NASH - Nonalcoholic SteatohepatitisPhase 3NCT06528314
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
A Phase 3 study testing Efruxifermin in people with NASH - Nonalcoholic Steatohepatitis and MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Akero Therapeutics, Inc at 345 sites in 21 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- Efruxifermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,150 participants
- Where
- 345 sitesin 21 countries
- Study dates
- 4 Oct 2024to Mar 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
345 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
345 sites in 21 countries
United States176 sites, 160 recruiting
- Recruiting
Akero Clinical Study Site
Akron, Ohio, 44320
Akero Site 0284
- Completed
Akero Clinical Study Site
Amarillo, Texas, 79106
- Recruiting
Akero Clinical Study Site
Arlington, Texas, 76012
Akero Site 1002
- Recruiting
Akero Clinical Study Site
Atlanta, Georgia, 30309
Akero Site 0230
- Recruiting
Akero Clinical Study Site
Atlanta, Georgia, 30327
Akero Site 1006
- Recruiting
Akero Clinical Study Site
Aurora, Colorado, 80045
Akero Site 0217
- Recruiting
Akero Clinical Study Site
Austin, Texas, 78745
Akero Site 0131
- Recruiting
Akero Clinical Study Site
Austin, Texas, 78757
Akero Site 9114
- Recruiting
Akero Clinical Study Site
Austin, Texas, 78757
Akero Site 0281
- Recruiting
Akero Clinical Study Site
Baltimore, Maryland, 21202
Akero Site 0108
- Recruiting
Akero Clinical Study Site
Bastrop, Louisiana, 71220
Akero Site 9220
- Recruiting
Akero Clinical Study Site
Bellaire, Texas, 77401
Akero Site 0165
- Recruiting
Akero Clinical Study Site
Bethesda, Maryland, 20889-0004
Akero Site 0227
- Recruiting
Akero Clinical Study Site
Birmingham, Alabama, 35209
Akero Site 0129
- Recruiting
Akero Clinical Study Site
Bradenton, Florida, 34208
Akero Site 0153
- Recruiting
Akero Clinical Study Site
Brandon, Florida, 33511
Akero Site 0222
- Recruiting
Akero Clinical Study Site
Brownsville, Texas, 78520
Akero Site 0154
- Recruiting
Akero Clinical Study Site
Buffalo, New York, 14203
Akero Site 0241
- Recruiting
Akero Clinical Study Site
Chandler, Arizona, 85224
Akero Site 9106
- Recruiting
Akero Clinical Study Site
Chapel Hill, North Carolina, 27516
Akero Site 0192
- Recruiting
Akero Clinical Study Site
Charleston, South Carolina, 29425
Akero Site 0246
- Recruiting
Akero Clinical Study Site
Charlotte, North Carolina, 28204
Akero Site 9147
- Recruiting
Akero Clinical Study Site
Charlotte, North Carolina, 28207
Akero Site 0225
- Recruiting
Akero Clinical Study Site
Chicago, Illinois, 60611
Akero Site 9245
- Recruiting
Akero Clinical Study Site
Clarksville, Tennessee, 37040
Akero Site 0144
- Completed
Akero Clinical Study Site
Clinton Township, Michigan, 48038
- Recruiting
Akero Clinical Study Site
Colorado Springs, Colorado, 80907
Akero Site 0260
- Recruiting
Akero Clinical Study Site
Columbia, Missouri, 65201
Akero Site 0141
- Recruiting
Akero Clinical Study Site
Columbia, South Carolina, 29204
Akero Site 0151
- Completed
Akero Clinical Study Site
Conway, Arkansas, 72032
- Recruiting
Akero Clinical Study Site
Coronado, California, 92118
Akero Site 0132
- Recruiting
Akero Clinical Study Site
Corpus Christi, Texas, 78404
Akero Site 0223
- Recruiting
Akero Clinical Study Site
Covington, Louisiana, 70433
Akero Site 0195
- Recruiting
Akero Clinical Study Site
Cutler Bay, Florida, 33189
Akero Site 0251
- Recruiting
Akero Clinical Study Site
Dallas, Texas, 75203
Akero Site 0126
- Recruiting
Akero Clinical Study Site
Dallas, Texas, 75216
Akero Site 0253
- Recruiting
Akero Clinical Study Site
Dallas, Texas, 75234
Akero Site 0221
- Completed
Akero Clinical Study Site
Dallas, Texas, 75246
- Recruiting
Akero Clinical Study Site
Dallas, Texas, 75390
Akero Site 0164
- Active, not recruiting
Akero Clinical Study Site
Daytona Beach, Florida, 32114
- Recruiting
Akero Clinical Study Site
Denison, Texas, 75020
Akero Site 0244
- Recruiting
Akero Clinical Study Site
Doral, Florida, 33126
Akero Site 0267
- Recruiting
Akero Clinical Study Site
Dothan, Alabama, 36301
Akero Site 0233
- Recruiting
Akero Clinical Study Site
Durham, North Carolina, 27710
Akero Site 0224
- Recruiting
Akero Clinical Study Site
Edinburg, Texas, 78539
Akero Site 9117
- Recruiting
Akero Clinical Study Site
Edinburg, Texas, 78539
Akero Site 9205
- Recruiting
Akero Clinical Study Site
Englewood, Colorado, 80113
Akero Site 9243
- Recruiting
Akero Clinical Study Site
Escondido, California, 92025
Akero Site 0266
- Recruiting
Akero Clinical Study Site
Fayetteville, North Carolina, 28304
Akero Site 9227
- Completed
Akero Clinical Study Site
Flagstaff, Arizona, 86001
- Recruiting
Akero Clinical Study Site
Flowood, Mississippi, 39232
Akero Site 0277
- Recruiting
Akero Clinical Study Site
Folsom, California, 95630
Akero Site 0263
- Recruiting
Akero Clinical Study Site
Fort Myers, Florida, 33912
Akero Site 9134
- Recruiting
Akero Clinical Study Site
Fort Sam Houston, Texas, 78234
Akero Site 0229
- Completed
Akero Clinical Study Site
Fort Worth, Texas, 76104
- Recruiting
Akero Clinical Study Site
Fountain Valley, California, 92708
Akero Site 1013
- Recruiting
Akero Clinical Study Site
Gainesville, Georgia, 30501
Akero Site 0183
- Completed
Akero Clinical Study Site
Garland, Texas, 75044
- Recruiting
Akero Clinical Study Site
Hammond, Indiana, 46324
Akero Site 0254
- Recruiting
Akero Clinical Study Site
Henderson, Nevada, 89052
Akero Site 1022
- Recruiting
Akero Clinical Study Site
Hermitage, Tennessee, 37076
Akero Site 9123
- Recruiting
Akero Clinical Study Site
Hershey, Pennsylvania, 17033
Akero Site 0264
- Recruiting
Akero Clinical Study Site
Hialeah Gardens, Florida, 33016
Akero Site 9242
- Recruiting
Akero Clinical Study Site
Houma, Louisiana, 70363
Akero Site 0112
- Recruiting
Akero Clinical Study Site
Houston, Texas, 77030
Akero Site 9223
- Recruiting
Akero Clinical Study Site
Houston, Texas, 77030
Akero Site 0293
- Recruiting
Akero Clinical Study Site
Houston, Texas, 77030
Akero Site 0258
- Recruiting
Akero Clinical Study Site
Houston, Texas, 77074
Akero Site 0249
- Recruiting
Akero Clinical Study Site
Houston, Texas, 77079
Akero Site 9252
- Recruiting
Akero Clinical Study Site
Indianapolis, Indiana, 46202
Akero Site 0290
- Recruiting
Akero Clinical Study Site
Inverness, Florida, 34452
Akero Site 9135
- Recruiting
Akero Clinical Study Site
Jackson, New Jersey, 08527
Akero Site 0105
- Completed
Akero Clinical Study Site
Jonesboro, Arkansas, 72401
- Recruiting
Akero Clinical Study Site
Kansas City, Missouri, 64131
Akero Site 9208
- Recruiting
Akero Clinical Study Site
Kingwood, Texas, 77339
Akero Site 1018
- Active, not recruiting
Akero Clinical Study Site
Lady Lake, Florida, 32159
- Recruiting
Akero Clinical Study Site
Lafayette, Louisiana, 70503
Akero Site 0282
- Recruiting
Akero Clinical Study Site
Lakewood Rch, Florida, 34211
Akero Site 9203
- Recruiting
Akero Clinical Study Site
Lancaster, California, 93534
Akero Site 0285
- Recruiting
Akero Clinical Study Site
Largo, Florida, 33777
Akero Site 9248
- Recruiting
Akero Clinical Study Site
Las Vegas, Nevada, 89106
Akero Site 9142
- Recruiting
Akero Clinical Study Site
Lehigh Acres, Florida, 33936
Akero Site 0271
- Recruiting
Akero Clinical Study Site
Little Rock, Arkansas, 72205
Akero Site 0106
- Recruiting
Akero Clinical Study Site
Long Beach, California, 90815
Akero Site 0188
- Recruiting
Akero Clinical Study Site
Los Angeles, California, 90015
Akero Site 1019
- Recruiting
Akero Clinical Study Site
Los Angeles, California, 90048
Akero Site 0236
- Recruiting
Akero Clinical Study Site
Louisville, Kentucky, 40202
Akero Site 0203
- Recruiting
Akero Clinical Study Site
Madison, Wisconsin, 53705
Akero Site 0259
- Recruiting
Akero Clinical Study Site
Manhasset, New York, 11030
Akero Site 0208
- Recruiting
Akero Clinical Study Site
Margate, Florida, 33063
Akero Site 0248
- Recruiting
Akero Clinical Study Site
Marietta, Georgia, 30060
Akero Site 9111
- Recruiting
Akero Clinical Study Site
Marrero, Louisiana, 70072
Akero Site 9102
- Recruiting
Akero Clinical Study Site
Metairie, Louisiana, 70006
Akero Site 0109
- Recruiting
Akero Clinical Study Site
Miami, Florida, 33136
Akero Site 0137
- Recruiting
Akero Clinical Study Site
Miami, Florida, 33175
Akero Site 0252
- Recruiting
Akero Clinical Study Site
Miami Gardens, Florida, 33014
Akero Site 0243
- Recruiting
Akero Clinical Study Site
Morehead City, North Carolina, 28557
Akero Site 9128
- Recruiting
Akero Clinical Study Site
Naples, Florida, 34102
Akero Site 0138
- Recruiting
Akero Clinical Study Site
Nashville, Tennessee, 37211
Akero Site 9130
- Recruiting
Akero Clinical Study Site
New Haven, Connecticut, 06511
Akero Site 0213
- Recruiting
Akero Clinical Study Site
New Port Richey, Florida, 34653
Akero Site 0257
- Recruiting
Akero Clinical Study Site
New York, New York, 10016
Akero Site 0198
- Recruiting
Akero Clinical Study Site
New York, New York, 10021
Akero Site 0148
- Recruiting
Akero Clinical Study Site
New York, New York, 10029
Akero Site 0160
- Recruiting
Akero Clinical Study Site
Newport Beach, California, 92663
Akero Site 0206
- Recruiting
Akero Clinical Study Site
Norfolk, Virginia, 23502
Akero Site 0143
- Recruiting
Akero Clinical Study Site
North Little Rock, Arkansas, 72117
Akero Site 9214
- Recruiting
Akero Clinical Study Site
Novi, Michigan, 48377
Akero Site 0204
- Recruiting
Akero Clinical Study Site
Ocala, Florida, 34471
Akero Site 9127
- Recruiting
Akero Clinical Study Site
Oklahoma City, Oklahoma, 73112
Akero Site 0291
- Recruiting
Akero Clinical Study Site
Orange, California, 92868
Akero Site 0261
- Completed
Akero Clinical Study Site
Orlando, Florida, 32806
- Recruiting
Akero Clinical Study Site
Orlando, Florida, 32807
Akero Site 0250
- Recruiting
Akero Clinical Study Site
Pasadena, California, 91105
Akero Site 9250
- Recruiting
Akero Clinical Study Site
Pasadena, Texas, 77505
Akero Site 0292
- Recruiting
Akero Clinical Study Site
Pembroke Pines, Florida, 33027
Akero Site 0239
- Recruiting
Akero Clinical Study Site
Peoria, Arizona, 85381
Akero Site 9104
- Completed
Akero Clinical Study Site
Pharr, Texas, 78577
- Recruiting
Akero Clinical Study Site
Philadelphia, Pennsylvania, 19104
Akero Site 0207
- Recruiting
Akero Clinical Study Site
Philadelphia, Pennsylvania, 19107
Akero Site 9132
- Recruiting
Akero Clinical Study Site
Pittsburgh, Pennsylvania, 15213
Akero Site 0102
- Recruiting
Akero Clinical Study Site
Raleigh, North Carolina, 27612
Akero Site 0169
- Recruiting
Akero Clinical Study Site
Redwood City, California, 94063
Akero Site 0191
- Recruiting
Akero Clinical Study Site
Richmond, Virginia, 23226-1925
Akero Site 0212
- Recruiting
Akero Clinical Study Site
Richmond, Virginia, 23236
Akero Site 0103
- Recruiting
Akero Clinical Study Site
Richmond, Virginia, 23249
Akero Site 9120
- Recruiting
Akero Clinical Study Site
Richmond, Virginia, 23284
Akero Site 9115
- Recruiting
Akero Clinical Study Site
Riverview, Florida, 33578
Akero Site 0295
- Recruiting
Akero Clinical Study Site
Roanoke, Virginia, 24014
Akero Site 0139
- Recruiting
Akero Clinical Study Site
Rochester, Minnesota, 55905
Akero Site 0240
- Recruiting
Akero Clinical Study Site
Rochester, New York, 14642
Akero Site 0228
- Recruiting
Akero Clinical Study Site
Sacramento, California, 95817
Akero Site 0274
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 78222
Akero Site 0185
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 78229
Akero Site 9202
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 78229
Akero Site 0125
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 78251
Akero Site 0289
- Recruiting
Akero Clinical Study Site
San Francisco, California, 94115
Akero Site 0147
- Recruiting
Akero Clinical Study Site
San Francisco, California, 94117
Akero Site 0269
- Recruiting
Akero Clinical Study Site
San Jose, California, 95116
Akero Site 0280
- Recruiting
Akero Clinical Study Site
Sarasota, Florida, 34240
Akero Site 9218
- Recruiting
Akero Clinical Study Site
Scottsdale, Arizona, 85258
Akero Site 0278
- Recruiting
Akero Clinical Study Site
Seattle, Washington, 98105
Akero Site 0119
- Recruiting
Akero Clinical Study Site
Shreveport, Louisiana, 71105
Akero Site 9145
- Completed
Akero Clinical Study Site
Snellville, Georgia, 30078
- Recruiting
Akero Clinical Study Site
Somers Point, New Jersey, 08244
Akero Site 0116
- Recruiting
Akero Clinical Study Site
South Bend, Indiana, 46635
Akero Site 9235
- Recruiting
Akero Clinical Study Site
South Dartmouth, Massachusetts, 02747
Akero Site 0181
- Recruiting
Akero Clinical Study Site
Southfield, Michigan, 48075
Akero Site 0210
- Recruiting
Akero Clinical Study Site
Sparta, New Jersey, 07871
Akero Site 0117
- Recruiting
Akero Clinical Study Site
Springboro, Ohio, 45066
Akero Site 9233
- Recruiting
Akero Clinical Study Site
St Louis, Missouri, 63110
Akero Site 0276
- Recruiting
Akero Clinical Study Site
St Louis, Missouri, 63123
Akero Site 0296
- Recruiting
Akero Clinical Study Site
Statesville, North Carolina, 28625
Akero Site 0142
- Completed
Akero Clinical Study Site
Sugar Land, Texas, 77478
- Recruiting
Akero Clinical Study Site
Sugar Land, Texas, 77478
Akero Site 0299
- Recruiting
Akero Clinical Study Site
Summerville, South Carolina, 29485
Akero Site 9238
- Recruiting
Akero Clinical Study Site
Tarzana, California, 91356
Akero Site 0297
- Recruiting
Akero Clinical Study Site
Temple Terrace, Florida, 33617
Akero Site 0242
- Recruiting
Akero Clinical Study Site
Topeka, Kansas, 66606
Akero Site 9136
- Recruiting
Akero Clinical Study Site
Tucson, Arizona, 85712
Akero Site 9210
- Recruiting
Akero Clinical Study Site
Tucson, Arizona, 85712
Akero Site 9144
- Recruiting
Akero Clinical Study Site
Tucson, Arizona, 85713
Akero Site 0234
- Recruiting
Akero Clinical Study Site
Tucson, Arizona, 85715
Akero Site 0209
- Recruiting
Akero Clinical Study Site
Vancouver, Washington, 98683
Akero Site 1016
- Completed
Akero Clinical Study Site
Venice, Florida, 34285
- Completed
Akero Clinical Study Site
Viera, Florida, 32940
- Recruiting
Akero Clinical Study Site
Waco, Texas, 76710
Akero Site 9246
- Recruiting
Akero Clinical Study Site
Waco, Texas, 76712
Akero Site 0279
- Recruiting
Akero Clinical Study Site
Washington D.C., District of Columbia, 20422
Akero Site 0262
- Recruiting
Akero Clinical Study Site
Webster, Texas, 77598
Akero Site 9204
- Recruiting
Akero Clinical Study Site
West Des Moines, Iowa, 50265
Akero Site 0146
- Recruiting
Akero Clinical Study Site
West Monroe, Louisiana, 71291
Akero Site 0283
- Recruiting
Akero Clinical Study Site
Westlake, Ohio, 44145
Akero Site 9226
- Recruiting
Akero Clinical Study Site
Weston, Florida, 33331
Akero Site 0270
- Recruiting
Akero Clinical Study Site
Wichita Falls, Texas, 76301
Akero Site 9247
- Recruiting
Akero Clinical Study Site
Zephyrhills, Florida, 33542
Akero Site 0235
India25 sites, 22 recruiting
- Recruiting
Akero Clinical Study Site
Chandigarh, Punjab, 160012
Akero Site 1908
- Recruiting
Akero Clinical Study Site
Coimbatore, Tamil Nadu, 641005
Akero Site 1920
- Recruiting
Akero Clinical Study Site
Hyderabad, Andhra Pradesh, 500 082
Akero Site 1929
- Recruiting
Akero Clinical Study Site
Hyderabad, Telangana, 500 004
Akero Site 1912
- Recruiting
Akero Clinical Study Site
Jaipur, Rajasthan, 302001
Akero Site 1903
- Recruiting
Akero Clinical Study Site
Jaipur, Rajasthan, 302001
Akero Site 1902
- Recruiting
Akero Clinical Study Site
Kolkata, West Bengal, 700020
Akero Site 1914
- Recruiting
Akero Clinical Study Site
Kolkata, West Bengal, 700020
Akero Site 1907
- Recruiting
Akero Clinical Study Site
Kolkata, West Bengal, 700073
Akero Site 1917
- Recruiting
Akero Clinical Study Site
Ludhiana, Punjab, 141002
Akero Site 1928
- Recruiting
Akero Clinical Study Site
Mumbai, Maharashtra, 400008
Akero Site 1931
- Recruiting
Akero Clinical Study Site
Mumbai, Maharashtra, 400012
Akero Site 1926
- Recruiting
Akero Clinical Study Site
Mysore, Karnataka, 570001
Akero Site 1930
- Recruiting
Akero Clinical Study Site
Nagpur, Maharashtra, 440010
Akero Site 1909
- Recruiting
Akero Clinical Study Site
New Delhi, National Capital Territory of Delhi, 110 070
Akero Site 1924
- Recruiting
Akero Clinical Study Site
New Delhi, National Capital Territory of Delhi, 110029
Akero Site 1904
- Recruiting
Akero Clinical Study Site
New Delhi, National Capital Territory of Delhi, 110060
Akero Site 1916
- Completed
Akero Clinical Study Site
Pune, Maharashtra, 412201
- Recruiting
Akero Clinical Study Site
Rishikesh, Uttarakhand, 249203
Akero Site 1923
- Completed
Akero Clinical Study Site
Surat, Gujarat, 395002
- Recruiting
Akero Clinical Study Site
Surat, Gujarat, 395009
Akero Site 1911
- Recruiting
Akero Clinical Study Site
Thiruvananthapuram, Kerala, 695011
Akero Site 1922
- Completed
Akero Clinical Study Site
Vadodara, Gujarat, 390007
- Recruiting
Akero Clinical Study Site
Varanasi, Uttar Pradesh, 221005
Akero Site 1919
- Recruiting
Akero Clinical Study Site
Varanasi, Uttar Pradesh, 221005
Akero Site 1921
Australia15 sites, 15 recruiting
- Recruiting
Akero Clinical Study Site
Adelaide, South Australia, 5000
Akero Site 0407
- Recruiting
Akero Clinical Study Site
Box Hill, Victoria, 3128
Akero Site 0412
- Recruiting
Akero Clinical Study Site
Broadmeadow, New South Wales, 2292
Akero Site 0408
- Recruiting
Akero Clinical Study Site
Clayton, Victoria, 3168
Akero Site 0402
- Recruiting
Akero Clinical Study Site
Coffs Harbour, New South Wales, 2450
Akero Site 0418
- Recruiting
Akero Clinical Study Site
Epping, Victoria, 3076
Akero Site 0410
- Recruiting
Akero Clinical Study Site
Heidelberg, Victoria, 3084
Akero Site 0405
- Recruiting
Akero Clinical Study Site
Herston, Queensland, 4029
Akero Site 0414
- Recruiting
Akero Clinical Study Site
Kingswood, New South Wales, 2747
Akero Site 0416
- Recruiting
Akero Clinical Study Site
Liverpool, New South Wales, 1871
Akero Site 0413
- Recruiting
Akero Clinical Study Site
Melbourne, Victoria, 3004
Akero Site 0403
- Recruiting
Akero Clinical Study Site
Murdoch, Western Australia, 6150
Akero Site 0411
- Recruiting
Akero Clinical Study Site
Nedlands, Western Australia, 6009
Akero Site 0415
- Recruiting
Akero Clinical Study Site
Perth, Western Australia, 6000
Akero Site 0406
- Recruiting
Akero Clinical Study Site
Westmead, New South Wales, 2145
Akero Site 0401
France15 sites, 15 recruiting
- Recruiting
Akero Clinical Study Site
Angers, Maine-et-Loire, 49933
Akero Site 0602
- Recruiting
Akero Clinical Study Site
Clichy, Hauts-de-Seine, 92118
Akero Site 0603
- Recruiting
Akero Clinical Study Site
Créteil, Val-de-Marne, 94010
Akero Site 0614
- Recruiting
Akero Clinical Study Site
Le Chesnay, Île-de-France Region, 78150
Akero Site 0612
- Recruiting
Akero Clinical Study Site
Lille, Hauts-de-France, 59037
Akero Site 0613
- Recruiting
Akero Clinical Study Site
Limoges, Haute-Vienne, 87042
Akero Site 0609
- Recruiting
Akero Clinical Study Site
Lyon, Rhône, 69004
Akero Site 0604
- Recruiting
Akero Clinical Study Site
Marseille, Provence-Alpes-Côte d'Azur Region, 13008
Akero Site 0601
- Recruiting
Akero Clinical Study Site
Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, 34295
Akero Site 0608
- Recruiting
Akero Clinical Study Site
Nice, Provence-Alpes-Côte d'Azur Region, 06202
Akero Site 0606
- Recruiting
Akero Clinical Study Site
Paris, Île-de-France Region, 75013
Akero Site 0605
- Recruiting
Akero Clinical Study Site
Pessac, Gironde, 33604
Akero Site 0615
- Recruiting
Akero Clinical Study Site
Strasbourg, Bas-Rhin, 67200
Akero Site 0607
- Recruiting
Akero Clinical Study Site
Toulouse, Occitanie, 31059
Akero Site 0610
- Recruiting
Akero Clinical Study Site
Vandœuvre-lès-Nancy, Lorraine, 54511
Akero Site 0611
Italy12 sites, 12 recruiting
- Recruiting
Akero Clinical Study Site
Bologna, 40138
Akero Site 0908
- Recruiting
Akero Clinical Study Site
Catania, 95100
Akero Site 0914
- Recruiting
Akero Clinical Study Site
Foggia, Apulia, 71122
Akero Site 0909
- Recruiting
Akero Clinical Study Site
Messina, 98124
Akero Site 0912
- Recruiting
Akero Clinical Study Site
Milan, 20122
Akero Site 0911
- Recruiting
Akero Clinical Study Site
Milan, 20122
Akero Site 0902
- Recruiting
Akero Clinical Study Site
Modena, 41124
Akero Site 0906
- Recruiting
Akero Clinical Study Site
Novara, 28100
Akero Site 0905
- Recruiting
Akero Clinical Study Site
Roma, 00168
Akero Site 0913
- Recruiting
Akero Clinical Study Site
Rozzano, Milan, 20089
Akero Site 0904
- Recruiting
Akero Clinical Study Site
San Giovanni Rotondo, Foggia, 71013
Akero Site 0901
- Recruiting
Akero Clinical Study Site
Torino, Turin, 10126
Akero Site 0910
Japan11 sites, 11 recruiting
- Recruiting
Akero Clinical Study Site
Bunkyō-Ku, Tokyo, 113-8413
Akero Site 5011
- Recruiting
Akero Clinical Study Site
Fukui-shi, Hukui, 918-8503
Akero Site 5007
- Recruiting
Akero Clinical Study Site
Kyoto, Kyoto, 602-8566
Akero Site 5003
- Recruiting
Akero Clinical Study Site
Maebashi, Gunma, 371-0821
Akero Site 5015
- Recruiting
Akero Clinical Study Site
Minato-Ku, Tokyo, 105-8470
Akero Site 5006
- Recruiting
Akero Clinical Study Site
Musashino, Tokyo, 180-8610
Akero Site 5002
- Recruiting
Akero Clinical Study Site
Ōgaki, Gihu, 503-8502
Akero Site 5013
- Recruiting
Akero Clinical Study Site
Shinjuku, Tokyo, 162-8666
Akero Site 5001
- Recruiting
Akero Clinical Study Site
Suita-shi, Osaka, 564-0013
Akero Site 5010
- Recruiting
Akero Clinical Study Site
Wakayama, 650-8158
Akero Site 5014
- Recruiting
Akero Clinical Study Site
Yokohama, Kanagawa, 236-0004
Akero Site 5008
Israel10 sites, 9 recruiting
- Recruiting
Akero Clinical Study Site
Afula, Northern District, 18101
Akero Site 0810
- Recruiting
Akero Clinical Study Site
Haifa, Haifa District, 3436212
Akero Site 0806
- Recruiting
Akero Clinical Study Site
Haifa, 3109601
Akero Site 0804
- Recruiting
Akero Clinical Study Site
Jerusalem, 9103102
Akero Site 0809
- Recruiting
Akero Clinical Study Site
Jerusalem, 9112001
Akero Site 0808
- Recruiting
Akero Clinical Study Site
Nahariya, Northern District, 22100
Akero Site 0807
- Completed
Akero Clinical Study Site
Petah Tikva, Central District, 4941492
- Recruiting
Akero Clinical Study Site
Ramat Gan, Central District, 5265601
Akero Site 0802
- Recruiting
Akero Clinical Study Site
Tel Aviv, 6423906
Akero Site 0801
- Recruiting
Akero Clinical Study Site
Tel Aviv, 69710
Akero Site 0811
Poland10 sites, 10 recruiting
- Recruiting
Akero Clinical Study Site
Częstochowa, Silesian Voivodeship, 42-202
Akero Site 1206
- Recruiting
Akero Clinical Study Site
Gdansk, Pomeranian Voivodeship, Poland 80-382
Akero Site 1201
- Recruiting
Akero Clinical Study Site
Katowice, Silesian Voivodeship, 40-752
Akero Site 1208
- Recruiting
Akero Clinical Study Site
Krakow, Lesser Poland Voivodeship, 31-501
Akero Site 1212
- Recruiting
Akero Clinical Study Site
Lodz, Lódzkie, 91-473
Akero Site 1214
- Recruiting
Akero Clinical Study Site
Poznan, Greater Poland Voivodeship, 61-293
Akero Site 1205
- Recruiting
Akero Clinical Study Site
Warsaw, Masovian Voivodeship, 00-215
Akero Site 1211
- Recruiting
Akero Clinical Study Site
Warsaw, Masovian Voivodeship, 02-672
Akero Site 1203
- Recruiting
Akero Clinical Study Site
Wroclaw, Lower Silesian Voivodeship, 50-381
Akero Site 1204
- Recruiting
Akero Clinical Study Site
Wroclaw, Lower Silesian Voivodeship, 53-673
Akero Site 1213
Spain9 sites, 8 recruiting
- Recruiting
Akero Clinical Study Site
Barcelona, 08035
Akero Site 1405
- Recruiting
Akero Clinical Study Site
Madrid, 28007
Akero Site 1401
- Recruiting
Akero Clinical Study Site
Madrid, 28027
Akero Site 1408
- Completed
Akero Clinical Study Site
Majadahonda, Madrid, 28222
- Recruiting
Akero Clinical Study Site
Sabadell, Barcelona, 08208
Akero Site 1409
- Recruiting
Akero Clinical Study Site
Santander, Cantabria, 39008
Akero Site 1406
- Recruiting
Akero Clinical Study Site
Seville, 41013
Akero Site 1402
- Recruiting
Akero Clinical Study Site
Valencia, 46010
Akero Site 1410
- Recruiting
Akero Clinical Study Site
Valencia, 46015
Akero Site 1403
Argentina7 sites, 7 recruiting
- Recruiting
Akero Clinical Study Site
Buenos Aires, Distrito Federal, C1406EEI
Akero Site 0306
- Recruiting
Akero Clinical Study Site
Buenos Aires, C1180AAX
Akero Site 0302
- Recruiting
Akero Clinical Study Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1056ABI
Akero Site 0305
- Recruiting
Akero Clinical Study Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB
Akero Site 0307
- Recruiting
Akero Clinical Study Site
La Plata, Buenos Aires, B1902AWL
Akero Site 0304
- Recruiting
Akero Clinical Study Site
Ramos Mejía, Buenos Aires, B1704ETD
Akero Site 0303
- Recruiting
Akero Clinical Study Site
Rosario, Sante Fe, S2002KDT
Akero Site 0308
Mexico7 sites, 7 recruiting
- Recruiting
Akero Clinical Study Site
Acapulco de Juárez, Guerrero, 39670
Akero Site 1107
- Recruiting
Akero Clinical Study Site
Benito Juárez, 3330
Akero Site 1105
- Recruiting
Akero Clinical Study Site
Cuauhtémoc, Mexico City, 06700
Akero Site 8237
- Recruiting
Akero Clinical Study Site
Guadalajara, Jalisco, 44130
Akero Site 1103
- Recruiting
Akero Clinical Study Site
Mérida, Yucatán, 97070
Akero Site 1108
- Recruiting
Akero Clinical Study Site
Mexico City, Mexico City, 01376
Akero Site 1106
- Recruiting
Akero Clinical Study Site
Mexico City, 14050
Akero Site 1109
South Korea7 sites, 7 recruiting
- Recruiting
Akero Clinical Study Site
Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], 41944
Akero Site 1306
- Recruiting
Akero Clinical Study Site
Daegu, Gyeongsangbugdo [Kyongsangbuk-do], 42601
Akero Site 1304
- Recruiting
Akero Clinical Study Site
Goyang-si, Gyeonggido, 10444
Akero Site 1303
- Recruiting
Akero Clinical Study Site
Incheon, Gyeonggi-do, 22332
Akero Site 1308
- Recruiting
Akero Clinical Study Site
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03080
Akero Site 1301
- Recruiting
Akero Clinical Study Site
Seoul, Seoul Teugbyeolsi, 04763
Akero Site 1305
- Recruiting
Akero Clinical Study Site
Wŏnju, Gangwon-do, 26426
Akero Site 1312
United Kingdom7 sites, 7 recruiting
- Recruiting
Akero Clinical Study Site
Birmingham, B15 2TH
Akero Site 1804
- Recruiting
Akero Clinical Study Site
London, England, SE5 9RS
Akero Site 1806
- Recruiting
Akero Clinical Study Site
London, NW3 2QG
Akero Site 1802
- Recruiting
Akero Clinical Study Site
London, SW10 9NH
Akero Site 1813
- Recruiting
Akero Clinical Study Site
Newcastle upon Tyne, NE7 7DN
Akero Site 1805
- Recruiting
Akero Clinical Study Site
Nottingham, England, NG7 2UH
Akero Site 1817
- Recruiting
Akero Clinical Study Site
Whitechapel, E1 1FR
Akero Site 1809
Canada6 sites, 6 recruiting
- Recruiting
Akero Clinical Study Site
Edmonton, Alberta, T6G 2X8
Akero Site 0501
- Recruiting
Akero Clinical Study Site
Montreal, Quebec, H2X 0A9
Akero Site 0506
- Recruiting
Akero Clinical Study Site
Terrebonne, Quebec, J7B6B7
Akero Site 0505
- Recruiting
Akero Clinical Study Site
Toronto, Ontario, M5G 2C4
Akero Site 0507
- Recruiting
Akero Clinical Study Site
Toronto, Ontario, M6H 3M1
Akero Site 0502
- Recruiting
Akero Clinical Study Site
Vaughan, Ontario, L4L 4Y7
Akero Site 0504
Germany6 sites, 5 recruiting
- Recruiting
Akero Clinical Study Site
Berlin, 13353
Akero Site 0701
- Completed
Akero Clinical Study Site
Frankfurt am Main, Hesse, 60590
- Recruiting
Akero Clinical Study Site
Homburg, Saarland, 66421
Akero Site 0716
- Recruiting
Akero Clinical Study Site
Leipzig, Saxony, 04103
Akero Site 0703
- Recruiting
Akero Clinical Study Site
Leipzig, Saxony, 04103
Akero Site 0708
- Recruiting
Akero Clinical Study Site
Lübeck, Schleswig-Holstein, 23538
Akero Site 0713
Chile5 sites, 5 recruiting
- Recruiting
Akero Clinical Study Site
La Serena, Coquimbo Region, 1700000
Akero Site 2104
- Recruiting
Akero Clinical Study Site
Las Condes, Santiago Metropolitan, 7500000
Akero Site 2101
- Recruiting
Akero Clinical Study Site
Santiago, Santiago Metropolitan, 8320000
Akero Site 2105
- Recruiting
Akero Clinical Study Site
Santiago, Santiago Metropolitan, 8330109
Akero Site 2102
- Recruiting
Akero Clinical Study Site
Santiago, Santiago Metropolitan, 8380000
Akero Site 2103
Switzerland5 sites, 5 recruiting
- Recruiting
Akero Clinical Study Site
Bern, 3010
Akero Site 1502
- Recruiting
Akero Clinical Study Site
Lugano, Canton Ticino, 6900
Akero Site 1505
- Recruiting
Akero Clinical Study Site
Olten, Canton of Solothurn, 4600
Akero Site 1504
- Recruiting
Akero Clinical Study Site
Sankt Gallen, 9007
Akero Site 1501
- Recruiting
Akero Clinical Study Site
Zurich, 8091
Akero Site 1506
Brazil4 sites, 4 recruiting
- Recruiting
Akero Clinical Study Site
Belo Horizonte, Minas Gerais, 30220-140
Akero Site 2002
- Recruiting
Akero Clinical Study Site
Brasília, Federal District, 71681-603
Akero Site 2004
- Recruiting
Akero Clinical Study Site
Goiânia, Goiás, 74690-900
Akero Site 2003
- Recruiting
Akero Clinical Study Site
Porto Alegre, Rio Grande do Sul, 90035-903
Akero Site 2001
Turkey (Türkiye)4 sites, 3 recruiting
- Completed
Akero Clinical Study Site
Ankara, 06560
- Recruiting
Akero Clinical Study Site
Bornova, İzmir, 35100
Akero Site 1703
- Recruiting
Akero Clinical Study Site
Bursa, 16059
Akero Site 1704
- Recruiting
Akero Clinical Study Site
Rize, 53020
Akero Site 1706
Puerto Rico3 sites, 3 recruiting
- Recruiting
Akero Clinical Study Site
Manati, 00674
Akero Site 0177
- Recruiting
Akero Clinical Study Site
Mayagüez, 00680
Akero Site 0272
- Recruiting
Akero Clinical Study Site
San Juan, 00927
Akero Site 9215
Denmark1 site, 1 recruiting
- Recruiting
Akero Clinical Study Site
Hvidovre, Region Sjælland, 2650
Akero Site 2201
About this study
Official title: 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.
- Conditions
- NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis
- Being tested
- Efruxifermin, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfruxiferminDrug
Administered by subcutaneous injection
PlaceboDrug
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| EFX 50 mg | Experimental | Not described Receives: Drug: Efruxifermin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.
Measured by composite of protocol-specified clinical events
Measured: 5 years
Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
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)
Measured: 96 Weeks
Secondary outcomes (19)
Change from baseline of non-invasive markers of liver fibrosis
ELF (scale of 6.7 to 11.3 with higher scores indicative of increased fibrosis)
Measured: 96 Weeks, 5 Years
Change from baseline of non-invasive markers of liver fibrosis
Pro-C3 (ug/L)
Measured: 96 Weeks, 5 Years
Change from baseline of non-invasive markers of liver fibrosis
Liver stiffness assessed by transient elastography (FibroScan®) (kPa)
Measured: 96 Weeks, 5 Years
Change from baseline of markers of liver injury
ALT (U/L) and AST (U/L)
Measured: 96 Weeks, 5 Years
Change from baseline of lipoproteins
Total cholesterol (mg/dL), Triglycerides (mg/dL), HDL-C (mg/dL), Non-HDL-C (mg/dL), and LDL-C (mg/dL)
Measured: 96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control
HbA1c (%)
Measured: 96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control
C-Peptide (ng/mL)
Measured: 96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control
Adiponectin (mg/L)
Measured: 96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control
Insulin (mIU/L)
Measured: 96 Weeks, 5 Years
Change from baseline of markers of insulin sensitivity and glycemic control
HOMA-IR (≥ 2.5 indicates insulin resistance)
Measured: 96 Weeks, 5 Years
Change from baseline of body weight (kg)
Measured: 96 Weeks, 5 Years
Safety and tolerability of EFX through the reporting of extent of exposure (weeks)
Measured: 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)
Proportion of subjects reporting adverse events
Measured: 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)
Proportion of subjects reporting adverse events
Measured: 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
Measured: 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
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)
Measured: 5 Years
Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis
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)
Measured: 96 Weeks
Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH
Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning)
Measured: 96 Weeks
Cohort 1 only: Proportion of subjects with Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis
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)
Measured: 96 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start4 Oct 2024
- Primary completionFeb 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akero Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528314
- Sponsor's protocol ID
- AK-US-001-0106
- Status last verified
- Oct 2026
- First submitted
- 28 Jun 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No