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Recruiting Phase 3 NCT06419374

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

Phase 3 – large-scale trial before approval
Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Sponsor: 89bio, Inc.

trial.available_in: БГ
Overview
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Who can participate
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). * Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors. * Biopsy-confirmed fibrosis stage F4 MASH (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). Key Exclusion Criteria: * 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. Other protocol-defined inclusion and exclusion criteria may apply.
Locations 23
Argentina (1)
89bio Clinical Study Site
Buenos Aires
Australia (1)
89bio Clinical Study Site
Adelaide
Belgium (1)
89bio Clinical Study Site
Brussels
Brazil (1)
89bio Clinical Study Site
Barretos
Bulgaria (1)
89bio Clinical Study Site
Gorna Oryahovitsa
Canada (1)
89bio Clinical Study Site
Calgary , Alberta
France (1)
89bio Clinical Study Site
Amiens
Germany (1)
89bio Clinical Study Site
Chemnitz
Hong Kong (1)
89bio Clinical Study Site
Hong Kong
Hungary (1)
89bio Clinical Study Site
Budapest
Israel (1)
89bio Clinical Study Site
Afula
Italy (1)
89bio Clinical Study Site
Bergamo
Mexico (1)
89bio Clinical Study Site
Chihuahua City
Netherlands (1)
89bio Clinical Study Site
Amsterdam
Poland (1)
89bio Clinical Study Site
Katowice
WITHDRAWN
Puerto Rico (1)
89bio Clinical Study Site
Mayagüez
Singapore (1)
89bio Clinical Study Site
Singapore
South Korea (1)
89bio Clinical Study Site
Bucheon-si
Spain (1)
89bio Clinical Study Site
Almería
Taiwan (1)
89bio Clinical Study Site
Chiayi City
Turkey (1)
89bio Clinical Study Site
Bornova , İzmir
United Kingdom (1)
89bio Clinical Study Site
Aberdeen
United States (1)
89bio Clinical Study Site
Birmingham , Alabama
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
24.05.2024
Completion date
01.08.2031
Registry ID
NCT06419374
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.