- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06215716
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).
The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of efruxifermin (EFX) in subjects with non-cirrhotic nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stage 2 or 3 (F2 or F3).
Approximately 1,650 subjects will be enrolled into 2 cohorts.
- 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Akero Study Director
- Phone Number: 650-487-6488
- Email: AkeroSynchrony@akerotx.com
Study Locations
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Buenos Aires, Argentina, C1118AAT
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0305
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Buenos Aires, Argentina, C1280AEB
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0301
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Buenos Aires, Argentina, C1180AAX
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0302
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Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0307
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La Plata, Buenos Aires, Argentina, B1902AWL
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0304
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Ramos Mejía, Buenos Aires, Argentina, B1704ETD
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0303
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentina, C1125ABE
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0306
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New South Wales
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Broadmeadow, New South Wales, Australia, 2292
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0408
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Coffs Harbour, New South Wales, Australia, 2450
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0418
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Kogarah, New South Wales, Australia, 2217
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0417
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Liverpool, New South Wales, Australia, 1871
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0413
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Penrith, New South Wales, Australia, 2750
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0416
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Westmead, New South Wales, Australia, 2145
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0401
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South Australia
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Adelaide, South Australia, Australia, 5000
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0407
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Victoria
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Caulfield South, Victoria, Australia, 3162
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0402
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Epping, Victoria, Australia, 3076
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0410
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Frankston, Victoria, Australia, 3128
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0412
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Heidelberg, Victoria, Australia, 3084
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0405
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Melbourne, Victoria, Australia, 3004
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0403
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0411
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Nedlands, Western Australia, Australia, 6009
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0415
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Perth, Western Australia, Australia, 6000
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0406
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Alberta
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Edmonton, Alberta, Canada, T6G 2X8
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0501
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Ontario
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Hamilton, Ontario, Canada, L8S 4K1
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0503
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Toronto, Ontario, Canada, M6H 3M1
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0502
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Vaughan, Ontario, Canada, L4L 4Y7
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0504
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0506
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Terrebonne, Quebec, Canada, J7B6B7
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0505
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Alpes-Maritimes
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Nice, Alpes-Maritimes, France, 06202
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0606
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, France, 69008
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0604
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Bas-Rhin
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Strasbourg, Bas-Rhin, France, 67091
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0607
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Haute-Vienne
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Limoges, Haute-Vienne, France, 87042
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0609
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Hauts-de-Seine
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Clichy, Hauts-de-Seine, France, 92110
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0603
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Lorraine
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Vandœuvre-lès-Nancy, Lorraine, France, 54511
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0611
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Maine-et-Loire
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Angers, Maine-et-Loire, France, 49933
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0602
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Occitanie
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Toulouse, Occitanie, France, 31059
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0610
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Provence-Alpes-Côte d'Azur Region
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Marseille, Provence-Alpes-Côte d'Azur Region, France, 13008
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0601
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Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, France, 34295
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0608
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Val-De-Marne
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Créteil, Val-De-Marne, France, 94010
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0614
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Yvelines, Île-de-France
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Versailles, Yvelines, Île-de-France, France, 78000
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0612
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Île-de-France Region
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Paris, Île-de-France Region, France, 75013
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0605
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Berlin, Germany, 10787
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0712
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Berlin, Germany, 13353
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0701
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Bavaria
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Würzburg, Bavaria, Germany, 97080
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0711
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Hesse
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Frankfurt am Main, Hesse, Germany, 60590
- Completed
- Akero Clinical Study Site
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Germany, 55131
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0710
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Saarland
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Homburg, Saarland, Germany, 66421
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0716
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Saxony
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Leipzig, Saxony, Germany, 04103
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0703
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Leipzig, Saxony, Germany, 04103
- Completed
- Akero Clinical Study Site
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 0713
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Gujarat
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Surat, Gujarat, India, 395002
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 1918
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Surat, Gujarat, India, 395009
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 1911
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Vadodara, Gujarat, India, 390007
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 1906
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Karnataka
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Mysore, Karnataka, India, 570001
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 1930
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Kerala
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Thiruvananthapuram, Kerala, India, 695011
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1922
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Maharashtra
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Dahegaon, Maharashtra, India, 441108
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1923
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Mumbai, Maharashtra, India, 400012
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1926
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Nagpur, Maharashtra, India, 440010
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1909
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Pune, Maharashtra, India, 412201
- Recruiting
- Akero Clinical Study Site
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Contact:
- Akero Site 1901
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110029
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1904
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New Delhi, National Capital Territory of Delhi, India, 110060
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1916
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New Delhi, National Capital Territory of Delhi, India, 110017
- Completed
- Akero Clinical Study Site
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New Delhi, National Capital Territory of Delhi, India, 110070
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1924
-
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Punjab
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Chandigarh, Punjab, India, 160012
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1908
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Rajasthan
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Jaipur, Rajasthan, India, 302001
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1902
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Tamil Nadu
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Coimbatore, Tamil Nadu, India, 641005
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1920
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Telangana
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Hyderabad, Telangana, India, 500 004
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1912
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Uttar Pradesh
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Varanasi, Uttar Pradesh, India, 221005
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1921
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West Bengal
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Kolkata, West Bengal, India, 700020
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1907
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Kolkata, West Bengal, India, 700073
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1917
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Jerusalem, Israel, 9103102
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0809
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Jerusalem, Israel, 9112001
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0808
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Tel Aviv, Israel, 6423906
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0801
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Central District
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Petah Tikva, Central District, Israel, 4941492
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0803
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Ramat Gan, Central District, Israel, 5265601
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0802
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Haifa District
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Haifa, Haifa District, Israel, 3109601
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0804
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Haifa, Haifa District, Israel, 3436212
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0806
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Northern District
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Afula, Northern District, Israel, 1834111
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0810
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Nahariya, Northern District, Israel, 22100
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0807
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Nazareth, Northern District, Israel, 1610001
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0805
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Bologna, Italy, 40138
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0908
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Foggia, Italy, 71122
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0909
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Messina, Italy, 98124
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0912
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Milan, Italy, 20122
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0902
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Modena, Italy, 41126
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0906
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Naples, Italy, 80131
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0907
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Novara, Italy, 28100
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0905
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Foggia
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San Giovanni Rotondo, Foggia, Italy, 71013
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0901
-
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Milan
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Rozzano, Milan, Italy, 20089
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0904
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Turin
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Torino, Turin, Italy, 10126
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0910
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Mexico City
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Cuauhtémoc, Mexico City, Mexico, 06700
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 8237
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Poland, 60-702
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1205
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Poland, 31-501
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1212
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1204
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Wroclaw, Lower Silesian Voivodeship, Poland, 53-673
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1213
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Poland, 00-215
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1211
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Warsaw, Masovian Voivodeship, Poland, 02-672
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1203
-
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Poland, 80-382
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1201
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Gdynia, Pomeranian Voivodeship, Poland, 81-537
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1202
-
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Silesian Voivodeship
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Częstochowa, Silesian Voivodeship, Poland, 42-202
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1206
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Katowice, Silesian Voivodeship, Poland, 40-040
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1208
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Katowice, Silesian Voivodeship, Poland, 40-081
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1209
-
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Poland, 90-127
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1214
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Manati, Puerto Rico, 00674
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0177
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Mayagüez, Puerto Rico, 00680
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0272
-
San Juan, Puerto Rico, 00927
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9215
-
-
-
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Daegu Gwang'yeogsi [Taegu-Kwangyokshi]
-
Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea, 41944
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1306
-
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, South Korea, 1232
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1303
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Incheon, Gyeonggi-do, South Korea, 22332
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1308
-
Seongnam-si, Gyeonggi-do, South Korea, 13620
- Completed
- Akero Clinical Study Site
-
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Gyeonggido [Kyonggi-do]
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Seongnam-si, Gyeonggido [Kyonggi-do], South Korea, 13520
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1307
-
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Gyeongsangbugdo [Kyongsangbuk-do]
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Daegu, Gyeongsangbugdo [Kyongsangbuk-do], South Korea, 42601
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1304
-
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Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
-
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 03080
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1301
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 04763
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1305
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-
-
-
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Barcelona, Spain, 08035
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1405
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Madrid, Spain, 28007
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1401
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Madrid, Spain, 28027
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1408
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Seville, Spain, 41013
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1402
-
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Barcelona
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Sabadell, Barcelona, Spain, 08208
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1409
-
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Cantabria
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Santander, Cantabria, Spain, 39008
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1406
-
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Madrid
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Majadahonda, Madrid, Spain, 28222
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1404
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València
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Valencia, València, Spain, 46015
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1403
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Valencia, València, Spain, 46026
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1407
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-
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Bern, Switzerland, 3010
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1502
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Sankt Gallen, Switzerland, 9007
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1501
-
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Canton of Solothurn
-
Olten, Canton of Solothurn, Switzerland, 4600
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1504
-
-
-
-
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Kaohsiung City, Taiwan, 833
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1602
-
Tainan, Taiwan, 704
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1603
-
Taoyuan, Taiwan, 333
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1605
-
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Changhua
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Changhua, Changhua, Taiwan, 500
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1604
-
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Taichung
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Taichung, Taichung, Taiwan, 40447
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1607
-
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Tainan
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Tainan, Tainan, Taiwan, 73657
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1606
-
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Taipei
-
Taipei City, Taipei, Taiwan, 10048
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1601
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-
-
-
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Bursa, Turkey (Türkiye), 16059
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1704
-
Rize, Turkey (Türkiye), 53020
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1706
-
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Ankara
-
Yenimahalle, Ankara, Turkey (Türkiye), 06500
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1705
-
-
İzmir
-
Bornova, İzmir, Turkey (Türkiye), 35100
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1703
-
-
-
-
England
-
Birmingham, England, United Kingdom, B15 2WB
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1804
-
Cambridge, England, United Kingdom, CB2 0QQ
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1801
-
Liverpool, England, United Kingdom, L9 7AL
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1816
-
London, England, United Kingdom, E1 1BB
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1809
-
London, England, United Kingdom, SW10 9NH
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1813
-
London, England, United Kingdom, SE5 9RS
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1806
-
London, England, United Kingdom, NW3 2QG
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1802
-
London, England, United Kingdom, W2 1NY
- Completed
- Akero Clinical Study Site
-
Newcastle upon Tyne, England, United Kingdom, NE7 7DN
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 1805
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0129
-
Dothan, Alabama, United States, 36301
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0233
-
-
Arizona
-
Chandler, Arizona, United States, 85224
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9106
-
Flagstaff, Arizona, United States, 86001
- Completed
- Akero Clinical Study Site
-
Peoria, Arizona, United States, 85381
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9104
-
Tucson, Arizona, United States, 85712
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9144
-
Tucson, Arizona, United States, 85715
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0209
-
Tucson, Arizona, United States, 85713
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0234
-
-
Arkansas
-
Conway, Arkansas, United States, 72032
- Completed
- Akero Clinical Study Site
-
Jonesboro, Arkansas, United States, 72401
- Completed
- Akero Clinical Study Site
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0106
-
North Little Rock, Arkansas, United States, 72117
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9214
-
-
California
-
Chula Vista, California, United States, 91910
- Completed
- Akero Clinical Study Site
-
Coronado, California, United States, 92118
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0132
-
Escondido, California, United States, 92025
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0266
-
Folsom, California, United States, 95630
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0263
-
Inglewood, California, United States, 90301
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0120
-
La Mesa, California, United States, 91942
- Completed
- Akero Clinical Study Site
-
Lancaster, California, United States, 93534
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0285
-
Lancaster, California, United States, 93534
- Completed
- Akero Clinical Study Site
-
Long Beach, California, United States, 90815
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0188
-
Los Angeles, California, United States, 90057
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0168
-
Los Angeles, California, United States, 90048
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0236
-
Los Angeles, California, United States, 90036
- Completed
- Akero Clinical Study Site
-
Newport Beach, California, United States, 92663
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0206
-
Orange, California, United States, 92868
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0261
-
Palm Springs, California, United States, 92262
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0197
-
Pasadena, California, United States, 91105
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9250
-
Redwood City, California, United States, 94063
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0191
-
Sacramento, California, United States, 95817
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0274
-
San Diego, California, United States, 92120
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0124
-
San Diego, California, United States, 92161
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0199
-
San Diego, California, United States, 92123
- Completed
- Akero Clinical Study Site
-
San Francisco, California, United States, 94115
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0147
-
San Francisco, California, United States, 94117
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0269
-
Santa Maria, California, United States, 93458
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0205
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0217
-
Colorado Springs, Colorado, United States, 80907
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0260
-
Englewood, Colorado, United States, 80113
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9243
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0213
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20007
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0268
-
Washington D.C., District of Columbia, United States, 20422
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0262
-
-
Florida
-
Bradenton, Florida, United States, 34208
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0153
-
Brandon, Florida, United States, 33511
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0222
-
Doral, Florida, United States, 33126
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0267
-
Fort Myers, Florida, United States, 33912
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9134
-
Gainesville, Florida, United States, 32610
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0114
-
Hialeah Gardens, Florida, United States, 33016
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9242
-
Inverness, Florida, United States, 34452
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9135
-
Jacksonville, Florida, United States, 32256
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0118
-
Lady Lake, Florida, United States, 32159
- Completed
- Akero Clinical Study Site
-
Lakewood Rch, Florida, United States, 34211
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9203
-
Largo, Florida, United States, 33777
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9248
-
Lehigh Acres, Florida, United States, 33936
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0271
-
Maitland, Florida, United States, 32751
- Completed
- Akero Clinical Study Site
-
Margate, Florida, United States, 33063
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0248
-
Miami, Florida, United States, 33136
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0137
-
Miami, Florida, United States, 33175
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0252
-
Miami Gardens, Florida, United States, 33014
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0243
-
Miami Lakes, Florida, United States, 33016
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9138
-
Naples, Florida, United States, 34102
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0138
-
New Port Richey, Florida, United States, 34653
- Completed
- Akero Clinical Study Site
-
Ocala, Florida, United States, 34471
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9127
-
Orlando, Florida, United States, 32807
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0250
-
Pembroke Pines, Florida, United States, 33027
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0239
-
Port Orange, Florida, United States, 32127
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9105
-
Riverview, Florida, United States, 33578
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0295
-
Sarasota, Florida, United States, 34240
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9218
-
Temple Terrace, Florida, United States, 33617
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0242
-
Venice, Florida, United States, 34285
- Completed
- Akero Clinical Study Site
-
Viera, Florida, United States, 32940
- Completed
- Akero Clinical Study Site
-
West Palm Beach, Florida, United States, 33401
- Completed
- Akero Clinical Study Site
-
Weston, Florida, United States, 33331
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0270
-
Winter Park, Florida, United States, 32789
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0157
-
Winter Park, Florida, United States, 32792
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0187
-
Zephyrhills, Florida, United States, 33542
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0235
-
-
Georgia
-
Atlanta, Georgia, United States, 30309
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0230
-
Columbus, Georgia, United States, 31904
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0156
-
Gainesville, Georgia, United States, 30501
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0183
-
Marietta, Georgia, United States, 30060
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9111
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9245
-
-
Indiana
-
Hammond, Indiana, United States, 46324
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0254
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0290
-
South Bend, Indiana, United States, 46635
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9235
-
-
Iowa
-
West Des Moines, Iowa, United States, 50265
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0146
-
-
Kansas
-
Topeka, Kansas, United States, 66606
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9136
-
Wichita, Kansas, United States, 67205
- Completed
- Akero Clinical Study Site
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0203
-
-
Louisiana
-
Bastrop, Louisiana, United States, 71220
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9220
-
Covington, Louisiana, United States, 70433
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0195
-
Houma, Louisiana, United States, 70363
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0112
-
Marrero, Louisiana, United States, 70072
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9102
-
Metairie, Louisiana, United States, 70006
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0109
-
New Orleans, Louisiana, United States, 70121
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0176
-
New Orleans, Louisiana, United States, 70112
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0196
-
Shreveport, Louisiana, United States, 71105
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9145
-
West Monroe, Louisiana, United States, 71291
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0283
-
-
Maryland
-
Baltimore, Maryland, United States, 21202
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0108
-
Glen Burnie, Maryland, United States, 21061
- Completed
- Akero Clinical Study Site
-
Greenbelt, Maryland, United States, 20770
- Completed
- Akero Clinical Study Site
-
-
Massachusetts
-
New Bedford, Massachusetts, United States, 02740
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0181
-
-
Michigan
-
Novi, Michigan, United States, 48377
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0204
-
Southfield, Michigan, United States, 48075
- Completed
- Akero Clinical Study Site
-
Wyoming, Michigan, United States, 49519
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0107
-
Ypsilanti, Michigan, United States, 48197
- Active, not recruiting
- Akero Clinical Study Site
-
-
Mississippi
-
Flowood, Mississippi, United States, 39232
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0277
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0141
-
Kansas City, Missouri, United States, 64131
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9208
-
St Louis, Missouri, United States, 63123
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0296
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9142
-
Las Vegas, Nevada, United States, 89109
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9219
-
Reno, Nevada, United States, 89511
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9240
-
-
New Jersey
-
Florham Park, New Jersey, United States, 07932
- Completed
- Akero Clinical Study Site
-
Jackson, New Jersey, United States, 08527
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0105
-
Ridgewood, New Jersey, United States, 07450
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0287
-
Somers Point, New Jersey, United States, 08244
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0116
-
Sparta, New Jersey, United States, 07871
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0117
-
-
New Mexico
-
Santa Fe, New Mexico, United States, 87505
- Completed
- Akero Clinical Study Site
-
-
New York
-
Buffalo, New York, United States, 14203
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0241
-
Manhasset, New York, United States, 11030
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0208
-
New York, New York, United States, 10029
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0160
-
New York, New York, United States, 10016
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0198
-
New York, New York, United States, 10021
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0148
-
New York, New York, United States, 10033
- Completed
- Akero Clinical Study Site
-
Rochester, New York, United States, 55905
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0240
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0192
-
Charlotte, North Carolina, United States, 28204
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9147
-
Durham, North Carolina, United States, 27710
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0224
-
Fayetteville, North Carolina, United States, 28303
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9227
-
Morehead City, North Carolina, United States, 28557
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9128
-
New Bern, North Carolina, United States, 28562
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0166
-
Raleigh, North Carolina, United States, 27612
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0169
-
Statesville, North Carolina, United States, 28625
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0142
-
-
Ohio
-
Columbus, Ohio, United States, 43213
- Completed
- Akero Clinical Study Site
-
Dayton, Ohio, United States, 45414
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0127
-
Springboro, Ohio, United States, 45066
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9233
-
Westlake, Ohio, United States, 44145
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9226
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0264
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9132
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0207
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0102
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0246
-
Columbia, South Carolina, United States, 29204
- Completed
- Akero Clinical Study Site
-
Summerville, South Carolina, United States, 29485
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9238
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37421
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0175
-
Clarksville, Tennessee, United States, 37040
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0144
-
Hermitage, Tennessee, United States, 37076
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9123
-
Nashville, Tennessee, United States, 37211
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9130
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0104
-
Austin, Texas, United States, 78745
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0131
-
Austin, Texas, United States, 78757
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0281
-
Bellaire, Texas, United States, 77401
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0165
-
Brownsville, Texas, United States, 78520
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0154
-
Corpus Christi, Texas, United States, 78404
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0223
-
Dallas, Texas, United States, 75230
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0128
-
Dallas, Texas, United States, 75203
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0126
-
Dallas, Texas, United States, 75234
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0221
-
Dallas, Texas, United States, 75390
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0164
-
Dallas, Texas, United States, 75216
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0253
-
Denison, Texas, United States, 75020
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0244
-
Edinburg, Texas, United States, 78539
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9117
-
Forney, Texas, United States, 75126
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0286
-
Fort Worth, Texas, United States, 76104
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9211
-
Houston, Texas, United States, 77079
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0265
-
Houston, Texas, United States, 77074
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0249
-
Houston, Texas, United States, 77004
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0293
-
Houston, Texas, United States, 77030
- Completed
- Akero Clinical Study Site
-
Houston, Texas, United States, 77084
- Completed
- Akero Clinical Study Site
-
Lewisville, Texas, United States, 75057
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0135
-
McAllen, Texas, United States, 78504
- Completed
- Akero Clinical Study Site
-
McAllen, Texas, United States, 78539
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9205
-
Pasadena, Texas, United States, 77505
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0292
-
San Antonio, Texas, United States, 78222
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0185
-
San Antonio, Texas, United States, 78229
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9202
-
San Antonio, Texas, United States, 78258
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9116
-
San Antonio, Texas, United States, 78215
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9103
-
San Antonio, Texas, United States, 78209
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9116
-
San Antonio, Texas, United States, 78240
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0140
-
San Antonio, Texas, United States, 782531
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0289
-
San Marcos, Texas, United States, 78666
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9141
-
San Marcos, Texas, United States, 78666-7502
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9141
-
Waco, Texas, United States, 76710
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9246
-
Waco, Texas, United States, 76712
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0279
-
Webster, Texas, United States, 77598
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9204
-
Wichita Falls, Texas, United States, 76301
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9247
-
-
Utah
-
Ogden, Utah, United States, 84405
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9230
-
Salt Lake City, Utah, United States, 84117
- Completed
- Akero Clinical Study Site
-
Sandy City, Utah, United States, 84092
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9241
-
South Ogden, Utah, United States, 84405
- Completed
- Akero Clinical Study Site
-
-
Virginia
-
Falls Church, Virginia, United States, 22042-3300
- Completed
- Akero Clinical Study Site
-
Newport News, Virginia, United States, 23602
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0170
-
Norfolk, Virginia, United States, 23502
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0143
-
Richmond, Virginia, United States, 23235
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0103
-
Richmond, Virginia, United States, 23249
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9120
-
Richmond, Virginia, United States, 23226
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0212
-
Richmond, Virginia, United States, 23298
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 9115
-
Roanoke, Virginia, United States, 24014
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0139
-
Suffolk, Virginia, United States, 23435
- Completed
- Akero Clinical Study Site
-
-
Washington
-
Seattle, Washington, United States, 98105
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0119
-
Spokane, Washington, United States, 99218
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0155
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- Recruiting
- Akero Clinical Study Site
-
Contact:
- Akero Site 0259
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
- Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
- Steatosis (scored 0 to 3),
- Ballooning degeneration (scored 0 to 2), and
- Lobular inflammation (scored 0 to 3).
- Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS <4 may be enrolled and are not required to meet 1 point in each of the components of NAS.
Exclusion Criteria:
- Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
- Presence of cirrhosis on liver biopsy (fibrosis stage 4).
- Type 1 or uncontrolled Type 2 diabetes.
Other inclusion and exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Administered by subcutaneous injection
|
|
Experimental: EFX 28 mg
|
Administered by subcutaneous injection
|
|
Experimental: EFX 50 mg
|
Administered by subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis
Time Frame: 52 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)
|
52 Weeks
|
|
Event-free survival
Time Frame: 240 Weeks
|
Based on time from randomization to the first clinical event including evidence of disease progression, liver decompensation events, liver transplantation or eligibility for liver transplantation, and all-cause mortality.
|
240 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cohort 1 Only: Resolution of NASH/MASH and no worsening of fibrosis
Time Frame: 52 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)
|
52 Weeks
|
|
Cohort 1 Only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
Time Frame: 52 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)
|
52 Weeks
|
|
Change from baseline of body weight (kg)
Time Frame: 52 Weeks, 240 Weeks
|
52 Weeks, 240 Weeks
|
|
|
To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)
Time Frame: 52 Weeks, 240 Weeks
|
52 Weeks, 240 Weeks
|
|
|
To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)
Time Frame: 52 Weeks, 240 Weeks
|
52 Weeks, 240 Weeks
|
|
|
To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)
Time Frame: 52 Weeks, 240 Weeks
|
52 Weeks, 240 Weeks
|
|
|
To assess the safety and tolerability of EFX through the reporting of abnormal clinical laboratory tests, ECGs, ultrasounds, vital sign assessments (number of patients)
Time Frame: 52 Weeks, 240 Weeks
|
52 Weeks, 240 Weeks
|
|
|
To assess the immunogenicity of EFX through the reporting of antidrug antibodies (number of patients)
Time Frame: 52 Weeks, 240 Weeks
|
52 Weeks, 240 Weeks
|
|
|
Resolution of NASH/MASH and no worsening of fibrosis
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: Week 240
|
Week 240
|
|
|
Change from baseline of non-invasive markers of liver fibrosis: Fibroscan, CAP
Time Frame: 52 Weeks
|
Liver stiffness assessed by transient elastography (FibroScan®) (kPa, CAP)
|
52 Weeks
|
|
Change from baseline of non-invasive markers of liver fibrosis: Fibroscan
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 52 Weeks, 240 Weeks
|
HbA1c (%)
|
52 Weeks, 240 Weeks
|
|
Change from baseline of markers of insulin sensitivity and glycemic control: Adiponectin
Time Frame: 52 Weeks, 240 Weeks
|
Adiponectin (mg/L)
|
52 Weeks, 240 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AK-US-001-0105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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