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Recruiting Phase 3 NCT06318169

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

Phase 3 – large-scale trial before approval
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Sponsor: 89bio, Inc.

trial.available_in: БГ
Overview
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
Who can participate
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF) * Biopsy-confirmed MASH with fibrosis stage F2 or F3 * Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants). Key Exclusion Criteria: * Chronic liver diseases other than MASH * 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 (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening Other inclusion and exclusion criteria may apply.
Locations 26
Argentina (1)
89bio Clinical Study Site
Buenos Aires
Australia (1)
89bio Clinical Study Site
Brisbane , Queensland
Belgium (1)
89bio Clinical Study Site
Brussels
Bulgaria (1)
89bio Clinical Study Site
Gorna Oryahovitsa
Canada (1)
89bio Clinical Study Site
Calgary , Alberta
Czech Republic (1)
89bio Clinical Study Site
Brno
France (1)
89bio Clinical Study Site
Amiens
Georgia (1)
89bio Clinical Study Site
Batumi
Germany (1)
89bio Clinical Study Site
Chemnitz
Hong Kong (1)
89bio Clinical Study Site
Hong Kong
India (1)
89bio Clinical Study Site
Guwahati , Assam
Israel (1)
89bio Clinical Study Site
Afula
Italy (1)
89bio Clinical Study Site
Bergamo
Japan (1)
89bio Clinical Study Site
Maebashi , Gunma
Mexico (1)
89bio Clinical Study Site
Chihuahua City
Netherlands (1)
89bio Clinical Study Site
Rotterdam , South Holland
Poland (1)
89bio Clinical Study Site
Katowice
WITHDRAWN
Puerto Rico (1)
89bio Clinical Study Site
Mayagüez
Singapore (1)
89bio Clinical Study Site
Singapore
South Africa (1)
89bio Clinical Study Site
Cape Town
South Korea (1)
89bio Clinical Study Site
Busan
Spain (1)
89bio Clinical Study Site
Barcelona
Taiwan (1)
89bio Clinical Study Site
Chiayi City
Turkey (1)
89bio Clinical Study Site
Adana
United Kingdom (1)
89bio Clinical Study Site
High Wycombe , Buckinghamshire
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
80 Years
Healthy volunteers
No
Start date
13.03.2024
Completion date
01.02.2029
Registry ID
NCT06318169
Source
anzctr
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