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Recruiting Phase 3 NCT06528314

A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Phase 3 – large-scale trial before approval
Conditions: NASH - Nonalcoholic Steatohepatitis MASH - Metabolic Dysfunction-Associated Steatohepatitis

Sponsor: Akero Therapeutics, Inc

trial.available_in: БГ
Overview
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
Who can participate
Inclusion Criteria: * Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of \>=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities * Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH Exclusion Criteria: * Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results * Type 1 diabetes or unstable Type 2 diabetes * Any current or prior history of decompensated liver disease Other inclusion and exclusion criteria may apply.
Interventions
Efruxifermin
DRUG
Placebo
DRUG
Locations 318
Argentina (7)
Akero Clinical Study Site
Buenos Aires , Buenos Aires
Akero Clinical Study Site
Buenos Aires , Distrito Federal
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Akero Clinical Study Site
Ciudad Autónoma de Buenos Aires , Buenos Aires
Akero Clinical Study Site
Ciudad Autónoma de Buenos Aires , Buenos Aires
Akero Clinical Study Site
La Plata , Buenos Aires
Akero Clinical Study Site
Ramos Mejía , Buenos Aires
Akero Clinical Study Site
Rosario , Sante Fe
Australia (14)
Akero Clinical Study Site
Adelaide , South Australia
Akero Clinical Study Site
Box Hill , Victoria
Akero Clinical Study Site
Broadmeadow , New South Wales
Akero Clinical Study Site
Clayton , Victoria
Akero Clinical Study Site
Epping , Victoria
Akero Clinical Study Site
Heidelberg , Victoria
Akero Clinical Study Site
Herston , Queensland
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Kingswood , New South Wales
Akero Clinical Study Site
Liverpool , New South Wales
Akero Clinical Study Site
Melbourne , Victoria
Akero Clinical Study Site
Murdoch , Western Australia
Akero Clinical Study Site
Nedlands , Western Australia
Akero Clinical Study Site
Perth , Western Australia
Akero Clinical Study Site
Westmead , New South Wales
Brazil (4)
Akero Clinical Study Site
Belo Horizonte , Minas Gerais
Akero Clinical Study Site
Brasília , Federal District
ACTIVE_NOT_RECRUITING
Akero Clinical Study Site
Goiânia , Goiás
Akero Clinical Study Site
Porto Alegre , Rio Grande do Sul
Canada (6)
Akero Clinical Study Site
Edmonton , Alberta
Akero Clinical Study Site
Montreal , Quebec
Akero Clinical Study Site
Terrebonne , Quebec
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Toronto , Ontario
Akero Clinical Study Site
Toronto , Ontario
Akero Clinical Study Site
Vaughan , Ontario
Chile (5)
Akero Clinical Study Site
La Serena , Coquimbo Region
Akero Clinical Study Site
Las Condes , Santiago Metropolitan
Akero Clinical Study Site
Santiago , Santiago Metropolitan
Akero Clinical Study Site
Santiago , Santiago Metropolitan
Akero Clinical Study Site
Santiago , Santiago Metropolitan
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France (14)
Akero Clinical Study Site
Angers , Maine-et-Loire
Akero Clinical Study Site
Clichy , Hauts-de-Seine
Akero Clinical Study Site
Créteil , Val-de-Marne
Akero Clinical Study Site
Le Chesnay , Île-de-France Region
Akero Clinical Study Site
Lille , Hauts-de-France
Akero Clinical Study Site
Limoges , Haute-Vienne
Akero Clinical Study Site
Lyon , Rhône
Akero Clinical Study Site
Marseille , Provence-Alpes-Côte d'Azur Region
Akero Clinical Study Site
Montpellier Cedex 5 , Provence-Alpes-Côte d'Azur Region
Akero Clinical Study Site
Nice , Provence-Alpes-Côte d'Azur Region
Akero Clinical Study Site
Paris , Île-de-France Region
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Strasbourg , Bas-Rhin
Akero Clinical Study Site
Toulouse , Occitanie
Akero Clinical Study Site
Vandœuvre-lès-Nancy , Lorraine
Germany (6)
Akero Clinical Study Site
Berlin , State of Berlin
Akero Clinical Study Site
Frankfurt am Main , Hesse
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Homburg , Saarland
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Leipzig , Saxony
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Leipzig , Saxony
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Lübeck , Schleswig-Holstein
India (25)
Akero Clinical Study Site
Chandigarh , Punjab
Akero Clinical Study Site
Coimbatore , Tamil Nadu
Akero Clinical Study Site
Hyderabad , Andhra Pradesh
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Hyderabad , Telangana
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Jaipur , Rajasthan
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Jaipur , Rajasthan
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Kolkata , West Bengal
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Kolkata , West Bengal
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Kolkata , West Bengal
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Ludhiana , Punjab
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Mumbai , Maharashtra
Akero Clinical Study Site
Mumbai , Maharashtra
Akero Clinical Study Site
Mysore , Karnataka
Akero Clinical Study Site
Nagpur , Maharashtra
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New Delhi , National Capital Territory of Delhi
Akero Clinical Study Site
New Delhi , National Capital Territory of Delhi
Akero Clinical Study Site
New Delhi , National Capital Territory of Delhi
Akero Clinical Study Site
Pune , Maharashtra
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Akero Clinical Study Site
Rishikesh , Uttarakhand
Akero Clinical Study Site
Surat , Gujarat
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Surat , Gujarat
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Thiruvananthapuram , Kerala
Akero Clinical Study Site
Vadodara , Gujarat
Akero Clinical Study Site
Varanasi , Uttar Pradesh
Akero Clinical Study Site
Varanasi , Uttar Pradesh
Israel (10)
Akero Clinical Study Site
Afula , Northern District
Akero Clinical Study Site
Haifa , Haifa District
Akero Clinical Study Site
Haifa , Haifa District
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Jerusalem , Jerusalem
Akero Clinical Study Site
Jerusalem , Jerusalem
Akero Clinical Study Site
Nahariya , Northern District
Akero Clinical Study Site
Petah Tikva , Central District
ACTIVE_NOT_RECRUITING
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Ramat Gan , Central District
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Tel Aviv , Tel Aviv
Akero Clinical Study Site
Tel Aviv , Tel Aviv
Italy (11)
Akero Clinical Study Site
Bologna
Akero Clinical Study Site
Catania
Akero Clinical Study Site
Foggia , Apulia
Akero Clinical Study Site
Messina , Messina
Akero Clinical Study Site
Milan , Milan
Akero Clinical Study Site
Milan , Milan
Akero Clinical Study Site
Modena
Akero Clinical Study Site
Novara , Novara
Akero Clinical Study Site
Rozzano , Milan
Akero Clinical Study Site
San Giovanni Rotondo , Foggia
Akero Clinical Study Site
Torino , Turin
Mexico (7)
Akero Clinical Study Site
Acapulco de Juárez , Guerrero
Akero Clinical Study Site
Benito Juárez
Akero Clinical Study Site
Cuauhtémoc , Mexico City
Akero Clinical Study Site
Guadalajara , Jalisco
Akero Clinical Study Site
Mérida , Yucatán
Akero Clinical Study Site
Mexico City , Mexico City
Akero Clinical Study Site
Mexico City
Poland (10)
Akero Clinical Study Site
Częstochowa , Silesian Voivodeship
Akero Clinical Study Site
Gdansk , Pomeranian Voivodeship
Akero Clinical Study Site
Katowice , Silesian Voivodeship
Akero Clinical Study Site
Krakow , Lesser Poland Voivodeship
Akero Clinical Study Site
Lodz , Lódzkie
Akero Clinical Study Site
Poznan , Greater Poland Voivodeship
Akero Clinical Study Site
Warsaw , Masovian Voivodeship
Akero Clinical Study Site
Warsaw , Masovian Voivodeship
Akero Clinical Study Site
Wroclaw , Lower Silesian Voivodeship
Akero Clinical Study Site
Wroclaw , Lower Silesian Voivodeship
Puerto Rico (3)
Akero Clinical Study Site
Manati , Manatí
Akero Clinical Study Site
Mayagüez , Puerto Rico
Akero Clinical Study Site
San Juan , Puerto Rico
South Korea (6)
Akero Clinical Study Site
Daegu , Daegu Gwang'Yeogsi [Taegu-Kwangyokshi]
Akero Clinical Study Site
Daegu , Gyeongsangbugdo [Kyongsangbuk-do]
Akero Clinical Study Site
Goyang-si , Gyeonggido
Akero Clinical Study Site
Incheon , Gyeonggi-do
Akero Clinical Study Site
Seoul , Seoul Teugbyeolsi [Seoul-T'Ukpyolshi]
Akero Clinical Study Site
Seoul , Seoul Teugbyeolsi
Spain (9)
Akero Clinical Study Site
Barcelona , Barcelona
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Madrid , Madrid
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Madrid , Madrid
Akero Clinical Study Site
Majadahonda , Madrid
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Sabadell , Barcelona
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Santander , Cantabria
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Seville , Sevilla
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Valencia , Valencia
Akero Clinical Study Site
Valencia , Valencia
Switzerland (4)
Akero Clinical Study Site
Bern , Canton of Bern
Akero Clinical Study Site
Lugano , Canton Ticino
Akero Clinical Study Site
Sankt Gallen , Canton of St. Gallen
Akero Clinical Study Site
Zurich , Canton of Zurich
Turkey (3)
Akero Clinical Study Site
Ankara , Ankara
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Akero Clinical Study Site
Bursa , Bursa
Akero Clinical Study Site
Rize , Rize Province
United Kingdom (7)
Akero Clinical Study Site
Birmingham
Akero Clinical Study Site
London , England
Akero Clinical Study Site
London
Akero Clinical Study Site
London
Akero Clinical Study Site
Newcastle upon Tyne
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Nottingham , England
Akero Clinical Study Site
Whitechapel
United States (167)
Akero Clinical Study Site
Akron , Ohio
Akero Clinical Study Site
Amarillo , Texas
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Atlanta , Georgia
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Aurora , Colorado
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Austin , Texas
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Austin , Texas
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Austin , Texas
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Baltimore , Maryland
Akero Clinical Study Site
Bastrop , Louisiana
Akero Clinical Study Site
Bellaire , Texas
Akero Clinical Study Site
Bethesda , Maryland
Akero Clinical Study Site
Birmingham , Alabama
Akero Clinical Study Site
Bradenton , Florida
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Brandon , Florida
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Brownsville , Texas
Akero Clinical Study Site
Buffalo , New York
Akero Clinical Study Site
Chandler , Arizona
Akero Clinical Study Site
Chapel Hill , North Carolina
Akero Clinical Study Site
Charleston , South Carolina
Akero Clinical Study Site
Charlotte , North Carolina
Akero Clinical Study Site
Charlotte , North Carolina
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Chicago , Illinois
Akero Clinical Study Site
Clarksville , Tennessee
Akero Clinical Study Site
Clinton Township , Michigan
ACTIVE_NOT_RECRUITING
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Colorado Springs , Colorado
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Columbia , South Carolina
Akero Clinical Study Site
Columbia , Missouri
Akero Clinical Study Site
Conway , Arkansas
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Coronado , California
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Corpus Christi , Texas
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Covington , Louisiana
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Cutler Bay , Florida
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Dallas , Texas
Akero Clinical Study Site
Dallas , Texas
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Dallas , Texas
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Dallas , Texas
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Dallas , Texas
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Denison , Texas
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Doral , Florida
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Dothan , Alabama
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Durham , North Carolina
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Edinburg , Texas
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Edinburg , Texas
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Englewood , Colorado
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Escondido , California
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Fayetteville , North Carolina
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Flagstaff , Arizona
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Flowood , Mississippi
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Folsom , California
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Fort Myers , Florida
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Fort Sam Houston , Texas
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Fort Worth , Texas
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Gainesville , Georgia
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Garland , Texas
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Hammond , Indiana
Akero Clinical Study Site
Hermitage , Tennessee
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Hershey , Pennsylvania
Akero Clinical Study Site
Hialeah Gardens , Florida
Akero Clinical Study Site
Houma , Louisiana
Akero Clinical Study Site
Houston , Texas
Akero Clinical Study Site
Houston , Texas
Akero Clinical Study Site
Houston , Texas
Akero Clinical Study Site
Houston , Texas
Akero Clinical Study Site
Houston , Texas
Akero Clinical Study Site
Indianapolis , Indiana
Akero Clinical Study Site
Inverness , Florida
Akero Clinical Study Site
Jackson , New Jersey
Akero Clinical Study Site
Jonesboro , Arkansas
ACTIVE_NOT_RECRUITING
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Kansas City , Missouri
Akero Clinical Study Site
Lafayette , Louisiana
Akero Clinical Study Site
Lakewood Rch , Florida
Akero Clinical Study Site
Lancaster , California
Akero Clinical Study Site
Largo , Florida
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Las Vegas , Nevada
Akero Clinical Study Site
Lehigh Acres , Florida
Akero Clinical Study Site
Little Rock , Arkansas
Akero Clinical Study Site
Long Beach , California
Akero Clinical Study Site
Los Angeles , California
Akero Clinical Study Site
Louisville , Kentucky
Akero Clinical Study Site
Madison , Wisconsin
Akero Clinical Study Site
Manhasset , New York
Akero Clinical Study Site
Margate , Florida
Akero Clinical Study Site
Marietta , Georgia
Akero Clinical Study Site
Marrero , Louisiana
Akero Clinical Study Site
Metairie , Louisiana
Akero Clinical Study Site
Miami , Florida
Akero Clinical Study Site
Miami , Florida
Akero Clinical Study Site
Miami Gardens , Florida
Akero Clinical Study Site
Morehead City , North Carolina
Akero Clinical Study Site
Naples , Florida
Akero Clinical Study Site
Nashville , Tennessee
Akero Clinical Study Site
New Haven , Connecticut
Akero Clinical Study Site
New Port Richey , Florida
Akero Clinical Study Site
New York , New York
Akero Clinical Study Site
New York , New York
Akero Clinical Study Site
New York , New York
Akero Clinical Study Site
Newport Beach , California
Akero Clinical Study Site
Norfolk , Virginia
Akero Clinical Study Site
North Little Rock , Arkansas
Akero Clinical Study Site
Novi , Michigan
Akero Clinical Study Site
Ocala , Florida
Akero Clinical Study Site
Oklahoma City , Oklahoma
Akero Clinical Study Site
Orange , California
Akero Clinical Study Site
Orlando , Florida
ACTIVE_NOT_RECRUITING
Akero Clinical Study Site
Orlando , Florida
Akero Clinical Study Site
Pasadena , Texas
Akero Clinical Study Site
Pasadena , California
Akero Clinical Study Site
Pembroke Pines , Florida
Akero Clinical Study Site
Peoria , Arizona
Akero Clinical Study Site
Pharr , Texas
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Philadelphia , Pennsylvania
Akero Clinical Study Site
Philadelphia , Pennsylvania
Akero Clinical Study Site
Pittsburgh , Pennsylvania
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Raleigh , North Carolina
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Redwood City , California
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Richmond , Virginia
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Richmond , Virginia
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Richmond , Virginia
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Richmond , Virginia
Akero Clinical Study Site
Riverview , Florida
Akero Clinical Study Site
Roanoke , Virginia
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Rochester , Minnesota
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Rochester , New York
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Russells Mills , Massachusetts
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Sacramento , California
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San Antonio , Texas
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San Antonio , Texas
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San Antonio , Texas
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San Antonio , Texas
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San Francisco , California
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San Francisco , California
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San Jose , California
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Sarasota , Florida
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Scottsdale , Arizona
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Seattle , Washington
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Shreveport , Louisiana
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Snellville , Georgia
ACTIVE_NOT_RECRUITING
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Somers Point , New Jersey
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South Bend , Indiana
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Southfield , Michigan
Akero Clinical Study Site
Sparta , New Jersey
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Springboro , Ohio
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St Louis , Missouri
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St Louis , Missouri
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Statesville , North Carolina
Akero Clinical Study Site
Sugar Land , Texas
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Sugar Land , Texas
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Summerville , South Carolina
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Tarzana , California
Akero Clinical Study Site
Temple Terrace , Florida
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Topeka , Kansas
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Tucson , Arizona
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Tucson , Arizona
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Tucson , Arizona
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Tucson , Arizona
Akero Clinical Study Site
Venice , Florida
ACTIVE_NOT_RECRUITING
Akero Clinical Study Site
Viera , Florida
ACTIVE_NOT_RECRUITING
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Waco , Texas
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Waco , Texas
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Washington D.C. , District of Columbia
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Webster , Texas
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West Des Moines , Iowa
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West Monroe , Louisiana
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Westlake , Ohio
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Weston , Florida
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Wichita Falls , Texas
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Zephyrhills , Florida
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
04.09.2024
Completion date
01.03.2030
Registry ID
NCT06528314
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.