A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Launched by AKERO THERAPEUTICS, INC · Jan 10, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called efruxifermin (EFX) to see if it can help people with non-cirrhotic Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH) who also have some scarring in their liver (fibrosis). The trial is taking place at multiple locations and will involve around 1,650 participants aged 18 to 80 years. It aims to find out if this new treatment is effective compared to a placebo, which is a dummy treatment that looks the same but has no active ingredients.
To be eligible for this study, participants need to have a history of certain health issues, like obesity, high blood pressure, or type 2 diabetes, and must have had a liver biopsy within the last 180 days showing fibrosis stage 2 or 3. Those who join the trial can expect to receive either the medication or a placebo and will be monitored throughout the study for their health and any side effects. It's important to note that individuals with other causes of liver disease or advanced liver scarring (cirrhosis) are not eligible to participate.
Gender
ALL
Eligibility criteria
- 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).
- 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.
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
Los Angeles, California, United States
Lakewood Ranch, Florida, United States
New Port Richey, Florida, United States
Port Orange, Florida, United States
Sarasota, Florida, United States
Marrero, Louisiana, United States
Kansas City, Missouri, United States
Chattanooga, Tennessee, United States
Edinburg, Texas, United States
Fort Worth, Texas, United States
San Antonio, 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
Chula Vista, California, United States
Fort Myers, Florida, United States
Inverness, Florida, United States
Miami Lakes, Florida, United States
Ocala, Florida, United States
Marietta, Georgia, United States
Topeka, Kansas, United States
Ypsilanti, Michigan, 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
San Antonio, Texas, United States
San Marcos, Texas, United States
Englewood, Colorado, United States
Hialeah Gardens, Florida, United States
South Bend, Indiana, United States
Bastrop, Louisiana, 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
Ogden, Utah, United States
Sandy, Utah, United States
Pasadena, California, United States
Chicago, Illinois, United States
Houston, Texas, United States
Birmingham, Alabama, United States
Conway, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
San Diego, California, United States
Jacksonville, Florida, United States
Lady Lake, Florida, United States
Maitland, Florida, United States
Viera, Florida, United States
Winter Park, Florida, United States
Columbus, Georgia, United States
Houma, Louisiana, United States
Metairie, Louisiana, United States
Baltimore, Maryland, United States
Greenbelt, Maryland, United States
Columbia, Missouri, United States
Florham Park, New Jersey, United States
Sparta, New Jersey, United States
Santa Fe, New Mexico, United States
New Bern, North Carolina, United States
Dayton, Ohio, United States
Amarillo, Texas, United States
Austin, Texas, United States
Bellaire, Texas, United States
Dallas, Texas, United States
Lewisville, Texas, United States
Peoria, Arizona, United States
Inglewood, California, United States
San Francisco, California, United States
Glen Burnie, Maryland, United States
Somers Point, New Jersey, United States
New York, New York, United States
Brownsville, Texas, United States
South Ogden, Utah, United States
Toronto, Ontario, Canada
Mesa, Arizona, United States
La Mesa, California, United States
Long Beach, California, United States
Shreveport, Louisiana, United States
Fayetteville, North Carolina, United States
Medford, Oregon, United States
Richmond, Virginia, United States
Manati, , Puerto Rico
Covington, Louisiana, United States
Statesville, North Carolina, United States
San Marcos, Texas, United States
Salt Lake City, Utah, United States
Spokane, Washington, United States
Bradenton, Florida, United States
Largo, Florida, United States
Naples, Florida, United States
West Des Moines, Iowa, United States
Wichita, Kansas, United States
South Dartmouth, Massachusetts, United States
Wyoming, Michigan, United States
Reno, Nevada, 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
New Delhi, Delhi, India
Surat, Gujarat, India
Vadodara, Gujarat, India
Thiruvananthapuram, Kerala, India
Nagpur, Maharashtra, India
Pune, Maharashtra, India
Jaipur, Rajasthan, India
Coimbatore, Tamil Nadu, India
Hyderabad, Telangana, India
Varanasi, Uttar Pradesh, India
Kolkata, West Bengal, India
Palm Springs, California, United States
West Palm Beach, Florida, United States
Raleigh, North Carolina, United States
Mcallen, Texas, United States
Suffolk, Virginia, United States
Broadmeadow, New South Wales, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Gainesville, Florida, United States
Dallas, Texas, United States
Seattle, Washington, United States
Hamilton, Ontario, Canada
Terrebonne, Quebec, Canada
Nice Cedex 3, Alpes Maritimes, France
Clichy, Hauts De Seine, France
Paris, Ile De France, France
Vandœuvre Lès Nancy, Lorraine, France
Montpellier Cedex 5, Provence Alpes Cote D'azur, France
Foggia, , Italy
Napoli, , Italy
Novara, , Italy
Wrocław, Dolnoslaskie, Poland
Krakow, Malopolskie, Poland
Warszawa, Mazowieckie, Poland
Gdańsk, Pomorskie, Poland
Gdynia, Pomorskie, Poland
Katowice, Slaskie, Poland
Poznań, Wielkopolskie, Poland
Częstochowa, śląskie, Poland
Santander, Cantabria, Spain
Valencia, València, Spain
Barcelona, , Spain
Coronado, California, United States
Santa Maria, California, United States
Miami, Florida, United States
Flagstaff, Arizona, United States
Lancaster, California, United States
Brandon, Florida, United States
Corpus Christi, Texas, United States
Adelaide, South Australia, Australia
Dahegaon, Maharashtra, India
Petah Tikva, Central District, Israel
Haifa, Haifa District, Israel
Nahariya, Northern District, Israel
Jerusalem, , Israel
Olten, Solothurn, Switzerland
Bern, , Switzerland
Sankt Gallen, , Switzerland
London, England, United Kingdom
Venice, Florida, United States
Buenos Aires, , Argentina
Caulfield South, Victoria, Australia
Edmonton, Alberta, Canada
Strasbourg, Bas Rhin, France
Limoges Cedex, Haute Vienne, France
Angers Cedex 9, Maine Et Loire, France
Toulouse, Occitanie, France
Marseille Cedex 08, Provence Alpes Côte D'azur, France
Lyon, Rhone Alpes, France
Würzburg, Bayern, Germany
Frankfurt Am Main, Hessen, Germany
Leipzig, Sachsen, Germany
Berlin, , Germany
San Giovanni Rotondo, Foggia, Italy
Bologna, , Italy
Messina, , Italy
Milan, , Italy
Daegu, Daegu Gwang'yeogsi [Taegu Kwangyokshi], Korea, Republic Of
Goyang Si, Gyeonggi Do, Korea, Republic Of
Incheon, Gyeonggi Do, Korea, Republic Of
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Warsaw, Mazowieckie, Poland
Sabadell, Barcelona, Spain
Majadahonda, Madrid, Spain
Madrid, , Spain
Sevilla, , Spain
Southfield, Michigan, United States
Epping, Victoria, Australia
Murdoch, Western Australia, Australia
Perth, Western Australia, Australia
Afula, Northern District, Israel
Tel Aviv, , Israel
Changhua City, Changhua, Taiwan
Taichung City, Taichung, Taiwan
Tainan City, Tainan, Taiwan
Yenimahalle, Ankara, Turkey
Bornova, Izmir, Turkey
Bursa, , Turkey
Rize, , Turkey
Mainz, Rheinland Pfalz, Germany
łódź, łódzkie, Poland
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Falls Church, Virginia, United States
Richmond, Virginia, United States
Ramos Mejia, Buenos Aires, Argentina
Buenos Aires, Distrito Federal, Argentina
Ramat Gan, Central District, Israel
Liverpool, England, United Kingdom
Newcastle Upon Tyne, England, United Kingdom
Dartmouth, Massachusetts, United States
New Orleans, Louisiana, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Newport News, Virginia, United States
Versailles, Yvelines, île De France, France
Lübeck, Schleswig Holstein, Germany
Nazareth, Northern District, Israel
Taipei City, Taipei, Taiwan
Tainan, , Taiwan
Taoyuan, , Taiwan
Cambridge, England, United Kingdom
Newport Beach, California, United States
New Haven, Connecticut, United States
Louisville, Kentucky, United States
La Plata, Buenos Aires, Argentina
Rozzano, Milan, Italy
Torino, Turin, Italy
Modena, , Italy
Kaohsiung, , Taiwan
Birmingham, England, United Kingdom
Dothan, Alabama, United States
Pembroke Pines, Florida, United States
Denison, Texas, United States
Aurora, Colorado, United States
Margate, Florida, United States
Zephyrhills, Florida, United States
Nedlands, Western Australia, Australia
Orlando, Florida, United States
Valencia, , Spain
Folsom, California, United States
Redwood City, 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
Liverpool, New South Wales, Australia
Escondido, California, United States
Doral, Florida, United States
Buffalo, New York, United States
Durham, North Carolina, United States
Frankston, Victoria, Australia
Novi, Michigan, United States
Marseille Cedex 08, , France
Versailles, , France
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
łódź, , Poland
Częstochowa, , Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported