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)
Status: Recruiting
Location: See all (275) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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).
Locations
United States
Alabama
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Birmingham
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Homewood
Arkansas
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Little Rock
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North Little Rock
Arizona
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Chandler
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Flagstaff
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Peoria
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Phoenix
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Tucson
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Tucson
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Tucson
California
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Camarillo
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Canoga Park
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Coronado
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Fountain Valley
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Fresno
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Huntington Park
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La Jolla
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Los Angeles
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Los Angeles
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Pasadena
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Poway
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Redwood City
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Rialto
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Sacramento
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Santa Ana
Colorado
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Littleton
Florida
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Clermont
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Fort Myers
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Gainesville
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Hialeah Gardens
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Homestead
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Jacksonville
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Lady Lake
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Lakewood Rch
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Lehigh Acres
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Maitland
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Miami
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Miami
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New Port Richey
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Ocala
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Ocoee
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Orlando
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University Park
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Viera
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Winter Park
Georgia
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Athens
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Atlanta
Iowa
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Iowa City
Illinois
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Chicago
Indiana
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Hammond
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New Albany
Kansas
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Kansas City
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Topeka
Louisiana
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Lafayette
Massachusetts
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Burlington
Maryland
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Baltimore
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Glen Burnie
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Greenbelt
Michigan
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Ann Arbor
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Clinton Township
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Detroit
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Wyoming
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Ypsilanti
Minnesota
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Minneapolis
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Rochester
Missouri
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St Louis
Mississippi
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Flowood
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Tupelo
North Carolina
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Asheville
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Durham
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Fayetteville
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Greenville
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Winston-salem
New Jersey
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Florham Park
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Somers Point
New Mexico
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Albuquerque
Nevada
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Las Vegas
New York
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New York
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New York
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New York
Ohio
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Akron
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Cincinnati
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Cleveland
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Columbus
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Dayton
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Liberty Township
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Westlake
Pennsylvania
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Philadelphia
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Pittsburgh
Rhode Island
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East Greenwich
South Carolina
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Charleston
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Columbia
South Dakota
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Rapid City
Tennessee
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Cordova
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Hermitage
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Nashville
Texas
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Austin
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Austin
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Brownsville
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Desoto
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Edinburg
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Farmers Branch
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Fort Worth
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Harlingen
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Houston
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Houston
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Houston
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Lubbock
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Pearland
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San Antonio
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San Antonio
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San Marcos
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Waco
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Waco
Utah
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Sandy City
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West Jordan
Virginia
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Richmond
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Richmond
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Richmond
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Richmond
Washington
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Seattle
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Seattle
Other Locations
Argentina
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Buenos Aires
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Buenos Aires
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Buenos Aires
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Buenos Aires
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Buenos Aires
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Caba
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Capital Federal
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Pilar
Australia
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Adelaide
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Fitzroy
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Greenslopes
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Heidelberg
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Herston
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Murdoch
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Perth
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South Brisbane
Belgium
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Brussels
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Brussels
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Brussels
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Edegem
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Genk
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Ghent
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Roeselare
Brazil
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Barretos
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Belo Horizonte
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Botucatu
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Goiânia
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Porto Alegre
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Salvador
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São José Do Rio Preto
Bulgaria
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Gorna Oryahovitsa
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Sofia
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Sofia
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Stara Zagora
Canada
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Calgary
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London
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Ottawa
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Toronto
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Vancouver
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Vancouver
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Vaughan
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Winnipeg
France
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Amiens
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Dijon
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Limoges
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Lyon
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Montpellier
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Nice
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Paris
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Paris
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Paris
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Pessac
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Strasbourg
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Toulouse
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Vandœuvre-lès-nancy
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Vénissieux
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Villejuif
Germany
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Chemnitz
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Frankfurt
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Freiburg Im Breisgau
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Hanover
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Homburg
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Münster
Hong Kong Special Administrative Region
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Hong Kong
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Shatin
Hungary
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Budapest
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Budapest
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Budapest
Israel
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Afula
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Beersheba
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ENROLLING_BY_INVITATION
Haifa
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Haifa
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Jerusalem
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Nahariya
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Petah Tikva
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Tel Aviv
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Tel Litwinsky
Italy
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Bergamo
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Foggia
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Milan
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Milan
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Novara
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Palermo
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Roma
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Rome
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Rozzano
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Torino
Mexico
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Chihuahua City
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Cuautitlán Izcalli
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Cuernavaca
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Jalisco
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Mérida
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Mexico City
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Mexico City
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Monterrey
Netherlands
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Amsterdam
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Rotterdam
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Tilburg
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Utrecht
Poland
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WITHDRAWN
Katowice
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Krakow
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Lodz
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Lodz
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Mysłowice
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Warsaw
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Warsaw
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Wroclaw
Republic of Korea
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Bucheon-si
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Busan
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Daegu
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Daegu
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Seoul
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Seoul
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Seoul
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Seoul
Singapore
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Singapore
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Singapore
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Singapore
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Singapore
Spain
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Almería
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Badalona
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Barcelona
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Barcelona
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Barcelona
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Córdoba
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Madrid
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WITHDRAWN
Málaga
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Pontevedra
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Santander
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Santiago De Compostela
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Zaragoza
Taiwan
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Chiayi City
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Kaohsiung City
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Tainan
Turkey
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Ankara
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Ankara
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Bornova
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Istanbul
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Istanbul
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Merkez
United Kingdom
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Aberdeen
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Bristol
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Hants
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Leeds
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London
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London
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London
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London
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Oxford
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Plymouth
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Port Talbot
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Southampton
Contact Information
Primary
ENLIGHTEN clinical trial
enlighten@89bio.com
1-415-432-9270
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2031-08
Participants
Target number of participants: 762
Treatments
Experimental: Pegozafermin
Placebo_comparator: Placebo
Matched placebo
Related Therapeutic Areas
Sponsors
Leads: 89bio, Inc.