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

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

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

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]).

Study Overview

Status

Recruiting

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

762

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, CP 1061
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Buenos Aires, Argentina, C1125ABE
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Buenos Aires, Argentina, C1012AAR
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      89bio Clinical Study Site
  - Buenos Aires, Argentina, C1425BGH
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      89bio Clinical Study Site
  - Buenos Aires, Argentina, C1425
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      89bio Clinical Study Site
  - Buenos Aires, Argentina, C1199ABB
    - Recruiting
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      89bio Clinical Study Site
  - CABA, Argentina, C1430CKE
    - Recruiting
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      89bio Clinical Study Site
  - Capital Federal, Argentina, C1280AEB
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      89bio Clinical Study Site
  - Pilar, Argentina, B1629AHJ
    - Recruiting
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      89bio Clinical Study Site
Australia
- - Adelaide, Australia, SA 5000
    - Recruiting
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      89bio Clinical Study Site
  - Fitzroy, Australia, 03065
    - Recruiting
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      89bio Clinical Study Site
  - Greenslopes, Australia, 04120
    - Recruiting
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      89bio Clinical Study Site
  - Heidelberg, Australia, 3084
    - Recruiting
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      89bio Clinical Study Site
  - Herston, Australia, Qld 4029
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      89bio Clinical Study Site
  - Murdoch, Australia, 06150
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      89bio Clinical Study Site
  - Perth, Australia, 06000
    - Recruiting
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      89bio Clinical Study Site
  - South Brisbane, Australia, 04101
    - Recruiting
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      89bio Clinical Study Site
Belgium
- - Brussels, Belgium, 01070
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      89bio Clinical Study Site
  - Brussels, Belgium, 01090
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      89bio Clinical Study Site
  - Brussels, Belgium, 1200
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      89bio Clinical Study Site
  - Edegem, Belgium, 02650
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      89bio Clinical Study Site
  - Genk, Belgium, 03600
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      89bio Clinical Study Site
  - Ghent, Belgium, 09000
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      89bio Clinical Study Site
  - Roeselare, Belgium, 08800
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      89bio Clinical Study Site
Brazil
- - Barretos, Brazil, 14784-400
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      89bio Clinical Study Site
  - Belo Horizonte, Brazil, 30220-140
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      89bio Clinical Study Site
  - Botucatu, Brazil, 18618-687
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      89bio Clinical Study Site
  - Goiânia, Brazil, 74605-050
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      89bio Clinical Study Site
  - Porto Alegre, Brazil, 90035-903
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      89bio Clinical Study Site
  - Rio de Janeiro, Brazil, 21941-617
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      89bio Clinical Study Site
  - Salvador, Brazil, 41820-460
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      89bio Clinical Study Site
  - São José do Rio Preto, Brazil, 15090-000
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      89bio Clinical Study Site
  - São Paulo, Brazil, 04038-002
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      89bio Clinical Study Site
  - Vitória, Brazil, 29055-450
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      89bio Clinical Study Site
Bulgaria
- - Gorna Oryahovitsa, Bulgaria, 05100
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      89bio Clinical Study Site
  - Sofia, Bulgaria, 01407
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      89bio Clinical Study Site
  - Sofia, Bulgaria, 01202
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      89bio Clinical Study Site
  - Stara Zagora, Bulgaria, 06003
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
Canada
- - Vaughan, Canada, L4L 4Y7
    - Withdrawn
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- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Recruiting
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      89bio Clinical Study Site
- British Columbia
  - Vancouver, British Columbia, Canada, V6Z2K5
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      89bio Clinical Study Site
  - Vancouver, British Columbia, Canada, V5Z 1M9
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      89bio Clinical Study Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 3P4
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      89bio Clinical Study Site
- Ontario
  - London, Ontario, Canada, N6A5A5
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      89bio Clinical Study Site
  - Ottawa, Ontario, Canada, K1H 8L6
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      89bio Clinical Study Site
  - Toronto, Ontario, Canada, M6H3M1
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      89bio Clinical Study Site
France
- - Amiens, France, 80054
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      89bio Clinical Study Site
  - Dijon, France, 21000
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      89bio Clinical Study Site
  - Limoges, France, 87000
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      89bio Clinical Study Site
  - Lyon, France, 69004
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      89bio Clinical Study Site
  - Montpellier, France, 34295
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      89bio Clinical Study Site
  - Nice, France, 06202
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      89bio Clinical Study Site
  - Paris, France, 75013
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      89bio Clinical Study Site
  - Paris, France, 75012
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      89bio Clinical Study Site
  - Paris, France, 75014
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      89bio Clinical Study Site
  - Pessac, France, 33604
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      89bio Clinical Study Site
  - Strasbourg, France, 67091
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      89bio Clinical Study Site
  - Toulouse, France, 31400
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      89bio Clinical Study Site
  - 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, 69694
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      89bio Clinical Study Site
Germany
- - Chemnitz, Germany, 9116
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      89bio Clinical Study Site
  - Frankfurt, Germany, 60590
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      89bio Clinical Study Site
  - Freiburg im Breisgau, Germany, 79110
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      89bio Clinical Study Site
  - Hanover, Germany, 30625
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      89bio Clinical Study Site
  - Homburg, Germany, 66421
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      89bio Clinical Study Site
  - Münster, Germany, 48149
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Shatin, Hong Kong
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
Hungary
- - Budapest, Hungary, 01027
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Budapest, Hungary, 01088
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Budapest, Hungary, H-1097
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
India
- - Gujrāt, India, 360001
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Sūrat, India, 395009
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
Israel
- - Afula, Israel, 1834111
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      89bio Clinical Study Site
  - Beersheba, Israel, 8410101
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Haifa, Israel, 3109601
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Haifa, Israel, 3436212
    - Enrolling by invitation
    - 89bio Clinical Study Site
  - Jerusalem, Israel, 9112001
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Nahariya, Israel, 2210001
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      89bio Clinical Study Site
  - Petah Tikva, Israel, 49100
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      89bio Clinical Study Site
  - Tel Aviv, Israel, 69710
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Tel Litwinsky, Israel, 5265601
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      89bio Clinical Study Site
Italy
- - Bergamo, Italy, 24127
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      89bio Clinical Study Site
  - Foggia, Italy, 71121
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      89bio Clinical Study Site
  - Milan, Italy, 20122
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Milan, Italy, 20162
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Novara, Italy, 28100
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Palermo, Italy, 90127
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      89bio Clinical Study Site
  - Roma, Italy, 00128
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Rome, Italy, 00168
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      89bio Clinical Study Site
  - Rozzano, Italy, 20089
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      89bio Clinical Study Site
  - Torino, Italy, 10124
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
Mexico
- - Chihuahua City, Mexico, 31217
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Cuautitlán Izcalli, Mexico, CP 54769
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      89bio Clinical Study Site
  - Cuernavaca, Mexico, 62250
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      89bio Clinical Study Site
  - Jalisco, Mexico, 44130
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      89bio Clinical Study Site
  - Mexico City, Mexico, 03330
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      89bio Clinical Study Site
  - Mexico City, Mexico, 06700
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Monterrey, Mexico, 64310
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      89bio Clinical Study Site
  - Mérida, Mexico, 97070
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      89bio Clinical Study Site
Netherlands
- - Amsterdam, Netherlands, 1081 HV
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      89bio Clinical Study Site
  - Rotterdam, Netherlands, 3015GD
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      89bio Clinical Study Site
  - Tilburg, Netherlands, 5022 GC
    - Recruiting
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      89bio Clinical Study Site
  - Utrecht, Netherlands, 3584 CX
    - Withdrawn
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Poland
- - Katowice, Poland, 40-752
    - Withdrawn
    - 89bio Clinical Study Site
  - Krakow, Poland, 31-501
    - Recruiting
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      89bio Clinical Study Site
  - Lodz, Poland, 91-363
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Lodz, Poland, 90-302
    - Recruiting
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    - Contact:
      
      89bio Clinical Study Site
  - Mysłowice, Poland, 41-400
    - Withdrawn
    - 89bio Clinical Study Site
  - Warsaw, Poland, 02-172
    - Recruiting
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      89bio Clinical Study Site
  - Warsaw, Poland, 04-501
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Warsaw, Poland, 00-215
    - Withdrawn
    - 89bio Clinical Study Site
  - Wroclaw, Poland, 53-673
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
Puerto Rico
- - Manati, Puerto Rico, 00674
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Mayagüez, Puerto Rico, 00680
    - Recruiting
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      89bio Clinical Study Site
  - San Juan, Puerto Rico, 00927
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
Singapore
- - Singapore, Singapore, 308433
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Singapore, Singapore, 529889
    - Recruiting
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      89bio Clinical Study Site
  - Singapore, Singapore, 169608
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Singapore, Singapore, 119074
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
South Korea
- - Bucheon-si, South Korea, 14584
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Busan, South Korea, 49241
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      89bio Clinical Study Site
  - Daegu, South Korea, 42415
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      89bio Clinical Study Site
  - Daegu, South Korea, 700-712
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      89bio Clinical Study Site
  - Incheon, South Korea, 22332
    - Recruiting
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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, 07895
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      89bio Clinical Study Site
  - Seoul, South Korea, 130-872
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      89bio Clinical Study Site
Spain
- - Almería, Spain, 04009
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      89bio Clinical Study Site
  - Badalona, Spain, 08916
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      89bio Clinical Study Site
  - Barcelona, Spain, 08041
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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
  - Córdoba, Spain, 14004
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      89bio Clinical Study Site
  - Madrid, Spain, 28007
    - Recruiting
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      89bio Clinical Study Site
  - Málaga, Spain, 29010
    - Withdrawn
    - 89bio Clinical Study Site
  - Pontevedra, Spain, 36071
    - Recruiting
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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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      89bio Clinical Study Site
  - Zaragoza, Spain, 50009
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      89bio Clinical Study Site
Taiwan
- - Chiayi City, Taiwan, 60002
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      89bio Clinical Study Site
  - Kaohsiung City, Taiwan, 80756
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      89bio Clinical Study Site
  - Tainan, Taiwan, 00704
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06100
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Ankara, Turkey (Türkiye), 6800
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Fatih, Turkey (Türkiye), 34093
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Istanbul, Turkey (Türkiye), 34010
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Istanbul, Turkey (Türkiye), 34722
    - Recruiting
    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Izmir, Turkey (Türkiye), 35360
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Umraniye, Turkey (Türkiye), 34764
    - Recruiting
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      89bio Clinical Study Site
  - Yüreğir, Turkey (Türkiye), 1370
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
- Rize Province
  - Merkez, Rize Province, Turkey (Türkiye), 53020
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      89bio Clinical Study Site
- İzmir
  - Bornova, İzmir, Turkey (Türkiye), 35040
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      89bio Clinical Study Site
United Kingdom
- - Aberdeen, United Kingdom, AB25 2ZN
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    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Bristol, United Kingdom, BS10 5NB
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    - Contact:
      
      89bio Clinical Study Site
  - Leeds, United Kingdom, LS9 7TF
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    - Contact:
      
      89bio Clinical Study Site
  - London, United Kingdom, SE5 9RS
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    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - London, United Kingdom, E1 1BB
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - London, United Kingdom, W2 1NY
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    - Contact:
      
      89bio Clinical Study Site
  - London, United Kingdom, NW3 2QG
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    - 89bio Clinical Study Site
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      89bio Clinical Study Site
  - Oxford, United Kingdom, OX3 9DU
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      89bio Clinical Study Site
  - Plymouth, United Kingdom, PL6 8DH
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      89bio Clinical Study Site
  - Port Talbot, United Kingdom, SA12 7BR
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      89bio Clinical Study Site
  - Portsmouth, United Kingdom, P06 3LY
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      89bio Clinical Study Site
  - Southampton, United Kingdom, SO16 6YD
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      89bio Clinical Study Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Homewood, Alabama, United States, 35209
    - Recruiting
    - 89bio Clinical Study Site
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      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
    - Withdrawn
    - 89bio Clinical Study Site
  - Peoria, Arizona, United States, 85381
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Phoenix, Arizona, United States, 85054
    - 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
  - Tucson, Arizona, United States, 85716
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Tucson, Arizona, United States, 85715
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - 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
  - Camarillo, California, United States, 93012
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Canoga Park, California, United States, 91304
    - 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
  - 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
  - Huntington Park, California, United States, 90255
    - Withdrawn
    - 89bio Clinical Study Site
  - La Jolla, California, United States, 92037-0887
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Los Angeles, California, United States, 90033
    - 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
  - 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
  - Redwood City, California, United States, 94063
    - 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
  - Sacramento, California, United States, 95817
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Santa Ana, California, United States, 92704
    - Withdrawn
    - 89bio Clinical Study Site
- Colorado
  - Littleton, Colorado, United States, 80120
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Florida
  - 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
  - Gainesville, Florida, United States, 32610
    - 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
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Lady Lake, Florida, United States, 32159
    - Withdrawn
    - 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
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Miami, Florida, United States, 33176-1530
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Miami, Florida, United States, 33144
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Miami, Florida, United States, 33176-7947
    - Withdrawn
    - 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
  - Orlando, Florida, United States, 32825
    - Withdrawn
    - 89bio Clinical Study Site
  - University Park, Florida, United States, 34201
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Viera, Florida, United States, 32940
    - 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
  - Atlanta, Georgia, United States, 30309
    - 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
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Topeka, Kansas, United States, 66606
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Louisiana
  - Lafayette, Louisiana, United States, 70503
    - 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
  - 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
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Clinton Township, Michigan, United States, 48038
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Detroit, Michigan, United States, 48202
    - 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
  - Minneapolis, Minnesota, United States, 55413
    - 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
  - Tupelo, Mississippi, United States, 38801
    - Withdrawn
    - 89bio Clinical Study Site
- Missouri
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - 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
    - Withdrawn
    - 89bio Clinical Study Site
  - Somers Point, New Jersey, United States, 08244
    - 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
  - New York, New York, United States, 10016
    - 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
    - Withdrawn
    - 89bio Clinical Study Site
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - 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
  - Greenville, North Carolina, United States, 27834
    - Withdrawn
    - 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
  - Cincinnati, Ohio, United States, 45267
    - 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
  - Columbus, Ohio, United States, 43210
    - 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
  - Westlake, Ohio, United States, 44145
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19148
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - 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
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Tennessee
  - 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, 78745
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Austin, Texas, United States, 78757-8059
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Austin, Texas, United States, 78757-8066
    - 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
  - DeSoto, Texas, United States, 75115
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Edinburg, Texas, United States, 78539
    - Withdrawn
    - 89bio Clinical Study Site
  - Farmers Branch, Texas, United States, 75234
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Harlingen, Texas, United States, 78550
    - 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
  - Houston, Texas, United States, 77074
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Lewisville, Texas, United States, 75067
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Lubbock, Texas, United States, 79410
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Mansfield, Texas, United States, 76063
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Pearland, Texas, United States, 77584
    - 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, 78229-4801
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - San Antonio, Texas, United States, 78229-5069
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - San Marcos, Texas, United States, 78666
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Waco, Texas, United States, 76712
    - 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
  - Sandy City, Utah, United States, 84092
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - West Jordan, Utah, United States, 84088
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
- Virginia
  - Richmond, Virginia, United States, 23298
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Richmond, Virginia, United States, 23226
    - Recruiting
    - 89bio Clinical Study Site
    - Contact:
      
      89bio Clinical Study Site
  - Richmond, Virginia, United States, 23229
    - Withdrawn
    - 89bio Clinical Study Site
  - Richmond, Virginia, United States, 23236
    - 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 75 years (inclusive) at time of signing the informed consent form (ICF).
Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and <50.0 kilograms (kg)/meters squared (m^2).

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 stable dose for at least 6 months prior to screening.

Other protocol-defined 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
Placebo Comparator: Placebo Matched placebo	Drug: Placebo Subcutaneous injection
Experimental: Pegozafermin	Biological: Pegozafermin Subcutaneous injection Other Names: BIO89-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Fibrosis Regression Time Frame: Baseline through Month 24	Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.	Baseline through Month 24
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events Time Frame: Baseline up to 5 years		Baseline up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score Time Frame: Baseline, up to Month 60	Baseline, up to Month 60
Change from Baseline in Alanine Aminotransferase (ALT) Level Time Frame: Baseline, up to Month 60	Baseline, up to Month 60
Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE) Time Frame: Baseline, up to Month 60	Baseline, up to Month 60
Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH) Time Frame: Baseline up to Month 60	Baseline up to Month 60

Collaborators and Investigators

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

Sponsor

89bio, Inc.

Investigators

Study Director: Maya Margalit, MD, 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)

May 24, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 17, 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

BIO89-100-132

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 Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

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