Last updated 42 days ago

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants with MASH and Fibrosis (ENLIGHTEN-Fibrosis)

1050 patients around the world
Available in Spain, Argentina, United States, Mexico
89bio, Inc.
1Research sites
1050Patients around the world

This study is for people with

Steatohepatitis
Metabolic dysfunction-associated steatohepatitis - MASH
Fatty liver/nash
Nonalcoholic steatohepatitis

Requirements for the patient

To 75 Years
All Gender

Medical requirements

Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
Biopsy-confirmed MASH with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. The qualifying biopsy must be either within 6 months of screening visit with additional requirements or obtained during screening period.
Body mass index (BMI) at screening ≥25.0 for non-Asian participants and ≥23 for Asian participants and <50.0 kilograms (kg)/meters squared (m^2).
Chronic liver diseases other than MASH/NASH.
History or 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 greater than 400 international units (IU)/day must be on stable dose for at least 6 months prior to screening.

Sites

PCR Cuautitlán Izcalli
Recruiting
Nicolás Bravo E1-3, 703Generalísimo José María Morelos y Pavón, Manzana 007, Generalísimo José María Morelos y Pavón, 54769 Cuautitlán Izcalli, Méx., Mexico
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