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NCT06318169 · ClinicalTrials.gov record · last posted 2026-08-05

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

Name: A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) — clinical trial record (NCT06318169)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

Sponsor89bio, Inc.

Started2024-03-13

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Protocol amendment history 4 changes detected by DataLookout

2026-08-06

Trial sites expanded: 361 → 365 locations

2026-07-09

Trial sites expanded: 349 → 361 locations

2026-06-05

Trial sites expanded: 342 → 349 locations

2026-05-06

Trial sites expanded: 331 → 342 locations

Trial Details

NCT Number	NCT06318169
Lead Sponsor	89bio, Inc.
Conditions	Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Enrollment	1,350 participants
Start Date	2024-03-13
Primary Completion	2029-02 (estimated)
Study Completion	2029-02 (estimated)
Updated on ClinicalTrials.gov	2026-08-05