Last updated 25 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.
8Research 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 80 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
Centro Gutman
Recruiting
Instituto de Diagnóstico e Investigaciones Metabólicas - IDIM - sede centro - CABA
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
Centro Médico Saavedra
Recruiting
Centro Medico GEDYT Gastroenterología Diagnóstica y Terapéutica
Recruiting
Buenos Aires Mácula S.A.
Recruiting
PCR Cuautitlán Izcalli
Recruiting
StudyENLIGHTEN-Fibrosis
Sponsor89bio, Inc.
Study typeInterventional
Conditions
Metabolic dysfunction-associated steatohepatitis - MASHNonalcoholic steatohepatitis
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06318169
