom, PR2 9QB
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Southampton, United Kingdom, SO16 6YD
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Stockton, United Kingdom, TS19
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Sunderland, United Kingdom, SR4 7TP
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Swansea, United Kingdom, SA6
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - York, United Kingdom, YO24 4LJ
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Buckinghamshire
  - High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Arizona
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Flagstaff, Arizona, United States, 86001
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Glendale, Arizona, United States, 85036
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Tucson, Arizona, United States, 85712
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Arkansas
  - Conway, Arkansas, United States, 72032
    - Terminated
    - 89bio Clinical Study Site
  - Little Rock, Arkansas, United States, 72211-3859
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - North Little Rock, Arkansas, United States, 72117
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- California
  - Canoga Park, California, United States, 91604
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Coronado, California, United States, 92118
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Escondido, California, United States, 92025
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Fresno, California, United States, 93720
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Gardena, California, United States, 90247
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Huntington Park, California, United States, 90255
    - Terminated
    - 89bio Clinical Study Site
  - Inglewood, California, United States, 90301
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - La Jolla, California, United States, 92037
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Lancaster, California, United States, 93534
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Long Beach, California, United States, 90815
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Los Angeles, California, United States, 90048
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Montclair, California, United States, 91763
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Orange, California, United States, 92868
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Panorama City, California, United States, 91402
    - Terminated
    - 89bio Clinical Study Site
  - Pasadena, California, United States, 91105
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Poway, California, United States, 92064
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Rialto, California, United States, 92377
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Santa Ana, California, United States, 92704-5763
    - Terminated
    - 89bio Clinical Study Site
  - Stanford, California, United States, 94305
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Victorville, California, United States, 92395
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Colorado
  - Colorado Springs, Colorado, United States, 80923
    - Terminated
    - 89bio Clinical Study Site
  - Littleton, Colorado, United States, 80120
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Florida
  - Brandon, Florida, United States, 33511
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Clermont, Florida, United States, 34711
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Fort Myers, Florida, United States, 33912
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Hialeah Gardens, Florida, United States, 33016
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Homestead, Florida, United States, 33030
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Jacksonville, Florida, United States, 32256
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Jupiter, Florida, United States, 33458
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Lady Lake, Florida, United States, 32159-6831
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Lady Lake, Florida, United States, 32159-8986
    - Terminated
    - 89bio Clinical Study Site
  - Lakewood Rch, Florida, United States, 34211
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Lehigh Acres, Florida, United States, 33936
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Maitland, Florida, United States, 32751-7258
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Maitland, Florida, United States, 32751-7497
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - New Port Richey, Florida, United States, 34653
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Ocala, Florida, United States, 34471
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Ocoee, Florida, United States, 34761
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Sarasota, Florida, United States, 34240
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Winter Park, Florida, United States, 32789
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Georgia
  - Athens, Georgia, United States, 30607
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Dalton, Georgia, United States, 30720
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Indiana
  - Hammond, Indiana, United States, 46324
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - New Albany, Indiana, United States, 47150
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - South Bend, Indiana, United States, 46635
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Kansas
  - Topeka, Kansas, United States, 66606
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Houma, Louisiana, United States, 70360
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Lake Charles, Louisiana, United States, 70605
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Marrero, Louisiana, United States, 70072
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - New Orleans, Louisiana, United States, 70115
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - West Monroe, Louisiana, United States, 71291
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Maryland
  - Baltimore, Maryland, United States, 21202
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Glen Burnie, Maryland, United States, 21061
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Greenbelt, Maryland, United States, 20770
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Massachusetts
  - Burlington, Massachusetts, United States, 01805
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Michigan
  - Chesterfield, Michigan, United States, 48047
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Wyoming, Michigan, United States, 49519
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Ypsilanti, Michigan, United States, 48197
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Minnesota
  - Maplewood, Minnesota, United States, 55109
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Missouri
  - St Louis, Missouri, United States, 63123
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- New Jersey
  - Florham Park, New Jersey, United States, 07932
    - Terminated
    - 89bio Clinical Study Site
  - Freehold, New Jersey, United States, 07728
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Warren Township, New Jersey, United States, 07059
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- New York
  - Carmel, New York, United States, 10512
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - New York, New York, United States, 10021
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - New York, New York, United States, 10033
    - Terminated
    - 89bio Clinical Study Site
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Fayetteville, North Carolina, United States, 28304
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Morehead City, North Carolina, United States, 28557
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Raleigh, North Carolina, United States, 27612
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Wilmington, North Carolina, United States, 28401
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Ohio
  - Akron, Ohio, United States, 44320
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Dayton, Ohio, United States, 45414
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Liberty Township, Ohio, United States, 45044
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Lima, Ohio, United States, 45801
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Springboro, Ohio, United States, 45066
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Westlake, Ohio, United States, 44145
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Rhode Island
  - East Greenwich, Rhode Island, United States, 02818
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Columbia, South Carolina, United States, 29204
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Cordova, Tennessee, United States, 38018
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Hermitage, Tennessee, United States, 37076
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Nashville, Tennessee, United States, 37211
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Texas
  - Amarillo, Texas, United States, 79106
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Austin, Texas, United States, 78757
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Austin, Texas, United States, 78757-8051
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Austin, Texas, United States, 78745
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Bellaire, Texas, United States, 77401
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Brownsville, Texas, United States, 78520
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Corpus Christi, Texas, United States, 78404
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - DeSoto, Texas, United States, 75115
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Denton, Texas, United States, 76201
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Edinburg, Texas, United States, 78539
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Farmers Branch, Texas, United States, 75234
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Fort Sam Houston, Texas, United States, 78234
    - Terminated
    - 89bio Clinical Study Site
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Garland, Texas, United States, 75044
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Georgetown, Texas, United States, 78628
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Georgetown, Texas, United States, 78626
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Houston, Texas, United States, 77030
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Houston, Texas, United States, 77099
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Katy, Texas, United States, 77494
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - San Antonio, Texas, United States, 78209
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - San Antonio, Texas, United States, 78215
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - San Antonio, Texas, United States, 78229-4801
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - San Antonio, Texas, United States, 78222
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Stafford, Texas, United States, 77477
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Sugar Land, Texas, United States, 77479
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Tomball, Texas, United States, 77584
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Waco, Texas, United States, 76301
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Waco, Texas, United States, 76710
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Utah
  - Ogden, Utah, United States, 84405
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Virginia
  - Richmond, Virginia, United States, 23226-1925
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Richmond, Virginia, United States, 23298
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Richmond, Virginia, United States, 23229
    - Terminated
    - 89bio Clinical Study Site
  - Richmond, Virginia, United States, 23236
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Washington
  - Seattle, Washington, United States, 98105
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Seattle, Washington, United States, 98101
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing 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) (≥23 kg/m^2 for Asian participants).

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 per liter (U/L)
Participants taking vitamin E (>400 international units [IU]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening

Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pegozafermin Regimen 1	Biological: Pegozafermin Subcutaneous injection Other Names: BIO89-100
Experimental: Pegozafermin Regimen 2	Biological: Pegozafermin Subcutaneous injection Other Names: BIO89-100
Placebo Comparator: Placebo Matched Placebo will be administered in Regimens 1 and 2.	Other: Placebo Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52 Time Frame: Week 52	Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis	Week 52
Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52 Time Frame: Week 52	Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.	Week 52
Time to First Occurrence of Disease Progression Time Frame: Up to 5 years	Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change from Baseline in Alanine Aminotransferase at Week 52 Time Frame: Baseline, Week 52	Baseline, Week 52
Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52 Time Frame: Baseline, Week 52	Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

89bio, Inc.

Investigators

Study Director: Millie Gottwald, PharmD, 89bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BIO89-100-131

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Clinical Trials on Placebo

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