NASH With FibrosisPhase 3NCT06215716
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
A Phase 3 study testing Efruxifermin in people with NASH With Fibrosis and MASH With Fibrosis, run by Akero Therapeutics, Inc at 359 sites in 18 countries.
Trial summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NASH With Fibrosis, MASH With Fibrosis
- 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
- 1,650 participants
- Where
- 359 sitesin 18 countries
- Study dates
- 1 Dec 2023to Feb 2033
- 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
- Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
- Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
- Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
- Steatosis (scored 0 to 3),
- Ballooning degeneration (scored 0 to 2), and
- Lobular inflammation (scored 0 to 3).
- Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS <4 may be enrolled and are not required to meet 1 point in each of the components of NAS.
Who cannot join
- Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
- Presence of cirrhosis on liver biopsy (fibrosis stage 4).
- Type 1 or uncontrolled Type 2 diabetes.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
359 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
359 sites in 18 countries
United States203 sites, 159 recruiting
- Recruiting
Akero Clinical Study Site
Amarillo, Texas, 79106
Akero Site 0104
- Recruiting
Akero Clinical Study Site
Atlanta, Georgia, 30309
Akero Site 0230
- 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
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, 27514
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
Chattanooga, Tennessee, 37421
Akero Site 0175
- Recruiting
Akero Clinical Study Site
Chicago, Illinois, 60637
Akero Site 9245
- Completed
Akero Clinical Study Site
Chula Vista, California, 91910
- Recruiting
Akero Clinical Study Site
Clarksville, Tennessee, 37040
Akero Site 0144
- Recruiting
Akero Clinical Study Site
Colorado Springs, Colorado, 80907
Akero Site 0260
- Recruiting
Akero Clinical Study Site
Columbia, Missouri, 65201
Akero Site 0141
- Completed
Akero Clinical Study Site
Columbia, South Carolina, 29204
- Completed
Akero Clinical Study Site
Columbus, Georgia, 31904
- Completed
Akero Clinical Study Site
Columbus, Ohio, 43213
- 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
Dallas, Texas, 75203
Akero Site 0126
- Recruiting
Akero Clinical Study Site
Dallas, Texas, 75216
Akero Site 0253
- Completed
Akero Clinical Study Site
Dallas, Texas, 75230
- Recruiting
Akero Clinical Study Site
Dallas, Texas, 75234
Akero Site 0221
- Recruiting
Akero Clinical Study Site
Dallas, Texas, 75390
Akero Site 0164
- Recruiting
Akero Clinical Study Site
Dayton, Ohio, 45414
Akero Site 0127
- 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
Englewood, Colorado, 80113
Akero Site 9243
- Recruiting
Akero Clinical Study Site
Escondido, California, 92025
Akero Site 0266
- Completed
Akero Clinical Study Site
Falls Church, Virginia, 22042-3300
- Recruiting
Akero Clinical Study Site
Fayetteville, North Carolina, 28303
Akero Site 9227
- Completed
Akero Clinical Study Site
Flagstaff, Arizona, 86001
- Completed
Akero Clinical Study Site
Florham Park, New Jersey, 07932
- 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
Forney, Texas, 75126
Akero Site 0286
- Recruiting
Akero Clinical Study Site
Fort Myers, Florida, 33912
Akero Site 9134
- Recruiting
Akero Clinical Study Site
Fort Worth, Texas, 76104
Akero Site 9211
- Recruiting
Akero Clinical Study Site
Gainesville, Florida, 32610
Akero Site 0114
- Recruiting
Akero Clinical Study Site
Gainesville, Georgia, 30501
Akero Site 0183
- Completed
Akero Clinical Study Site
Glen Burnie, Maryland, 21061
- Completed
Akero Clinical Study Site
Greenbelt, Maryland, 20770
- Recruiting
Akero Clinical Study Site
Hammond, Indiana, 46324
Akero Site 0254
- 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, 77004
Akero Site 0293
- Completed
Akero Clinical Study Site
Houston, Texas, 77030
- 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
Houston, Texas, 77079
Akero Site 0265
- Completed
Akero Clinical Study Site
Houston, Texas, 77084
- Recruiting
Akero Clinical Study Site
Indianapolis, Indiana, 46202
Akero Site 0290
- Completed
Akero Clinical Study Site
Inglewood, California, 90301
- Recruiting
Akero Clinical Study Site
Inverness, Florida, 34452
Akero Site 9135
- Recruiting
Akero Clinical Study Site
Jackson, New Jersey, 08527
Akero Site 0105
- Recruiting
Akero Clinical Study Site
Jacksonville, Florida, 32256
Akero Site 0118
- Completed
Akero Clinical Study Site
Jonesboro, Arkansas, 72401
- Recruiting
Akero Clinical Study Site
Kansas City, Missouri, 64131
Akero Site 9208
- Completed
Akero Clinical Study Site
La Mesa, California, 91942
- Completed
Akero Clinical Study Site
Lady Lake, Florida, 32159
- Recruiting
Akero Clinical Study Site
Lakewood Rch, Florida, 34211
Akero Site 9203
- Completed
Akero Clinical Study Site
Lancaster, California, 93534
- 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
- Completed
Akero Clinical Study Site
Las Vegas, Nevada, 89109
- Recruiting
Akero Clinical Study Site
Lehigh Acres, Florida, 33936
Akero Site 0271
- Completed
Akero Clinical Study Site
Lewisville, Texas, 75057
- Recruiting
Akero Clinical Study Site
Little Rock, Arkansas, 72205
Akero Site 0106
- Recruiting
Akero Clinical Study Site
Long Beach, California, 90815
Akero Site 0188
- Completed
Akero Clinical Study Site
Los Angeles, California, 90036
- Recruiting
Akero Clinical Study Site
Los Angeles, California, 90048
Akero Site 0236
- Recruiting
Akero Clinical Study Site
Los Angeles, California, 90057
Akero Site 0168
- Recruiting
Akero Clinical Study Site
Louisville, Kentucky, 40202
Akero Site 0203
- Recruiting
Akero Clinical Study Site
Madison, Wisconsin, 53705
Akero Site 0259
- Completed
Akero Clinical Study Site
Maitland, Florida, 32751
- 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
- Completed
Akero Clinical Study Site
McAllen, Texas, 78504
- Recruiting
Akero Clinical Study Site
McAllen, Texas, 78539
Akero Site 9205
- 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
Miami Lakes, Florida, 33016
Akero Site 9138
- 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 Bedford, Massachusetts, 02740
Akero Site 0181
- Recruiting
Akero Clinical Study Site
New Bern, North Carolina, 28562
Akero Site 0166
- Recruiting
Akero Clinical Study Site
New Haven, Connecticut, 06520
Akero Site 0213
- Recruiting
Akero Clinical Study Site
New Orleans, Louisiana, 70112
Akero Site 0196
- Recruiting
Akero Clinical Study Site
New Orleans, Louisiana, 70121
Akero Site 0176
- Completed
Akero Clinical Study Site
New Port Richey, Florida, 34653
- 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
- Completed
Akero Clinical Study Site
New York, New York, 10033
- Recruiting
Akero Clinical Study Site
Newport Beach, California, 92663
Akero Site 0206
- Completed
Akero Clinical Study Site
Newport News, Virginia, 23602
- 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
- Completed
Akero Clinical Study Site
Ogden, Utah, 84405
- Recruiting
Akero Clinical Study Site
Orange, California, 92868
Akero Site 0261
- Recruiting
Akero Clinical Study Site
Orlando, Florida, 32807
Akero Site 0250
- Completed
Akero Clinical Study Site
Palm Springs, California, 92262
- 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
- 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
Port Orange, Florida, 32127
Akero Site 9105
- 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
Reno, Nevada, 89511
Akero Site 9240
- Recruiting
Akero Clinical Study Site
Richmond, Virginia, 23226
Akero Site 0212
- Recruiting
Akero Clinical Study Site
Richmond, Virginia, 23235
Akero Site 0103
- Recruiting
Akero Clinical Study Site
Richmond, Virginia, 23249
Akero Site 9120
- Recruiting
Akero Clinical Study Site
Richmond, Virginia, 23298
Akero Site 9115
- Recruiting
Akero Clinical Study Site
Ridgewood, New Jersey, 07450
Akero Site 0287
- 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, New York, 55905
Akero Site 0240
- Recruiting
Akero Clinical Study Site
Sacramento, California, 95817
Akero Site 0274
- Completed
Akero Clinical Study Site
Salt Lake City, Utah, 84117
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 78209
Akero Site 9116
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 78215
Akero Site 9103
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 78222
Akero Site 0185
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 78229
Akero Site 0125
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 78229
Akero Site 9202
- Completed
Akero Clinical Study Site
San Antonio, Texas, 78240
- Recruiting
Akero Clinical Study Site
San Antonio, Texas, 782531
Akero Site 0289
- Completed
Akero Clinical Study Site
San Diego, California, 92120
- Completed
Akero Clinical Study Site
San Diego, California, 92123
- Recruiting
Akero Clinical Study Site
San Diego, California, 92161
Akero Site 0199
- Recruiting
Akero Clinical Study Site
San Francisco, California, 94115
Akero Site 0147
- Recruiting
Akero Clinical Study Site
San Francisco, California, 94117
Akero Site 0269
- Completed
Akero Clinical Study Site
San Marcos, Texas, 78666-7502
- Recruiting
Akero Clinical Study Site
Sandy City, Utah, 84092
Akero Site 9241
- Completed
Akero Clinical Study Site
Santa Fe, New Mexico, 87505
- Recruiting
Akero Clinical Study Site
Santa Maria, California, 93458
Akero Site 0205
- Recruiting
Akero Clinical Study Site
Sarasota, Florida, 34240
Akero Site 9218
- Recruiting
Akero Clinical Study Site
Seattle, Washington, 98105
Akero Site 0119
- Recruiting
Akero Clinical Study Site
Shreveport, Louisiana, 71105
Akero Site 9145
- 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
- Completed
Akero Clinical Study Site
South Ogden, Utah, 84405
- Completed
Akero Clinical Study Site
Southfield, Michigan, 48075
- Recruiting
Akero Clinical Study Site
Sparta, New Jersey, 07871
Akero Site 0117
- Recruiting
Akero Clinical Study Site
Spokane, Washington, 99218
Akero Site 0155
- Recruiting
Akero Clinical Study Site
Springboro, Ohio, 45066
Akero Site 9233
- 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
Suffolk, Virginia, 23435
- Recruiting
Akero Clinical Study Site
Summerville, South Carolina, 29485
Akero Site 9238
- 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
- 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
- Completed
Akero Clinical Study Site
Waco, Texas, 76712
- Completed
Akero Clinical Study Site
Washington D.C., District of Columbia, 20007
- 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
- Completed
Akero Clinical Study Site
West Palm Beach, Florida, 33401
- Recruiting
Akero Clinical Study Site
Westlake, Ohio, 44145
Akero Site 9226
- Recruiting
Akero Clinical Study Site
Weston, Florida, 33331
Akero Site 0270
- Completed
Akero Clinical Study Site
Wichita, Kansas, 67205
- Recruiting
Akero Clinical Study Site
Wichita Falls, Texas, 76301
Akero Site 9247
- Recruiting
Akero Clinical Study Site
Winter Park, Florida, 32789
Akero Site 0157
- Recruiting
Akero Clinical Study Site
Winter Park, Florida, 32792
Akero Site 0187
- Recruiting
Akero Clinical Study Site
Wyoming, Michigan, 49519
Akero Site 0107
- Completed
Akero Clinical Study Site
Ypsilanti, Michigan, 48197
- Recruiting
Akero Clinical Study Site
Zephyrhills, Florida, 33542
Akero Site 0235
India24 sites, 19 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
Dahegaon, Maharashtra, 441108
Akero Site 1923
- 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
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
- Completed
Akero Clinical Study Site
New Delhi, National Capital Territory of Delhi, 110017
- 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
- Recruiting
Akero Clinical Study Site
New Delhi, National Capital Territory of Delhi, 110070
Akero Site 1924
- Completed
Akero Clinical Study Site
Pune, Maharashtra, 412201
- Completed
Akero Clinical Study Site
Secunderabad, Telangana, 500003
- 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
Broadmeadow, New South Wales, 2292
Akero Site 0408
- Recruiting
Akero Clinical Study Site
Caulfield South, Victoria, 3162
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
Frankston, Victoria, 3128
Akero Site 0412
- Recruiting
Akero Clinical Study Site
Heidelberg, Victoria, 3084
Akero Site 0405
- Recruiting
Akero Clinical Study Site
Kogarah, New South Wales, 2217
Akero Site 0417
- 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
Penrith, New South Wales, 2750
Akero Site 0416
- 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
France13 sites, 13 recruiting
- Recruiting
Akero Clinical Study Site
Angers, Maine-et-Loire, 49933
Akero Site 0602
- Recruiting
Akero Clinical Study Site
Clichy, Hauts-de-Seine, 92110
Akero Site 0603
- Recruiting
Akero Clinical Study Site
Créteil, Val-De-Marne, 94010
Akero Site 0614
- Recruiting
Akero Clinical Study Site
Limoges, Haute-Vienne, 87042
Akero Site 0609
- Recruiting
Akero Clinical Study Site
Lyon, Auvergne-Rhône-Alpes, 69008
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, Alpes-Maritimes, 06202
Akero Site 0606
- Recruiting
Akero Clinical Study Site
Paris, Île-de-France Region, 75013
Akero Site 0605
- Recruiting
Akero Clinical Study Site
Strasbourg, Bas-Rhin, 67091
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
- Recruiting
Akero Clinical Study Site
Versailles, Yvelines, Île-de-France, 78000
Akero Site 0612
Poland13 sites, 11 recruiting
- Recruiting
Akero Clinical Study Site
Częstochowa, Silesian Voivodeship, 42-202
Akero Site 1206
- Recruiting
Akero Clinical Study Site
Gdansk, Pomeranian Voivodeship, 80-382
Akero Site 1201
- Active, not recruiting
Akero Clinical Study Site
Gdynia, Pomeranian Voivodeship, 81-537
- Recruiting
Akero Clinical Study Site
Katowice, Silesian Voivodeship, 40-040
Akero Site 1208
- Recruiting
Akero Clinical Study Site
Katowice, Silesian Voivodeship, 40-081
Akero Site 1209
- Recruiting
Akero Clinical Study Site
Krakow, Lesser Poland Voivodeship, 31-501
Akero Site 1212
- Recruiting
Akero Clinical Study Site
Lodz, Łódź Voivodeship, 90-127
Akero Site 1214
- Recruiting
Akero Clinical Study Site
Poznan, Greater Poland Voivodeship, 60-702
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
- Completed
Akero Clinical Study Site
Warsaw, Masovian Voivodeship, 04-501
- 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
Italy12 sites, 12 recruiting
- Recruiting
Akero Clinical Study Site
Bologna, 40138
Akero Site 0908
- Recruiting
Akero Clinical Study Site
Foggia, 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, 41126
Akero Site 0906
- Recruiting
Akero Clinical Study Site
Naples, 80131
Akero Site 0907
- 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
Germany10 sites, 8 recruiting
- Recruiting
Akero Clinical Study Site
Berlin, 10787
Akero Site 0712
- 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 0708
- Recruiting
Akero Clinical Study Site
Leipzig, Saxony, 04103
Akero Site 0703
- Completed
Akero Clinical Study Site
Leipzig, Saxony, 04103
- Recruiting
Akero Clinical Study Site
Lübeck, Schleswig-Holstein, 23538
Akero Site 0713
- Recruiting
Akero Clinical Study Site
Mainz, Rhineland-Palatinate, 55131
Akero Site 0710
- Recruiting
Akero Clinical Study Site
Würzburg, Bavaria, 97080
Akero Site 0711
Israel10 sites, 8 recruiting
- Recruiting
Akero Clinical Study Site
Afula, Northern District, 1834111
Akero Site 0810
- Recruiting
Akero Clinical Study Site
Haifa, Haifa District, 3109601
Akero Site 0804
- Recruiting
Akero Clinical Study Site
Haifa, Haifa District, 3436212
Akero Site 0806
- 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
Nazareth, Northern District, 1610001
- 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
Spain9 sites, 9 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
- Recruiting
Akero Clinical Study Site
Majadahonda, Madrid, 28222
Akero Site 1404
- 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, València, 46015
Akero Site 1403
- Recruiting
Akero Clinical Study Site
Valencia, València, 46026
Akero Site 1407
United Kingdom9 sites, 8 recruiting
- Recruiting
Akero Clinical Study Site
Birmingham, England, B15 2WB
Akero Site 1804
- Recruiting
Akero Clinical Study Site
Cambridge, England, CB2 0QQ
Akero Site 1801
- Recruiting
Akero Clinical Study Site
Liverpool, England, L9 7AL
Akero Site 1816
- Recruiting
Akero Clinical Study Site
London, England, E1 1BB
Akero Site 1809
- Recruiting
Akero Clinical Study Site
London, England, NW3 2QG
Akero Site 1802
- Recruiting
Akero Clinical Study Site
London, England, SE5 9RS
Akero Site 1806
- Recruiting
Akero Clinical Study Site
London, England, SW10 9NH
Akero Site 1813
- Completed
Akero Clinical Study Site
London, England, W2 1NY
- Recruiting
Akero Clinical Study Site
Newcastle upon Tyne, England, NE7 7DN
Akero Site 1805
South Korea8 sites, 6 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, Gyeonggi-do, 1232
Akero Site 1303
- Recruiting
Akero Clinical Study Site
Incheon, Gyeonggi-do, 22332
Akero Site 1308
- Completed
Akero Clinical Study Site
Seongnam-si, Gyeonggi-do, 13620
- Completed
Akero Clinical Study Site
Seongnam-si, Gyeonggido [Kyonggi-do], 13520
- Recruiting
Akero Clinical Study Site
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03080
Akero Site 1301
- Recruiting
Akero Clinical Study Site
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 04763
Akero Site 1305
Argentina7 sites, 6 recruiting
- Recruiting
Akero Clinical Study Site
Buenos Aires, Distrito Federal, C1125ABE
Akero Site 0306
- Recruiting
Akero Clinical Study Site
Buenos Aires, C1118AAT
Akero Site 0305
- Recruiting
Akero Clinical Study Site
Buenos Aires, C1180AAX
Akero Site 0302
- Completed
Akero Clinical Study Site
Buenos Aires, C1280AEB
- 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
Taiwan7 sites, 7 recruiting
- Recruiting
Akero Clinical Study Site
Changhua, Changhua, 500
Akero Site 1604
- Recruiting
Akero Clinical Study Site
Kaohsiung City, 833
Akero Site 1602
- Recruiting
Akero Clinical Study Site
Taichung, Taichung, 40447
Akero Site 1607
- Recruiting
Akero Clinical Study Site
Tainan, Tainan, 73657
Akero Site 1606
- Recruiting
Akero Clinical Study Site
Tainan, 704
Akero Site 1603
- Recruiting
Akero Clinical Study Site
Taipei City, Taipei, 10048
Akero Site 1601
- Recruiting
Akero Clinical Study Site
Taoyuan, 333
Akero Site 1605
Canada6 sites, 6 recruiting
- Recruiting
Akero Clinical Study Site
Edmonton, Alberta, T6G 2X8
Akero Site 0501
- Recruiting
Akero Clinical Study Site
Hamilton, Ontario, L8S 4K1
Akero Site 0503
- Recruiting
Akero Clinical Study Site
Montreal, Quebec, H2X 3E4
Akero Site 0506
- Recruiting
Akero Clinical Study Site
Terrebonne, Quebec, J7B 6B7
Akero Site 0505
- Recruiting
Akero Clinical Study Site
Toronto, Ontario, M6H 3M1
Akero Site 0502
- Recruiting
Akero Clinical Study Site
Vaughan, Ontario, L4L 4Y7
Akero Site 0504
Turkey (Türkiye)4 sites, 3 recruiting
- 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
- Completed
Akero Clinical Study Site
Yenimahalle, Ankara, 06500
Mexico3 sites, 1 recruiting
- Withdrawn
Akero Clinical Study Site
Acapulco de Juárez, Guerrero, 39670
- Recruiting
Akero Clinical Study Site
Cuauhtémoc, Mexico City, 06700
Akero Site 8237
- Withdrawn
Akero Clinical Study Site
Mexico City, 14050
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
Switzerland3 sites, 3 recruiting
- Recruiting
Akero Clinical Study Site
Bern, 3010
Akero Site 1502
- Recruiting
Akero Clinical Study Site
Olten, Canton of Solothurn, 4600
Akero Site 1504
- Recruiting
Akero Clinical Study Site
Sankt Gallen, 9007
Akero Site 1501
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).
The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Read the detailed description
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of efruxifermin (EFX) in subjects with non-cirrhotic nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stage 2 or 3 (F2 or F3).
Approximately 1,650 subjects will be enrolled into 2 cohorts.
Cohort 1 will enroll approximately 750 subjects with biopsy-confirmed NASH/MASH and fibrosis stage F2 or F3. Subjects in Cohort 1 will undergo evaluation of histologic efficacy endpoints at Week 52.
Cohort 2 will enroll approximately 900 subjects with biopsy-confirmed fibrosis stage F3. Subjects in Cohort 2 may enroll regardless of NAFLD Activity Score (NAS). Subjects in Cohort 2 will undergo liver biopsy assessment at Week 96.
Eligible subjects will be randomized in a 1:1:1 ratio to receive:
- EFX 28 mg administered subcutaneously once weekly
- EFX 50 mg administered subcutaneously once weekly
- Placebo administered subcutaneously once weekly
Subjects will participate in:
- a screening period of up to 12 weeks,
- a 52-week primary histology endpoint treatment period (Cohort 1),
- a 96-week secondary histology endpoint period (Cohort 2),
- long-term treatment and clinical outcomes follow-up for up to approximately -240 weeks total treatment duration, and
- a follow-up visit approximately 30 days after the last dose of study drug.
The study will evaluate the effects of EFX compared with placebo on histologic improvement in NASH/MASH, fibrosis regression, noninvasive markers of liver fibrosis, biochemistry markers of lipidic and glycemic metabolism, liver-related clinical outcomes, and long-term safety.
Clinical outcomes assessments include evaluation of liver-related events and all-cause mortality. Key secondary and long-term outcome assessments include evaluation of fibrosis progression, liver stiffness by FibroScan, and Enhanced Liver Fibrosis (ELF) score at prespecified time points including Weeks 96 and 240.
Subjects who discontinue study drug may continue study assessments according to the protocol schedule to support long-term efficacy and safety evaluations.
- Conditions
- NASH With Fibrosis, MASH With Fibrosis
- Being tested
- Efruxifermin, Placebo
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 28 mg | Experimental | Not described Receives: Drug: Efruxifermin |
| 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.
Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis
Based on NAS (scored by 0-3 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 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
Measured: 52 Weeks
Event-free survival
Based on time from randomization to the first clinical event including evidence of disease progression, liver decompensation events, liver transplantation or eligibility for liver transplantation, and all-cause mortality.
Measured: 240 Weeks
Secondary outcomes (20)
Cohort 1 Only: Resolution of NASH/MASH and no worsening of fibrosis
Based on NAS (scored by 0-3 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 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
Measured: 52 Weeks
Cohort 1 Only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
Based on NAS (scored by 0-3 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 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
Measured: 52 Weeks
Change from baseline of non-invasive markers of liver fibrosis: Fibroscan
Liver stiffness assessed by transient elastography (FibroScan)
Measured: 96 Weeks, 240 Weeks
Change from baseline in non-invasive markers of liver fibrosis: ELF score
The ELF score measures the severity of liver fibrosis and estimates the risk of disease progression to cirrhosis or liver-related events, with higher scores indicating higher liver fibrosis level and higher risk of disease progression.
Measured: 96 Weeks, 240 Weeks
Progression to Cirrhosis F4 Based on NASH CRN Fibrosis Score
NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
Measured: 96 Weeks and 240 Weeks
Change from baseline of non-invasive markers of liver fibrosis: ELF score
The ELF score measures the severity of liver fibrosis and estimates the risk of disease progression to cirrhosis or liver-related events, with higher scores indicating higher liver fibrosis level and higher risk of disease progression.
Measured: 52 Weeks
Change from baseline of non-invasive markers of liver fibrosis: ELF score components (TIMP-1, HA, PIIINP, Pro-C3)
Tissue inhibitor of metalloproteinase-1 [TIMP-1], hyaluronic acid [HA], amino terminal pro-peptide of type 3 procollagen [PIIINP]), and propeptide of type 3 procollagen (Pro-C3)
Measured: 52 Weeks
Change from baseline of non-invasive markers of liver fibrosis: Fibroscan
Liver stiffness assessed by transient elastography (FibroScan)
Measured: 52 Weeks
Change from baseline in non-invasive markers of liver fibrosis: ELF score components: TIMP-1, HA, PIIINP, Pro-C3
The ELF score measures the severity of liver fibrosis and estimates the risk of disease progression to cirrhosis or liver-related events, with higher scores indicating higher liver fibrosis level and higher risk of disease progression.
Measured: Week 240
Change from baseline of markers of liver injury: ALT, AST, GGT
ALT (U/L), AST (U/L), GGT (U/L)
Measured: 52 Weeks, 240 Weeks
Change from baseline of markers of liver injury: Uric Acid
Uric acid (mg/dL)
Measured: 52 Weeks, 240 Weeks
Change from baseline of lipoproteins: Total cholesterol, TG, Non-HDL-C, HDL-C, and LDL-C
Total cholesterol (mg/dL), TG (mg/dL), Non-HDL-C (mg/dL), HDL-C (mg/dL), and LDL-C (mg/dL)
Measured: 52 Weeks, 240 Weeks
Change from baseline of markers of insulin sensitivity and glycemic control: HbA1c
HbA1c (%)
Measured: 52 Weeks, 240 Weeks
Change from baseline of markers of insulin sensitivity and glycemic control: Adiponectin
Adiponectin (mg/L)
Measured: 52 Weeks, 240 Weeks
Change from baseline of body weight (kg)
Measured: 52 Weeks, 240 Weeks
To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)
Measured: 52 Weeks, 240 Weeks
To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)
Measured: 52 Weeks, 240 Weeks
To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)
Measured: 52 Weeks, 240 Weeks
To assess the safety and tolerability of EFX through the reporting of abnormal clinical laboratory tests, ECGs, ultrasounds, vital sign assessments (number of patients)
Measured: 52 Weeks, 240 Weeks
To assess the immunogenicity of EFX through the reporting of antidrug antibodies (number of patients)
Measured: 52 Weeks, 240 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Dec 2023
- Primary completionFeb 2033 (estimated)
- Study completionFeb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH With FibrosisStudies 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
- 1,650 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
- NCT06215716
- Sponsor's protocol ID
- AK-US-001-0105
- Status last verified
- Oct 2026
- First submitted
- 6 Dec 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No