A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Launched by 89BIO, INC. · May 14, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called pegozafermin to see how well it works and how safe it is for people with compensated cirrhosis caused by a liver condition known as Metabolic Dysfunction-Associated Steatohepatitis (MASH). Compensated cirrhosis means that while the liver is damaged, it is still functioning well enough to manage daily life. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with this specific type of liver damage and have at least one metabolic risk factor, like obesity or diabetes.
If you or a loved one is considering participating, you should know that participants will receive the study medication and will be monitored closely by medical professionals throughout the trial. It's important to note that certain conditions, such as other liver diseases or uncontrolled diabetes, may exclude someone from participating. Overall, this study aims to provide valuable information on a potential new treatment for a serious liver condition, and participants will play a crucial role in advancing our understanding of this disease.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
- • At least 1 metabolic risk factor.
- • Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis \[NASH\] Clinical Research Network (CRN) system) with compensated cirrhosis.
- • Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).
- Key Exclusion Criteria:
- • Liver disorder other than MASH.
- • History or evidence of hepatic decompensation.
- • History or evidence of hepatocellular carcinoma.
- • Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
- • ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
- • Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.
- • Other inclusion and exclusion criteria may apply.
About 89bio, Inc.
89bio, Inc. is a biotechnology company focused on developing innovative therapies for metabolic diseases and liver disorders. With a commitment to advancing science and improving patient outcomes, 89bio leverages cutting-edge research and technology to create novel treatments that address unmet medical needs. The company’s lead product candidates aim to target conditions such as nonalcoholic steatohepatitis (NASH) and other associated metabolic disorders. By fostering collaboration and employing a patient-centric approach, 89bio is dedicated to advancing the frontiers of medicine and enhancing the quality of life for individuals affected by these challenging health issues.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chandler, Arizona, United States
Tucson, Arizona, United States
Ocala, Florida, United States
Florham Park, New Jersey, United States
Hermitage, Tennessee, United States
Edinburg, Texas, United States
Orlando, Florida, United States
Little Rock, Arkansas, United States
Huntington Park, California, United States
Rialto, California, United States
Santa Ana, California, United States
Fort Myers, Florida, United States
Viera, Florida, United States
Athens, Georgia, United States
New Albany, Indiana, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Glen Burnie, Maryland, United States
Greenbelt, Maryland, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Westlake, Ohio, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Waco, Texas, United States
Waco, Texas, United States
Sandy, Utah, United States
Seattle, Washington, United States
Peoria, Arizona, United States
Hialeah Gardens, Florida, United States
Atlanta, Georgia, United States
Las Vegas, Nevada, United States
Kraków, , Poland
Warszawa, , Poland
North Little Rock, Arkansas, United States
Ocoee, Florida, United States
Winter Park, Florida, United States
Brownsville, Texas, United States
Fountain Valley, California, United States
Clermont, Florida, United States
New Port Richey, Florida, United States
Richmond, Virginia, United States
Flagstaff, Arizona, United States
Poway, California, United States
Lady Lake, Florida, United States
Hammond, Indiana, United States
Baltimore, Maryland, United States
Albuquerque, New Mexico, United States
Fayetteville, North Carolina, United States
Columbia, South Carolina, United States
Cordova, Tennessee, United States
Farmers Branch, Texas, United States
Homewood, Alabama, United States
Tucson, Arizona, United States
Flowood, Mississippi, United States
Desoto, Texas, United States
Vancouver, British Columbia, Canada
Canoga Park, California, United States
Clinton Township, Michigan, United States
Ypsilanti, Michigan, United States
Greenville, North Carolina, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Lubbock, Texas, United States
Pearland, Texas, United States
Rochester, Minnesota, United States
East Greenwich, Rhode Island, United States
Camarillo, California, United States
Lehigh Acres, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Lafayette, Louisiana, United States
Nashville, Tennessee, United States
Heidelberg, , Australia
Lodz, , Poland
Pasadena, California, United States
Winston Salem, North Carolina, United States
Wrocław, , Poland
Barcelona, , Spain
Santander, , Spain
Miami, Florida, United States
University Park, Florida, United States
Iowa City, Iowa, United States
West Jordan, Utah, United States
Gorna Oryahovitsa, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Toronto, Ontario, Canada
Kaohsiung, , Taiwan
Wyoming, Michigan, United States
Minneapolis, Minnesota, United States
Rapid City, South Dakota, United States
Harlingen, Texas, United States
Buenos Aires, , Argentina
Fitzroy, , Australia
Greenslopes, , Australia
Córdoba, , Spain
Madrid, , Spain
Littleton, Colorado, United States
Villejuif, , France
Afula, , Israel
Haifa, , Israel
Mysłowice, , Poland
łódź, , Poland
Chiayi City, , Taiwan
Coronado, California, United States
Gainesville, Florida, United States
Burlington, Massachusetts, United States
Asheville, North Carolina, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
San Marcos, Texas, United States
Seattle, Washington, United States
Buenos Aires, , Argentina
Adelaide, , Australia
Herston, , Australia
Murdoch, , Australia
South Brisbane, , Australia
Brussel, , Belgium
Bruxelles, , Belgium
Gent, , Belgium
Roeselare, , Belgium
Sofia, , Bulgaria
Winnipeg, Manitoba, Canada
Ottawa, Ontario, Canada
Amiens, , France
Dijon, , France
Limoges, , France
Lyon, , France
Nice, , France
Paris, , France
Pessac Cedex, , France
Toulouse, , France
Vandœuvre Lès Nancy, , France
Freiburg, , Germany
Homburg, , Germany
Shatin, , Hong Kong
Budapest, , Hungary
Be'er Sheva, , Israel
Jerusalem, , Israel
Nahariyya, , Israel
Tel Aviv, , Israel
Bergamo, , Italy
Foggia, , Italy
Milano, , Italy
Roma, , Italy
Rome, , Italy
Amsterdam, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Zaragoza, , Spain
Istanbul, , Turkey
London, , United Kingdom
Plymouth, , United Kingdom
Port Talbot, , United Kingdom
Buenos Aires, , Argentina
Caba, , Argentina
Calgary, Alberta, Canada
Lakewood Ranch, Florida, United States
Capital Federal, , Argentina
Münster, , Germany
Palermo, , Italy
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Katowice, , Poland
Pontevedra, , Spain
Santiago De Compostela, , Spain
Southampton, , United Kingdom
Redwood City, California, United States
Miami, Florida, United States
Chicago, Illinois, United States
Ann Arbor, Michigan, United States
New York, New York, United States
Cincinnati, Ohio, United States
Edegem, , Belgium
Genk, , Belgium
Montpellier, , France
Strasbourg, , France
Vénissieux, , France
Frankfurt, , Germany
Hong Kong, , Hong Kong
Petach Tikva, , Israel
Tel Hashomer, , Israel
Novara, , Italy
Rozzano, , Italy
Torino, , Italy
Bucheon, , Korea, Republic Of
Warsaw, , Poland
Singapore, , Singapore
Almeria, , Spain
Badalona, , Spain
Tainan, , Taiwan
Bornova, Izmir, Turkey
Merkez, Rize, Turkey
Ankara, , Turkey
Vancouver, British Columbia, Canada
Los Angeles, California, United States
Jacksonville, Florida, United States
Detroit, Michigan, United States
Akron, Ohio, United States
Pilar, , Argentina
London, Ontario, Canada
Chihuahua, , Mexico
Ciudad De Mexico, , Mexico
Cuautitlán Izcalli, , Mexico
Cuernavaca, , Mexico
Jalisco, , Mexico
Merida, , Mexico
Monterrey, , Mexico
Tilburg, , Netherlands
Singapore, , Singapore
Malaga, , Spain
Aberdeen, , United Kingdom
London, , United Kingdom
Hannover, , Germany
Sacramento, California, United States
Richmond, Virginia, United States
Belo Horizonte, , Brazil
São José Do Rio Preto, , Brazil
Vaughan, , Canada
Chemnitz, , Germany
Bristol, , United Kingdom
Patients applied
Trial Officials
Maya Margalit, MD
Study Director
89bio, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported