A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Last updated: January 31, 2025
Sponsor: Akero Therapeutics, Inc
Overall Status: Active - Enrolling

Phase

3

Condition

Primary Biliary Cholangitis

Liver Disease

Treatment

Placebo

Efruxifermin

Clinical Study ID

NCT06161571
AK-US-001-0107
  • Ages 18-80
  • All Genders

Study Summary

The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.

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

Total Participants: 700
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 10, 2023
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Akero Clinical Study Site

    Ramos Mejia, Buenos Aires B1704ETD
    Argentina

    Site Not Available

  • Akero Clinical Study Site

    Buenos Aires, Distrito Federal C1125ABE
    Argentina

    Site Not Available

  • Akero Clinical Study Site

    Broadmeadow, New South Wales 2292
    Australia

    Site Not Available

  • Akero Clinical Study Site

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Akero Clinical Study Site

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Akero Clinical Study Site

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Akero Clinical Study Site

    Epping, Victoria 3076
    Australia

    Site Not Available

  • Akero Clinical Study Site

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Akero Clinical Study Site

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Akero Clinical Study Site

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Akero Clinical Study Site

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Akero Clinical Study Site

    Edmonton, Alberta T6G 2X8
    Canada

    Site Not Available

  • Akero Clinical Study Site

    Hamilton, Ontario L8S 4K1
    Canada

    Site Not Available

  • Akero Clinical Study Site

    Toronto, Ontario M6H 3M1
    Canada

    Site Not Available

  • Akero Clinical Study Site

    Vaughan, Ontario L4L 4Y7
    Canada

    Site Not Available

  • Akero Clinical Study Site

    Terrebonne, Quebec J7B6B7
    Canada

    Site Not Available

  • Akero Clinical Study Site

    New Delhi, Delhi 110029
    India

    Site Not Available

  • Akero Clinical Study Site

    Surat, Gujarat 395002
    India

    Site Not Available

  • Akero Clinical Study Site

    Vadodara, Gujarat 390007
    India

    Site Not Available

  • Akero Clinical Study Site

    Thiruvananthapuram, Kerala 695011
    India

    Site Not Available

  • Akero Clinical Study Site

    Dahegaon, Maharashtra 441108
    India

    Site Not Available

  • Akero Clinical Study Site

    Mumbai, Maharashtra 400012
    India

    Site Not Available

  • Akero Clinical Study Site

    Nagpur, Maharashtra 440010
    India

    Site Not Available

  • Akero Clinical Study Site

    Pune, Maharashtra 412201
    India

    Site Not Available

  • Akero Clinical Study Site

    Chandigarh, Punjab 160012
    India

    Site Not Available

  • Akero Clinical Study Site

    Jaipur, Rajasthan 302001
    India

    Site Not Available

  • Akero Clinical Study Site

    Coimbatore, Tamil Nadu 641005
    India

    Site Not Available

  • Akero Clinical Study Site

    Hyderabad, Telangana 500 004
    India

    Site Not Available

  • Akero Clinical Study Site

    Varanasi, Uttar Pradesh 221005
    India

    Site Not Available

  • Akero Clinical Study Site

    Kolkata, West Bengal 700150
    India

    Site Not Available

  • Akero Clinical Study Site

    Petah Tikva, Central District 4941492
    Israel

    Site Not Available

  • Akero Clinical Study Site

    Ramat Gan, Central District 5265601
    Israel

    Site Not Available

  • Akero Clinical Study Site

    Haifa, Haifa District 3109601
    Israel

    Site Not Available

  • Akero Clinical Study Site

    Afula, Northern District 1834111
    Israel

    Site Not Available

  • Akero Clinical Study Site

    Nahariya, Northern District 22100
    Israel

    Site Not Available

  • Akero Clinical Study Site

    Nazareth, Northern District 16234
    Israel

    Site Not Available

  • Akero Clinical Study Site

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Akero Clinical Study Site

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Akero Clinical Study Site

    Goyang-Si, Gyeonggi-Do 1232
    Korea, Republic of

    Site Not Available

  • Akero Clinical Study Site

    Seongnam-si, Gyeonggi-Do 13496
    Korea, Republic of

    Site Not Available

  • Akero Clinical Study Site

    Incheon, Gyeonggi-do 22332
    Korea, Republic of

    Site Not Available

  • Akero Clinical Study Site

    Daegu, Gyeongsangbugdo 42601
    Korea, Republic of

    Site Not Available

  • Akero Clinical Study Site

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Akero Clinical Study Site

    Ciudad de México, Distrito Federal 06700
    Mexico

    Site Not Available

  • Akero Clinical Study Site

    Manatí, 00674
    Puerto Rico

    Site Not Available

  • Akero Clinical Study Site

    San Juan, 00927
    Puerto Rico

    Site Not Available

  • Akero Clinical Study Site

    Olten, Solothurn 4600
    Switzerland

    Site Not Available

  • Akero Clinical Study Site

    Bern, 3010
    Switzerland

    Site Not Available

  • Akero Clinical Study Site

    Sankt Gallen, 9007
    Switzerland

    Site Not Available

  • Akero Clinical Study Site

    Changhua City, Changhua 500
    Taiwan

    Site Not Available

  • Akero Clinical Study Site

    Taichung City, Taichung 40447
    Taiwan

    Site Not Available

  • Akero Clinical Study Site

    Tainan City, Tainan 73657
    Taiwan

    Site Not Available

  • Akero Clinical Study Site

    Taipei City, 10048
    Taiwan

    Site Not Available

  • Akero Clinical Study Site

    Yenimahalle, Ankara 06500
    Turkey

    Site Not Available

  • Akero Clinical Study Site

    Bornova, Izmir 35100
    Turkey

    Site Not Available

  • Akero Clinical Study Site

    Bursa, 16059
    Turkey

    Site Not Available

  • Akero Clinical Study Site

    Rize, 53020
    Turkey

    Site Not Available

  • Akero Clinical Study Site

    Liverpool, England L9 7AL
    United Kingdom

    Site Not Available

  • Akero Clinical Study Site

    London, England SE5 9RS
    United Kingdom

    Site Not Available

  • Akero Clinical Study Site

    Newcastle-upon-Tyne, England NE7 7DN
    United Kingdom

    Site Not Available

  • Akero Clinical Study Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Akero Clinical Study Site

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Akero Clinical Study Site

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • Akero Clinical Study Site

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Akero Clinical Study Site

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Akero Clinical Study Site

    Conway, Arkansas 72032
    United States

    Site Not Available

  • Akero Clinical Study Site

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Akero Clinical Study Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Akero Clinical Study Site

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Akero Clinical Study Site

    Chula Vista, California 91910
    United States

    Site Not Available

  • Akero Clinical Study Site

    Coronado, California 92118
    United States

    Site Not Available

  • Akero Clinical Study Site

    Cypress, California 90630
    United States

    Site Not Available

  • Akero Clinical Study Site

    Inglewood, California 90301
    United States

    Site Not Available

  • Akero Clinical Study Site

    La Mesa, California 91942
    United States

    Site Not Available

  • Akero Clinical Study Site

    Lancaster, California 93534
    United States

    Site Not Available

  • Akero Clinical Study Site

    Los Angeles, California 90036-4669
    United States

    Site Not Available

  • Akero Clinical Study Site

    Palm Springs, California 92262
    United States

    Site Not Available

  • Akero Clinical Study Site

    San Diego, California 92123
    United States

    Site Not Available

  • Akero Clinical Study Site

    San Francisco, California 94115
    United States

    Site Not Available

  • Akero Clinical Study Site

    Santa Maria, California 93458
    United States

    Site Not Available

  • Akero Clinical Study Site

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Akero Clinical Study Site

    Bradenton, Florida 34208
    United States

    Site Not Available

  • Akero Clinical Study Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Akero Clinical Study Site

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Akero Clinical Study Site

    Hialeah Gardens, Florida 33016
    United States

    Site Not Available

  • Akero Clinical Study Site

    Inverness, Florida 34452
    United States

    Site Not Available

  • Akero Clinical Study Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Akero Clinical Study Site

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • Akero Clinical Study Site

    Lakewood Ranch, Florida 34211
    United States

    Site Not Available

  • Akero Clinical Study Site

    Largo, Florida 33777
    United States

    Site Not Available

  • Akero Clinical Study Site

    Maitland, Florida 32751
    United States

    Site Not Available

  • Akero Clinical Study Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Akero Clinical Study Site

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Akero Clinical Study Site

    Naples, Florida 34102
    United States

    Site Not Available

  • Akero Clinical Study Site

    Ocala, Florida 34471
    United States

    Site Not Available

  • Akero Clinical Study Site

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Akero Clinical Study Site

    Sarasota, Florida 34240
    United States

    Site Not Available

  • Akero Clinical Study Site

    The Villages, Florida 32162
    United States

    Site Not Available

  • Akero Clinical Study Site

    Venice, Florida 34285
    United States

    Site Not Available

  • Akero Clinical Study Site

    Viera, Florida 32940
    United States

    Site Not Available

  • Akero Clinical Study Site

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Akero Clinical Study Site

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Akero Clinical Study Site

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Akero Clinical Study Site

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Akero Clinical Study Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Akero Clinical Study Site

    South Bend, Indiana 46635
    United States

    Site Not Available

  • Akero Clinical Study Site

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Akero Clinical Study Site

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Akero Clinical Study Site

    Wichita, Kansas 67205
    United States

    Site Not Available

  • Akero Clinical Study Site

    Bastrop, Louisiana 71220
    United States

    Site Not Available

  • Akero Clinical Study Site

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Akero Clinical Study Site

    Houma, Louisiana 70363
    United States

    Site Not Available

  • Akero Clinical Study Site

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Akero Clinical Study Site

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Akero Clinical Study Site

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Akero Clinical Study Site

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Akero Clinical Study Site

    Baltimore, Maryland 21202
    United States

    Site Not Available

  • Akero Clinical Study Site

    Glen Burnie, Maryland 21061
    United States

    Site Not Available

  • Akero Clinical Study Site

    Greenbelt, Maryland 20770
    United States

    Site Not Available

  • Akero Clinical Study Site

    Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Akero Clinical Study Site

    South Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Akero Clinical Study Site

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Akero Clinical Study Site

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Akero Clinical Study Site

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Akero Clinical Study Site

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Akero Clinical Study Site

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Akero Clinical Study Site

    Reno, Nevada 89511
    United States

    Site Not Available

  • Akero Clinical Study Site

    Brick, New Jersey 08724
    United States

    Site Not Available

  • Akero Clinical Study Site

    Brick Township, New Jersey 08724
    United States

    Site Not Available

  • Akero Clinical Study Site

    Florham Park, New Jersey 07932
    United States

    Site Not Available

  • Akero Clinical Study Site

    Somers Point, New Jersey 08244
    United States

    Site Not Available

  • Akero Clinical Study Site

    Sparta, New Jersey 07871
    United States

    Site Not Available

  • Akero Clinical Study Site

    Santa Fe, New Mexico 87505
    United States

    Site Not Available

  • Akero Clinical Study Site

    New York, New York 10033
    United States

    Site Not Available

  • Akero Clinical Study Site

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • Akero Clinical Study Site

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Akero Clinical Study Site

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Akero Clinical Study Site

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Akero Clinical Study Site

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Akero Clinical Study Site

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Akero Clinical Study Site

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Akero Clinical Study Site

    Dayton, Ohio 45414
    United States

    Site Not Available

  • Akero Clinical Study Site

    Springboro, Ohio 45066
    United States

    Site Not Available

  • Akero Clinical Study Site

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Akero Clinical Study Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Akero Clinical Study Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Akero Clinical Study Site

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • Akero Clinical Study Site

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • Akero Clinical Study Site

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Akero Clinical Study Site

    Clarksville, Tennessee 37040
    United States

    Site Not Available

  • Akero Clinical Study Site

    Hermitage, Tennessee 37076
    United States

    Site Not Available

  • Akero Clinical Study Site

    Nashville, Tennessee 37211
    United States

    Site Not Available

  • Akero Clinical Study Site

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Akero Clinical Study Site

    Austin, Texas 78757
    United States

    Site Not Available

  • Akero Clinical Study Site

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Akero Clinical Study Site

    Brownsville, Texas 78520
    United States

    Site Not Available

  • Akero Clinical Study Site

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Akero Clinical Study Site

    Dallas, Texas 75234
    United States

    Site Not Available

  • Akero Clinical Study Site

    Edinburg, Texas 78539
    United States

    Site Not Available

  • Akero Clinical Study Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Akero Clinical Study Site

    Houston, Texas 77079
    United States

    Site Not Available

  • Akero Clinical Study Site

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Akero Clinical Study Site

    McAllen, Texas 78504
    United States

    Site Not Available

  • Akero Clinical Study Site

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Akero Clinical Study Site

    San Marcos, Texas 78666-7502
    United States

    Site Not Available

  • Akero Clinical Study Site

    Waco, Texas 76710
    United States

    Site Not Available

  • Akero Clinical Study Site

    Webster, Texas 77598
    United States

    Site Not Available

  • Akero Clinical Study Site

    Wichita Falls, Texas 76301
    United States

    Site Not Available

  • Akero Clinical Study Site

    Ogden, Utah 84405
    United States

    Site Not Available

  • Akero Clinical Study Site

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • Akero Clinical Study Site

    Sandy, Utah 84092
    United States

    Site Not Available

  • Akero Clinical Study Site

    South Ogden, Utah 84405
    United States

    Site Not Available

  • Akero Clinical Study Site

    Falls Church, Virginia 22042-3300
    United States

    Site Not Available

  • Akero Clinical Study Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Akero Clinical Study Site

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Akero Clinical Study Site

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • Akero Clinical Study Site

    Suffolk, Virginia 23435
    United States

    Site Not Available

  • Akero Clinical Study Site

    Seattle, Washington 98105
    United States

    Site Not Available

  • Akero Clinical Study Site

    Spokane, Washington 99218
    United States

    Site Not Available

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