A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

May 14, 2026 updated by: Akero Therapeutics, Inc

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2150

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Akero Study Director
Phone Number: 650-487-6488
Email: AkeroSynchrony@akerotx.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1180AAX
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0302
- Buenos Aires
  - Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1056ABI
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0305
  - Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0307
  - La Plata, Buenos Aires, Argentina, B1902AWL
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0304
  - Ramos Mejía, Buenos Aires, Argentina, B1704ETD
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0303
- Distrito Federal
  - Buenos Aires, Distrito Federal, Argentina, C1406EEI
    - Active, not recruiting
    - Akero Clinical Study Site
- Sante Fe
  - Rosario, Sante Fe, Argentina, S2002KDT
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0308
Australia
- New South Wales
  - Broadmeadow, New South Wales, Australia, 2292
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0408
  - Coffs Harbour, New South Wales, Australia, 2450
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0418
  - Kingswood, New South Wales, Australia, 2747
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0416
  - Liverpool, New South Wales, Australia, 1871
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0413
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0401
- Queensland
  - Herston, Queensland, Australia, 4029
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0414
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0407
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0412
  - Clayton, Victoria, Australia, 3168
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0402
  - Epping, Victoria, Australia, 3076
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0410
  - Heidelberg, Victoria, Australia, 3084
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0405
  - Melbourne, Victoria, Australia, 3004
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0403
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0411
  - Nedlands, Western Australia, Australia, 6009
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0415
  - Perth, Western Australia, Australia, 6000
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0406
Brazil
- Federal District
  - Brasília, Federal District, Brazil, 71681-603
    - Active, not recruiting
    - Akero Clinical Study Site
- Goiás
  - Goiânia, Goiás, Brazil, 74690-900
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 2003
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30220-140
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 2002
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 2001
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2X8
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0501
- Ontario
  - Toronto, Ontario, Canada, M6H 3M1
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0502
  - Toronto, Ontario, Canada, M5G 2C4
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0507
  - Vaughan, Ontario, Canada, L4L 4Y7
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0504
- Quebec
  - Montreal, Quebec, Canada, H2X 0A9
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0506
  - Terrebonne, Quebec, Canada, J7B6B7
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0505
Chile
- Coquimbo Region
  - La Serena, Coquimbo Region, Chile, 1700000
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 2104
- Santiago Metropolitan
  - Las Condes, Santiago Metropolitan, Chile, 7500000
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 2101
  - Santiago, Santiago Metropolitan, Chile, 8320000
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 2105
  - Santiago, Santiago Metropolitan, Chile, 8330109
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 2102
  - Santiago, Santiago Metropolitan, Chile, 8380000
    - Active, not recruiting
    - Akero Clinical Study Site
France
- Bas-Rhin
  - Strasbourg, Bas-Rhin, France, 67200
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0607
- Haute-Vienne
  - Limoges, Haute-Vienne, France, 87042
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0609
- Hauts-de-France
  - Lille, Hauts-de-France, France, 59037
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0613
- Hauts-de-Seine
  - Clichy, Hauts-de-Seine, France, 92118
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0603
- Lorraine
  - Vandœuvre-lès-Nancy, Lorraine, France, 54511
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0611
- Maine-et-Loire
  - Angers, Maine-et-Loire, France, 49933
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0602
- Occitanie
  - Toulouse, Occitanie, France, 31059
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0610
- Provence-Alpes-Côte d'Azur Region
  - Marseille, Provence-Alpes-Côte d'Azur Region, France, 13008
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0601
  - Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, France, 34295
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0608
  - Nice, Provence-Alpes-Côte d'Azur Region, France, 06202
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0606
- Rhône
  - Lyon, Rhône, France, 69004
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0604
- Val-de-Marne
  - Créteil, Val-de-Marne, France, 94010
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0614
- Île-de-France Region
  - Le Chesnay, Île-de-France Region, France, 78150
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0612
  - Paris, Île-de-France Region, France, 75013
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0605
Germany
- - Berlin, Germany, 13353
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0701
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60590
    - Active, not recruiting
    - Akero Clinical Study Site
- Saarland
  - Homburg, Saarland, Germany, 66421
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0716
- Saxony
  - Leipzig, Saxony, Germany, 04103
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0708
- Schleswig-Holstein
  - Lübeck, Schleswig-Holstein, Germany, 23538
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0713
India
- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 500 082
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1929
- Gujarat
  - Surat, Gujarat, India, 395009
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1911
  - Surat, Gujarat, India, 395002
    - Active, not recruiting
    - Akero Clinical Study Site
  - Vadodara, Gujarat, India, 390007
    - Active, not recruiting
    - Akero Clinical Study Site
- Karnataka
  - Mysore, Karnataka, India, 570001
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1930
- Kerala
  - Thiruvananthapuram, Kerala, India, 695011
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1922
- Maharashtra
  - Mumbai, Maharashtra, India, 400012
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1926
  - Mumbai, Maharashtra, India, 400008
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1931
  - Nagpur, Maharashtra, India, 440010
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1909
  - Pune, Maharashtra, India, 412201
    - Active, not recruiting
    - Akero Clinical Study Site
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110 070
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1924
  - New Delhi, National Capital Territory of Delhi, India, 110029
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1904
  - New Delhi, National Capital Territory of Delhi, India, 110060
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1916
- Punjab
  - Chandigarh, Punjab, India, 160012
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1908
  - Ludhiana, Punjab, India, 141002
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1928
- Rajasthan
  - Jaipur, Rajasthan, India, 302001
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1902
- Tamil Nadu
  - Coimbatore, Tamil Nadu, India, 641005
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1920
- Telangana
  - Hyderabad, Telangana, India, 500 004
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1912
- Uttar Pradesh
  - Varanasi, Uttar Pradesh, India, 221005
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1921
- Uttarakhand
  - Rishikesh, Uttarakhand, India, 249203
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1923
- West Bengal
  - Kolkata, West Bengal, India, 700020
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1907
  - Kolkata, West Bengal, India, 700073
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1917
Israel
- - Haifa, Israel, 3109601
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0804
  - Jerusalem, Israel, 9103102
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0809
  - Jerusalem, Israel, 9112001
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0808
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0801
  - Tel Aviv, Israel, 69710
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0811
- Central District
  - Petah Tikva, Central District, Israel, 4941492
    - Active, not recruiting
    - Akero Clinical Study Site
  - Ramat Gan, Central District, Israel, 5265601
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0802
- Haifa District
  - Haifa, Haifa District, Israel, 3436212
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0806
- Northern District
  - Afula, Northern District, Israel, 18101
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0810
  - Nahariya, Northern District, Israel, 22100
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0807
Italy
- - Bologna, Italy, 40138
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0908
  - Catania, Italy, 95100
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0914
  - Messina, Italy, 98124
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0912
  - Milan, Italy, 20122
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0902
  - Modena, Italy, 41124
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0906
  - Novara, Italy, 28100
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0905
- Apulia
  - Foggia, Apulia, Italy, 71122
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0909
- Foggia
  - San Giovanni Rotondo, Foggia, Italy, 71013
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0901
- Milan
  - Rozzano, Milan, Italy, 20089
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0904
- Turin
  - Torino, Turin, Italy, 10126
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0910
Mexico
- - Benito Juárez, Mexico, 3330
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1105
  - Mexico City, Mexico, 14050
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1109
- Guerrero
  - Acapulco de Juárez, Guerrero, Mexico, 39670
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1107
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44130
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1103
- Mexico City
  - Cuauhtémoc, Mexico City, Mexico, 06700
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 8237
  - Mexico City, Mexico City, Mexico, 01376
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1106
- Yucatán
  - Mérida, Yucatán, Mexico, 97070
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1108
Poland
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 61-293
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1205
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 31-501
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1212
- Lower Silesian Voivodeship
  - Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1204
  - Wroclaw, Lower Silesian Voivodeship, Poland, 53-673
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1213
- Lódzkie
  - Lodz, Lódzkie, Poland, 91-473
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1214
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 00-215
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1211
  - Warsaw, Masovian Voivodeship, Poland, 02-672
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1203
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Poland, Poland 80-382
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1201
- Silesian Voivodeship
  - Częstochowa, Silesian Voivodeship, Poland, 42-202
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1206
  - Katowice, Silesian Voivodeship, Poland, 40-752
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1208
Puerto Rico
- - Manati, Puerto Rico, 00674
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0177
  - Mayagüez, Puerto Rico, 00680
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0272
  - San Juan, Puerto Rico, 00927
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9215
South Korea
- Daegu Gwang'yeogsi [Taegu-Kwangyokshi]
  - Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea, 41944
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1306
- Gyeonggi-do
  - Incheon, Gyeonggi-do, South Korea, 22332
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1308
- Gyeonggido
  - Goyang-si, Gyeonggido, South Korea, 10444
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1303
- Gyeongsangbugdo [Kyongsangbuk-do]
  - Daegu, Gyeongsangbugdo [Kyongsangbuk-do], South Korea, 42601
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1304
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 04763
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1305
- Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
  - Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 03080
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1301
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1405
  - Madrid, Spain, 28007
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1401
  - Madrid, Spain, 28027
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1408
  - Seville, Spain, 41013
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1402
  - Valencia, Spain, 46010
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1410
  - Valencia, Spain, 46015
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1403
- Barcelona
  - Sabadell, Barcelona, Spain, 08208
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1409
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1406
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Active, not recruiting
    - Akero Clinical Study Site
Switzerland
- - Bern, Switzerland, 3010
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1502
  - Sankt Gallen, Switzerland, 9007
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1501
  - Zurich, Switzerland, 8091
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1506
- Canton Ticino
  - Lugano, Canton Ticino, Switzerland, 6900
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1505
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06560
    - Active, not recruiting
    - Akero Clinical Study Site
  - Bursa, Turkey (Türkiye), 16059
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1704
  - Rize, Turkey (Türkiye), 53020
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1706
- İzmir
  - Bornova, İzmir, Turkey (Türkiye), 35100
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1703
United Kingdom
- - Birmingham, United Kingdom, B15 2TH
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1804
  - London, United Kingdom, NW3 2QG
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1802
  - London, United Kingdom, SW10 9NH
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1813
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1805
  - Whitechapel, United Kingdom, E1 1FR
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1809
- England
  - London, England, United Kingdom, SE5 9RS
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1806
  - Nottingham, England, United Kingdom, NG7 2UH
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1817
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0129
  - Dothan, Alabama, United States, 36301
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0233
- Arizona
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9106
  - Flagstaff, Arizona, United States, 86001
    - Active, not recruiting
    - Akero Clinical Study Site
  - Peoria, Arizona, United States, 85381
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9104
  - Scottsdale, Arizona, United States, 85258
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0278
  - Tucson, Arizona, United States, 85712
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9144
  - Tucson, Arizona, United States, 85715
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0209
  - Tucson, Arizona, United States, 85713
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0234
- Arkansas
  - Conway, Arkansas, United States, 72032
    - Active, not recruiting
    - Akero Clinical Study Site
  - Jonesboro, Arkansas, United States, 72401
    - Active, not recruiting
    - Akero Clinical Study Site
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0106
  - North Little Rock, Arkansas, United States, 72117
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9214
- California
  - Coronado, California, United States, 92118
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0132
  - Escondido, California, United States, 92025
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0266
  - Folsom, California, United States, 95630
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0263
  - Lancaster, California, United States, 93534
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0285
  - Long Beach, California, United States, 90815
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0188
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0236
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0206
  - Orange, California, United States, 92868
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0261
  - Pasadena, California, United States, 91105
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9250
  - Redwood City, California, United States, 94063
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0191
  - Sacramento, California, United States, 95817
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0274
  - San Francisco, California, United States, 94115
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0147
  - San Francisco, California, United States, 94117
    - Active, not recruiting
    - Akero Clinical Study Site
  - San Jose, California, United States, 95116
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0280
  - Tarzana, California, United States, 91356
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0297
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0217
  - Colorado Springs, Colorado, United States, 80907
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0260
  - Englewood, Colorado, United States, 80113
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9243
- Connecticut
  - New Haven, Connecticut, United States, 06511
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0213
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20422
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0262
- Florida
  - Bradenton, Florida, United States, 34208
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0153
  - Brandon, Florida, United States, 33511
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0222
  - Cutler Bay, Florida, United States, 33189
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0251
  - Doral, Florida, United States, 33126
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0267
  - Fort Myers, Florida, United States, 33912
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9134
  - Hialeah Gardens, Florida, United States, 33016
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9242
  - Inverness, Florida, United States, 34452
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9135
  - Lakewood Rch, Florida, United States, 34211
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9203
  - Largo, Florida, United States, 33777
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9248
  - Lehigh Acres, Florida, United States, 33936
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0271
  - Margate, Florida, United States, 33063
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0248
  - Miami, Florida, United States, 33136
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0137
  - Miami, Florida, United States, 33175
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0252
  - Miami Gardens, Florida, United States, 33014
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0243
  - Naples, Florida, United States, 34102
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0138
  - New Port Richey, Florida, United States, 34653
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0257
  - Ocala, Florida, United States, 34471
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9127
  - Orlando, Florida, United States, 32807
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0250
  - Orlando, Florida, United States, 32806
    - Active, not recruiting
    - Akero Clinical Study Site
  - Pembroke Pines, Florida, United States, 33027
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0239
  - Riverview, Florida, United States, 33578
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0295
  - Sarasota, Florida, United States, 34240
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9218
  - Temple Terrace, Florida, United States, 33617
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0242
  - Venice, Florida, United States, 34285
    - Active, not recruiting
    - Akero Clinical Study Site
  - Viera, Florida, United States, 32940
    - Active, not recruiting
    - Akero Clinical Study Site
  - Weston, Florida, United States, 33331
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0270
  - Zephyrhills, Florida, United States, 33542
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0235
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0230
  - Gainesville, Georgia, United States, 30501
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0183
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9111
  - Snellville, Georgia, United States, 30078
    - Active, not recruiting
    - Akero Clinical Study Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9245
- Indiana
  - Hammond, Indiana, United States, 46324
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0254
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0290
  - South Bend, Indiana, United States, 46635
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9235
- Iowa
  - West Des Moines, Iowa, United States, 50265
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0146
- Kansas
  - Topeka, Kansas, United States, 66606
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9136
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0203
- Louisiana
  - Bastrop, Louisiana, United States, 71220
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9220
  - Covington, Louisiana, United States, 70433
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0195
  - Houma, Louisiana, United States, 70363
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0112
  - Lafayette, Louisiana, United States, 70503
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0282
  - Marrero, Louisiana, United States, 70072
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9102
  - Metairie, Louisiana, United States, 70006
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0109
  - Shreveport, Louisiana, United States, 71105
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9145
  - West Monroe, Louisiana, United States, 71291
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0283
- Maryland
  - Baltimore, Maryland, United States, 21202
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0108
  - Bethesda, Maryland, United States, 20889-0004
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0227
- Massachusetts
  - South Dartmouth, Massachusetts, United States, 02747
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0181
- Michigan
  - Clinton Township, Michigan, United States, 48038
    - Active, not recruiting
    - Akero Clinical Study Site
  - Novi, Michigan, United States, 48377
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0204
  - Southfield, Michigan, United States, 48075
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0210
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0240
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0277
- Missouri
  - Columbia, Missouri, United States, 65201
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0141
  - Kansas City, Missouri, United States, 64131
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9208
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0276
  - St Louis, Missouri, United States, 63123
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0296
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9142
- New Jersey
  - Jackson, New Jersey, United States, 08527
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0105
  - Somers Point, New Jersey, United States, 08244
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0116
  - Sparta, New Jersey, United States, 07871
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0117
- New York
  - Buffalo, New York, United States, 14203
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0241
  - Manhasset, New York, United States, 11030
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0208
  - New York, New York, United States, 10029
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0160
  - New York, New York, United States, 10016
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0198
  - New York, New York, United States, 10021
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0148
  - Rochester, New York, United States, 14642
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0228
- North Carolina
  - Chapel Hill, North Carolina, United States, 27516
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0192
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9147
  - Charlotte, North Carolina, United States, 28207
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0225
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0224
  - Fayetteville, North Carolina, United States, 28304
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9227
  - Morehead City, North Carolina, United States, 28557
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9128
  - Raleigh, North Carolina, United States, 27612
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0169
  - Statesville, North Carolina, United States, 28625
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0142
- Ohio
  - Akron, Ohio, United States, 44320
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0284
  - Springboro, Ohio, United States, 45066
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9233
  - Westlake, Ohio, United States, 44145
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9226
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0291
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0264
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9132
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0207
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0102
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0246
  - Columbia, South Carolina, United States, 29204
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0151
  - Summerville, South Carolina, United States, 29485
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9238
- Tennessee
  - Clarksville, Tennessee, United States, 37040
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0144
  - Hermitage, Tennessee, United States, 37076
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9123
  - Nashville, Tennessee, United States, 37211
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9130
- Texas
  - Amarillo, Texas, United States, 79106
    - Active, not recruiting
    - Akero Clinical Study Site
  - Arlington, Texas, United States, 76012
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 1002
  - Austin, Texas, United States, 78745
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0131
  - Austin, Texas, United States, 78757
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0281
  - Bellaire, Texas, United States, 77401
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0165
  - Brownsville, Texas, United States, 78520
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0154
  - Corpus Christi, Texas, United States, 78404
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0223
  - Dallas, Texas, United States, 75203
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0126
  - Dallas, Texas, United States, 75234
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0221
  - Dallas, Texas, United States, 75390
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0164
  - Dallas, Texas, United States, 75216
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0253
  - Dallas, Texas, United States, 75246
    - Active, not recruiting
    - Akero Clinical Study Site
  - Denison, Texas, United States, 75020
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0244
  - Edinburg, Texas, United States, 78539
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9205
  - Fort Sam Houston, Texas, United States, 78234
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0229
  - Fort Worth, Texas, United States, 76104
    - Active, not recruiting
    - Akero Clinical Study Site
  - Garland, Texas, United States, 75044
    - Active, not recruiting
    - Akero Clinical Study Site
  - Houston, Texas, United States, 77079
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9252
  - Houston, Texas, United States, 77030
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0258
  - Houston, Texas, United States, 77074
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0249
  - Pasadena, Texas, United States, 77505
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0292
  - Pharr, Texas, United States, 78577
    - Active, not recruiting
    - Akero Clinical Study Site
  - San Antonio, Texas, United States, 78222
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0185
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0125
  - San Antonio, Texas, United States, 78251
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0289
  - Sugar Land, Texas, United States, 77478
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0299
  - Sugar Land, Texas, United States, 77478
    - Active, not recruiting
    - Akero Clinical Study Site
  - Waco, Texas, United States, 76710
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9246
  - Waco, Texas, United States, 76712
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0279
  - Webster, Texas, United States, 77598
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9204
  - Wichita Falls, Texas, United States, 76301
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9247
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0143
  - Richmond, Virginia, United States, 23236
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0103
  - Richmond, Virginia, United States, 23249
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9120
  - Richmond, Virginia, United States, 23226-1925
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0212
  - Richmond, Virginia, United States, 23284
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 9115
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0139
- Washington
  - Seattle, Washington, United States, 98105
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0119
- Wisconsin
  - Madison, Wisconsin, United States, 53705
    - Recruiting
    - Akero Clinical Study Site
    - Contact:
      
      Akero Site 0259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of >=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities
Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

Exclusion Criteria:

Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
Type 1 diabetes or unstable Type 2 diabetes
Any current or prior history of decompensated liver disease

Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Administered by subcutaneous injection
Experimental: EFX 50 mg	Drug: Efruxifermin Administered by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc. Time Frame: 5 years	Measured by composite of protocol-specified clinical events	5 years
Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis Time Frame: 96 Weeks	Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)	96 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of non-invasive markers of liver fibrosis Time Frame: 96 Weeks, 5 Years	ELF (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis)	96 Weeks, 5 Years
Change from baseline of non-invasive markers of liver fibrosis Time Frame: 96 Weeks, 5 Years	Pro-C3 (ug/L)	96 Weeks, 5 Years
Change from baseline of non-invasive markers of liver fibrosis Time Frame: 96 Weeks, 5 Years	Liver stiffness assessed by transient elastography (FibroScan®) (kPa)	96 Weeks, 5 Years
Change from baseline of markers of liver injury Time Frame: 96 Weeks, 5 Years	ALT (U/L) and AST (U/L)	96 Weeks, 5 Years
Change from baseline of lipoproteins Time Frame: 96 Weeks, 5 Years	Total cholesterol (mg/dL), Triglycerides (mg/dL), HDL-C (mg/dL), Non-HDL-C (mg/dL), and LDL-C (mg/dL)	96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control Time Frame: 96 Weeks, 5 Years	HbA1c (%)	96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control Time Frame: 96 Weeks, 5 Years	C-Peptide (ng/mL)	96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control Time Frame: 96 Weeks, 5 Years	Adiponectin (mg/L)	96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control Time Frame: 96 Weeks, 5 Years	Insulin (mIU/L)	96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control Time Frame: 96 Weeks, 5 Years	HOMA-IR (≥ 2.5 indicates insulin resistance)	96 Weeks, 5 Years
Change from baseline of body weight (kg) Time Frame: 96 Weeks, 5 Years		96 Weeks, 5 Years
Safety and tolerability of EFX through the reporting of extent of exposure (weeks) Time Frame: From first dose through end of study (up to 5 Years)		From first dose through end of study (up to 5 Years)
Safety and tolerability of EFX through the reporting of adverse events (frequency of events) Time Frame: From first dose through end of study (up to 5 Years)	Proportion of subjects reporting adverse events	From first dose through end of study (up to 5 Years)
Safety and tolerability of EFX through the reporting of adverse events (severity of events) Time Frame: From first dose through end of study (up to 5 Years)	Proportion of subjects reporting adverse events	From first dose through end of study (up to 5 Years)
Number of participants with abnormal laboratory tests results, abnormal ECGs, abnormal ultrasounds, abnormal vital sign assessments Time Frame: From first dose through end of study (up to 5 years)		From first dose through end of study (up to 5 years)
Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis Time Frame: 5 Years	Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)	5 Years
Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis Time Frame: 96 Weeks	Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)	96 Weeks
Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH Time Frame: 96 Weeks	Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning)	96 Weeks
Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis Time Frame: 96 Weeks	Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)	96 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akero Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

AK-US-001-0106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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