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

Status: Recruiting
Location: See all (236) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)

• Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASH clinical research network (CRN) System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation or NAS \<4 and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of at least 1 in steatosis. A historical biopsy must be within 6 months of screening visit (with additional requirements).

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

Locations
United States
Alabama
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Birmingham
Arkansas
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Conway
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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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Glendale
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Tucson
California
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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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Gardena
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Huntington Park
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Inglewood
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Long Beach
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Los Angeles
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Montclair
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Orange
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Panorama City
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Pasadena
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Poway
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Rialto
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Santa Ana
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Victorville
Colorado
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Littleton
Florida
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Brandon
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Clermont
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Fort Myers
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Hialeah Gardens
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Jacksonville
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Jupiter
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Lady Lake
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Lady Lake
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Lakewood Rch
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Maitland
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New Port Richey
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Ocala
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Ocoee
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Sarasota
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Winter Park
Georgia
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Athens
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Dalton
Iowa
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Iowa City
Indiana
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Hammond
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New Albany
Kansas
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Topeka
Louisiana
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West Monroe
Maryland
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Baltimore
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Glen Burnie
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Greenbelt
Michigan
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Chesterfield
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Wyoming
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Ypsilanti
Minnesota
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Rochester
Mississippi
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Flowood
North Carolina
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Charlotte
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Durham
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Fayetteville
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Winston-salem
New Jersey
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Florham Park
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Warren Township
New Mexico
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Albuquerque
Nevada
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Las Vegas
Ohio
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Akron
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Cleveland
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Dayton
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Liberty Township
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Springboro
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Westlake
Rhode Island
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East Greenwich
South Carolina
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Charleston
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Columbia
Tennessee
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Cordova
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Hermitage
Texas
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Austin
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Austin
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Bellaire
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Brownsville
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Corpus Christi
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Desoto
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Edinburg
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Farmers Branch
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Fort Sam Houston
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Fort Worth
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Garland
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Georgetown
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Georgetown
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Houston
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Katy
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San Antonio
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San Antonio
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San Antonio
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San Antonio
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Stafford
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Tomball
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Waco
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Waco
Utah
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Ogden
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
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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Bedford Park
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Brisbane
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Clayton
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Fitzroy
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Heidelberg
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Herston
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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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Edegem
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Ghent
Bulgaria
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Gorna Oryahovitsa
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Sofia
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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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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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Bordeaux
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Lille
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Limoges
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Lyon
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Montpellier
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Nantes
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Nice
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Paris
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Paris
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Pierre-bénite
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Strasbourg
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Toulouse
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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 Am Main
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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
Israel
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Afula
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Beersheba
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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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Ramat Gan
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Tel Aviv
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Tel Aviv
Italy
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Bergamo
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Milan
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Milan
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Milan
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Modena
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Palermo
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Rome
Japan
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Kawasaki
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Yokohama
Netherlands
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Amsterdam
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Rotterdam
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Utrecht
Poland
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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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Warsaw
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Wroclaw
Republic of Korea
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Busan
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Daegu
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Incheon
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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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Barcelona
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Barcelona
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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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Majadahonda
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Málaga
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Pontevedra
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Santander
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Santiago De Compostela
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Seville
Taiwan
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Chiayi City
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Kaohsiung City
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Taipei
United Kingdom
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Bristol
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Glasgow
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High Wycombe
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Hull
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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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Preston
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Southampton
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Stockton
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Swansea
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York
Contact Information
Primary
ENLIGHTEN clinical trial
enlighten@89bio.com
1-415-432-9270
Time Frame
Start Date: 2024-03-13
Estimated Completion Date: 2029-02
Participants
Target number of participants: 1050
Treatments
Experimental: Pegozafermin Regimen 1
Experimental: Pegozafermin Regimen 2
Placebo_comparator: Placebo
Matched Placebo will be administered in Regimens 1 and 2.
Sponsors
Leads: 89bio, Inc.

This content was sourced from clinicaltrials.gov