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NCT06419374 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, sponsored by 89bio.

Recruiting
Registry status
Phase 3
Development phase
762
Enrollment target
20
Study locations

NCT06419374: Recruiting Phase 3 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, sponsored by 89bio.

NCT06419374 is a Phase 3 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis that is actively recruiting participants, run by 89bio. The registered enrollment target is 762 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06419374, a Phase 3 study of Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, is actively recruiting participants, sponsored by 89bio.

RECRUITING
Registry status
Phase 3
Development phase
762 participants
Enrollment target
20
Study locations

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

Primary Outcome

Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.

Conditions Studied

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

Interventions

  • DRUG Placebo
  • BIOLOGICAL Pegozafermin

Study Locations (20)

California

  • 89bio Clinical Study Site - Camarillo
  • 89bio Clinical Study Site - Canoga Park
  • 89bio Clinical Study Site - Coronado
  • 89bio Clinical Study Site - Fountain Valley
  • 89bio Clinical Study Site - Fresno
  • 89bio Clinical Study Site - Huntington Park
  • 89bio Clinical Study Site - La Jolla
  • 89bio Clinical Study Site - Los Angeles
  • 89bio Clinical Study Site - Los Angeles

Arizona

  • 89bio Clinical Study Site - Chandler
  • 89bio Clinical Study Site - Flagstaff
  • 89bio Clinical Study Site - Peoria
  • 89bio Clinical Study Site - Phoenix
  • 89bio Clinical Study Site - Tucson
  • 89bio Clinical Study Site - Tucson
  • 89bio Clinical Study Site - Tucson

Alabama

  • 89bio Clinical Study Site - Birmingham
  • 89bio Clinical Study Site - Homewood

Arkansas

  • 89bio Clinical Study Site - Little Rock
  • 89bio Clinical Study Site - North Little Rock

Trial Details

FieldValue
Enrollment Target 762 participants
Start Date 2024-05-24
Est. Completion 2031-08
Phase Phase 3
89bio

7 total trials

What NCT06419374 shows while recruiting

NCT06419374 is an interventional study that assigns participants to a tested intervention. The registered 762 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 1 condition, with Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06419374 names 20 study sites across 4 states, led by California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT06419374 about?

NCT06419374 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH". 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 \[previously known as nonalcoholic steatohepatitis, NASH\]).

What is the current status of trial NCT06419374?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 762 participants. The study started on 2024-05-24. Estimated completion is 2031-08.

What conditions does trial NCT06419374 study?

This clinical trial studies the following conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis.

What interventions are being tested in trial NCT06419374?

The interventions under investigation include: Placebo (DRUG), Pegozafermin (BIOLOGICAL).

Who is sponsoring clinical trial NCT06419374?

This trial is sponsored by 89bio, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06419374 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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How this trial's enrollment target compares

Where NCT06419374's enrollment target sits among peer trials

762 449th of 2000 higher than 1,552 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06419374

Source: ClinicalTrials.gov NCT06419374, the US trial registry maintained by the National Library of Medicine. NCT06419374 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.