Phase
Condition
Primary Biliary Cholangitis
Liver Disease
Treatment
Placebo
Efruxifermin
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Main Study Only:
Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in theRepublic of Korea) years of age inclusive, on the day of signing informed consent
Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2diabetes
Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasivelydiagnosed NASH/MASH or NAFLD/MASLD
Open-Label Rollover
- Prior participation in the placebo arm of a previous Akero Phase 2 study
Exclusion
Exclusion Criteria:
Other causes of liver disease based on medical history and/or liver histology and/orcentral laboratory results, including but not limited to: alcoholic liver disease,autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosingcholangitis [PSC], autoimmune hepatitis), drug induced hepatotoxicity, Wilsondisease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
Type 1 or unstable Type 2 diabetes
A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.
Other inclusion and exclusion criteria may apply.
Study Design
Connect with a study center
Akero Clinical Study Site
Ramos Mejia, Buenos Aires B1704ETD
ArgentinaSite Not Available
Akero Clinical Study Site
Buenos Aires, Distrito Federal C1125ABE
ArgentinaSite Not Available
Akero Clinical Study Site
Broadmeadow, New South Wales 2292
AustraliaSite Not Available
Akero Clinical Study Site
Westmead, New South Wales 2145
AustraliaSite Not Available
Akero Clinical Study Site
Adelaide, South Australia 5000
AustraliaSite Not Available
Akero Clinical Study Site
Clayton, Victoria 3168
AustraliaSite Not Available
Akero Clinical Study Site
Epping, Victoria 3076
AustraliaSite Not Available
Akero Clinical Study Site
Heidelberg, Victoria 3084
AustraliaSite Not Available
Akero Clinical Study Site
Melbourne, Victoria 3004
AustraliaSite Not Available
Akero Clinical Study Site
Murdoch, Western Australia 6150
AustraliaSite Not Available
Akero Clinical Study Site
Perth, Western Australia 6000
AustraliaSite Not Available
Akero Clinical Study Site
Edmonton, Alberta T6G 2X8
CanadaSite Not Available
Akero Clinical Study Site
Hamilton, Ontario L8S 4K1
CanadaSite Not Available
Akero Clinical Study Site
Toronto, Ontario M6H 3M1
CanadaSite Not Available
Akero Clinical Study Site
Vaughan, Ontario L4L 4Y7
CanadaSite Not Available
Akero Clinical Study Site
Terrebonne, Quebec J7B6B7
CanadaSite Not Available
Akero Clinical Study Site
New Delhi, Delhi 110029
IndiaSite Not Available
Akero Clinical Study Site
Surat, Gujarat 395002
IndiaSite Not Available
Akero Clinical Study Site
Vadodara, Gujarat 390007
IndiaSite Not Available
Akero Clinical Study Site
Thiruvananthapuram, Kerala 695011
IndiaSite Not Available
Akero Clinical Study Site
Dahegaon, Maharashtra 441108
IndiaSite Not Available
Akero Clinical Study Site
Mumbai, Maharashtra 400012
IndiaSite Not Available
Akero Clinical Study Site
Nagpur, Maharashtra 440010
IndiaSite Not Available
Akero Clinical Study Site
Pune, Maharashtra 412201
IndiaSite Not Available
Akero Clinical Study Site
Chandigarh, Punjab 160012
IndiaSite Not Available
Akero Clinical Study Site
Jaipur, Rajasthan 302001
IndiaSite Not Available
Akero Clinical Study Site
Coimbatore, Tamil Nadu 641005
IndiaSite Not Available
Akero Clinical Study Site
Hyderabad, Telangana 500 004
IndiaSite Not Available
Akero Clinical Study Site
Varanasi, Uttar Pradesh 221005
IndiaSite Not Available
Akero Clinical Study Site
Kolkata, West Bengal 700150
IndiaSite Not Available
Akero Clinical Study Site
Petah Tikva, Central District 4941492
IsraelSite Not Available
Akero Clinical Study Site
Ramat Gan, Central District 5265601
IsraelSite Not Available
Akero Clinical Study Site
Haifa, Haifa District 3109601
IsraelSite Not Available
Akero Clinical Study Site
Afula, Northern District 1834111
IsraelSite Not Available
Akero Clinical Study Site
Nahariya, Northern District 22100
IsraelSite Not Available
Akero Clinical Study Site
Nazareth, Northern District 16234
IsraelSite Not Available
Akero Clinical Study Site
Jerusalem, 9112001
IsraelSite Not Available
Akero Clinical Study Site
Tel Aviv, 6423906
IsraelSite Not Available
Akero Clinical Study Site
Goyang-Si, Gyeonggi-Do 1232
Korea, Republic ofSite Not Available
Akero Clinical Study Site
Seongnam-si, Gyeonggi-Do 13496
Korea, Republic ofSite Not Available
Akero Clinical Study Site
Incheon, Gyeonggi-do 22332
Korea, Republic ofSite Not Available
Akero Clinical Study Site
Daegu, Gyeongsangbugdo 42601
Korea, Republic ofSite Not Available
Akero Clinical Study Site
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofSite Not Available
Akero Clinical Study Site
Ciudad de México, Distrito Federal 06700
MexicoSite Not Available
Akero Clinical Study Site
Manatí, 00674
Puerto RicoSite Not Available
Akero Clinical Study Site
San Juan, 00927
Puerto RicoSite Not Available
Akero Clinical Study Site
Olten, Solothurn 4600
SwitzerlandSite Not Available
Akero Clinical Study Site
Bern, 3010
SwitzerlandSite Not Available
Akero Clinical Study Site
Sankt Gallen, 9007
SwitzerlandSite Not Available
Akero Clinical Study Site
Changhua City, Changhua 500
TaiwanSite Not Available
Akero Clinical Study Site
Taichung City, Taichung 40447
TaiwanSite Not Available
Akero Clinical Study Site
Tainan City, Tainan 73657
TaiwanSite Not Available
Akero Clinical Study Site
Taipei City, 10048
TaiwanSite Not Available
Akero Clinical Study Site
Yenimahalle, Ankara 06500
TurkeySite Not Available
Akero Clinical Study Site
Bornova, Izmir 35100
TurkeySite Not Available
Akero Clinical Study Site
Bursa, 16059
TurkeySite Not Available
Akero Clinical Study Site
Rize, 53020
TurkeySite Not Available
Akero Clinical Study Site
Liverpool, England L9 7AL
United KingdomSite Not Available
Akero Clinical Study Site
London, England SE5 9RS
United KingdomSite Not Available
Akero Clinical Study Site
Newcastle-upon-Tyne, England NE7 7DN
United KingdomSite Not Available
Akero Clinical Study Site
Birmingham, Alabama 35209
United StatesSite Not Available
Akero Clinical Study Site
Chandler, Arizona 85224
United StatesSite Not Available
Akero Clinical Study Site
Flagstaff, Arizona 86001
United StatesSite Not Available
Akero Clinical Study Site
Peoria, Arizona 85381
United StatesSite Not Available
Akero Clinical Study Site
Tucson, Arizona 85712
United StatesSite Not Available
Akero Clinical Study Site
Conway, Arkansas 72032
United StatesSite Not Available
Akero Clinical Study Site
Jonesboro, Arkansas 72401
United StatesSite Not Available
Akero Clinical Study Site
Little Rock, Arkansas 72205
United StatesSite Not Available
Akero Clinical Study Site
North Little Rock, Arkansas 72117
United StatesSite Not Available
Akero Clinical Study Site
Chula Vista, California 91910
United StatesSite Not Available
Akero Clinical Study Site
Coronado, California 92118
United StatesSite Not Available
Akero Clinical Study Site
Cypress, California 90630
United StatesSite Not Available
Akero Clinical Study Site
Inglewood, California 90301
United StatesSite Not Available
Akero Clinical Study Site
La Mesa, California 91942
United StatesSite Not Available
Akero Clinical Study Site
Lancaster, California 93534
United StatesSite Not Available
Akero Clinical Study Site
Los Angeles, California 90036-4669
United StatesSite Not Available
Akero Clinical Study Site
Palm Springs, California 92262
United StatesSite Not Available
Akero Clinical Study Site
San Diego, California 92123
United StatesSite Not Available
Akero Clinical Study Site
San Francisco, California 94115
United StatesSite Not Available
Akero Clinical Study Site
Santa Maria, California 93458
United StatesSite Not Available
Akero Clinical Study Site
Englewood, Colorado 80113
United StatesSite Not Available
Akero Clinical Study Site
Bradenton, Florida 34208
United StatesSite Not Available
Akero Clinical Study Site
Brandon, Florida 33511
United StatesSite Not Available
Akero Clinical Study Site
Fort Myers, Florida 33912
United StatesSite Not Available
Akero Clinical Study Site
Hialeah Gardens, Florida 33016
United StatesSite Not Available
Akero Clinical Study Site
Inverness, Florida 34452
United StatesSite Not Available
Akero Clinical Study Site
Jacksonville, Florida 32256
United StatesSite Not Available
Akero Clinical Study Site
Lady Lake, Florida 32159
United StatesSite Not Available
Akero Clinical Study Site
Lakewood Ranch, Florida 34211
United StatesSite Not Available
Akero Clinical Study Site
Largo, Florida 33777
United StatesSite Not Available
Akero Clinical Study Site
Maitland, Florida 32751
United StatesSite Not Available
Akero Clinical Study Site
Miami, Florida 33136
United StatesSite Not Available
Akero Clinical Study Site
Miami Lakes, Florida 33016
United StatesSite Not Available
Akero Clinical Study Site
Naples, Florida 34102
United StatesSite Not Available
Akero Clinical Study Site
Ocala, Florida 34471
United StatesSite Not Available
Akero Clinical Study Site
Port Orange, Florida 32127
United StatesSite Not Available
Akero Clinical Study Site
Sarasota, Florida 34240
United StatesSite Not Available
Akero Clinical Study Site
The Villages, Florida 32162
United StatesSite Not Available
Akero Clinical Study Site
Venice, Florida 34285
United StatesSite Not Available
Akero Clinical Study Site
Viera, Florida 32940
United StatesSite Not Available
Akero Clinical Study Site
West Palm Beach, Florida 33401
United StatesSite Not Available
Akero Clinical Study Site
Winter Park, Florida 32789
United StatesSite Not Available
Akero Clinical Study Site
Columbus, Georgia 31904
United StatesSite Not Available
Akero Clinical Study Site
Gainesville, Georgia 30501
United StatesSite Not Available
Akero Clinical Study Site
Marietta, Georgia 30060
United StatesSite Not Available
Akero Clinical Study Site
South Bend, Indiana 46635
United StatesSite Not Available
Akero Clinical Study Site
West Des Moines, Iowa 50265
United StatesSite Not Available
Akero Clinical Study Site
Topeka, Kansas 66606
United StatesSite Not Available
Akero Clinical Study Site
Wichita, Kansas 67205
United StatesSite Not Available
Akero Clinical Study Site
Bastrop, Louisiana 71220
United StatesSite Not Available
Akero Clinical Study Site
Covington, Louisiana 70433
United StatesSite Not Available
Akero Clinical Study Site
Houma, Louisiana 70363
United StatesSite Not Available
Akero Clinical Study Site
Marrero, Louisiana 70072
United StatesSite Not Available
Akero Clinical Study Site
Metairie, Louisiana 70006
United StatesSite Not Available
Akero Clinical Study Site
New Orleans, Louisiana 70121
United StatesSite Not Available
Akero Clinical Study Site
Shreveport, Louisiana 71103
United StatesSite Not Available
Akero Clinical Study Site
Baltimore, Maryland 21202
United StatesSite Not Available
Akero Clinical Study Site
Glen Burnie, Maryland 21061
United StatesSite Not Available
Akero Clinical Study Site
Greenbelt, Maryland 20770
United StatesSite Not Available
Akero Clinical Study Site
Dartmouth, Massachusetts 02747
United StatesSite Not Available
Akero Clinical Study Site
South Dartmouth, Massachusetts 02747
United StatesSite Not Available
Akero Clinical Study Site
Southfield, Michigan 48075
United StatesSite Not Available
Akero Clinical Study Site
Wyoming, Michigan 49519
United StatesSite Not Available
Akero Clinical Study Site
Ypsilanti, Michigan 48197
United StatesSite Not Available
Akero Clinical Study Site
Kansas City, Missouri 64131
United StatesSite Not Available
Akero Clinical Study Site
Las Vegas, Nevada 89106
United StatesSite Not Available
Akero Clinical Study Site
Reno, Nevada 89511
United StatesSite Not Available
Akero Clinical Study Site
Brick, New Jersey 08724
United StatesSite Not Available
Akero Clinical Study Site
Brick Township, New Jersey 08724
United StatesSite Not Available
Akero Clinical Study Site
Florham Park, New Jersey 07932
United StatesSite Not Available
Akero Clinical Study Site
Somers Point, New Jersey 08244
United StatesSite Not Available
Akero Clinical Study Site
Sparta, New Jersey 07871
United StatesSite Not Available
Akero Clinical Study Site
Santa Fe, New Mexico 87505
United StatesSite Not Available
Akero Clinical Study Site
New York, New York 10033
United StatesSite Not Available
Akero Clinical Study Site
Chapel Hill, North Carolina 27516
United StatesSite Not Available
Akero Clinical Study Site
Charlotte, North Carolina 28204
United StatesSite Not Available
Akero Clinical Study Site
Fayetteville, North Carolina 28304
United StatesSite Not Available
Akero Clinical Study Site
Morehead City, North Carolina 28557
United StatesSite Not Available
Akero Clinical Study Site
New Bern, North Carolina 28562
United StatesSite Not Available
Akero Clinical Study Site
Raleigh, North Carolina 27612
United StatesSite Not Available
Akero Clinical Study Site
Statesville, North Carolina 28625
United StatesSite Not Available
Akero Clinical Study Site
Dayton, Ohio 45414
United StatesSite Not Available
Akero Clinical Study Site
Springboro, Ohio 45066
United StatesSite Not Available
Akero Clinical Study Site
Westlake, Ohio 44145
United StatesSite Not Available
Akero Clinical Study Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Akero Clinical Study Site
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Akero Clinical Study Site
Columbia, South Carolina 29204
United StatesSite Not Available
Akero Clinical Study Site
Summerville, South Carolina 29485
United StatesSite Not Available
Akero Clinical Study Site
Chattanooga, Tennessee 37421
United StatesSite Not Available
Akero Clinical Study Site
Clarksville, Tennessee 37040
United StatesSite Not Available
Akero Clinical Study Site
Hermitage, Tennessee 37076
United StatesSite Not Available
Akero Clinical Study Site
Nashville, Tennessee 37211
United StatesSite Not Available
Akero Clinical Study Site
Amarillo, Texas 79106
United StatesSite Not Available
Akero Clinical Study Site
Austin, Texas 78757
United StatesSite Not Available
Akero Clinical Study Site
Bellaire, Texas 77401
United StatesSite Not Available
Akero Clinical Study Site
Brownsville, Texas 78520
United StatesSite Not Available
Akero Clinical Study Site
Corpus Christi, Texas 78404
United StatesSite Not Available
Akero Clinical Study Site
Dallas, Texas 75234
United StatesSite Not Available
Akero Clinical Study Site
Edinburg, Texas 78539
United StatesSite Not Available
Akero Clinical Study Site
Fort Worth, Texas 76104
United StatesSite Not Available
Akero Clinical Study Site
Houston, Texas 77079
United StatesSite Not Available
Akero Clinical Study Site
Lewisville, Texas 75057
United StatesSite Not Available
Akero Clinical Study Site
McAllen, Texas 78504
United StatesSite Not Available
Akero Clinical Study Site
San Antonio, Texas 78258
United StatesSite Not Available
Akero Clinical Study Site
San Marcos, Texas 78666-7502
United StatesSite Not Available
Akero Clinical Study Site
Waco, Texas 76710
United StatesSite Not Available
Akero Clinical Study Site
Webster, Texas 77598
United StatesSite Not Available
Akero Clinical Study Site
Wichita Falls, Texas 76301
United StatesSite Not Available
Akero Clinical Study Site
Ogden, Utah 84405
United StatesSite Not Available
Akero Clinical Study Site
Salt Lake City, Utah 84117
United StatesSite Not Available
Akero Clinical Study Site
Sandy, Utah 84092
United StatesSite Not Available
Akero Clinical Study Site
South Ogden, Utah 84405
United StatesSite Not Available
Akero Clinical Study Site
Falls Church, Virginia 22042-3300
United StatesSite Not Available
Akero Clinical Study Site
Norfolk, Virginia 23502
United StatesSite Not Available
Akero Clinical Study Site
Richmond, Virginia 23249
United StatesSite Not Available
Akero Clinical Study Site
Roanoke, Virginia 24014
United StatesSite Not Available
Akero Clinical Study Site
Suffolk, Virginia 23435
United StatesSite Not Available
Akero Clinical Study Site
Seattle, Washington 98105
United StatesSite Not Available
Akero Clinical Study Site
Spokane, Washington 99218
United StatesSite Not Available
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