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NCT06528314PHASE3Recruiting

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

Akero Therapeutics, Inc

Start Date

9/4/2024

Completion Date

3/1/2030

Summary

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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

DRUG

Efruxifermin

DRUG

Placebo

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Conditions

NASH - Nonalcoholic SteatohepatitisMASH - Metabolic Dysfunction-Associated Steatohepatitis

Locations

Akero Clinical Study Site

Birmingham, Alabama 35209

United States

Akero Clinical Study Site

Dothan, Alabama 36301

United States

Akero Clinical Study Site

Chandler, Arizona 85224

United States

Akero Clinical Study Site

Flagstaff, Arizona 86001

United States

Akero Clinical Study Site

Peoria, Arizona 85381

United States

Akero Clinical Study Site

Scottsdale, Arizona 85258

United States

Akero Clinical Study Site

Tucson, Arizona 85712

United States

Akero Clinical Study Site

Tucson, Arizona 85712

United States

Akero Clinical Study Site

Tucson, Arizona 85713

United States

Akero Clinical Study Site

Tucson, Arizona 85715

United States

Akero Clinical Study Site

Conway, Arkansas 72032

United States

Akero Clinical Study Site

Jonesboro, Arkansas 72401

United States

Akero Clinical Study Site

Little Rock, Arkansas 72205

United States

Akero Clinical Study Site

North Little Rock, Arkansas 72117

United States

Akero Clinical Study Site

Coronado, California 92118

United States

Akero Clinical Study Site

Escondido, California 92025

United States

Akero Clinical Study Site

Folsom, California 95630

United States

Akero Clinical Study Site

Fountain Valley, California 92708

United States

Akero Clinical Study Site

Lancaster, California 93534

United States

Akero Clinical Study Site

Long Beach, California 90815

United States

Akero Clinical Study Site

Los Angeles, California 90048

United States

Akero Clinical Study Site

Newport Beach, California 92663

United States

Akero Clinical Study Site

Orange, California 92868

United States

Akero Clinical Study Site

Pasadena, California 91105

United States

Akero Clinical Study Site

Redwood City, California 94063

United States

Akero Clinical Study Site

Sacramento, California 95817

United States

Akero Clinical Study Site

San Francisco, California 94115

United States

Akero Clinical Study Site

San Francisco, California 94117

United States

Akero Clinical Study Site

San Jose, California 95116

United States

Akero Clinical Study Site

Tarzana, California 91356

United States

Akero Clinical Study Site

Aurora, Colorado 80045

United States

Akero Clinical Study Site

Colorado Springs, Colorado 80907

United States

Akero Clinical Study Site

Englewood, Colorado 80113

United States

Akero Clinical Study Site

New Haven, Connecticut 06511

United States

Akero Clinical Study Site

Washington D.C., District of Columbia 20422

United States

Akero Clinical Study Site

Bradenton, Florida 34208

United States

Akero Clinical Study Site

Brandon, Florida 33511

United States

Akero Clinical Study Site

Cutler Bay, Florida 33189

United States

Akero Clinical Study Site

Doral, Florida 33126

United States

Akero Clinical Study Site

Fort Myers, Florida 33912

United States

Akero Clinical Study Site

Hialeah Gardens, Florida 33016

United States

Akero Clinical Study Site

Inverness, Florida 34452

United States

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Lakewood Rch, Florida 34211

United States

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Largo, Florida 33777

United States

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Lehigh Acres, Florida 33936

United States

Akero Clinical Study Site

Margate, Florida 33063

United States

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Miami, Florida 33136

United States

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Miami, Florida 33175

United States

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Miami Gardens, Florida 33014

United States

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Naples, Florida 34102

United States

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New Port Richey, Florida 34653

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Ocala, Florida 34471

United States

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Orlando, Florida 32806

United States

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Orlando, Florida 32807

United States

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Pembroke Pines, Florida 33027

United States

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Riverview, Florida 33578

United States

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Sarasota, Florida 34240

United States

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Temple Terrace, Florida 33617

United States

Akero Clinical Study Site

Venice, Florida 34285

United States

Akero Clinical Study Site

Viera, Florida 32940

United States

Akero Clinical Study Site

Weston, Florida 33331

United States

Akero Clinical Study Site

Zephyrhills, Florida 33542

United States

Akero Clinical Study Site

Atlanta, Georgia 30309

United States

Akero Clinical Study Site

Gainesville, Georgia 30501

United States

Akero Clinical Study Site

Marietta, Georgia 30060

United States

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Snellville, Georgia 30078

United States

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Chicago, Illinois 60611

United States

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Hammond, Indiana 46324

United States

Akero Clinical Study Site

Indianapolis, Indiana 46202

United States

Akero Clinical Study Site

South Bend, Indiana 46635

United States

Akero Clinical Study Site

West Des Moines, Iowa 50265

United States

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Topeka, Kansas 66606

United States

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Louisville, Kentucky 40202

United States

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Bastrop, Louisiana 71220

United States

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Covington, Louisiana 70433

United States

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Houma, Louisiana 70363

United States

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Lafayette, Louisiana 70503

United States

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Marrero, Louisiana 70072

United States

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Metairie, Louisiana 70006

United States

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Shreveport, Louisiana 71105

United States

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West Monroe, Louisiana 71291

United States

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Baltimore, Maryland 21202

United States

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Bethesda, Maryland 20889-0004

United States

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South Dartmouth, Massachusetts 02747

United States

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Clinton Township, Michigan 48038

United States

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Novi, Michigan 48377

United States

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Southfield, Michigan 48075

United States

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Rochester, Minnesota 55905

United States

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Flowood, Mississippi 39232

United States

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Columbia, Missouri 65201

United States

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Kansas City, Missouri 64131

United States

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St Louis, Missouri 63110

United States

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St Louis, Missouri 63123

United States

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Las Vegas, Nevada 89106

United States

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Jackson, New Jersey 08527

United States

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Somers Point, New Jersey 08244

United States

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Sparta, New Jersey 07871

United States

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Buffalo, New York 14203

United States

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Manhasset, New York 11030

United States

Akero Clinical Study Site

New York, New York 10016

United States

Akero Clinical Study Site

New York, New York 10021

United States

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New York, New York 10029

United States

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Rochester, New York 14642

United States

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Chapel Hill, North Carolina 27516

United States

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Charlotte, North Carolina 28204

United States

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Charlotte, North Carolina 28207

United States

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Durham, North Carolina 27710

United States

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Fayetteville, North Carolina 28304

United States

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Morehead City, North Carolina 28557

United States

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Raleigh, North Carolina 27612

United States

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Statesville, North Carolina 28625

United States

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Akron, Ohio 44320

United States

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Springboro, Ohio 45066

United States

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Westlake, Ohio 44145

United States

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Oklahoma City, Oklahoma 73112

United States

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Hershey, Pennsylvania 17033

United States

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Philadelphia, Pennsylvania 19104

United States

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Philadelphia, Pennsylvania 19107

United States

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Pittsburgh, Pennsylvania 15213

United States

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Charleston, South Carolina 29425

United States

Akero Clinical Study Site

Columbia, South Carolina 29204

United States

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Summerville, South Carolina 29485

United States

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Clarksville, Tennessee 37040

United States

Akero Clinical Study Site

Hermitage, Tennessee 37076

United States

Akero Clinical Study Site

Nashville, Tennessee 37211

United States

Akero Clinical Study Site

Amarillo, Texas 79106

United States

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Arlington, Texas 76012

United States

Akero Clinical Study Site

Austin, Texas 78745

United States

Akero Clinical Study Site

Austin, Texas 78757

United States

Akero Clinical Study Site

Austin, Texas 78757

United States

Akero Clinical Study Site

Bellaire, Texas 77401

United States

Akero Clinical Study Site

Brownsville, Texas 78520

United States

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Corpus Christi, Texas 78404

United States

Akero Clinical Study Site

Dallas, Texas 75203

United States

Akero Clinical Study Site

Dallas, Texas 75216

United States

Akero Clinical Study Site

Dallas, Texas 75234

United States

Akero Clinical Study Site

Dallas, Texas 75246

United States

Akero Clinical Study Site

Dallas, Texas 75390

United States

Akero Clinical Study Site

Denison, Texas 75020

United States

Akero Clinical Study Site

Edinburg, Texas 78539

United States

Akero Clinical Study Site

Edinburg, Texas 78539

United States

Akero Clinical Study Site

Fort Sam Houston, Texas 78234

United States

Akero Clinical Study Site

Fort Worth, Texas 76104

United States

Akero Clinical Study Site

Garland, Texas 75044

United States

Akero Clinical Study Site

Houston, Texas 77030

United States

Akero Clinical Study Site

Houston, Texas 77030

United States

Akero Clinical Study Site

Houston, Texas 77030

United States

Akero Clinical Study Site

Houston, Texas 77074

United States

Akero Clinical Study Site

Houston, Texas 77079

United States

Akero Clinical Study Site

Pasadena, Texas 77505

United States

Akero Clinical Study Site

Pharr, Texas 78577

United States

Akero Clinical Study Site

San Antonio, Texas 78222

United States

Akero Clinical Study Site

San Antonio, Texas 78229

United States

Akero Clinical Study Site

San Antonio, Texas 78229

United States

Akero Clinical Study Site

San Antonio, Texas 78251

United States

Akero Clinical Study Site

Sugar Land, Texas 77478

United States

Akero Clinical Study Site

Sugar Land, Texas 77478

United States

Akero Clinical Study Site

Waco, Texas 76710

United States

Akero Clinical Study Site

Waco, Texas 76712

United States

Akero Clinical Study Site

Webster, Texas 77598

United States

Akero Clinical Study Site

Wichita Falls, Texas 76301

United States

Akero Clinical Study Site

Norfolk, Virginia 23502

United States

Akero Clinical Study Site

Richmond, Virginia 23226-1925

United States

Akero Clinical Study Site

Richmond, Virginia 23236

United States

Akero Clinical Study Site

Richmond, Virginia 23249

United States

Akero Clinical Study Site

Richmond, Virginia 23284

United States

Akero Clinical Study Site

Roanoke, Virginia 24014

United States

Akero Clinical Study Site

Seattle, Washington 98105

United States

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Madison, Wisconsin 53705

United States

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Ciudad Autónoma de Buenos Aires, Buenos Aires C1056ABI

Argentina

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Ciudad Autónoma de Buenos Aires, Buenos Aires C1199ABB

Argentina

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La Plata, Buenos Aires B1902AWL

Argentina

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Ramos Mejía, Buenos Aires B1704ETD

Argentina

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Buenos Aires, Distrito Federal C1406EEI

Argentina

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Rosario, Sante Fe S2002KDT

Argentina

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Buenos Aires, C1180AAX

Argentina

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Broadmeadow, New South Wales 2292

Australia

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Coffs Harbour, New South Wales 2450

Australia

Akero Clinical Study Site

Kingswood, New South Wales 2747

Australia

Akero Clinical Study Site

Liverpool, New South Wales 1871

Australia

Akero Clinical Study Site

Westmead, New South Wales 2145

Australia

Akero Clinical Study Site

Herston, Queensland 4029

Australia

Akero Clinical Study Site

Adelaide, South Australia 5000

Australia

Akero Clinical Study Site

Box Hill, Victoria 3128

Australia

Akero Clinical Study Site

Clayton, Victoria 3168

Australia

Akero Clinical Study Site

Epping, Victoria 3076

Australia

Akero Clinical Study Site

Heidelberg, Victoria 3084

Australia

Akero Clinical Study Site

Melbourne, Victoria 3004

Australia

Akero Clinical Study Site

Murdoch, Western Australia 6150

Australia

Akero Clinical Study Site

Nedlands, Western Australia 6009

Australia

Akero Clinical Study Site

Perth, Western Australia 6000

Australia

Akero Clinical Study Site

Brasília, Federal District 71681-603

Brazil

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Goiânia, Goiás 74690-900

Brazil

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Belo Horizonte, Minas Gerais 30220-140

Brazil

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Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Akero Clinical Study Site

Edmonton, Alberta T6G 2X8

Canada

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Toronto, Ontario M5G 2C4

Canada

Akero Clinical Study Site

Toronto, Ontario M6H 3M1

Canada

Akero Clinical Study Site

Vaughan, Ontario L4L 4Y7

Canada

Akero Clinical Study Site

Montreal, Quebec H2X 0A9

Canada

Akero Clinical Study Site

Terrebonne, Quebec J7B6B7

Canada

Akero Clinical Study Site

La Serena, Coquimbo Region 1700000

Chile

Akero Clinical Study Site

Las Condes, Santiago Metropolitan 7500000

Chile

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Santiago, Santiago Metropolitan 8320000

Chile

Akero Clinical Study Site

Santiago, Santiago Metropolitan 8330109

Chile

Akero Clinical Study Site

Santiago, Santiago Metropolitan 8380000

Chile

Akero Clinical Study Site

Strasbourg, Bas-Rhin 67200

France

Akero Clinical Study Site

Limoges, Haute-Vienne 87042

France

Akero Clinical Study Site

Lille, Hauts-de-France 59037

France

Akero Clinical Study Site

Clichy, Hauts-de-Seine 92118

France

Akero Clinical Study Site

Vandœuvre-lès-Nancy, Lorraine 54511

France

Akero Clinical Study Site

Angers, Maine-et-Loire 49933

France

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Toulouse, Occitanie 31059

France

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Marseille, Provence-Alpes-Côte d'Azur Region 13008

France

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Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region 34295

France

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Nice, Provence-Alpes-Côte d'Azur Region 06202

France

Akero Clinical Study Site

Lyon, Rhône 69004

France

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Créteil, Val-de-Marne 94010

France

Akero Clinical Study Site

Le Chesnay, Île-de-France Region 78150

France

Akero Clinical Study Site

Paris, Île-de-France Region 75013

France

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Frankfurt am Main, Hesse 60590

Germany

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Homburg, Saarland 66421

Germany

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Leipzig, Saxony 04103

Germany

Akero Clinical Study Site

Leipzig, Saxony 04103

Germany

Akero Clinical Study Site

Lübeck, Schleswig-Holstein 23538

Germany

Akero Clinical Study Site

Berlin, 13353

Germany

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Hyderabad, Andhra Pradesh 500 082

India

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Surat, Gujarat 395002

India

Akero Clinical Study Site

Surat, Gujarat 395009

India

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Vadodara, Gujarat 390007

India

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Mysore, Karnataka 570001

India

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Thiruvananthapuram, Kerala 695011

India

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Mumbai, Maharashtra 400008

India

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Mumbai, Maharashtra 400012

India

Akero Clinical Study Site

Nagpur, Maharashtra 440010

India

Akero Clinical Study Site

Pune, Maharashtra 412201

India

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New Delhi, National Capital Territory of Delhi 110 070

India

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New Delhi, National Capital Territory of Delhi 110029

India

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New Delhi, National Capital Territory of Delhi 110060

India

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Chandigarh, Punjab 160012

India

Akero Clinical Study Site

Ludhiana, Punjab 141002

India

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Jaipur, Rajasthan 302001

India

Akero Clinical Study Site

Jaipur, Rajasthan 302001

India

Akero Clinical Study Site

Coimbatore, Tamil Nadu 641005

India

Akero Clinical Study Site

Hyderabad, Telangana 500 004

India

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Varanasi, Uttar Pradesh 221005

India

Akero Clinical Study Site

Varanasi, Uttar Pradesh 221005

India

Akero Clinical Study Site

Rishikesh, Uttarakhand 249203

India

Akero Clinical Study Site

Kolkata, West Bengal 700020

India

Akero Clinical Study Site

Kolkata, West Bengal 700020

India

Akero Clinical Study Site

Kolkata, West Bengal 700073

India

Akero Clinical Study Site

Petah Tikva, Central District 4941492

Israel

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Ramat Gan, Central District 5265601

Israel

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Haifa, Haifa District 3436212

Israel

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Afula, Northern District 18101

Israel

Akero Clinical Study Site

Nahariya, Northern District 22100

Israel

Akero Clinical Study Site

Haifa, 3109601

Israel

Akero Clinical Study Site

Jerusalem, 9103102

Israel

Akero Clinical Study Site

Jerusalem, 9112001

Israel

Akero Clinical Study Site

Tel Aviv, 6423906

Israel

Akero Clinical Study Site

Tel Aviv, 69710

Israel

Akero Clinical Study Site

Foggia, Apulia 71122

Italy

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San Giovanni Rotondo, Foggia 71013

Italy

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Rozzano, Milan 20089

Italy

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Torino, Turin 10126

Italy

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Bologna, 40138

Italy

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Catania, 95100

Italy

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Messina, 98124

Italy

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Milan, 20122

Italy

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Milan, 20122

Italy

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Modena, 41124

Italy

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Novara, 28100

Italy

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Roma, 00168

Italy

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Acapulco de Juárez, Guerrero 39670

Mexico

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Guadalajara, Jalisco 44130

Mexico

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Cuauhtémoc, Mexico City 06700

Mexico

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Mexico City, Mexico City 01376

Mexico

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Mérida, Yucatán 97070

Mexico

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Benito Juárez, 3330

Mexico

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Mexico City, 14050

Mexico

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Poznan, Greater Poland Voivodeship 61-293

Poland

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Krakow, Lesser Poland Voivodeship 31-501

Poland

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Wroclaw, Lower Silesian Voivodeship 50-381

Poland

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Wroclaw, Lower Silesian Voivodeship 53-673

Poland

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Lodz, Lódzkie 91-473

Poland

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Warsaw, Masovian Voivodeship 00-215

Poland

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Warsaw, Masovian Voivodeship 02-672

Poland

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Gdansk, Pomeranian Voivodeship Poland 80-382

Poland

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Częstochowa, Silesian Voivodeship 42-202

Poland

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Katowice, Silesian Voivodeship 40-752

Poland

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Manati, 00674

Puerto Rico

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Mayagüez, 00680

Puerto Rico

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San Juan, 00927

Puerto Rico

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Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi] 41944

South Korea

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Incheon, Gyeonggi-do 22332

South Korea

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Goyang-si, Gyeonggido 10444

South Korea

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Daegu, Gyeongsangbugdo [Kyongsangbuk-do] 42601

South Korea

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Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi] 03080

South Korea

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Seoul, Seoul Teugbyeolsi 04763

South Korea

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Sabadell, Barcelona 08208

Spain

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Santander, Cantabria 39008

Spain

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Majadahonda, Madrid 28222

Spain

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Barcelona, 08035

Spain

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Madrid, 28007

Spain

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Madrid, 28027

Spain

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Seville, 41013

Spain

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Valencia, 46010

Spain

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Valencia, 46015

Spain

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Lugano, Canton Ticino 6900

Switzerland

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Bern, 3010

Switzerland

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Sankt Gallen, 9007

Switzerland

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Zurich, 8091

Switzerland

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Bornova, İzmir 35100

Turkey (Türkiye)

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Ankara, 06560

Turkey (Türkiye)

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Bursa, 16059

Turkey (Türkiye)

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Rize, 53020

Turkey (Türkiye)

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London, England SE5 9RS

United Kingdom

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Nottingham, England NG7 2UH

United Kingdom

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Birmingham, B15 2TH

United Kingdom

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London, NW3 2QG

United Kingdom

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London, SW10 9NH

United Kingdom

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Newcastle upon Tyne, NE7 7DN

United Kingdom

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Whitechapel, E1 1FR

United Kingdom