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NCT06318169 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis, sponsored by 89bio.

Recruiting
Registry status
Phase 3
Development phase
1,350
Enrollment target
20
Study locations

NCT06318169: Recruiting Phase 3 study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis, sponsored by 89bio.

NCT06318169 is a Phase 3 study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis that is actively recruiting participants, run by 89bio. The registered enrollment target is 1,350 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06318169, a Phase 3 study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis, is actively recruiting participants, sponsored by 89bio.

RECRUITING
Registry status
Phase 3
Development phase
1,350 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis

Conditions Studied

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Interventions

  • OTHER Placebo
  • BIOLOGICAL Pegozafermin

Study Locations (20)

California

  • 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 - Gardena
  • 89bio Clinical Study Site - Huntington Park
  • 89bio Clinical Study Site - Inglewood
  • 89bio Clinical Study Site - La Jolla
  • 89bio Clinical Study Site - Lancaster
  • 89bio Clinical Study Site - Long Beach
  • 89bio Clinical Study Site - Los Angeles
  • 89bio Clinical Study Site - Montclair

Arizona

  • 89bio Clinical Study Site - Chandler
  • 89bio Clinical Study Site - Flagstaff
  • 89bio Clinical Study Site - Glendale
  • 89bio Clinical Study Site - Tucson

Arkansas

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

Alabama

  • 89bio Clinical Study Site - Birmingham

Trial Details

FieldValue
Enrollment Target 1,350 participants
Start Date 2024-03-13
Est. Completion 2029-02
Phase Phase 3
89bio

7 total trials

What NCT06318169 shows while recruiting

NCT06318169 is an interventional study that assigns participants to a tested intervention. Its 1,350 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% higher).

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

NCT06318169 names 20 study sites across 4 states, led by California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT06318169 about?

NCT06318169 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)". 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.

What is the current status of trial NCT06318169?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,350 participants. The study started on 2024-03-13. Estimated completion is 2029-02.

What conditions does trial NCT06318169 study?

This clinical trial studies the following conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis.

What interventions are being tested in trial NCT06318169?

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

Who is sponsoring clinical trial NCT06318169?

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

Where is trial NCT06318169 being conducted?

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

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT06318169's enrollment target sits among peer trials

1,350 181st of 2000 higher than 1,820 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 NCT06318169

Source: ClinicalTrials.gov NCT06318169, the US trial registry maintained by the National Library of Medicine. NCT06318169 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.