RecruitingPhase 3NCT06528314

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH


Sponsor

Akero Therapeutics, Inc

Enrollment

1,150 participants

Start Date

Sep 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
  • Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

Exclusion Criteria3

  • 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

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Interventions

DRUGEfruxifermin

Administered by subcutaneous injection

DRUGPlacebo

Administered by subcutaneous injection


Locations(316)

Akero Clinical Study Site

Birmingham, Alabama, United States

Akero Clinical Study Site

Dothan, Alabama, United States

Akero Clinical Study Site

Chandler, Arizona, United States

Akero Clinical Study Site

Flagstaff, Arizona, United States

Akero Clinical Study Site

Peoria, Arizona, United States

Akero Clinical Study Site

Scottsdale, Arizona, United States

Akero Clinical Study Site

Tucson, Arizona, United States

Akero Clinical Study Site

Tucson, Arizona, United States

Akero Clinical Study Site

Tucson, Arizona, United States

Akero Clinical Study Site

Tucson, Arizona, United States

Akero Clinical Study Site

Conway, Arkansas, United States

Akero Clinical Study Site

Jonesboro, Arkansas, United States

Akero Clinical Study Site

Little Rock, Arkansas, United States

Akero Clinical Study Site

North Little Rock, Arkansas, United States

Akero Clinical Study Site

Coronado, California, United States

Akero Clinical Study Site

Escondido, California, United States

Akero Clinical Study Site

Folsom, California, United States

Akero Clinical Study Site

Lancaster, California, United States

Akero Clinical Study Site

Long Beach, California, United States

Akero Clinical Study Site

Los Angeles, California, United States

Akero Clinical Study Site

Newport Beach, California, United States

Akero Clinical Study Site

Orange, California, United States

Akero Clinical Study Site

Pasadena, California, United States

Akero Clinical Study Site

Redwood City, California, United States

Akero Clinical Study Site

Sacramento, California, United States

Akero Clinical Study Site

San Francisco, California, United States

Akero Clinical Study Site

San Francisco, California, United States

Akero Clinical Study Site

San Jose, California, United States

Akero Clinical Study Site

Tarzana, California, United States

Akero Clinical Study Site

Aurora, Colorado, United States

Akero Clinical Study Site

Colorado Springs, Colorado, United States

Akero Clinical Study Site

Englewood, Colorado, United States

Akero Clinical Study Site

New Haven, Connecticut, United States

Akero Clinical Study Site

Washington D.C., District of Columbia, United States

Akero Clinical Study Site

Bradenton, Florida, United States

Akero Clinical Study Site

Brandon, Florida, United States

Akero Clinical Study Site

Cutler Bay, Florida, United States

Akero Clinical Study Site

Doral, Florida, United States

Akero Clinical Study Site

Fort Myers, Florida, United States

Akero Clinical Study Site

Hialeah Gardens, Florida, United States

Akero Clinical Study Site

Inverness, Florida, United States

Akero Clinical Study Site

Lakewood Rch, Florida, United States

Akero Clinical Study Site

Largo, Florida, United States

Akero Clinical Study Site

Lehigh Acres, Florida, United States

Akero Clinical Study Site

Margate, Florida, United States

Akero Clinical Study Site

Miami, Florida, United States

Akero Clinical Study Site

Miami, Florida, United States

Akero Clinical Study Site

Miami Gardens, Florida, United States

Akero Clinical Study Site

Naples, Florida, United States

Akero Clinical Study Site

New Port Richey, Florida, United States

Akero Clinical Study Site

Ocala, Florida, United States

Akero Clinical Study Site

Orlando, Florida, United States

Akero Clinical Study Site

Orlando, Florida, United States

Akero Clinical Study Site

Pembroke Pines, Florida, United States

Akero Clinical Study Site

Riverview, Florida, United States

Akero Clinical Study Site

Sarasota, Florida, United States

Akero Clinical Study Site

Temple Terrace, Florida, United States

Akero Clinical Study Site

Venice, Florida, United States

Akero Clinical Study Site

Viera, Florida, United States

Akero Clinical Study Site

Weston, Florida, United States

Akero Clinical Study Site

Zephyrhills, Florida, United States

Akero Clinical Study Site

Atlanta, Georgia, United States

Akero Clinical Study Site

Gainesville, Georgia, United States

Akero Clinical Study Site

Marietta, Georgia, United States

Akero Clinical Study Site

Snellville, Georgia, United States

Akero Clinical Study Site

Chicago, Illinois, United States

Akero Clinical Study Site

Hammond, Indiana, United States

Akero Clinical Study Site

Indianapolis, Indiana, United States

Akero Clinical Study Site

South Bend, Indiana, United States

Akero Clinical Study Site

West Des Moines, Iowa, United States

Akero Clinical Study Site

Topeka, Kansas, United States

Akero Clinical Study Site

Louisville, Kentucky, United States

Akero Clinical Study Site

Bastrop, Louisiana, United States

Akero Clinical Study Site

Covington, Louisiana, United States

Akero Clinical Study Site

Houma, Louisiana, United States

Akero Clinical Study Site

Lafayette, Louisiana, United States

Akero Clinical Study Site

Marrero, Louisiana, United States

Akero Clinical Study Site

Metairie, Louisiana, United States

Akero Clinical Study Site

Shreveport, Louisiana, United States

Akero Clinical Study Site

West Monroe, Louisiana, United States

Akero Clinical Study Site

Baltimore, Maryland, United States

Akero Clinical Study Site

Bethesda, Maryland, United States

Akero Clinical Study Site

South Dartmouth, Massachusetts, United States

Akero Clinical Study Site

Clinton Township, Michigan, United States

Akero Clinical Study Site

Novi, Michigan, United States

Akero Clinical Study Site

Southfield, Michigan, United States

Akero Clinical Study Site

Rochester, Minnesota, United States

Akero Clinical Study Site

Flowood, Mississippi, United States

Akero Clinical Study Site

Columbia, Missouri, United States

Akero Clinical Study Site

Kansas City, Missouri, United States

Akero Clinical Study Site

St Louis, Missouri, United States

Akero Clinical Study Site

St Louis, Missouri, United States

Akero Clinical Study Site

Las Vegas, Nevada, United States

Akero Clinical Study Site

Jackson, New Jersey, United States

Akero Clinical Study Site

Somers Point, New Jersey, United States

Akero Clinical Study Site

Sparta, New Jersey, United States

Akero Clinical Study Site

Buffalo, New York, United States

Akero Clinical Study Site

Manhasset, New York, United States

Akero Clinical Study Site

New York, New York, United States

Akero Clinical Study Site

New York, New York, United States

Akero Clinical Study Site

New York, New York, United States

Akero Clinical Study Site

Rochester, New York, United States

Akero Clinical Study Site

Chapel Hill, North Carolina, United States

Akero Clinical Study Site

Charlotte, North Carolina, United States

Akero Clinical Study Site

Charlotte, North Carolina, United States

Akero Clinical Study Site

Durham, North Carolina, United States

Akero Clinical Study Site

Fayetteville, North Carolina, United States

Akero Clinical Study Site

Morehead City, North Carolina, United States

Akero Clinical Study Site

Raleigh, North Carolina, United States

Akero Clinical Study Site

Statesville, North Carolina, United States

Akero Clinical Study Site

Akron, Ohio, United States

Akero Clinical Study Site

Springboro, Ohio, United States

Akero Clinical Study Site

Westlake, Ohio, United States

Akero Clinical Study Site

Oklahoma City, Oklahoma, United States

Akero Clinical Study Site

Hershey, Pennsylvania, United States

Akero Clinical Study Site

Philadelphia, Pennsylvania, United States

Akero Clinical Study Site

Philadelphia, Pennsylvania, United States

Akero Clinical Study Site

Pittsburgh, Pennsylvania, United States

Akero Clinical Study Site

Charleston, South Carolina, United States

Akero Clinical Study Site

Columbia, South Carolina, United States

Akero Clinical Study Site

Summerville, South Carolina, United States

Akero Clinical Study Site

Clarksville, Tennessee, United States

Akero Clinical Study Site

Hermitage, Tennessee, United States

Akero Clinical Study Site

Nashville, Tennessee, United States

Akero Clinical Study Site

Amarillo, Texas, United States

Akero Clinical Study Site

Austin, Texas, United States

Akero Clinical Study Site

Austin, Texas, United States

Akero Clinical Study Site

Austin, Texas, United States

Akero Clinical Study Site

Bellaire, Texas, United States

Akero Clinical Study Site

Brownsville, Texas, United States

Akero Clinical Study Site

Corpus Christi, Texas, United States

Akero Clinical Study Site

Dallas, Texas, United States

Akero Clinical Study Site

Dallas, Texas, United States

Akero Clinical Study Site

Dallas, Texas, United States

Akero Clinical Study Site

Dallas, Texas, United States

Akero Clinical Study Site

Dallas, Texas, United States

Akero Clinical Study Site

Denison, Texas, United States

Akero Clinical Study Site

Edinburg, Texas, United States

Akero Clinical Study Site

Edinburg, Texas, United States

Akero Clinical Study Site

Fort Sam Houston, Texas, United States

Akero Clinical Study Site

Fort Worth, Texas, United States

Akero Clinical Study Site

Garland, Texas, United States

Akero Clinical Study Site

Houston, Texas, United States

Akero Clinical Study Site

Houston, Texas, United States

Akero Clinical Study Site

Houston, Texas, United States

Akero Clinical Study Site

Houston, Texas, United States

Akero Clinical Study Site

Houston, Texas, United States

Akero Clinical Study Site

Pasadena, Texas, United States

Akero Clinical Study Site

Pharr, Texas, United States

Akero Clinical Study Site

San Antonio, Texas, United States

Akero Clinical Study Site

San Antonio, Texas, United States

Akero Clinical Study Site

San Antonio, Texas, United States

Akero Clinical Study Site

San Antonio, Texas, United States

Akero Clinical Study Site

Sugar Land, Texas, United States

Akero Clinical Study Site

Sugar Land, Texas, United States

Akero Clinical Study Site

Waco, Texas, United States

Akero Clinical Study Site

Waco, Texas, United States

Akero Clinical Study Site

Webster, Texas, United States

Akero Clinical Study Site

Wichita Falls, Texas, United States

Akero Clinical Study Site

Norfolk, Virginia, United States

Akero Clinical Study Site

Richmond, Virginia, United States

Akero Clinical Study Site

Richmond, Virginia, United States

Akero Clinical Study Site

Richmond, Virginia, United States

Akero Clinical Study Site

Richmond, Virginia, United States

Akero Clinical Study Site

Roanoke, Virginia, United States

Akero Clinical Study Site

Seattle, Washington, United States

Akero Clinical Study Site

Madison, Wisconsin, United States

Akero Clinical Study Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Akero Clinical Study Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Akero Clinical Study Site

La Plata, Buenos Aires, Argentina

Akero Clinical Study Site

Ramos Mejía, Buenos Aires, Argentina

Akero Clinical Study Site

Buenos Aires, Distrito Federal, Argentina

Akero Clinical Study Site

Rosario, Sante Fe, Argentina

Akero Clinical Study Site

Buenos Aires, Argentina

Akero Clinical Study Site

Broadmeadow, New South Wales, Australia

Akero Clinical Study Site

Liverpool, New South Wales, Australia

Akero Clinical Study Site

Westmead, New South Wales, Australia

Akero Clinical Study Site

Herston, Queensland, Australia

Akero Clinical Study Site

Adelaide, South Australia, Australia

Akero Clinical Study Site

Box Hill, Victoria, Australia

Akero Clinical Study Site

Clayton, Victoria, Australia

Akero Clinical Study Site

Epping, Victoria, Australia

Akero Clinical Study Site

Heidelberg, Victoria, Australia

Akero Clinical Study Site

Melbourne, Victoria, Australia

Akero Clinical Study Site

Murdoch, Western Australia, Australia

Akero Clinical Study Site

Nedlands, Western Australia, Australia

Akero Clinical Study Site

Perth, Western Australia, Australia

Akero Clinical Study Site

Brasília, Federal District, Brazil

Akero Clinical Study Site

Goiânia, Goiás, Brazil

Akero Clinical Study Site

Belo Horizonte, Minas Gerais, Brazil

Akero Clinical Study Site

Porto Alegre, Rio Grande do Sul, Brazil

Akero Clinical Study Site

Edmonton, Alberta, Canada

Akero Clinical Study Site

Toronto, Ontario, Canada

Akero Clinical Study Site

Toronto, Ontario, Canada

Akero Clinical Study Site

Vaughan, Ontario, Canada

Akero Clinical Study Site

Montreal, Quebec, Canada

Akero Clinical Study Site

Terrebonne, Quebec, Canada

Akero Clinical Study Site

La Serena, Coquimbo Region, Chile

Akero Clinical Study Site

Las Condes, Santiago Metropolitan, Chile

Akero Clinical Study Site

Santiago, Santiago Metropolitan, Chile

Akero Clinical Study Site

Santiago, Santiago Metropolitan, Chile

Akero Clinical Study Site

Santiago, Santiago Metropolitan, Chile

Akero Clinical Study Site

Strasbourg, Bas-Rhin, France

Akero Clinical Study Site

Limoges, Haute-Vienne, France

Akero Clinical Study Site

Lille, Hauts-de-France, France

Akero Clinical Study Site

Clichy, Hauts-de-Seine, France

Akero Clinical Study Site

Vandœuvre-lès-Nancy, Lorraine, France

Akero Clinical Study Site

Angers, Maine-et-Loire, France

Akero Clinical Study Site

Toulouse, Occitanie, France

Akero Clinical Study Site

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

Akero Clinical Study Site

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

Akero Clinical Study Site

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

Akero Clinical Study Site

Lyon, Rhône, France

Akero Clinical Study Site

Créteil, Val-de-Marne, France

Akero Clinical Study Site

Le Chesnay, Île-de-France Region, France

Akero Clinical Study Site

Paris, Île-de-France Region, France

Akero Clinical Study Site

Frankfurt am Main, Hesse, Germany

Akero Clinical Study Site

Homburg, Saarland, Germany

Akero Clinical Study Site

Leipzig, Saxony, Germany

Akero Clinical Study Site

Leipzig, Saxony, Germany

Akero Clinical Study Site

Lübeck, Schleswig-Holstein, Germany

Akero Clinical Study Site

Berlin, Germany

Akero Clinical Study Site

Hyderabad, Andhra Pradesh, India

Akero Clinical Study Site

Surat, Gujarat, India

Akero Clinical Study Site

Surat, Gujarat, India

Akero Clinical Study Site

Vadodara, Gujarat, India

Akero Clinical Study Site

Mysore, Karnataka, India

Akero Clinical Study Site

Thiruvananthapuram, Kerala, India

Akero Clinical Study Site

Mumbai, Maharashtra, India

Akero Clinical Study Site

Mumbai, Maharashtra, India

Akero Clinical Study Site

Nagpur, Maharashtra, India

Akero Clinical Study Site

Pune, Maharashtra, India

Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, India

Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, India

Akero Clinical Study Site

New Delhi, National Capital Territory of Delhi, India

Akero Clinical Study Site

Chandigarh, Punjab, India

Akero Clinical Study Site

Ludhiana, Punjab, India

Akero Clinical Study Site

Jaipur, Rajasthan, India

Akero Clinical Study Site

Jaipur, Rajasthan, India

Akero Clinical Study Site

Coimbatore, Tamil Nadu, India

Akero Clinical Study Site

Hyderabad, Telangana, India

Akero Clinical Study Site

Varanasi, Uttar Pradesh, India

Akero Clinical Study Site

Varanasi, Uttar Pradesh, India

Akero Clinical Study Site

Rishikesh, Uttarakhand, India

Akero Clinical Study Site

Kolkata, West Bengal, India

Akero Clinical Study Site

Kolkata, West Bengal, India

Akero Clinical Study Site

Kolkata, West Bengal, India

Akero Clinical Study Site

Petah Tikva, Central District, Israel

Akero Clinical Study Site

Ramat Gan, Central District, Israel

Akero Clinical Study Site

Haifa, Haifa District, Israel

Akero Clinical Study Site

Afula, Northern District, Israel

Akero Clinical Study Site

Nahariya, Northern District, Israel

Akero Clinical Study Site

Haifa, Israel

Akero Clinical Study Site

Jerusalem, Israel

Akero Clinical Study Site

Jerusalem, Israel

Akero Clinical Study Site

Tel Aviv, Israel

Akero Clinical Study Site

Tel Aviv, Israel

Akero Clinical Study Site

Foggia, Apulia, Italy

Akero Clinical Study Site

San Giovanni Rotondo, Foggia, Italy

Akero Clinical Study Site

Rozzano, Milan, Italy

Akero Clinical Study Site

Torino, Turin, Italy

Akero Clinical Study Site

Bologna, Italy

Akero Clinical Study Site

Catania, Italy

Akero Clinical Study Site

Messina, Italy

Akero Clinical Study Site

Milan, Italy

Akero Clinical Study Site

Milan, Italy

Akero Clinical Study Site

Modena, Italy

Akero Clinical Study Site

Novara, Italy

Akero Clinical Study Site

Acapulco de Juárez, Guerrero, Mexico

Akero Clinical Study Site

Guadalajara, Jalisco, Mexico

Akero Clinical Study Site

Cuauhtémoc, Mexico City, Mexico

Akero Clinical Study Site

Mexico City, Mexico City, Mexico

Akero Clinical Study Site

Mérida, Yucatán, Mexico

Akero Clinical Study Site

Benito Juárez, Mexico

Akero Clinical Study Site

Mexico City, Mexico

Akero Clinical Study Site

Poznan, Greater Poland Voivodeship, Poland

Akero Clinical Study Site

Krakow, Lesser Poland Voivodeship, Poland

Akero Clinical Study Site

Wroclaw, Lower Silesian Voivodeship, Poland

Akero Clinical Study Site

Wroclaw, Lower Silesian Voivodeship, Poland

Akero Clinical Study Site

Lodz, Lódzkie, Poland

Akero Clinical Study Site

Warsaw, Masovian Voivodeship, Poland

Akero Clinical Study Site

Warsaw, Masovian Voivodeship, Poland

Akero Clinical Study Site

Częstochowa, Silesian Voivodeship, Poland

Akero Clinical Study Site

Katowice, Silesian Voivodeship, Poland

Akero Clinical Study Site

Manatí, Puerto Rico

Akero Clinical Study Site

Mayagüez, Puerto Rico

Akero Clinical Study Site

San Juan, Puerto Rico

Akero Clinical Study Site

Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea

Akero Clinical Study Site

Incheon, Gyeonggi-do, South Korea

Akero Clinical Study Site

Goyang-si, Gyeonggido, South Korea

Akero Clinical Study Site

Daegu, Gyeongsangbugdo [Kyongsangbuk-do], South Korea

Akero Clinical Study Site

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Akero Clinical Study Site

Seoul, Seoul Teugbyeolsi, South Korea

Akero Clinical Study Site

Sabadell, Barcelona, Spain

Akero Clinical Study Site

Santander, Cantabria, Spain

Akero Clinical Study Site

Majadahonda, Madrid, Spain

Akero Clinical Study Site

Barcelona, Spain

Akero Clinical Study Site

Madrid, Spain

Akero Clinical Study Site

Madrid, Spain

Akero Clinical Study Site

Seville, Spain

Akero Clinical Study Site

Valencia, Spain

Akero Clinical Study Site

Valencia, Spain

Akero Clinical Study Site

Lugano, Canton Ticino, Switzerland

Akero Clinical Study Site

Bern, Switzerland

Akero Clinical Study Site

Sankt Gallen, Switzerland

Akero Clinical Study Site

Zurich, Switzerland

Akero Clinical Study Site

Ankara, Turkey (Türkiye)

Akero Clinical Study Site

Bursa, Turkey (Türkiye)

Akero Clinical Study Site

Rize, Turkey (Türkiye)

Akero Clinical Study Site

London, England, United Kingdom

Akero Clinical Study Site

Nottingham, England, United Kingdom

Akero Clinical Study Site

Birmingham, United Kingdom

Akero Clinical Study Site

London, United Kingdom

Akero Clinical Study Site

London, United Kingdom

Akero Clinical Study Site

Newcastle upon Tyne, United Kingdom

Akero Clinical Study Site

Whitechapel, United Kingdom

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NCT06528314


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