Last updated 25 days ago
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
762 patients around the world
Available in Spain, Argentina, United States
89bio, Inc.
8Research sites
762Patients around the world
This study is for people with
Steatohepatitis
Metabolic dysfunction-associated steatohepatitis - MASH
Fatty liver/nash
Nonalcoholic steatohepatitis
Cirrhosis
Compensated cirrhosis
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).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).
- 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.
Sites
Centro Gutman
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Instituto de Diagnóstico e Investigaciones Metabólicas - IDIM - sede centro - CABA
Recruiting
Buenos Aires Mácula S.A.
Recruiting
Centro Médico Saavedra
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
Centro Medico GEDYT Gastroenterología Diagnóstica y Terapéutica
Recruiting
PCR Cuautitlán Izcalli
Recruiting
StudyENLIGHTEN-Cirrhosis
Sponsor89bio, Inc.
Study typeInterventional
Conditions
Metabolic dysfunction-associated steatohepatitis - MASHNonalcoholic steatohepatitisCompensated cirrhosis
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06419374
