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Clinical Trials in the USA / NCT06419374
Recruiting Phase 3

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

NCT06419374 · tracked via the Priya Life Science USA tracker
Sponsor
89bio, Inc.
Phase
Phase 3
Started
2024-05-24
Last updated
2026-09-03

Condition(s) studied

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Investigational drug(s) / intervention(s)

PegozaferminPlacebo

Pegozafermin: Subcutaneous injection

Placebo: Subcutaneous injection

Study summary

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 \[previously known as nonalcoholic steatohepatitis, NASH\]).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (326)

FacilityCityRegionStatus
89bio Clinical Study Site Birmingham Alabama Recruiting
89bio Clinical Study Site Homewood Alabama Recruiting
89bio Clinical Study Site Chandler Arizona Recruiting
89bio Clinical Study Site Flagstaff Arizona Withdrawn
89bio Clinical Study Site Peoria Arizona Recruiting
89bio Clinical Study Site Phoenix Arizona Recruiting
89bio Clinical Study Site Sun City Arizona Recruiting
89bio Clinical Study Site Tucson Arizona Recruiting
89bio Clinical Study Site Tucson Arizona Recruiting
89bio Clinical Study Site Tucson Arizona Recruiting
89bio Clinical Study Site Little Rock Arkansas Recruiting
89bio Clinical Study Site North Little Rock Arkansas Recruiting
89bio Clinical Study Site Camarillo California Recruiting
89bio Clinical Study Site Canoga Park California Recruiting
89bio Clinical Study Site Coronado California Recruiting
89bio Clinical Study Site Fountain Valley California Recruiting
89bio Clinical Study Site Fresno California Recruiting
89bio Clinical Study Site Huntington Park California Withdrawn
89bio Clinical Study Site La Jolla California Recruiting
89bio Clinical Study Site Los Angeles California Recruiting
89bio Clinical Study Site Los Angeles California Recruiting
89bio Clinical Study Site Pasadena California Recruiting
89bio Clinical Study Site Poway California Recruiting
89bio Clinical Study Site Redwood City California Recruiting
89bio Clinical Study Site Rialto California Recruiting
89bio Clinical Study Site Sacramento California Recruiting
89bio Clinical Study Site Santa Ana California Withdrawn
89bio Clinical Study Site Littleton Colorado Recruiting
89bio Clinical Study Site Clermont Florida Recruiting
89bio Clinical Study Site Fort Myers Florida Recruiting
89bio Clinical Study Site Gainesville Florida Recruiting
89bio Clinical Study Site Hialeah Gardens Florida Recruiting
89bio Clinical Study Site Homestead Florida Recruiting
89bio Clinical Study Site Jacksonville Florida Recruiting
89bio Clinical Study Site Jacksonville Florida Recruiting
89bio Clinical Study Site Lady Lake Florida Withdrawn
89bio Clinical Study Site Lakewood Rch Florida Recruiting
89bio Clinical Study Site Lehigh Acres Florida Recruiting
89bio Clinical Study Site Maitland Florida Withdrawn
89bio Clinical Study Site Miami Florida Recruiting

+ 286 more sites — see the full list on the official registry below.

More 89bio, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06419374 on ClinicalTrials.gov ↗ ← All trials in the USA