Phase
Condition
Liver Disease
Primary Biliary Cholangitis
Scar Tissue
Treatment
Placebo
Pegozafermin
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Males or non-pregnant females aged between 18 and 80 years (inclusive) at time ofsigning the informed consent form (ICF)
Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASHclinical research network (CRN) System and NAS ≥4, with a score of at least 1 ineach of steatosis, ballooning degeneration, and lobular inflammation or NAS <4and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of atleast 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) (≥23kg/m^2 for Asian countries)
Exclusion
Key Exclusion Criteria:
Chronic liver diseases other than MASH/NASH
Evidence of cirrhosis on screening liver biopsy
Have type 1 diabetes or poorly controlled type 2 diabetes
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units perliter (U/L)
Participants taking vitamin E (>400 international units [IU]/day) or pioglitazonemust be on stable dose for at least 6 months prior to screening
Other inclusion and exclusion criteria may apply.
Study Design
Connect with a study center
89bio Clinical Study Site
Buenos Aires, C1425
ArgentinaActive - Recruiting
89bio Clinical Study Site
Caba, C1430CKE
ArgentinaActive - Recruiting
89bio Clinical Study Site
Capital Federal, C1280AEB
ArgentinaActive - Recruiting
89bio Clinical Study Site
Pilar, 1629
ArgentinaActive - Recruiting
89bio Clinical Study Site
Brisbane, Queensland 4120
AustraliaActive - Recruiting
89bio Clinical Study Site
Herston, Queensland 4019
AustraliaActive - Recruiting
89bio Clinical Study Site
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
89bio Clinical Study Site
Adelaide, South Australia 5000
AustraliaActive - Recruiting
89bio Clinical Study Site
Bedford Park, South Australia 5042
AustraliaActive - Recruiting
89bio Clinical Study Site
Clayton, Victoria 3168
AustraliaActive - Recruiting
89bio Clinical Study Site
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
89bio Clinical Study Site
Perth, West Australia 6000
AustraliaActive - Recruiting
89bio Clinical Study Site
Fitzroy, 3065
AustraliaActive - Recruiting
89bio Clinical Study Site
Brussels, 1070
BelgiumActive - Recruiting
89bio Clinical Study Site
Edegem, 2650
BelgiumActive - Recruiting
89bio Clinical Study Site
Ghent, 9000
BelgiumActive - Recruiting
89bio Clinical Study Site
Gorna Oryahovitsa, 5100
BulgariaActive - Recruiting
89bio Clinical Study Site
Sofia, 1202
BulgariaActive - Recruiting
89bio Clinical Study Site
Stara Zagora, 6003
BulgariaActive - Recruiting
89bio Clinical Study Site
Calgary, Alberta T2N 4Z6
CanadaActive - Recruiting
89bio Clinical Study Site
Vancouver, British Columbia V6Z2K5
CanadaActive - Recruiting
89bio Clinical Study Site
Winnipeg, Manitoba R3T 2N2
CanadaActive - Recruiting
89bio Clinical Study Site
London, Ontario N6A 5A5
CanadaActive - Recruiting
89bio Clinical Study Site
Ottawa, Ontario K1H8L6
CanadaActive - Recruiting
89bio Clinical Study Site
Toronto, Ontario M6H 3M1
CanadaActive - Recruiting
89bio Clinical Study Site
Amiens, 80080
FranceActive - Recruiting
89bio Clinical Study Site
Bordeaux, 33604
FranceActive - Recruiting
89bio Clinical Study Site
Lille, 59000
FranceActive - Recruiting
89bio Clinical Study Site
Limoges, 87042
FranceActive - Recruiting
89bio Clinical Study Site
Lyon, 69004
FranceActive - Recruiting
89bio Clinical Study Site
Nantes, 44093
FranceActive - Recruiting
89bio Clinical Study Site
Nice, 06200
FranceActive - Recruiting
89bio Clinical Study Site
Paris, 75013
FranceActive - Recruiting
89bio Clinical Study Site
Pierre-Bénite, 69310
FranceActive - Recruiting
89bio Clinical Study Site
Strasbourg, 67000
FranceActive - Recruiting
89bio Clinical Study Site
Toulouse,
FranceActive - Recruiting
89bio Clinical Study Site
Vandœuvre-lès-Nancy, 54500
FranceActive - Recruiting
89bio Clinical Study Site
Villejuif, 94800
FranceActive - Recruiting
89bio Clinical Study Site
Frankfurt am Main, 60596
GermanyActive - Recruiting
89bio Clinical Study Site
Freiburg, 79106
GermanyActive - Recruiting
89bio Clinical Study Site
Homburg, 66421
GermanyActive - Recruiting
89bio Clinical Study Site
Münster, 48149
GermanyActive - Recruiting
89bio Clinical Study Site
Hong Kong, 0000
Hong KongActive - Recruiting
89bio Clinical Study Site
Shatin, 0000
Hong KongActive - Recruiting
89bio Clinical Study Site
Afula, 1834111
IsraelActive - Recruiting
89bio Clinical Study Site
Be'er Sheva, 8410500
IsraelActive - Recruiting
89bio Clinical Study Site
Haifa, 3109601
IsraelActive - Recruiting
89bio Clinical Study Site
Jerusalem,
IsraelActive - Recruiting
89bio Clinical Study Site
Petah tikva, 4941492
IsraelActive - Recruiting
89bio Clinical Study Site
Ramat Gan, 52621
IsraelActive - Recruiting
89bio Clinical Study Site
Tel Aviv,
IsraelActive - Recruiting
89bio Clinical Study Site
Bergamo, 24127
ItalyActive - Recruiting
89bio Clinical Study Site
Milan, 20152
ItalyActive - Recruiting
89bio Clinical Study Site
Milano, 20162
ItalyActive - Recruiting
89bio Clinical Study Site
Modena, 41126
ItalyActive - Recruiting
89bio Clinical Study Site
Palermo, 90127
ItalyActive - Recruiting
89bio Clinical Study Site
Rome, 00136
ItalyActive - Recruiting
89bio Clinical Study Site
Busan, 49241
Korea, Republic ofActive - Recruiting
89bio Clinical Study Site
Daegu, 42415
Korea, Republic ofActive - Recruiting
89bio Clinical Study Site
Incheon, 22332
Korea, Republic ofActive - Recruiting
89bio Clinical Study Site
Seoul, 07985
Korea, Republic ofActive - Recruiting
89bio Clinical Study Site
Rotterdam, Zuid Holland 3015C
NetherlandsActive - Recruiting
89bio Clinical Study Site
Amsterdam, 1081HV
NetherlandsActive - Recruiting
89bio Clinical Study Site
Utrecht, 3584CX
NetherlandsActive - Recruiting
89bio Clinical Study Site
Katowice, 40-752
PolandActive - Recruiting
89bio Clinical Study Site
Kraków, 31-501
PolandActive - Recruiting
89bio Clinical Study Site
Mysłowice, 41-400
PolandActive - Recruiting
89bio Clinical Study Site
Warsaw, 02-172
PolandActive - Recruiting
89bio Clinical Study Site
Warszawa, 00-215
PolandActive - Recruiting
89bio Clinical Study Site
Wrocław, 53-673
PolandActive - Recruiting
89bio Clinical Study Site
Łódź, 90-302
PolandActive - Recruiting
89bio Clinical Study Site
Singapore, 529889
SingaporeActive - Recruiting
89bio Clinical Study Site
Barcelona, 08041
SpainActive - Recruiting
89bio Clinical Study Site
Córdoba, 14004
SpainActive - Recruiting
89bio Clinical Study Site
Madrid, 28007
SpainActive - Recruiting
89bio Clinical Study Site
Majadahonda, 28222
SpainActive - Recruiting
89bio Clinical Study Site
Málaga, 29010
SpainActive - Recruiting
89bio Clinical Study Site
Pontevedra, 36071
SpainActive - Recruiting
89bio Clinical Study Site
Santander, 39008
SpainActive - Recruiting
89bio Clinical Study Site
Santiago De Compostela, 15706
SpainActive - Recruiting
89bio Clinical Study Site
Sevilla, 41013
SpainActive - Recruiting
89bio Clinical Study Site
Chiayi City, 60002
TaiwanActive - Recruiting
89bio Clinical Study Site
Kaohsiung, 807
TaiwanActive - Recruiting
89bio Clinical Study Site
Taipei, 100225
TaiwanActive - Recruiting
89bio Clinical Study Site
High Wycombe, Buckinghamshire HP11 2QW
United KingdomActive - Recruiting
89bio Clinical Study Site
Bristol, BS6 6LT
United KingdomActive - Recruiting
89bio Clinical Study Site
Glasgow, G514TY
United KingdomActive - Recruiting
89bio Clinical Study Site
Hull, HU3 2JZ
United KingdomActive - Recruiting
89bio Clinical Study Site
London, NW32QG
United KingdomActive - Recruiting
89bio Clinical Study Site
Oxford, OX3 9DU
United KingdomActive - Recruiting
89bio Clinical Study Site
Preston, PR2 9QB
United KingdomActive - Recruiting
89bio Clinical Study Site
Southampton, SO16 6YD
United KingdomActive - Recruiting
89bio Clinical Study Site
Stockton, TS19
United KingdomActive - Recruiting
89bio Clinical Study Site
Swansea, SA6
United KingdomActive - Recruiting
89bio Clinical Study Site
York, YO24 4LJ
United KingdomActive - Recruiting
89bio Clinical Study Site
Birmingham, Alabama 35209
United StatesActive - Recruiting
89bio Clinical Study Site
Chandler, Arizona 85224
United StatesActive - Recruiting
89bio Clinical Study Site
Flagstaff, Arizona 86001
United StatesActive - Recruiting
89bio Clinical Study Site
Glendale, Arizona 85036
United StatesActive - Recruiting
89bio Clinical Study Site
Tucson, Arizona 85712
United StatesActive - Recruiting
89bio Clinical Study Site
Conway, Arkansas 72032
United StatesTerminated
89bio Clinical Study Site
Little Rock, Arkansas 72211-3859
United StatesActive - Recruiting
89bio Clinical Study Site
North Little Rock, Arkansas 72117
United StatesActive - Recruiting
89bio Clinical Study Site
Canoga Park, California 91604
United StatesActive - Recruiting
89bio Clinical Study Site
Coronado, California 92118
United StatesActive - Recruiting
89bio Clinical Study Site
Fountain Valley, California 92708
United StatesActive - Recruiting
89bio Clinical Study Site
Gardena, California 90247
United StatesActive - Recruiting
89bio Clinical Study Site
Huntington Park, California 90255
United StatesActive - Recruiting
89bio Clinical Study Site
Inglewood, California 90301
United StatesActive - Recruiting
89bio Clinical Study Site
Long Beach, California 90815
United StatesActive - Recruiting
89bio Clinical Study Site
Montclair, California 91763
United StatesActive - Recruiting
89bio Clinical Study Site
Panorama City, California 91402
United StatesActive - Recruiting
89bio Clinical Study Site
Pasadena, California 91105
United StatesActive - Recruiting
89bio Clinical Study Site
Poway, California 92064
United StatesActive - Recruiting
89bio Clinical Study Site
Rialto, California 92377
United StatesActive - Recruiting
89bio Clinical Study Site
Santa Ana, California 92704-5763
United StatesTerminated
89bio Clinical Study Site
Littleton, Colorado 80120
United StatesActive - Recruiting
89bio Clinical Study Site
Clermont, Florida 34711
United StatesActive - Recruiting
89bio Clinical Study Site
Fort Myers, Florida 33912
United StatesActive - Recruiting
89bio Clinical Study Site
Hialeah Gardens, Florida 33016
United StatesActive - Recruiting
89bio Clinical Study Site
Jacksonville, Florida 32256
United StatesActive - Recruiting
89bio Clinical Study Site
Lady Lake, Florida 32159-8986
United StatesTerminated
89bio Clinical Study Site
Lakewood Ranch, Florida 34211
United StatesActive - Recruiting
89bio Clinical Study Site
Maitland, Florida 32751-7258
United StatesActive - Recruiting
89bio Clinical Study Site
New Port Richey, Florida 34653
United StatesActive - Recruiting
89bio Clinical Study Site
Ocala, Florida 34471
United StatesActive - Recruiting
89bio Clinical Study Site
Ocoee, Florida 34761
United StatesActive - Recruiting
89bio Clinical Study Site
Sarasota, Florida 34240
United StatesActive - Recruiting
89bio Clinical Study Site
Winter Park, Florida 32789
United StatesActive - Recruiting
89bio Clinical Study Site
Athens, Georgia 30607
United StatesActive - Recruiting
89bio Clinical Study Site
Dalton, Georgia 30720
United StatesActive - Recruiting
89bio Clinical Study Site
Hammond, Indiana 46324
United StatesActive - Recruiting
89bio Clinical Study Site
New Albany, Indiana 47150
United StatesActive - Recruiting
89bio Clinical Study Site
Iowa City, Iowa 52242
United StatesActive - Recruiting
89bio Clinical Study Site
Topeka, Kansas 66606
United StatesActive - Recruiting
89bio Clinical Study Site
West Monroe, Louisiana 71291
United StatesActive - Recruiting
89bio Clinical Study Site
Baltimore, Maryland 21202
United StatesActive - Recruiting
89bio Clinical Study Site
Glen Burnie, Maryland 21061
United StatesActive - Recruiting
89bio Clinical Study Site
Greenbelt, Maryland 20770
United StatesActive - Recruiting
89bio Clinical Study Site
Chesterfield, Michigan 48047
United StatesActive - Recruiting
89bio Clinical Study Site
Wyoming, Michigan 49519
United StatesActive - Recruiting
89bio Clinical Study Site
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
89bio Clinical Study Site
Rochester, Minnesota 55905
United StatesActive - Recruiting
89bio Clinical Study Site
Flowood, Mississippi 39232
United StatesActive - Recruiting
89bio Clinical Study Site
Las Vegas, Nevada 89106
United StatesActive - Recruiting
89bio Clinical Study Site
Florham Park, New Jersey 07932
United StatesTerminated
89bio Clinical Study Site
Warren, New Jersey 07059
United StatesActive - Recruiting
89bio Clinical Study Site
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
89bio Clinical Study Site
Charlotte, North Carolina 28207
United StatesActive - Recruiting
89bio Clinical Study Site
Durham, North Carolina 27710
United StatesActive - Recruiting
89bio Clinical Study Site
Fayetteville, North Carolina 28304
United StatesActive - Recruiting
89bio Clinical Study Site
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
89bio Clinical Study Site
Dayton, Ohio 45414
United StatesActive - Recruiting
89bio Clinical Study Site
Liberty Township, Ohio 45044
United StatesActive - Recruiting
89bio Clinical Study Site
Springboro, Ohio 45066
United StatesActive - Recruiting
89bio Clinical Study Site
Westlake, Ohio 44145
United StatesActive - Recruiting
89bio Clinical Study Site
East Greenwich, Rhode Island 02818
United StatesActive - Recruiting
89bio Clinical Study Site
Charleston, South Carolina 29425
United StatesActive - Recruiting
89bio Clinical Study Site
Columbia, South Carolina 29204
United StatesActive - Recruiting
89bio Clinical Study Site
Cordova, Tennessee 38018
United StatesActive - Recruiting
89bio Clinical Study Site
Hermitage, Tennessee 37076
United StatesActive - Recruiting
89bio Clinical Study Site
Austin, Texas 78757
United StatesActive - Recruiting
89bio Clinical Study Site
Bellaire, Texas 77401
United StatesActive - Recruiting
89bio Clinical Study Site
Brownsville, Texas 78520
United StatesActive - Recruiting
89bio Clinical Study Site
Corpus Christi, Texas 78404
United StatesActive - Recruiting
89bio Clinical Study Site
DeSoto, Texas 75115
United StatesActive - Recruiting
89bio Clinical Study Site
Edinburg, Texas 78539
United StatesActive - Recruiting
89bio Clinical Study Site
Farmers Branch, Texas 75234
United StatesActive - Recruiting
89bio Clinical Study Site
Fort Sam Houston, Texas 78234
United StatesActive - Recruiting
89bio Clinical Study Site
Fort Worth, Texas 76104
United StatesActive - Recruiting
89bio Clinical Study Site
Garland, Texas 75044
United StatesActive - Recruiting
89bio Clinical Study Site
Georgetown, Texas 78626
United StatesActive - Recruiting
89bio Clinical Study Site
Houston, Texas 77099
United StatesActive - Recruiting
89bio Clinical Study Site
Katy, Texas 77494
United StatesActive - Recruiting
89bio Clinical Study Site
San Antonio, Texas 78222
United StatesActive - Recruiting
89bio Clinical Study Site
Stafford, Texas 77477
United StatesActive - Recruiting
89bio Clinical Study Site
Tomball, Texas 77584
United StatesActive - Recruiting
89bio Clinical Study Site
Waco, Texas 76301
United StatesActive - Recruiting
89bio Clinical Study Site
Wichita Falls, Texas 76301
United StatesSite Not Available
89bio Clinical Study Site
Ogden, Utah 84405
United StatesActive - Recruiting
89bio Clinical Study Site
Richmond, Virginia 23298
United StatesActive - Recruiting
89bio Clinical Study Site
Seattle, Washington 98105
United StatesActive - Recruiting
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