- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06215716
En studie som evaluerer efroxifermin hos personer med ikke-cirrhotisk ikke-alkoholisk Steatohepatitt (NASH)/metabolsk dysfunksjon-assosiert Steatohepatitt (MASH) og fibrose
En fase 3, randomisert, dobbeltblind, placebokontrollert studie som evaluerer sikkerheten og effekten av efruxifermin hos personer med ikke-cirrhotisk ikke-alkoholisk Steatohepatitt (NASH)/metabolsk dysfunksjon-assosiert Steatohepatitt (MASH) og fibrose
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Akero Study Director
- Telefonnummer: 650-487-6488
- E-post: AkeroSynchrony@akerotx.com
Studiesteder
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Buenos Aires, Argentina, C1118AAT
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0305
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Buenos Aires, Argentina, C1280AEB
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0301
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Buenos Aires, Argentina, C1180AAX
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0302
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Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0307
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La Plata, Buenos Aires, Argentina, B1902AWL
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0304
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Ramos Mejía, Buenos Aires, Argentina, B1704ETD
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0303
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentina, C1125ABE
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0306
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New South Wales
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Broadmeadow, New South Wales, Australia, 2292
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0408
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Coffs Harbour, New South Wales, Australia, 2450
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0418
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Kogarah, New South Wales, Australia, 2217
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0417
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Liverpool, New South Wales, Australia, 1871
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0413
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Penrith, New South Wales, Australia, 2750
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0416
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Westmead, New South Wales, Australia, 2145
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0401
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South Australia
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Adelaide, South Australia, Australia, 5000
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0407
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Victoria
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Caulfield South, Victoria, Australia, 3162
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0402
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Epping, Victoria, Australia, 3076
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0410
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Frankston, Victoria, Australia, 3128
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0412
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Heidelberg, Victoria, Australia, 3084
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0405
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Melbourne, Victoria, Australia, 3004
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0403
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0411
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Nedlands, Western Australia, Australia, 6009
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0415
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Perth, Western Australia, Australia, 6000
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0406
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Alberta
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Edmonton, Alberta, Canada, T6G 2X8
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0501
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0503
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Toronto, Ontario, Canada, M6H 3M1
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0502
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Vaughan, Ontario, Canada, L4L 4Y7
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0504
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0506
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Terrebonne, Quebec, Canada, J7B6B7
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0505
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Alabama
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Birmingham, Alabama, Forente stater, 35209
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0129
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Dothan, Alabama, Forente stater, 36301
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0233
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9106
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Flagstaff, Arizona, Forente stater, 86001
- Fullført
- Akero Clinical Study Site
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Peoria, Arizona, Forente stater, 85381
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9104
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Tucson, Arizona, Forente stater, 85712
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9144
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Tucson, Arizona, Forente stater, 85715
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0209
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Tucson, Arizona, Forente stater, 85713
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0234
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Arkansas
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Conway, Arkansas, Forente stater, 72032
- Fullført
- Akero Clinical Study Site
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Jonesboro, Arkansas, Forente stater, 72401
- Fullført
- Akero Clinical Study Site
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Little Rock, Arkansas, Forente stater, 72205
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0106
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North Little Rock, Arkansas, Forente stater, 72117
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9214
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California
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Chula Vista, California, Forente stater, 91910
- Fullført
- Akero Clinical Study Site
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Coronado, California, Forente stater, 92118
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0132
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Escondido, California, Forente stater, 92025
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0266
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Folsom, California, Forente stater, 95630
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0263
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Inglewood, California, Forente stater, 90301
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0120
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La Mesa, California, Forente stater, 91942
- Fullført
- Akero Clinical Study Site
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Lancaster, California, Forente stater, 93534
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0285
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Lancaster, California, Forente stater, 93534
- Fullført
- Akero Clinical Study Site
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Long Beach, California, Forente stater, 90815
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0188
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Los Angeles, California, Forente stater, 90057
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0168
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Los Angeles, California, Forente stater, 90048
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0236
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Los Angeles, California, Forente stater, 90036
- Fullført
- Akero Clinical Study Site
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Newport Beach, California, Forente stater, 92663
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0206
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Orange, California, Forente stater, 92868
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0261
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Palm Springs, California, Forente stater, 92262
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0197
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Pasadena, California, Forente stater, 91105
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9250
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Redwood City, California, Forente stater, 94063
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0191
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Sacramento, California, Forente stater, 95817
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0274
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San Diego, California, Forente stater, 92120
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0124
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San Diego, California, Forente stater, 92161
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0199
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San Diego, California, Forente stater, 92123
- Fullført
- Akero Clinical Study Site
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San Francisco, California, Forente stater, 94115
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0147
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San Francisco, California, Forente stater, 94117
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0269
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Santa Maria, California, Forente stater, 93458
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0205
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0217
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Colorado Springs, Colorado, Forente stater, 80907
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0260
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Englewood, Colorado, Forente stater, 80113
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9243
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Connecticut
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New Haven, Connecticut, Forente stater, 06520
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0213
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20422
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0262
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Washington D.C., District of Columbia, Forente stater, 20007
- Fullført
- Akero Clinical Study Site
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Florida
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Bradenton, Florida, Forente stater, 34208
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0153
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Brandon, Florida, Forente stater, 33511
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0222
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Doral, Florida, Forente stater, 33126
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0267
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Fort Myers, Florida, Forente stater, 33912
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9134
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Gainesville, Florida, Forente stater, 32610
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0114
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Hialeah Gardens, Florida, Forente stater, 33016
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9242
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Inverness, Florida, Forente stater, 34452
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9135
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Jacksonville, Florida, Forente stater, 32256
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0118
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Lady Lake, Florida, Forente stater, 32159
- Fullført
- Akero Clinical Study Site
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Lakewood Rch, Florida, Forente stater, 34211
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9203
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Largo, Florida, Forente stater, 33777
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9248
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Lehigh Acres, Florida, Forente stater, 33936
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0271
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Maitland, Florida, Forente stater, 32751
- Fullført
- Akero Clinical Study Site
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Margate, Florida, Forente stater, 33063
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0248
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Miami, Florida, Forente stater, 33136
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0137
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Miami, Florida, Forente stater, 33175
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0252
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Miami Gardens, Florida, Forente stater, 33014
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0243
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Miami Lakes, Florida, Forente stater, 33016
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9138
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Naples, Florida, Forente stater, 34102
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0138
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New Port Richey, Florida, Forente stater, 34653
- Fullført
- Akero Clinical Study Site
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Ocala, Florida, Forente stater, 34471
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9127
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Orlando, Florida, Forente stater, 32807
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0250
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Pembroke Pines, Florida, Forente stater, 33027
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0239
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Port Orange, Florida, Forente stater, 32127
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9105
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Riverview, Florida, Forente stater, 33578
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0295
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Sarasota, Florida, Forente stater, 34240
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9218
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Temple Terrace, Florida, Forente stater, 33617
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0242
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Venice, Florida, Forente stater, 34285
- Fullført
- Akero Clinical Study Site
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Viera, Florida, Forente stater, 32940
- Fullført
- Akero Clinical Study Site
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West Palm Beach, Florida, Forente stater, 33401
- Fullført
- Akero Clinical Study Site
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Weston, Florida, Forente stater, 33331
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0270
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Winter Park, Florida, Forente stater, 32789
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0157
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Winter Park, Florida, Forente stater, 32792
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0187
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Zephyrhills, Florida, Forente stater, 33542
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0235
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Georgia
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Atlanta, Georgia, Forente stater, 30309
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0230
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Columbus, Georgia, Forente stater, 31904
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0156
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Gainesville, Georgia, Forente stater, 30501
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0183
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Marietta, Georgia, Forente stater, 30060
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9111
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Illinois
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Chicago, Illinois, Forente stater, 60637
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9245
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Indiana
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Hammond, Indiana, Forente stater, 46324
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0254
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Indianapolis, Indiana, Forente stater, 46202
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0290
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South Bend, Indiana, Forente stater, 46635
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9235
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Iowa
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West Des Moines, Iowa, Forente stater, 50265
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0146
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Kansas
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Topeka, Kansas, Forente stater, 66606
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9136
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Wichita, Kansas, Forente stater, 67205
- Fullført
- Akero Clinical Study Site
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0203
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Louisiana
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Bastrop, Louisiana, Forente stater, 71220
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 9220
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Covington, Louisiana, Forente stater, 70433
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0195
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Houma, Louisiana, Forente stater, 70363
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0112
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Marrero, Louisiana, Forente stater, 70072
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9102
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Metairie, Louisiana, Forente stater, 70006
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0109
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New Orleans, Louisiana, Forente stater, 70121
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0176
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New Orleans, Louisiana, Forente stater, 70112
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0196
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Shreveport, Louisiana, Forente stater, 71105
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9145
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West Monroe, Louisiana, Forente stater, 71291
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0283
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Maryland
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Baltimore, Maryland, Forente stater, 21202
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0108
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Glen Burnie, Maryland, Forente stater, 21061
- Fullført
- Akero Clinical Study Site
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Greenbelt, Maryland, Forente stater, 20770
- Fullført
- Akero Clinical Study Site
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Massachusetts
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New Bedford, Massachusetts, Forente stater, 02740
- Rekruttering
- Akero Clinical Study Site
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Ta kontakt med:
- Akero Site 0181
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Michigan
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Novi, Michigan, Forente stater, 48377
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0204
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Southfield, Michigan, Forente stater, 48075
- Fullført
- Akero Clinical Study Site
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Wyoming, Michigan, Forente stater, 49519
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0107
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Ypsilanti, Michigan, Forente stater, 48197
- Fullført
- Akero Clinical Study Site
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Mississippi
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Flowood, Mississippi, Forente stater, 39232
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0277
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Missouri
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Columbia, Missouri, Forente stater, 65201
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0141
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Kansas City, Missouri, Forente stater, 64131
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9208
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St Louis, Missouri, Forente stater, 63123
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0296
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9142
-
Las Vegas, Nevada, Forente stater, 89109
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9219
-
Reno, Nevada, Forente stater, 89511
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9240
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New Jersey
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Florham Park, New Jersey, Forente stater, 07932
- Fullført
- Akero Clinical Study Site
-
Jackson, New Jersey, Forente stater, 08527
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0105
-
Ridgewood, New Jersey, Forente stater, 07450
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0287
-
Somers Point, New Jersey, Forente stater, 08244
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0116
-
Sparta, New Jersey, Forente stater, 07871
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0117
-
-
New Mexico
-
Santa Fe, New Mexico, Forente stater, 87505
- Fullført
- Akero Clinical Study Site
-
-
New York
-
Buffalo, New York, Forente stater, 14203
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0241
-
Manhasset, New York, Forente stater, 11030
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0208
-
New York, New York, Forente stater, 10029
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0160
-
New York, New York, Forente stater, 10016
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0198
-
New York, New York, Forente stater, 10021
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0148
-
New York, New York, Forente stater, 10033
- Fullført
- Akero Clinical Study Site
-
Rochester, New York, Forente stater, 55905
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0240
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27514
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0192
-
Charlotte, North Carolina, Forente stater, 28204
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9147
-
Durham, North Carolina, Forente stater, 27710
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0224
-
Fayetteville, North Carolina, Forente stater, 28303
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9227
-
Morehead City, North Carolina, Forente stater, 28557
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9128
-
New Bern, North Carolina, Forente stater, 28562
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0166
-
Raleigh, North Carolina, Forente stater, 27612
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0169
-
Statesville, North Carolina, Forente stater, 28625
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0142
-
-
Ohio
-
Columbus, Ohio, Forente stater, 43213
- Fullført
- Akero Clinical Study Site
-
Dayton, Ohio, Forente stater, 45414
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0127
-
Springboro, Ohio, Forente stater, 45066
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9233
-
Westlake, Ohio, Forente stater, 44145
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9226
-
-
Pennsylvania
-
Hershey, Pennsylvania, Forente stater, 17033
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0264
-
Philadelphia, Pennsylvania, Forente stater, 19107
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9132
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0207
-
Pittsburgh, Pennsylvania, Forente stater, 15213
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0102
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0246
-
Columbia, South Carolina, Forente stater, 29204
- Fullført
- Akero Clinical Study Site
-
Summerville, South Carolina, Forente stater, 29485
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9238
-
-
Tennessee
-
Chattanooga, Tennessee, Forente stater, 37421
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0175
-
Clarksville, Tennessee, Forente stater, 37040
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0144
-
Hermitage, Tennessee, Forente stater, 37076
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9123
-
Nashville, Tennessee, Forente stater, 37211
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9130
-
-
Texas
-
Amarillo, Texas, Forente stater, 79106
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0104
-
Austin, Texas, Forente stater, 78745
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0131
-
Austin, Texas, Forente stater, 78757
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0281
-
Bellaire, Texas, Forente stater, 77401
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0165
-
Brownsville, Texas, Forente stater, 78520
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0154
-
Corpus Christi, Texas, Forente stater, 78404
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0223
-
Dallas, Texas, Forente stater, 75230
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0128
-
Dallas, Texas, Forente stater, 75203
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0126
-
Dallas, Texas, Forente stater, 75234
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0221
-
Dallas, Texas, Forente stater, 75390
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0164
-
Dallas, Texas, Forente stater, 75216
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0253
-
Denison, Texas, Forente stater, 75020
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0244
-
Edinburg, Texas, Forente stater, 78539
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9117
-
Forney, Texas, Forente stater, 75126
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0286
-
Fort Worth, Texas, Forente stater, 76104
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9211
-
Houston, Texas, Forente stater, 77079
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0265
-
Houston, Texas, Forente stater, 77074
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0249
-
Houston, Texas, Forente stater, 77004
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0293
-
Houston, Texas, Forente stater, 77030
- Fullført
- Akero Clinical Study Site
-
Houston, Texas, Forente stater, 77084
- Fullført
- Akero Clinical Study Site
-
Lewisville, Texas, Forente stater, 75057
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0135
-
McAllen, Texas, Forente stater, 78504
- Fullført
- Akero Clinical Study Site
-
McAllen, Texas, Forente stater, 78539
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9205
-
Pasadena, Texas, Forente stater, 77505
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0292
-
San Antonio, Texas, Forente stater, 78222
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0185
-
San Antonio, Texas, Forente stater, 78229
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9202
-
San Antonio, Texas, Forente stater, 78258
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9116
-
San Antonio, Texas, Forente stater, 78215
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9103
-
San Antonio, Texas, Forente stater, 78209
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9116
-
San Antonio, Texas, Forente stater, 78240
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0140
-
San Antonio, Texas, Forente stater, 782531
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0289
-
San Marcos, Texas, Forente stater, 78666
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9141
-
San Marcos, Texas, Forente stater, 78666-7502
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9141
-
Waco, Texas, Forente stater, 76710
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9246
-
Waco, Texas, Forente stater, 76712
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0279
-
Webster, Texas, Forente stater, 77598
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9204
-
Wichita Falls, Texas, Forente stater, 76301
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9247
-
-
Utah
-
Ogden, Utah, Forente stater, 84405
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9230
-
Salt Lake City, Utah, Forente stater, 84117
- Fullført
- Akero Clinical Study Site
-
Sandy City, Utah, Forente stater, 84092
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9241
-
South Ogden, Utah, Forente stater, 84405
- Fullført
- Akero Clinical Study Site
-
-
Virginia
-
Falls Church, Virginia, Forente stater, 22042-3300
- Fullført
- Akero Clinical Study Site
-
Newport News, Virginia, Forente stater, 23602
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0170
-
Norfolk, Virginia, Forente stater, 23502
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0143
-
Richmond, Virginia, Forente stater, 23235
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0103
-
Richmond, Virginia, Forente stater, 23249
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9120
-
Richmond, Virginia, Forente stater, 23226
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0212
-
Richmond, Virginia, Forente stater, 23298
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9115
-
Roanoke, Virginia, Forente stater, 24014
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0139
-
Suffolk, Virginia, Forente stater, 23435
- Fullført
- Akero Clinical Study Site
-
-
Washington
-
Seattle, Washington, Forente stater, 98105
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0119
-
Spokane, Washington, Forente stater, 99218
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0155
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53705
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0259
-
-
-
-
Alpes-Maritimes
-
Nice, Alpes-Maritimes, Frankrike, 06202
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0606
-
-
Auvergne-Rhône-Alpes
-
Lyon, Auvergne-Rhône-Alpes, Frankrike, 69008
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0604
-
-
Bas-Rhin
-
Strasbourg, Bas-Rhin, Frankrike, 67091
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0607
-
-
Haute-Vienne
-
Limoges, Haute-Vienne, Frankrike, 87042
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0609
-
-
Hauts-de-Seine
-
Clichy, Hauts-de-Seine, Frankrike, 92110
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0603
-
-
Lorraine
-
Vandœuvre-lès-Nancy, Lorraine, Frankrike, 54511
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0611
-
-
Maine-et-Loire
-
Angers, Maine-et-Loire, Frankrike, 49933
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0602
-
-
Occitanie
-
Toulouse, Occitanie, Frankrike, 31059
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0610
-
-
Provence-Alpes-Côte d'Azur Region
-
Marseille, Provence-Alpes-Côte d'Azur Region, Frankrike, 13008
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0601
-
Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, Frankrike, 34295
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0608
-
-
Val-De-Marne
-
Créteil, Val-De-Marne, Frankrike, 94010
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0614
-
-
Yvelines, Île-de-France
-
Versailles, Yvelines, Île-de-France, Frankrike, 78000
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0612
-
-
Île-de-France Region
-
Paris, Île-de-France Region, Frankrike, 75013
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0605
-
-
-
-
Gujarat
-
Surat, Gujarat, India, 395002
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1918
-
Surat, Gujarat, India, 395009
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1911
-
Vadodara, Gujarat, India, 390007
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1906
-
-
Karnataka
-
Mysore, Karnataka, India, 570001
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1930
-
-
Kerala
-
Thiruvananthapuram, Kerala, India, 695011
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1922
-
-
Maharashtra
-
Dahegaon, Maharashtra, India, 441108
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1923
-
Mumbai, Maharashtra, India, 400012
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1926
-
Nagpur, Maharashtra, India, 440010
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1909
-
Pune, Maharashtra, India, 412201
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1901
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, India, 110029
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1904
-
New Delhi, National Capital Territory of Delhi, India, 110060
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1916
-
New Delhi, National Capital Territory of Delhi, India, 110017
- Fullført
- Akero Clinical Study Site
-
New Delhi, National Capital Territory of Delhi, India, 110070
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1924
-
-
Punjab
-
Chandigarh, Punjab, India, 160012
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1908
-
-
Rajasthan
-
Jaipur, Rajasthan, India, 302001
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1902
-
-
Tamil Nadu
-
Coimbatore, Tamil Nadu, India, 641005
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1920
-
-
Telangana
-
Hyderabad, Telangana, India, 500 004
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1912
-
-
Uttar Pradesh
-
Varanasi, Uttar Pradesh, India, 221005
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1921
-
-
West Bengal
-
Kolkata, West Bengal, India, 700020
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1907
-
Kolkata, West Bengal, India, 700073
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1917
-
-
-
-
-
Jerusalem, Israel, 9103102
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0809
-
Jerusalem, Israel, 9112001
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0808
-
Tel Aviv, Israel, 6423906
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0801
-
-
Central District
-
Petah Tikva, Central District, Israel, 4941492
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0803
-
Ramat Gan, Central District, Israel, 5265601
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0802
-
-
Haifa District
-
Haifa, Haifa District, Israel, 3109601
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0804
-
Haifa, Haifa District, Israel, 3436212
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0806
-
-
Northern District
-
Afula, Northern District, Israel, 1834111
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0810
-
Nahariya, Northern District, Israel, 22100
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0807
-
Nazareth, Northern District, Israel, 1610001
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0805
-
-
-
-
-
Bologna, Italia, 40138
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0908
-
Foggia, Italia, 71122
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0909
-
Messina, Italia, 98124
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0912
-
Milan, Italia, 20122
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0902
-
Modena, Italia, 41126
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0906
-
Naples, Italia, 80131
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0907
-
Novara, Italia, 28100
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0905
-
-
Foggia
-
San Giovanni Rotondo, Foggia, Italia, 71013
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0901
-
-
Milan
-
Rozzano, Milan, Italia, 20089
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0904
-
-
Turin
-
Torino, Turin, Italia, 10126
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0910
-
-
-
-
Mexico City
-
Cuauhtémoc, Mexico City, Mexico, 06700
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 8237
-
-
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polen, 60-702
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1205
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Polen, 31-501
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1212
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polen, 50-381
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1204
-
Wroclaw, Lower Silesian Voivodeship, Polen, 53-673
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1213
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 00-215
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1211
-
Warsaw, Masovian Voivodeship, Polen, 02-672
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1203
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polen, 80-382
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1201
-
Gdynia, Pomeranian Voivodeship, Polen, 81-537
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1202
-
-
Silesian Voivodeship
-
Częstochowa, Silesian Voivodeship, Polen, 42-202
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1206
-
Katowice, Silesian Voivodeship, Polen, 40-040
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1208
-
Katowice, Silesian Voivodeship, Polen, 40-081
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1209
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Polen, 90-127
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1214
-
-
-
-
-
Manati, Puerto Rico, 00674
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0177
-
Mayagüez, Puerto Rico, 00680
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0272
-
San Juan, Puerto Rico, 00927
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 9215
-
-
-
-
-
Barcelona, Spania, 08035
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1405
-
Madrid, Spania, 28007
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1401
-
Madrid, Spania, 28027
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1408
-
Seville, Spania, 41013
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1402
-
-
Barcelona
-
Sabadell, Barcelona, Spania, 08208
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1409
-
-
Cantabria
-
Santander, Cantabria, Spania, 39008
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1406
-
-
Madrid
-
Majadahonda, Madrid, Spania, 28222
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1404
-
-
València
-
Valencia, València, Spania, 46015
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1403
-
Valencia, València, Spania, 46026
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1407
-
-
-
-
England
-
Birmingham, England, Storbritannia, B15 2WB
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1804
-
Cambridge, England, Storbritannia, CB2 0QQ
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1801
-
Liverpool, England, Storbritannia, L9 7AL
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1816
-
London, England, Storbritannia, E1 1BB
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1809
-
London, England, Storbritannia, SW10 9NH
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1813
-
London, England, Storbritannia, SE5 9RS
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1806
-
London, England, Storbritannia, NW3 2QG
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1802
-
London, England, Storbritannia, W2 1NY
- Fullført
- Akero Clinical Study Site
-
Newcastle upon Tyne, England, Storbritannia, NE7 7DN
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1805
-
-
-
-
-
Bern, Sveits, 3010
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1502
-
Sankt Gallen, Sveits, 9007
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1501
-
-
Canton of Solothurn
-
Olten, Canton of Solothurn, Sveits, 4600
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1504
-
-
-
-
Daegu Gwang'yeogsi [Taegu-Kwangyokshi]
-
Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], Sør -Korea, 41944
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1306
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Sør -Korea, 1232
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1303
-
Incheon, Gyeonggi-do, Sør -Korea, 22332
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1308
-
Seongnam-si, Gyeonggi-do, Sør -Korea, 13620
- Fullført
- Akero Clinical Study Site
-
-
Gyeonggido [Kyonggi-do]
-
Seongnam-si, Gyeonggido [Kyonggi-do], Sør -Korea, 13520
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1307
-
-
Gyeongsangbugdo [Kyongsangbuk-do]
-
Daegu, Gyeongsangbugdo [Kyongsangbuk-do], Sør -Korea, 42601
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1304
-
-
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
-
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Sør -Korea, 03080
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1301
-
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Sør -Korea, 04763
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1305
-
-
-
-
-
Kaohsiung City, Taiwan, 833
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1602
-
Tainan, Taiwan, 704
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1603
-
Taoyuan, Taiwan, 333
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1605
-
-
Changhua
-
Changhua, Changhua, Taiwan, 500
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1604
-
-
Taichung
-
Taichung, Taichung, Taiwan, 40447
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1607
-
-
Tainan
-
Tainan, Tainan, Taiwan, 73657
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1606
-
-
Taipei
-
Taipei City, Taipei, Taiwan, 10048
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1601
-
-
-
-
-
Bursa, Tyrkia (Türkiye), 16059
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1704
-
Rize, Tyrkia (Türkiye), 53020
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1706
-
-
Ankara
-
Yenimahalle, Ankara, Tyrkia (Türkiye), 06500
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1705
-
-
İzmir
-
Bornova, İzmir, Tyrkia (Türkiye), 35100
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 1703
-
-
-
-
-
Berlin, Tyskland, 10787
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0712
-
Berlin, Tyskland, 13353
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0701
-
-
Bavaria
-
Würzburg, Bavaria, Tyskland, 97080
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0711
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 60590
- Fullført
- Akero Clinical Study Site
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, Tyskland, 55131
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0710
-
-
Saarland
-
Homburg, Saarland, Tyskland, 66421
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0716
-
-
Saxony
-
Leipzig, Saxony, Tyskland, 04103
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0703
-
Leipzig, Saxony, Tyskland, 04103
- Fullført
- Akero Clinical Study Site
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Tyskland, 23538
- Rekruttering
- Akero Clinical Study Site
-
Ta kontakt med:
- Akero Site 0713
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- Hanner og ikke-gravide, ikke-ammende kvinner mellom 18 og 80 år inkludert, basert på datoen for screeningbesøket.
- Tidligere historie eller tilstedeværelse av 2 av 4 komponenter av metabolsk syndrom (fedme, dyslipidemi, forhøyet blodtrykk, forhøyet fastende glukose) eller type 2 diabetes
- FibroScan®-måling > 7,5 kPa
- ELF-score ≥ 7,7
Biopsi-påvist NASH. Må ha tatt en leverbiopsi oppnådd ≤ 180 dager før screening med fibrose stadium 2 eller 3 og en ikke-alkoholisk fettleversykdom (NAFLD) aktivitetsscore (NAS) på ≥ 4 med minst en score på 1 i hvert av følgende NAS-komponenter:
- Steatose (scoret 0 til 3),
- Ballongdegenerasjon (scoret 0 til 2), og
- Lobular betennelse (skårer 0 til 3).
Ekskluderingskriterier:
- Andre årsaker til leversykdom basert på sykehistorie og/eller leverhistologi og/eller sentrale laboratorieresultater
- Tilstedeværelse av skrumplever på leverbiopsi (fase 4 fibrose)
- Type 1 eller ukontrollert type 2 diabetes
Andre inkluderings- og eksklusjonskriterier kan gjelde.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Administreres ved subkutan injeksjon
|
|
Eksperimentell: EFX 28 mg
|
Administreres ved subkutan injeksjon
|
|
Eksperimentell: EFX 50 mg
|
Administreres ved subkutan injeksjon
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Begivenhetsfri overlevelse
Tidsramme: 240 uker
|
Basert på tid fra randomisering til første kliniske hendelse inkludert bevis på sykdomsprogresjon, leverdekompensasjonshendelser, levertransplantasjon eller kvalifisering for levertransplantasjon og dødelighet av alle årsaker.
|
240 uker
|
|
Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis
Tidsramme: 52 Weeks
|
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)
|
52 Weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Endring fra baseline for kroppsvekt (kg)
Tidsramme: 52 uker, 240 uker
|
52 uker, 240 uker
|
|
|
For å vurdere sikkerheten og toleransen til EFX gjennom rapportering av eksponeringsomfang (uker)
Tidsramme: 52 uker, 240 uker
|
52 uker, 240 uker
|
|
|
For å vurdere sikkerheten og toleransen til EFX gjennom rapportering av uønskede hendelser (alvorlighetsgrad av hendelser)
Tidsramme: 52 uker, 240 uker
|
52 uker, 240 uker
|
|
|
For å vurdere sikkerheten og toleransen til EFX gjennom rapportering av uønskede hendelser (hyppighet av hendelser)
Tidsramme: 52 uker, 240 uker
|
52 uker, 240 uker
|
|
|
For å vurdere sikkerheten og toleransen til EFX gjennom rapportering av unormale kliniske laboratorietester, EKG, ultralyd, vurderinger av vitale tegn (antall pasienter)
Tidsramme: 52 uker, 240 uker
|
52 uker, 240 uker
|
|
|
For å vurdere immunogenisiteten til EFX gjennom rapportering av antistoff-antistoffer (antall pasienter)
Tidsramme: 52 uker, 240 uker
|
52 uker, 240 uker
|
|
|
Change from baseline of non-invasive markers of liver fibrosis: ELF score components (TIMP-1, HA, PIIINP, Pro-C3)
Tidsramme: 52 Weeks
|
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)
|
52 Weeks
|
|
Change from baseline of non-invasive markers of liver fibrosis: Fibroscan
Tidsramme: 96 Weeks, 240 Weeks
|
Liver stiffness assessed by transient elastography (FibroScan)
|
96 Weeks, 240 Weeks
|
|
Change from baseline of markers of liver injury: ALT, AST, GGT
Tidsramme: 52 Weeks, 240 Weeks
|
ALT (U/L), AST (U/L), GGT (U/L)
|
52 Weeks, 240 Weeks
|
|
Change from baseline of markers of liver injury: Uric Acid
Tidsramme: 52 Weeks, 240 Weeks
|
Uric acid (mg/dL)
|
52 Weeks, 240 Weeks
|
|
Change from baseline of lipoproteins: Total cholesterol, TG, Non-HDL-C, HDL-C, and LDL-C
Tidsramme: 52 Weeks, 240 Weeks
|
Total cholesterol (mg/dL), TG (mg/dL), Non-HDL-C (mg/dL), HDL-C (mg/dL), and LDL-C (mg/dL)
|
52 Weeks, 240 Weeks
|
|
Change from baseline of markers of insulin sensitivity and glycemic control: HbA1c
Tidsramme: 52 Weeks, 240 Weeks
|
HbA1c (%)
|
52 Weeks, 240 Weeks
|
|
Change from baseline of markers of insulin sensitivity and glycemic control: Adiponectin
Tidsramme: 52 Weeks, 240 Weeks
|
Adiponectin (mg/L)
|
52 Weeks, 240 Weeks
|
|
Cohort 1 Only: Resolution of NASH/MASH and no worsening of fibrosis
Tidsramme: 52 Weeks
|
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)
|
52 Weeks
|
|
Cohort 1 Only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
Tidsramme: 52 Weeks
|
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)
|
52 Weeks
|
|
Change from baseline of non-invasive markers of liver fibrosis: ELF score
Tidsramme: 52 Weeks
|
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.
|
52 Weeks
|
|
Change from baseline in non-invasive markers of liver fibrosis: ELF score
Tidsramme: 96 Weeks, 240 Weeks
|
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.
|
96 Weeks, 240 Weeks
|
|
Change from baseline in non-invasive markers of liver fibrosis: ELF score components: TIMP-1, HA, PIIINP, Pro-C3
Tidsramme: Week 240
|
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.
|
Week 240
|
|
Change from baseline of non-invasive markers of liver fibrosis: Fibroscan
Tidsramme: 52 Weeks
|
Liver stiffness assessed by transient elastography (FibroScan)
|
52 Weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AK-US-001-0105
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