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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 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. The trial reports 20 study locations across 4 states.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,350 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2029-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06318169
The ClinicalTrials.gov registry entry for NCT06318169 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is 89bio, which has 7 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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