Last updated 43 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.
1Research 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

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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