A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Launched by AKERO THERAPEUTICS, INC · Jul 25, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called efruxifermin (EFX) for people with compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). Compensated cirrhosis means that while there is significant liver damage, the liver is still functioning well enough to manage normal bodily functions. The trial is taking place at multiple locations and is designed to compare efruxifermin to a placebo (a treatment that looks like the drug but has no active ingredients) to see if it can improve liver health in these patients.
To be eligible for the trial, participants need to be between the ages of 65 and 74 or 29 and 219 years old and have been diagnosed with compensated cirrhosis due to NASH/MASH. This can be confirmed through a liver biopsy or other non-invasive tests. However, people with certain other liver diseases, unstable diabetes, or a history of more severe liver disease are not eligible. Participants can expect to receive either the medication or a placebo, and they will be monitored closely throughout the study to assess their liver health and any side effects. This trial aims to provide important information about the effectiveness and safety of efruxifermin for those affected by this condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 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
About Akero Therapeutics, Inc
Akero Therapeutics, Inc. is a biopharmaceutical company dedicated to the development of innovative therapies for patients with serious liver diseases, particularly non-alcoholic steatohepatitis (NASH). Leveraging advanced science and a robust pipeline, Akero focuses on addressing unmet medical needs through its proprietary drug candidates that target metabolic and fibrotic pathways. Committed to advancing patient care, the company prioritizes clinical research, collaboration, and patient-centric approaches in its pursuit of transformative treatments that improve health outcomes and quality of life for individuals affected by liver disorders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lakewood Ranch, Florida, United States
New Port Richey, Florida, United States
Sarasota, Florida, United States
Marrero, Louisiana, United States
Kansas City, Missouri, United States
Edinburg, Texas, United States
Fort Worth, Texas, United States
Webster, Texas, United States
San Juan, , Puerto Rico
Chandler, Arizona, United States
Tucson, Arizona, United States
North Little Rock, Arkansas, United States
Los Angeles, California, United States
Fort Myers, Florida, United States
Inverness, Florida, United States
Ocala, Florida, United States
Marietta, Georgia, United States
Topeka, Kansas, United States
Flowood, Mississippi, United States
Las Vegas, Nevada, United States
Charlotte, North Carolina, United States
Morehead City, North Carolina, United States
Hermitage, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Garland, Texas, United States
Englewood, Colorado, United States
Hialeah Gardens, Florida, United States
South Bend, Indiana, United States
Bastrop, Louisiana, United States
Fayetteville, North Carolina, United States
Springboro, Ohio, United States
Westlake, Ohio, United States
Summerville, South Carolina, United States
Houston, Texas, United States
Waco, Texas, United States
Wichita Falls, Texas, United States
Pasadena, California, United States
Houston, Texas, United States
Birmingham, Alabama, United States
Conway, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Viera, Florida, United States
Houma, Louisiana, United States
Metairie, Louisiana, United States
Baltimore, Maryland, United States
Columbia, Missouri, United States
Sparta, New Jersey, United States
Columbia, South Carolina, United States
Amarillo, Texas, United States
Austin, Texas, United States
Bellaire, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Peoria, Arizona, United States
San Francisco, California, United States
Somers Point, New Jersey, United States
Brownsville, Texas, United States
Toronto, Ontario, Canada
Manatí, , Puerto Rico
Long Beach, California, United States
Shreveport, Louisiana, United States
Covington, Louisiana, United States
Statesville, North Carolina, United States
Bradenton, Florida, United States
Naples, Florida, United States
Gainesville, Georgia, United States
South Dartmouth, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Clarksville, Tennessee, United States
Norfolk, Virginia, United States
Roanoke, Virginia, United States
Westmead, New South Wales, Australia
Vaughan, Ontario, Canada
Surat, Gujarat, India
Vadodara, Gujarat, India
Thiruvananthapuram, Kerala, India
Nagpur, Maharashtra, India
Pune, Maharashtra, India
Jaipur, Rajasthan, India
Hyderabad, Telangana, India
Varanasi, Uttar Pradesh, India
Kolkata, West Bengal, India
Raleigh, North Carolina, United States
Broadmeadow, New South Wales, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Dallas, Texas, United States
Seattle, Washington, United States
Terrebonne, Quebec, Canada
Paris, Ile De France, France
Vandœuvre Lès Nancy, Lorraine, France
Montpellier Cedex 5, Provence Alpes Cote D'azur, France
Novara, , Italy
Santander, Cantabria, Spain
Barcelona, , Spain
Coronado, California, United States
Miami, Florida, United States
Clayton, Victoria, Australia
Flagstaff, Arizona, United States
Brandon, Florida, United States
Corpus Christi, Texas, United States
Adelaide, South Australia, Australia
Nahariya, Northern District, Israel
Jerusalem, , Israel
Bern, , Switzerland
Sankt Gallen, , Switzerland
Venice, Florida, United States
Edmonton, Alberta, Canada
Limoges Cedex, Haute Vienne, France
Angers Cedex 9, Maine Et Loire, France
Toulouse, Occitanie, France
Marseille Cedex 08, Provence Alpes Côte D'azur, France
Frankfurt Am Main, Hessen, Germany
Leipzig, Sachsen, Germany
Berlin, , Germany
Milan, , Italy
Daegu, Daegu Gwang'yeogsi [Taegu Kwangyokshi], Korea, Republic Of
Incheon, Gyeonggi Do, Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Sabadell, Barcelona, Spain
Majadahonda, Madrid, Spain
Madrid, , Spain
Madrid, , Spain
Sevilla, , Spain
Southfield, Michigan, United States
Epping, Victoria, Australia
Murdoch, Western Australia, Australia
Perth, Western Australia, Australia
Haifa, Haifa District, Israel
Tel Aviv, , Israel
Bursa, , Turkey
London, England, United Kingdom
New York, New York, United States
Chapel Hill, North Carolina, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Ramos Mejia, Buenos Aires, Argentina
Mumbai, Maharashtra, India
Chandigarh, Punjab, India
Ramat Gan, Central District, Israel
Dartmouth, Massachusetts, United States
New York, New York, United States
Buenos Aires, , Argentina
Lübeck, Schleswig Holstein, Germany
Snellville, Georgia, United States
Clinton Township, Michigan, United States
Jackson, New Jersey, United States
Charlotte, North Carolina, United States
Newport Beach, California, United States
Louisville, Kentucky, United States
La Plata, Buenos Aires, Argentina
Dothan, Alabama, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Denison, Texas, United States
Sugar Land, Texas, United States
Box Hill, Victoria, Australia
Clichy, Hauts De Seine, France
Surat, Gujarat, India
Aurora, Colorado, United States
Margate, Florida, United States
Zephyrhills, Florida, United States
Nedlands, Western Australia, Australia
New Delhi, Delhi, India
Ludhiana, Punjab, India
Lugano, Ticino, Switzerland
Herston, Queensland, Australia
Lyon, Rhône, France
Mysore, Karnataka, India
Valencia, , Spain
Zürich, , Switzerland
Folsom, California, United States
Orange, California, United States
Colorado Springs, Colorado, United States
Miami Gardens, Florida, United States
Temple Terrace, Florida, United States
Hammond, Indiana, United States
Rochester, New York, United States
Fort Sam Houston, Texas, United States
Liverpool, New South Wales, Australia
Nice Cedex 3, Provence Alpes Côte D'azur, France
Le Chesnay, île De France, France
Mumbai, Maharashtra, India
Escondido, California, United States
Cutler Bay, Florida, United States
Doral, Florida, United States
Lehigh Acres, Florida, United States
Chicago, Illinois, United States
Rochester, Minnesota, United States
Buffalo, New York, United States
Charleston, South Carolina, United States
Pharr, Texas, United States
Richmond, Virginia, United States
Santiago, Región Metropolitana De Santiago, Chile
Hyderabad, Andhra Pradesh, India
Rishikesh, Uttaranchal, India
Mayagüez, , Puerto Rico
Durham, North Carolina, United States
New Haven, Connecticut, United States
Atlanta, Georgia, United States
Novi, Michigan, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Las Condes, Región Metropolitana, Chile
Strasbourg, Bas Rhin, France
Afula, Northern District, Israel
Marseille Cedex 08, , France
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Santiago, , Chile
Las Condes, , Chile
Nice Cedex 3, , France
Lyon, , France
Le Chesnay, , France
West Monroe, Louisiana, United States
Manhasset, New York, United States
Akron, Ohio, United States
Foggia, Apulia, Italy
Ankara, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported