A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Launched by 89BIO, INC. · Mar 13, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The ENLIGHTEN-Fibrosis trial is studying a new treatment called pegozafermin for adults with a liver condition known as Metabolic Dysfunction-associated Steatotic Liver Disease (MASH), which can also be referred to as nonalcoholic steatohepatitis (NASH). This study specifically focuses on patients who have liver fibrosis, which is a type of scarring in the liver, at stages 2 or 3. Researchers want to see how effective and safe this treatment is in improving liver health.
To participate in this trial, you need to be between 18 and 75 years old and have been diagnosed with MASH that has been confirmed by a liver biopsy. You should also have a body mass index (BMI) of 25 or higher (or 23 for Asian participants) but less than 50. Participants will have the opportunity to receive either of two doses of pegozafermin and will be monitored throughout the study for any effects and improvements. If you have other chronic liver diseases, have a history of severe liver scarring, or have certain diabetes conditions, you may not be eligible. This trial is currently recruiting participants, and being involved could help advance research in treating liver disease.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
- • Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASH clinical research network (CRN) System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation or NAS \<4 and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of at least 1 in steatosis. A historical biopsy must be within 6 months of screening visit (with additional requirements).
- • Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian countries)
- Key Exclusion Criteria:
- • Chronic liver diseases other than MASH/NASH
- • Evidence of cirrhosis on screening liver biopsy
- • Have type 1 diabetes or poorly controlled type 2 diabetes
- • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
- • Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone 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
Montclair, California, United States
Ocala, Florida, United States
Sarasota, Florida, United States
Florham Park, New Jersey, United States
Hermitage, Tennessee, United States
Austin, Texas, United States
Edinburg, Texas, United States
Wichita Falls, Texas, United States
Birmingham, Alabama, United States
Glendale, Arizona, United States
Little Rock, Arkansas, United States
Fresno, California, United States
Huntington Park, California, United States
Panorama City, California, United States
Rialto, California, United States
Fort Myers, Florida, United States
Athens, Georgia, United States
New Albany, Indiana, United States
Topeka, Kansas, United States
Glen Burnie, Maryland, United States
Greenbelt, Maryland, United States
Dayton, Ohio, United States
Springboro, Ohio, United States
Westlake, Ohio, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Garland, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Ogden, Utah, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Toronto, Ontario, Canada
Long Beach, California, United States
Conway, Arkansas, United States
Hialeah Gardens, Florida, United States
Las Vegas, Nevada, United States
Kraków, , Poland
Warszawa, , Poland
Paris, , France
łódź, , Poland
North Little Rock, Arkansas, United States
Gardena, California, United States
Jacksonville, Florida, United States
Ocoee, Florida, United States
Winter Park, Florida, United States
West Monroe, Louisiana, United States
Brownsville, Texas, United States
Waco, Texas, United States
Edegem, , Belgium
Fountain Valley, California, United States
Santa Ana, California, United States
Clermont, Florida, United States
Maitland, Florida, United States
New Port Richey, Florida, United States
Flagstaff, Arizona, United States
Canoga Park, California, United States
Inglewood, California, United States
Poway, California, United States
Lady Lake, Florida, United States
Dalton, Georgia, United States
Hammond, Indiana, United States
Baltimore, Maryland, United States
Warren, New Jersey, United States
Albuquerque, New Mexico, United States
Fayetteville, North Carolina, United States
Columbia, South Carolina, United States
Cordova, Tennessee, United States
Corpus Christi, Texas, United States
Farmers Branch, Texas, United States
Georgetown, Texas, United States
Stafford, Texas, United States
Modena, , Italy
Lady Lake, Florida, United States
Chesterfield, Michigan, United States
Flowood, Mississippi, United States
Desoto, Texas, United States
Heidelberg, Victoria, Australia
Vancouver, British Columbia, Canada
High Wycombe, Buckinghamshire, United Kingdom
Ypsilanti, Michigan, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Rochester, Minnesota, United States
Charlotte, North Carolina, United States
Liberty Township, Ohio, United States
East Greenwich, Rhode Island, United States
Herston, Queensland, Australia
Jerusalem, , Israel
Brisbane, Queensland, Australia
Clayton, Victoria, Australia
London, , United Kingdom
Stockton, , United Kingdom
Swansea, , United Kingdom
Pasadena, California, United States
Winston Salem, North Carolina, United States
Katy, Texas, United States
South Brisbane, Queensland, Australia
Bedford Park, South Australia, Australia
Gorna Oryahovitsa, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Shatin, , Hong Kong
Be'er Sheva, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Wrocław, , Poland
Barcelona, , Spain
Santander, , Spain
Kaohsiung, , Taiwan
Bristol, , United Kingdom
Hull, , United Kingdom
Preston, , United Kingdom
Iowa City, Iowa, United States
Wyoming, Michigan, United States
Córdoba, , Spain
Madrid, , Spain
Littleton, Colorado, United States
Georgetown, Texas, United States
Buenos Aires, , Argentina
Adelaide, South Australia, Australia
Ghent, , Belgium
Sofia, , Bulgaria
Ottawa, Ontario, Canada
Villejuif, , France
Afula, , Israel
Haifa, , Israel
Tel Aviv, , Israel
Milan, , Italy
Mysłowice, , Poland
Warsaw, , Poland
łódź, , Poland
Chiayi City, , Taiwan
Glasgow, , United Kingdom
York, , United Kingdom
Coronado, California, United States
Lyon, , France
Vandœuvre Lès Nancy, , France
Homburg, , Germany
Bergamo, , Italy
Fort Sam Houston, Texas, United States
Caba, , Argentina
Perth, West Australia, Australia
Brussels, , Belgium
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Bordeaux, , France
Lille, , France
Limoges, , France
Nantes, , France
Nice, , France
Pierre Bénite, , France
Toulouse, , France
Milan, , Italy
Incheon, , Korea, Republic Of
Rotterdam, Zuid Holland, Netherlands
Amsterdam, , Netherlands
Utrecht, , Netherlands
Singapore, , Singapore
Sevilla, , Spain
Lakewood Ranch, Florida, United States
Durham, North Carolina, United States
Bellaire, Texas, United States
Capital Federal, , Argentina
Winnipeg, Manitoba, Canada
Amiens, , France
Strasbourg, , France
Frankfurt Am Main, , Germany
Freiburg, , Germany
Münster, , Germany
Hong Kong, , Hong Kong
Milano, , Italy
Palermo, , Italy
Rome, , Italy
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Katowice, , Poland
Pontevedra, , Spain
Santiago De Compostela, , Spain
Taipei, , Taiwan
Oxford, , United Kingdom
Southampton, , United Kingdom
Tomball, Texas, United States
Pilar, , Argentina
Fitzroy, , Australia
Vancouver, British Columbia, Canada
London, Ontario, Canada
Singapore, , Singapore
Majadahonda, , Spain
Málaga, , Spain
Orange, California, United States
Brandon, Florida, United States
Jupiter, Florida, United States
Vaughan, Ontario, Canada
Vénissieux, , France
Chemnitz, , Germany
Hannover, , Germany
Patients applied
Trial Officials
Millie Gottwald, PharmD
Study Director
89bio, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported