- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06215716
En undersøgelse, der evaluerer efroxifermin hos personer med ikke-cirrhotisk ikke-alkoholisk steatohepatitis (NASH)/metabolisk dysfunktion-associeret steatohepatitis (MASH) og fibrose
En fase 3, randomiseret, dobbeltblind, placebokontrolleret undersøgelse, der evaluerer sikkerheden og effektiviteten af efroxifermin hos forsøgspersoner med ikke-cirrhotic nonalcoholic steatohepatitis (NASH)/metabolisk dysfunktion-associeret steatohepatitis (MASH) og fibrose
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
- 750 F2/F3 subjects in Cohort 1
- 900 F3 subjects in Cohort 2
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,
- 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, progression to cirrhosis, noninvasive markers of liver fibrosis, 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, Enhanced Liver Fibrosis (ELF) score, and progression to cirrhosis at prespecified time points including Weeks 96 and 240.
An interim analysis of the primary clinical outcomes endpoint may be performed after all subjects in Cohort 2 have completed the Week 96 visit or discontinued from the study and a prespecified number of clinical outcome events have occurred.
Subjects who discontinue study drug may continue study assessments according to the protocol schedule to support long-term efficacy and safety evaluations.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Akero Study Director
- Telefonnummer: 650-487-6488
- E-mail: AkeroSynchrony@akerotx.com
Studiesteder
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Buenos Aires, Argentina, C1118AAT
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0305
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Buenos Aires, Argentina, C1280AEB
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0301
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Buenos Aires, Argentina, C1180AAX
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- 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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Kontakt:
- Akero Site 0307
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La Plata, Buenos Aires, Argentina, B1902AWL
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0304
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Ramos Mejía, Buenos Aires, Argentina, B1704ETD
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- 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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Kontakt:
- Akero Site 0306
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New South Wales
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Broadmeadow, New South Wales, Australien, 2292
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0408
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Coffs Harbour, New South Wales, Australien, 2450
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0418
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Kogarah, New South Wales, Australien, 2217
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0417
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Liverpool, New South Wales, Australien, 1871
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0413
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Penrith, New South Wales, Australien, 2750
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0416
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Westmead, New South Wales, Australien, 2145
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0401
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South Australia
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Adelaide, South Australia, Australien, 5000
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0407
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Victoria
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Caulfield South, Victoria, Australien, 3162
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0402
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Epping, Victoria, Australien, 3076
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0410
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Frankston, Victoria, Australien, 3128
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0412
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Heidelberg, Victoria, Australien, 3084
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0405
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Melbourne, Victoria, Australien, 3004
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0403
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Western Australia
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Murdoch, Western Australia, Australien, 6150
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0411
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Nedlands, Western Australia, Australien, 6009
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0415
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Perth, Western Australia, Australien, 6000
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- 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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Kontakt:
- 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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Kontakt:
- Akero Site 0503
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Toronto, Ontario, Canada, M6H 3M1
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0502
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Vaughan, Ontario, Canada, L4L 4Y7
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- 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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Kontakt:
- Akero Site 0506
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Terrebonne, Quebec, Canada, J7B6B7
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0505
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England
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Birmingham, England, Det Forenede Kongerige, B15 2WB
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 1804
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Cambridge, England, Det Forenede Kongerige, CB2 0QQ
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 1801
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Liverpool, England, Det Forenede Kongerige, L9 7AL
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 1816
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London, England, Det Forenede Kongerige, E1 1BB
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 1809
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London, England, Det Forenede Kongerige, SW10 9NH
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 1813
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London, England, Det Forenede Kongerige, SE5 9RS
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 1806
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London, England, Det Forenede Kongerige, NW3 2QG
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 1802
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London, England, Det Forenede Kongerige, W2 1NY
- Afsluttet
- Akero Clinical Study Site
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Newcastle upon Tyne, England, Det Forenede Kongerige, NE7 7DN
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 1805
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Alabama
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Birmingham, Alabama, Forenede Stater, 35209
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0129
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Dothan, Alabama, Forenede Stater, 36301
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0233
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9106
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Flagstaff, Arizona, Forenede Stater, 86001
- Afsluttet
- Akero Clinical Study Site
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Peoria, Arizona, Forenede Stater, 85381
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9104
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Tucson, Arizona, Forenede Stater, 85712
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9144
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Tucson, Arizona, Forenede Stater, 85715
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0209
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Tucson, Arizona, Forenede Stater, 85713
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0234
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Arkansas
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Conway, Arkansas, Forenede Stater, 72032
- Afsluttet
- Akero Clinical Study Site
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Jonesboro, Arkansas, Forenede Stater, 72401
- Afsluttet
- Akero Clinical Study Site
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Little Rock, Arkansas, Forenede Stater, 72205
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0106
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North Little Rock, Arkansas, Forenede Stater, 72117
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9214
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California
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Chula Vista, California, Forenede Stater, 91910
- Afsluttet
- Akero Clinical Study Site
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Coronado, California, Forenede Stater, 92118
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0132
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Escondido, California, Forenede Stater, 92025
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0266
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Folsom, California, Forenede Stater, 95630
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0263
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Inglewood, California, Forenede Stater, 90301
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0120
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La Mesa, California, Forenede Stater, 91942
- Afsluttet
- Akero Clinical Study Site
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Lancaster, California, Forenede Stater, 93534
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0285
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Lancaster, California, Forenede Stater, 93534
- Afsluttet
- Akero Clinical Study Site
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Long Beach, California, Forenede Stater, 90815
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0188
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Los Angeles, California, Forenede Stater, 90057
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0168
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Los Angeles, California, Forenede Stater, 90048
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0236
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Los Angeles, California, Forenede Stater, 90036
- Afsluttet
- Akero Clinical Study Site
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Newport Beach, California, Forenede Stater, 92663
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0206
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Orange, California, Forenede Stater, 92868
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0261
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Palm Springs, California, Forenede Stater, 92262
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0197
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Pasadena, California, Forenede Stater, 91105
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9250
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Redwood City, California, Forenede Stater, 94063
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0191
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Sacramento, California, Forenede Stater, 95817
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0274
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San Diego, California, Forenede Stater, 92120
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0124
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San Diego, California, Forenede Stater, 92161
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0199
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San Diego, California, Forenede Stater, 92123
- Afsluttet
- Akero Clinical Study Site
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San Francisco, California, Forenede Stater, 94115
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0147
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San Francisco, California, Forenede Stater, 94117
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0269
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Santa Maria, California, Forenede Stater, 93458
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0205
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0217
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0260
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Englewood, Colorado, Forenede Stater, 80113
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9243
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0213
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0268
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Washington D.C., District of Columbia, Forenede Stater, 20422
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0262
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Florida
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Bradenton, Florida, Forenede Stater, 34208
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0153
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Brandon, Florida, Forenede Stater, 33511
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0222
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Doral, Florida, Forenede Stater, 33126
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0267
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Fort Myers, Florida, Forenede Stater, 33912
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9134
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Gainesville, Florida, Forenede Stater, 32610
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0114
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Hialeah Gardens, Florida, Forenede Stater, 33016
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9242
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Inverness, Florida, Forenede Stater, 34452
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9135
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Jacksonville, Florida, Forenede Stater, 32256
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0118
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Lady Lake, Florida, Forenede Stater, 32159
- Afsluttet
- Akero Clinical Study Site
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Lakewood Rch, Florida, Forenede Stater, 34211
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9203
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Largo, Florida, Forenede Stater, 33777
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9248
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Lehigh Acres, Florida, Forenede Stater, 33936
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0271
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Maitland, Florida, Forenede Stater, 32751
- Afsluttet
- Akero Clinical Study Site
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Margate, Florida, Forenede Stater, 33063
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0248
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Miami, Florida, Forenede Stater, 33136
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0137
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Miami, Florida, Forenede Stater, 33175
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0252
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Miami Gardens, Florida, Forenede Stater, 33014
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0243
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Miami Lakes, Florida, Forenede Stater, 33016
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9138
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Naples, Florida, Forenede Stater, 34102
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0138
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New Port Richey, Florida, Forenede Stater, 34653
- Afsluttet
- Akero Clinical Study Site
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Ocala, Florida, Forenede Stater, 34471
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9127
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Orlando, Florida, Forenede Stater, 32807
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0250
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Pembroke Pines, Florida, Forenede Stater, 33027
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0239
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Port Orange, Florida, Forenede Stater, 32127
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9105
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Riverview, Florida, Forenede Stater, 33578
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0295
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Sarasota, Florida, Forenede Stater, 34240
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9218
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Temple Terrace, Florida, Forenede Stater, 33617
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0242
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Venice, Florida, Forenede Stater, 34285
- Afsluttet
- Akero Clinical Study Site
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Viera, Florida, Forenede Stater, 32940
- Afsluttet
- Akero Clinical Study Site
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West Palm Beach, Florida, Forenede Stater, 33401
- Afsluttet
- Akero Clinical Study Site
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Weston, Florida, Forenede Stater, 33331
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 0270
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Winter Park, Florida, Forenede Stater, 32789
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0157
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Winter Park, Florida, Forenede Stater, 32792
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0187
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Zephyrhills, Florida, Forenede Stater, 33542
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0235
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0230
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Columbus, Georgia, Forenede Stater, 31904
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0156
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Gainesville, Georgia, Forenede Stater, 30501
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0183
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Marietta, Georgia, Forenede Stater, 30060
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9111
-
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- Akero Clinical Study Site
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Kontakt:
- Akero Site 9245
-
-
Indiana
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Hammond, Indiana, Forenede Stater, 46324
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0254
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Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0290
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South Bend, Indiana, Forenede Stater, 46635
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9235
-
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Iowa
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West Des Moines, Iowa, Forenede Stater, 50265
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0146
-
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9136
-
Wichita, Kansas, Forenede Stater, 67205
- Afsluttet
- Akero Clinical Study Site
-
-
Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0203
-
-
Louisiana
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Bastrop, Louisiana, Forenede Stater, 71220
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9220
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Covington, Louisiana, Forenede Stater, 70433
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0195
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Houma, Louisiana, Forenede Stater, 70363
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0112
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Marrero, Louisiana, Forenede Stater, 70072
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9102
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Metairie, Louisiana, Forenede Stater, 70006
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0109
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New Orleans, Louisiana, Forenede Stater, 70121
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0176
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New Orleans, Louisiana, Forenede Stater, 70112
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0196
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Shreveport, Louisiana, Forenede Stater, 71105
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9145
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West Monroe, Louisiana, Forenede Stater, 71291
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0283
-
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Maryland
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Baltimore, Maryland, Forenede Stater, 21202
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0108
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Glen Burnie, Maryland, Forenede Stater, 21061
- Afsluttet
- Akero Clinical Study Site
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Greenbelt, Maryland, Forenede Stater, 20770
- Afsluttet
- Akero Clinical Study Site
-
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Massachusetts
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New Bedford, Massachusetts, Forenede Stater, 02740
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0181
-
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Michigan
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Novi, Michigan, Forenede Stater, 48377
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0204
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Southfield, Michigan, Forenede Stater, 48075
- Afsluttet
- Akero Clinical Study Site
-
Wyoming, Michigan, Forenede Stater, 49519
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0107
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Ypsilanti, Michigan, Forenede Stater, 48197
- Aktiv, ikke rekrutterende
- Akero Clinical Study Site
-
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Mississippi
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Flowood, Mississippi, Forenede Stater, 39232
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0277
-
-
Missouri
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Columbia, Missouri, Forenede Stater, 65201
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0141
-
Kansas City, Missouri, Forenede Stater, 64131
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9208
-
St Louis, Missouri, Forenede Stater, 63123
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0296
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9142
-
Las Vegas, Nevada, Forenede Stater, 89109
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9219
-
Reno, Nevada, Forenede Stater, 89511
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9240
-
-
New Jersey
-
Florham Park, New Jersey, Forenede Stater, 07932
- Afsluttet
- Akero Clinical Study Site
-
Jackson, New Jersey, Forenede Stater, 08527
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0105
-
Ridgewood, New Jersey, Forenede Stater, 07450
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0287
-
Somers Point, New Jersey, Forenede Stater, 08244
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0116
-
Sparta, New Jersey, Forenede Stater, 07871
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0117
-
-
New Mexico
-
Santa Fe, New Mexico, Forenede Stater, 87505
- Afsluttet
- Akero Clinical Study Site
-
-
New York
-
Buffalo, New York, Forenede Stater, 14203
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0241
-
Manhasset, New York, Forenede Stater, 11030
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0208
-
New York, New York, Forenede Stater, 10029
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0160
-
New York, New York, Forenede Stater, 10016
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0198
-
New York, New York, Forenede Stater, 10021
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0148
-
New York, New York, Forenede Stater, 10033
- Afsluttet
- Akero Clinical Study Site
-
Rochester, New York, Forenede Stater, 55905
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0240
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater, 27514
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0192
-
Charlotte, North Carolina, Forenede Stater, 28204
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9147
-
Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0224
-
Fayetteville, North Carolina, Forenede Stater, 28303
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9227
-
Morehead City, North Carolina, Forenede Stater, 28557
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9128
-
New Bern, North Carolina, Forenede Stater, 28562
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0166
-
Raleigh, North Carolina, Forenede Stater, 27612
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0169
-
Statesville, North Carolina, Forenede Stater, 28625
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0142
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43213
- Afsluttet
- Akero Clinical Study Site
-
Dayton, Ohio, Forenede Stater, 45414
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0127
-
Springboro, Ohio, Forenede Stater, 45066
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9233
-
Westlake, Ohio, Forenede Stater, 44145
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9226
-
-
Pennsylvania
-
Hershey, Pennsylvania, Forenede Stater, 17033
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0264
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9132
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0207
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0102
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0246
-
Columbia, South Carolina, Forenede Stater, 29204
- Afsluttet
- Akero Clinical Study Site
-
Summerville, South Carolina, Forenede Stater, 29485
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9238
-
-
Tennessee
-
Chattanooga, Tennessee, Forenede Stater, 37421
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0175
-
Clarksville, Tennessee, Forenede Stater, 37040
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0144
-
Hermitage, Tennessee, Forenede Stater, 37076
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9123
-
Nashville, Tennessee, Forenede Stater, 37211
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9130
-
-
Texas
-
Amarillo, Texas, Forenede Stater, 79106
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0104
-
Austin, Texas, Forenede Stater, 78745
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0131
-
Austin, Texas, Forenede Stater, 78757
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0281
-
Bellaire, Texas, Forenede Stater, 77401
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0165
-
Brownsville, Texas, Forenede Stater, 78520
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0154
-
Corpus Christi, Texas, Forenede Stater, 78404
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0223
-
Dallas, Texas, Forenede Stater, 75230
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0128
-
Dallas, Texas, Forenede Stater, 75203
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0126
-
Dallas, Texas, Forenede Stater, 75234
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0221
-
Dallas, Texas, Forenede Stater, 75390
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0164
-
Dallas, Texas, Forenede Stater, 75216
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0253
-
Denison, Texas, Forenede Stater, 75020
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0244
-
Edinburg, Texas, Forenede Stater, 78539
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9117
-
Forney, Texas, Forenede Stater, 75126
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0286
-
Fort Worth, Texas, Forenede Stater, 76104
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9211
-
Houston, Texas, Forenede Stater, 77079
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0265
-
Houston, Texas, Forenede Stater, 77074
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0249
-
Houston, Texas, Forenede Stater, 77004
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0293
-
Houston, Texas, Forenede Stater, 77030
- Afsluttet
- Akero Clinical Study Site
-
Houston, Texas, Forenede Stater, 77084
- Afsluttet
- Akero Clinical Study Site
-
Lewisville, Texas, Forenede Stater, 75057
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0135
-
McAllen, Texas, Forenede Stater, 78504
- Afsluttet
- Akero Clinical Study Site
-
McAllen, Texas, Forenede Stater, 78539
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9205
-
Pasadena, Texas, Forenede Stater, 77505
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0292
-
San Antonio, Texas, Forenede Stater, 78222
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0185
-
San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9202
-
San Antonio, Texas, Forenede Stater, 78258
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9116
-
San Antonio, Texas, Forenede Stater, 78215
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9103
-
San Antonio, Texas, Forenede Stater, 78209
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9116
-
San Antonio, Texas, Forenede Stater, 78240
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0140
-
San Antonio, Texas, Forenede Stater, 782531
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0289
-
San Marcos, Texas, Forenede Stater, 78666
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9141
-
San Marcos, Texas, Forenede Stater, 78666-7502
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9141
-
Waco, Texas, Forenede Stater, 76710
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9246
-
Waco, Texas, Forenede Stater, 76712
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0279
-
Webster, Texas, Forenede Stater, 77598
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9204
-
Wichita Falls, Texas, Forenede Stater, 76301
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9247
-
-
Utah
-
Ogden, Utah, Forenede Stater, 84405
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9230
-
Salt Lake City, Utah, Forenede Stater, 84117
- Afsluttet
- Akero Clinical Study Site
-
Sandy City, Utah, Forenede Stater, 84092
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9241
-
South Ogden, Utah, Forenede Stater, 84405
- Afsluttet
- Akero Clinical Study Site
-
-
Virginia
-
Falls Church, Virginia, Forenede Stater, 22042-3300
- Afsluttet
- Akero Clinical Study Site
-
Newport News, Virginia, Forenede Stater, 23602
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0170
-
Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0143
-
Richmond, Virginia, Forenede Stater, 23235
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0103
-
Richmond, Virginia, Forenede Stater, 23249
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9120
-
Richmond, Virginia, Forenede Stater, 23226
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0212
-
Richmond, Virginia, Forenede Stater, 23298
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9115
-
Roanoke, Virginia, Forenede Stater, 24014
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0139
-
Suffolk, Virginia, Forenede Stater, 23435
- Afsluttet
- Akero Clinical Study Site
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98105
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0119
-
Spokane, Washington, Forenede Stater, 99218
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0155
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53705
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0259
-
-
-
-
Alpes-Maritimes
-
Nice, Alpes-Maritimes, Frankrig, 06202
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0606
-
-
Auvergne-Rhône-Alpes
-
Lyon, Auvergne-Rhône-Alpes, Frankrig, 69008
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0604
-
-
Bas-Rhin
-
Strasbourg, Bas-Rhin, Frankrig, 67091
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0607
-
-
Haute-Vienne
-
Limoges, Haute-Vienne, Frankrig, 87042
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0609
-
-
Hauts-de-Seine
-
Clichy, Hauts-de-Seine, Frankrig, 92110
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0603
-
-
Lorraine
-
Vandœuvre-lès-Nancy, Lorraine, Frankrig, 54511
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0611
-
-
Maine-et-Loire
-
Angers, Maine-et-Loire, Frankrig, 49933
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0602
-
-
Occitanie
-
Toulouse, Occitanie, Frankrig, 31059
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0610
-
-
Provence-Alpes-Côte d'Azur Region
-
Marseille, Provence-Alpes-Côte d'Azur Region, Frankrig, 13008
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0601
-
Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, Frankrig, 34295
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0608
-
-
Val-De-Marne
-
Créteil, Val-De-Marne, Frankrig, 94010
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0614
-
-
Yvelines, Île-de-France
-
Versailles, Yvelines, Île-de-France, Frankrig, 78000
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0612
-
-
Île-de-France Region
-
Paris, Île-de-France Region, Frankrig, 75013
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0605
-
-
-
-
Gujarat
-
Surat, Gujarat, Indien, 395002
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1918
-
Surat, Gujarat, Indien, 395009
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1911
-
Vadodara, Gujarat, Indien, 390007
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1906
-
-
Karnataka
-
Mysore, Karnataka, Indien, 570001
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1930
-
-
Kerala
-
Thiruvananthapuram, Kerala, Indien, 695011
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1922
-
-
Maharashtra
-
Dahegaon, Maharashtra, Indien, 441108
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1923
-
Mumbai, Maharashtra, Indien, 400012
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1926
-
Nagpur, Maharashtra, Indien, 440010
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1909
-
Pune, Maharashtra, Indien, 412201
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1901
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Indien, 110029
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1904
-
New Delhi, National Capital Territory of Delhi, Indien, 110060
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1916
-
New Delhi, National Capital Territory of Delhi, Indien, 110017
- Afsluttet
- Akero Clinical Study Site
-
New Delhi, National Capital Territory of Delhi, Indien, 110070
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1924
-
-
Punjab
-
Chandigarh, Punjab, Indien, 160012
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1908
-
-
Rajasthan
-
Jaipur, Rajasthan, Indien, 302001
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1902
-
-
Tamil Nadu
-
Coimbatore, Tamil Nadu, Indien, 641005
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1920
-
-
Telangana
-
Hyderabad, Telangana, Indien, 500 004
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1912
-
-
Uttar Pradesh
-
Varanasi, Uttar Pradesh, Indien, 221005
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1921
-
-
West Bengal
-
Kolkata, West Bengal, Indien, 700020
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1907
-
Kolkata, West Bengal, Indien, 700073
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1917
-
-
-
-
-
Jerusalem, Israel, 9103102
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0809
-
Jerusalem, Israel, 9112001
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0808
-
Tel Aviv, Israel, 6423906
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0801
-
-
Central District
-
Petah Tikva, Central District, Israel, 4941492
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0803
-
Ramat Gan, Central District, Israel, 5265601
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0802
-
-
Haifa District
-
Haifa, Haifa District, Israel, 3109601
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0804
-
Haifa, Haifa District, Israel, 3436212
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0806
-
-
Northern District
-
Afula, Northern District, Israel, 1834111
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0810
-
Nahariya, Northern District, Israel, 22100
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0807
-
Nazareth, Northern District, Israel, 1610001
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0805
-
-
-
-
-
Bologna, Italien, 40138
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0908
-
Foggia, Italien, 71122
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0909
-
Messina, Italien, 98124
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0912
-
Milan, Italien, 20122
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0902
-
Modena, Italien, 41126
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0906
-
Naples, Italien, 80131
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0907
-
Novara, Italien, 28100
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0905
-
-
Foggia
-
San Giovanni Rotondo, Foggia, Italien, 71013
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0901
-
-
Milan
-
Rozzano, Milan, Italien, 20089
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0904
-
-
Turin
-
Torino, Turin, Italien, 10126
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0910
-
-
-
-
Mexico City
-
Cuauhtémoc, Mexico City, Mexico, 06700
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 8237
-
-
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polen, 60-702
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1205
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Polen, 31-501
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1212
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polen, 50-381
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1204
-
Wroclaw, Lower Silesian Voivodeship, Polen, 53-673
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1213
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 00-215
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1211
-
Warsaw, Masovian Voivodeship, Polen, 02-672
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1203
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polen, 80-382
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1201
-
Gdynia, Pomeranian Voivodeship, Polen, 81-537
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1202
-
-
Silesian Voivodeship
-
Częstochowa, Silesian Voivodeship, Polen, 42-202
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1206
-
Katowice, Silesian Voivodeship, Polen, 40-040
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1208
-
Katowice, Silesian Voivodeship, Polen, 40-081
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1209
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Polen, 90-127
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1214
-
-
-
-
-
Manati, Puerto Rico, 00674
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0177
-
Mayagüez, Puerto Rico, 00680
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0272
-
San Juan, Puerto Rico, 00927
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 9215
-
-
-
-
-
Bern, Schweiz, 3010
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1502
-
Sankt Gallen, Schweiz, 9007
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1501
-
-
Canton of Solothurn
-
Olten, Canton of Solothurn, Schweiz, 4600
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1504
-
-
-
-
-
Barcelona, Spanien, 08035
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1405
-
Madrid, Spanien, 28007
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1401
-
Madrid, Spanien, 28027
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1408
-
Seville, Spanien, 41013
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1402
-
-
Barcelona
-
Sabadell, Barcelona, Spanien, 08208
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1409
-
-
Cantabria
-
Santander, Cantabria, Spanien, 39008
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1406
-
-
Madrid
-
Majadahonda, Madrid, Spanien, 28222
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1404
-
-
València
-
Valencia, València, Spanien, 46015
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1403
-
Valencia, València, Spanien, 46026
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1407
-
-
-
-
Daegu Gwang'yeogsi [Taegu-Kwangyokshi]
-
Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], Sydkorea, 41944
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1306
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Sydkorea, 1232
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1303
-
Incheon, Gyeonggi-do, Sydkorea, 22332
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1308
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Afsluttet
- Akero Clinical Study Site
-
-
Gyeonggido [Kyonggi-do]
-
Seongnam-si, Gyeonggido [Kyonggi-do], Sydkorea, 13520
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1307
-
-
Gyeongsangbugdo [Kyongsangbuk-do]
-
Daegu, Gyeongsangbugdo [Kyongsangbuk-do], Sydkorea, 42601
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1304
-
-
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
-
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Sydkorea, 03080
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1301
-
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Sydkorea, 04763
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1305
-
-
-
-
-
Kaohsiung City, Taiwan, 833
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1602
-
Tainan, Taiwan, 704
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1603
-
Taoyuan, Taiwan, 333
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1605
-
-
Changhua
-
Changhua, Changhua, Taiwan, 500
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1604
-
-
Taichung
-
Taichung, Taichung, Taiwan, 40447
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1607
-
-
Tainan
-
Tainan, Tainan, Taiwan, 73657
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1606
-
-
Taipei
-
Taipei City, Taipei, Taiwan, 10048
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1601
-
-
-
-
-
Bursa, Tyrkiet (Türkiye), 16059
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1704
-
Rize, Tyrkiet (Türkiye), 53020
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1706
-
-
Ankara
-
Yenimahalle, Ankara, Tyrkiet (Türkiye), 06500
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1705
-
-
İzmir
-
Bornova, İzmir, Tyrkiet (Türkiye), 35100
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 1703
-
-
-
-
-
Berlin, Tyskland, 10787
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0712
-
Berlin, Tyskland, 13353
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0701
-
-
Bavaria
-
Würzburg, Bavaria, Tyskland, 97080
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0711
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 60590
- Afsluttet
- Akero Clinical Study Site
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, Tyskland, 55131
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0710
-
-
Saarland
-
Homburg, Saarland, Tyskland, 66421
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0716
-
-
Saxony
-
Leipzig, Saxony, Tyskland, 04103
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0703
-
Leipzig, Saxony, Tyskland, 04103
- Afsluttet
- Akero Clinical Study Site
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Tyskland, 23538
- Rekruttering
- Akero Clinical Study Site
-
Kontakt:
- Akero Site 0713
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Hanner og ikke-gravide, ikke-ammende hunner mellem 18 - 80 år inklusive, baseret på datoen for screeningsbesøget.
- Tidligere historie eller tilstedeværelse af 2 ud af 4 komponenter af metabolisk syndrom (fedme, dyslipidæmi, forhøjet blodtryk, forhøjet fastende glukose) eller type 2-diabetes
- FibroScan®-måling > 7,5 kPa
- ELF-score ≥ 7,7
Biopsi-bevist NASH. Skal have haft en leverbiopsi opnået ≤ 180 dage før screening med fibrose trin 2 eller 3 og en ikke-alkoholisk fedtleversygdom (NAFLD) aktivitetsscore (NAS) på ≥ 4 med mindst en score på 1 i hver af følgende NAS komponenter:
- Steatose (scoret 0 til 3),
- Ballondegeneration (scoret 0 til 2), og
- Lobulær inflammation (scoret 0 til 3).
Ekskluderingskriterier:
- Andre årsager til leversygdom baseret på sygehistorie og/eller leverhistologi og/eller centrale laboratorieresultater
- Tilstedeværelse af skrumpelever på leverbiopsi (fase 4 fibrose)
- Type 1 eller ukontrolleret type 2 diabetes
Andre inklusions- og eksklusionskriterier kan være gældende.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Indgives ved subkutan injektion
|
|
Eksperimentel: EFX 28 mg
|
Indgives ved subkutan injektion
|
|
Eksperimentel: EFX 50 mg
|
Indgives ved subkutan injektion
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Kun kohorte 1: Opløsning af NASH/MASH og en ≥ 1 trins forbedring af fibrose
Tidsramme: 52 uger
|
Baseret på NAS (scoret med 0-1 for steatose, 0-3 for inflammation og 0-2 for ballondannelse) og NASH CRN fibrose-score (scoret med en fibrose-score på 0-4, hvor 0 = ingen fibrose, 1 = centrilobulær pericellulær fibrose, 2 = centrilobulær og periportal fibrose, 3 = brodannende fibrose, 4 = cirrhose)
|
52 uger
|
|
Begivenhedsfri overlevelse
Tidsramme: 240 uger
|
Baseret på tid fra randomisering til den første kliniske hændelse, inklusive tegn på sygdomsprogression, leverdekompensation, levertransplantation eller berettigelse til levertransplantation og dødelighed af alle årsager.
|
240 uger
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Kun kohorte 1: Opløsning af NASH/MASH og ingen forværring af fibrose
Tidsramme: 52 uger
|
Baseret på NAS (scoret med 0-1 for steatose, 0-3 for inflammation og 0-2 for ballondannelse) og NASH CRN fibrose-score (scoret med en fibrose-score på 0-4, hvor 0 = ingen fibrose, 1 = centrilobulær pericellulær fibrose, 2 = centrilobulær og periportal fibrose, 3 = brodannende fibrose, 4 = cirrhose)
|
52 uger
|
|
Kun kohorte 1: ≥ 1 stadie forbedring af fibrose og ingen forværring af steatohepatitis
Tidsramme: 52 uger
|
Baseret på NAS (scoret med 0-1 for steatose, 0-3 for inflammation og 0-2 for ballondannelse) og NASH CRN fibrose-score (scoret med en fibrose-score på 0-4, hvor 0 = ingen fibrose, 1 = centrilobulær pericellulær fibrose, 2 = centrilobulær og periportal fibrose, 3 = brodannende fibrose, 4 = cirrhose)
|
52 uger
|
|
Ændring fra baseline af kropsvægt (kg)
Tidsramme: 52 uger, 240 uger
|
52 uger, 240 uger
|
|
|
At vurdere sikkerheden og tolerabiliteten af EFX gennem rapportering af omfanget af eksponering (uger)
Tidsramme: 52 uger, 240 uger
|
52 uger, 240 uger
|
|
|
At vurdere sikkerheden og tolerabiliteten af EFX gennem rapportering af uønskede hændelser (hændelsers sværhedsgrad)
Tidsramme: 52 uger, 240 uger
|
52 uger, 240 uger
|
|
|
At vurdere sikkerheden og tolerabiliteten af EFX gennem rapportering af uønskede hændelser (hyppighed af hændelser)
Tidsramme: 52 uger, 240 uger
|
52 uger, 240 uger
|
|
|
At vurdere sikkerheden og tolerabiliteten af EFX gennem rapportering af unormale kliniske laboratorietests, EKG'er, ultralyd, vurderinger af vitale tegn (antal patienter)
Tidsramme: 52 uger, 240 uger
|
52 uger, 240 uger
|
|
|
At vurdere immunogeniciteten af EFX gennem rapportering af antistof-antistoffer (antal patienter)
Tidsramme: 52 uger, 240 uger
|
52 uger, 240 uger
|
|
|
Resolution of NASH/MASH and no worsening of fibrosis
Tidsramme: 96 Weeks, 240 Weeks
|
Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
|
96 Weeks, 240 Weeks
|
|
Change from baseline of non-invasive markers of liver fibrosis: ELF score
Tidsramme: 52 Weeks
|
ELF (scale of 6.7 to 9.8 when higher scores indicative of increased fibrosis)
|
52 Weeks
|
|
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 in non-invasive markers of liver fibrosis: ELF score
Tidsramme: 96 Weeks, 240 Weeks
|
ELF score scale of 6.7 to 9.8 when higher scores are indicative of increased fibrosis
|
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
|
Week 240
|
|
|
Change from baseline of non-invasive markers of liver fibrosis: Fibroscan, CAP
Tidsramme: 52 Weeks
|
Liver stiffness assessed by transient elastography (FibroScan®) (kPa, CAP)
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AK-US-001-0105
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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