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En undersøgelse, der evaluerer Pegozafermins effektivitet og sikkerhed hos deltagere med MASH og fibrose (ENLIGHTEN-Fibrose)

1. september 2026 opdateret af: 89bio, Inc.

Et fase 3-studie til evaluering af Pegozafermins effektivitet og sikkerhed hos personer med metabolisk dysfunktion-associeret steatohepatitis (MASH) og fibrose

Studiet vil vurdere effektiviteten og sikkerheden af 2 dosisregimer af pegozafermin til behandling af leverfibrose stadium 2 eller 3 hos voksne deltagere med MASH (tidligere kendt som nonalcoholic steatohepatitis [NASH]).

Studieoversigt

Status

Rekruttering

Betingelser

Metabolisk dysfunktion-associeret steatotisk leversygdom (MASH) / ikke-alkoholisk steatohepatitis (NASH) med fibrose

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1350

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Undersøgelse Kontakt Backup

Navn: Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below.
Telefonnummer: 888-662-6728 (U.S. Only)
E-mail: global-roche-genentech-trials@gene.com

Studiesteder

Argentina
- - Buenos Aires, Argentina, 1061
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  - Buenos Aires, Argentina, 1125
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  - Buenos Aires, Argentina, C1425
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  - Buenos Aires, Argentina, 1181
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  - Buenos Aires, Argentina, C1012AAR
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  - Buenos Aires, Argentina, C1061AAS
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  - Caba, Argentina, C1430CKE
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  - Capital Federal, Argentina, C1280AEB
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  - Pilar, Argentina, 1629
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Australien
- - Fitzroy, Australien, 3065
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  - Murdoch, Australien, 6150
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- Queensland
  - Brisbane, Queensland, Australien, 4120
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  - Herston, Queensland, Australien, 4019
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  - South Brisbane, Queensland, Australien, 4101
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- South Australia
  - Adelaide, South Australia, Australien, 5000
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  - Bedford Park, South Australia, Australien, 5042
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- Victoria
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  - Heidelberg, Victoria, Australien, 3084
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- Western Australia
  - Perth, Western Australia, Australien, 6000
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Belgien
- - Brussels, Belgien, 1070
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  - Brussels, Belgien, 1020
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  - Edegem, Belgien, 2650
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  - Genk, Belgien, 3600
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  - Ghent, Belgien, 9000
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  - Jette, Belgien, 1090
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Bulgarien
- - Gorna Oryahovitsa, Bulgarien, 5100
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  - Sofia, Bulgarien, 1431
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  - Sofia, Bulgarien, 1407
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  - Sofia, Bulgarien, 1202
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  - Stara Zagora, Bulgarien, 6003
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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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  - Toronto, Ontario, Canada, M6H 3M1
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  - Toronto, Ontario, Canada, M5G2C4
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  - Vaughan, Ontario, Canada, L4L 4Y7
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Det Forenede Kongerige
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  - Glasgow, Det Forenede Kongerige, G514TY
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  - Oxford, Det Forenede Kongerige, OX3 9DU
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  - High Wycombe, Buckinghamshire, Det Forenede Kongerige, HP11 2QW
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Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35209
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- Arizona
  - Chandler, Arizona, Forenede Stater, 85224
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  - Flagstaff, Arizona, Forenede Stater, 86001
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  - Glendale, Arizona, Forenede Stater, 85036
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  - Sun City, Arizona, Forenede Stater, 85351
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  - Tucson, Arizona, Forenede Stater, 85716
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  - Tucson, Arizona, Forenede Stater, 85712-4018
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- Arkansas
  - Conway, Arkansas, Forenede Stater, 72032
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  - Little Rock, Arkansas, Forenede Stater, 72211-3859
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  - North Little Rock, Arkansas, Forenede Stater, 72117
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- California
  - Canoga Park, California, Forenede Stater, 91604
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  - Coronado, California, Forenede Stater, 92118
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  - Escondido, California, Forenede Stater, 92025
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  - Fountain Valley, California, Forenede Stater, 92708
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  - Fresno, California, Forenede Stater, 93720
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  - Gardena, California, Forenede Stater, 90247
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  - Huntington Park, California, Forenede Stater, 90255
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  - Inglewood, California, Forenede Stater, 90301
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  - La Jolla, California, Forenede Stater, 92037
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  - Lancaster, California, Forenede Stater, 93534
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  - Long Beach, California, Forenede Stater, 90815
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  - Los Angeles, California, Forenede Stater, 90048
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  - Montclair, California, Forenede Stater, 91763
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  - Orange, California, Forenede Stater, 92868
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  - Panorama City, California, Forenede Stater, 91402
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  - Pasadena, California, Forenede Stater, 91105
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  - Poway, California, Forenede Stater, 92064
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  - Rialto, California, Forenede Stater, 92377
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  - Santa Ana, California, Forenede Stater, 92704-5763
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  - Stanford, California, Forenede Stater, 94305
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  - Victorville, California, Forenede Stater, 92395
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- Colorado
  - Colorado Springs, Colorado, Forenede Stater, 80923
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  - Littleton, Colorado, Forenede Stater, 80120
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- Florida
  - Brandon, Florida, Forenede Stater, 33511
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  - Clermont, Florida, Forenede Stater, 34711
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  - Fort Myers, Florida, Forenede Stater, 33912
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  - Hialeah Gardens, Florida, Forenede Stater, 33016
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  - Homestead, Florida, Forenede Stater, 33030
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  - Jacksonville, Florida, Forenede Stater, 32256
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  - Jupiter, Florida, Forenede Stater, 33458
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  - Lady Lake, Florida, Forenede Stater, 32159-6831
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  - Lady Lake, Florida, Forenede Stater, 32159-8986
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  - Lakewood Rch, Florida, Forenede Stater, 34211
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  - Lehigh Acres, Florida, Forenede Stater, 33936
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  - Maitland, Florida, Forenede Stater, 32751-7258
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  - Maitland, Florida, Forenede Stater, 32751-7497
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  - Miami, Florida, Forenede Stater, 33176
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  - New Port Richey, Florida, Forenede Stater, 34653
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  - Ocala, Florida, Forenede Stater, 34471
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  - Ocoee, Florida, Forenede Stater, 34761
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  - Sarasota, Florida, Forenede Stater, 34240
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  - Winter Park, Florida, Forenede Stater, 32789
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- Georgia
  - Athens, Georgia, Forenede Stater, 30607
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  - Dalton, Georgia, Forenede Stater, 30720
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  - Marietta, Georgia, Forenede Stater, 30060
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- Illinois
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- Indiana
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- Iowa
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- Kentucky
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- Louisiana
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  - Marrero, Louisiana, Forenede Stater, 70072
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- Maryland
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  - Greenbelt, Maryland, Forenede Stater, 20770
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- Massachusetts
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- Michigan
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- Minnesota
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- Mississippi
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- Missouri
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- Nevada
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- New Jersey
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  - Freehold, New Jersey, Forenede Stater, 07728
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  - Warren Township, New Jersey, Forenede Stater, 07059
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- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87109
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- New York
  - Albany, New York, Forenede Stater, 12206
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  - Carmel, New York, Forenede Stater, 10512
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  - New York, New York, Forenede Stater, 10021
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  - New York, New York, Forenede Stater, 10033
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- North Carolina
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  - Durham, North Carolina, Forenede Stater, 27710
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  - Fayetteville, North Carolina, Forenede Stater, 28304
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  - Morehead City, North Carolina, Forenede Stater, 28557
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  - Raleigh, North Carolina, Forenede Stater, 27612
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  - Wilmington, North Carolina, Forenede Stater, 28401
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Winston-Salem, North Carolina, Forenede Stater, 27103
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Ohio
  - Akron, Ohio, Forenede Stater, 44320
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Cleveland, Ohio, Forenede Stater, 44106
    - Trukket tilbage
    - 89bio Clinical Study Site
  - Dayton, Ohio, Forenede Stater, 45414
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Dayton, Ohio, Forenede Stater, 45145
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Liberty Township, Ohio, Forenede Stater, 45044
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Lima, Ohio, Forenede Stater, 45801
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Springboro, Ohio, Forenede Stater, 45066
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Westlake, Ohio, Forenede Stater, 44145
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Rhode Island
  - East Greenwich, Rhode Island, Forenede Stater, 02818
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Columbia, South Carolina, Forenede Stater, 29204
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Tennessee
  - Chattanooga, Tennessee, Forenede Stater, 37421
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Cordova, Tennessee, Forenede Stater, 38018
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Hermitage, Tennessee, Forenede Stater, 37076
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Nashville, Tennessee, Forenede Stater, 37211
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Texas
  - Amarillo, Texas, Forenede Stater, 79106
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Austin, Texas, Forenede Stater, 78757
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Austin, Texas, Forenede Stater, 78757-8051
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Austin, Texas, Forenede Stater, 78745
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Bellaire, Texas, Forenede Stater, 77401
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Brownsville, Texas, Forenede Stater, 78520
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Corpus Christi, Texas, Forenede Stater, 78404
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - DeSoto, Texas, Forenede Stater, 75115
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Denton, Texas, Forenede Stater, 76201
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Edinburg, Texas, Forenede Stater, 78539
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Farmers Branch, Texas, Forenede Stater, 75234
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Fort Sam Houston, Texas, Forenede Stater, 78234
    - Trukket tilbage
    - 89bio Clinical Study Site
  - Fort Worth, Texas, Forenede Stater, 76104
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Garland, Texas, Forenede Stater, 75044
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Georgetown, Texas, Forenede Stater, 78628
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Georgetown, Texas, Forenede Stater, 78626
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Houston, Texas, Forenede Stater, 77030
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Houston, Texas, Forenede Stater, 77099
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Houston, Texas, Forenede Stater, 77090
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Katy, Texas, Forenede Stater, 77494
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Lewisville, Texas, Forenede Stater, 75067
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Lubbock, Texas, Forenede Stater, 79424
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - San Antonio, Texas, Forenede Stater, 78209
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - San Antonio, Texas, Forenede Stater, 78215
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - San Antonio, Texas, Forenede Stater, 78229-4801
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - San Antonio, Texas, Forenede Stater, 78229
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - San Antonio, Texas, Forenede Stater, 78222
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Southlake, Texas, Forenede Stater, 76092
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Stafford, Texas, Forenede Stater, 77477
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Sugar Land, Texas, Forenede Stater, 77479
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Tomball, Texas, Forenede Stater, 77584
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Tyler, Texas, Forenede Stater, 75701
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Waco, Texas, Forenede Stater, 76301
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Waco, Texas, Forenede Stater, 76710
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Utah
  - Ogden, Utah, Forenede Stater, 84405
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Virginia
  - Richmond, Virginia, Forenede Stater, 23226-1925
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Richmond, Virginia, Forenede Stater, 23298
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Richmond, Virginia, Forenede Stater, 23236
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Richmond, Virginia, Forenede Stater, 23229
    - Aktiv, ikke rekrutterende
    - 89bio Clinical Study Site
  - Roanoke, Virginia, Forenede Stater, 24014
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Washington
  - Bellevue, Washington, Forenede Stater, 98004
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Seattle, Washington, Forenede Stater, 98105
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Seattle, Washington, Forenede Stater, 98101
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Tacoma, Washington, Forenede Stater, 98405
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Frankrig
- - Amiens, Frankrig, 80080
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Angers, Frankrig, 49933
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Bordeaux, Frankrig, 33604
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Clichy, Frankrig, 92110
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Lille, Frankrig, 59000
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Limoges, Frankrig, 87042
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Lyon, Frankrig, 69004
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Montpellier, Frankrig, 34090
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Nantes, Frankrig, 44093
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Nice, Frankrig, 06200
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Paris, Frankrig, 75013
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Paris, Frankrig, 75012
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Paris, Frankrig, 75014
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Pierre-Bénite, Frankrig, 69310
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Strasbourg, Frankrig, 67000
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Toulouse, Frankrig, 31076
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Toulouse, Frankrig
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Vandœuvre-lès-Nancy, Frankrig, 54500
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Villejuif, Frankrig, 94800
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Vénissieux, Frankrig, 69200
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Georgien
- - Batumi, Georgien, 6000
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Batumi, Georgien, 6010
    - Trukket tilbage
    - 89bio Clinical Study Site
  - Tbilisi, Georgien, 0177
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Tbilisi, Georgien, 0159
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Tbilisi, Georgien, 0159
    - Rekruttering
    - 89bio_Clinical Study Site
    - Kontakt:
      
      89bio_Clinical Study Site
Holland
- - Amsterdam, Holland, 1081HV
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Utrecht, Holland, 3584CX
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- South Holland
  - Rotterdam, South Holland, Holland, 3015C
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Hong Kong
- - Hong Kong, Hong Kong, 0000
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Shatin, Hong Kong, 0000
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Indien
- - Bhubaneswar, Indien, 751024
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Gujrāt, Indien, 360001
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Nagpur, Indien, 440012
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - New Delhi, Indien, 110029
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Surat, Indien, 395009
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Wardha, Indien, 442004
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Assam
  - Guwahati, Assam, Indien, 701032
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Uttar Pradesh
  - Allahābād, Uttar Pradesh, Indien, 211002
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- West Bengal
  - Kolkata, West Bengal, Indien, 700150
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Israel
- - Afula, Israel, 1834111
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Beersheba, Israel, 8410500
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Haifa, Israel, 3109601
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Haifa, Israel, 3436212
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Jerusalem, Israel
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Nahariya, Israel, 2210001
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Petah Tikva, Israel, 4941492
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Ramat Gan, Israel, 52621
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Tel Aviv, Israel
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Tel Aviv, Israel, 6971014
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Italien
- - Bergamo, Italien, 24127
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Foggia, Italien, 71121
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Milan, Italien, 20152
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Milan, Italien, 20089
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Milan, Italien, 20162
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Modena, Italien, 41126
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Naples, Italien, 80131
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Novara, Italien, 28100
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Palermo, Italien, 90127
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Roma, Italien, 00128
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Rome, Italien, 00136
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Rome, Italien, 169
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Torino, Italien, 10126
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Japan
- - Ehime, Japan, 798-8510
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Ehime, Japan, 791-0295
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Fukuoka, Japan, 814-0180
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Gifu, Japan, 500-8323
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Kumamoto, Japan, 862-0971
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Nagano, Japan, 381-0006
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Okayama, Japan, 700-8558
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Osaka, Japan, 545-0051
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Osaka, Japan, 564-0013
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Saga, Japan, 849-0937
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Sapporo, Japan, 062-0921
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Gunma
  - Maebashi, Gunma, Japan, 371-0821
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Hokkaido
  - Sapporo, Hokkaido, Japan, 065-0012
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Iwate
  - Hizume, Iwate, Japan, 028-3695
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
- Kanagawa
  - Kawasaki, Kanagawa, Japan, 215-0026
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Yokohama, Kanagawa, Japan, 236-004
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Mexico
- - Chihuahua City, Mexico, 31217
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Cuautitlán Izcalli, Mexico, 54769
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Jalisco, Mexico, 44130
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Mexico City, Mexico, 03330
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Mexico City, Mexico, 06700
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Morelos, Mexico, 62270
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Nuevo León, Mexico, 64310
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Yucatán, Mexico, 97070
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Polen
- - Katowice, Polen, 40-752
    - Trukket tilbage
    - 89bio Clinical Study Site
  - Krakow, Polen, 31-501
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Lodz, Polen, 91-363
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Lodz, Polen, 90-302
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Mysłowice, Polen, 41-400
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Warsaw, Polen, 02-172
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Warsaw, Polen, 04-501
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Warsaw, Polen, 00-215
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Wroclaw, Polen, 53-673
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Puerto Rico
- - Manati, Puerto Rico, 00674
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Mayagüez, Puerto Rico, 00680
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - San Juan, Puerto Rico, 00927
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Singapore
- - Singapore, Singapore, 169856
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Singapore, Singapore, 308433
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Singapore, Singapore, 529889
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
  - Singapore, Singapore, 119228
    - Rekruttering
    - 89bio Clinical Study Site
    - Kontakt:
      
      89bio Clinical Study Site
Spanien
- - Barcelona, Spanien, 08041
    - Rekruttering
    - 89bio Clinical Study Site
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  - Barcelona, Spanien, 08035
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Sydafrika
- - Cape Town, Sydafrika, 7530
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  - Johannesburg, Sydafrika, 2196
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  - Worcester, Sydafrika, 6850
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Sydkorea
- - Busan, Sydkorea, 49241
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  - Daegu, Sydkorea, 42415
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  - Gyeonggi-do, Sydkorea, 16247
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  - Incheon, Sydkorea, 22332
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  - Seoul, Sydkorea, 03080
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  - Seoul, Sydkorea, 06591
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  - Seoul, Sydkorea, 07061
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  - Seoul, Sydkorea, 02447
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  - Seoul, Sydkorea, 07985
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  - Seoul, Sydkorea, 08308
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Taiwan
- - Chiayi City, Taiwan, 60002
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  - Kaohsiung City, Taiwan, 807
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Tjekkiet
- - Brno, Tjekkiet, 625 00
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  - Ostrava, Tjekkiet, 708 52
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  - Pilsen, Tjekkiet, 30100
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Tyrkiet (Türkiye)
- - Adana, Tyrkiet (Türkiye), 1370
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  - Ankara, Tyrkiet (Türkiye), 06230
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  - Ankara, Tyrkiet (Türkiye), 06800
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Tyskland
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Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Nøgleinklusionskriterier:

Mænd eller ikke-gravide kvinder i alderen mellem 18 og 75 år (inklusive) på tidspunktet for underskrivelsen af den informerede samtykkeformular (ICF)
Biopsi-bekræftet MASH (tidligere kaldet NASH) med fibrosestadium F2 eller F3 pr. NASH CRN-system og NAS ≥4, med en score på mindst 1 i hver af steatose, ballondegeneration og lobulær inflammation (kvalificerende biopsi skal enten være inden for 6 måneders screeningsbesøg [med yderligere krav] eller opnået i screeningsperioden)
Body mass index (BMI) ved screening ≥25,0 (≥23 for asiatiske deltagere) og <50,0 kg (kg)/kvadratmeter (m^2)

Nøgleekskluderingskriterier:

Andre kroniske leversygdomme end MASH/NASH
Anamnese eller tegn på skrumpelever ved screening af leverbiopsi
Har type 1-diabetes eller dårligt kontrolleret type 2-diabetes
Alaninaminotransferase (ALT) eller aspartataminotransferase (AST) ≥250 enheder pr. liter (U/L)
Deltagere, der tager vitamin E (>400 internationale enheder [IE]/dag), skal have en stabil dosis i mindst 6 måneder før screening

Andre inklusions- og eksklusionskriterier kan være gældende.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Firedobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Pegozafermin regime 1	Biologisk: Pegozafermin Subkutan injektion Andre navne: BIO89-100
Eksperimentel: Pegozafermin regime 2	Biologisk: Pegozafermin Subkutan injektion Andre navne: BIO89-100
Placebo komparator: Placebo Matchet placebo vil blive administreret i regime 1 og 2.	Andet: Placebo Subkutan injektion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Antal deltagere med en forbedring på mindst ≥1 fibrosegrad uden forværring af steatohepatitis i uge 52 Tidsramme: Uge 52	Forværring af steatohepatitis defineres som en stigning i non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation eller steatose	Uge 52
Antal deltagere med opløsning af steatohepatitis uden forværring af fibrose ved uge 52 Tidsramme: Uge 52	Løsning af steatohepatitis defineres som total fravær af ballooning (score=0) og fravær eller mild inflammation (score 0 til 1). Forværring af fibrose defineres som progression af fibrose med ≥1 stadium.	Uge 52
Tid til første forekomst af sygdomsprogression Tidsramme: Op til 5 år	Den endelige analyse af tiden til første forekomst af sygdomsprogression vil blive målt ved en kombination af protokolfastsatte kliniske hændelser	Op til 5 år

Sekundære resultatmål

Resultatmål	Tidsramme
Procentvis ændring fra baseline i alanin-aminotransferase ved uge 52 Tidsramme: Baseline, uge 52	Baseline, uge 52
Absolut ændring fra baseline i forbedret leverfibrose (ELF) score ved uge 52 Tidsramme: Baseline, uge 52	Baseline, uge 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

89bio, Inc.

Efterforskere

Studieleder: Clinical Trials, 89bio, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. marts 2024

Primær færdiggørelse (Anslået)

1. februar 2029

Studieafslutning (Anslået)

1. februar 2029

Datoer for studieregistrering

Først indsendt

13. marts 2024

Først indsendt, der opfyldte QC-kriterier

13. marts 2024

Først opslået (Faktiske)

19. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

BIO89-100-131

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

En undersøgelse, der evaluerer Pegozafermins effektivitet og sikkerhed hos deltagere med MASH og fibrose (ENLIGHTEN-Fibrose)

Et fase 3-studie til evaluering af Pegozafermins effektivitet og sikkerhed hos personer med metabolisk dysfunktion-associeret steatohepatitis (MASH) og fibrose

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

produkt fremstillet i og eksporteret fra U.S.A.