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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 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. The trial reports 20 study locations across 4 states.
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 \[previously known as nonalcoholic steatohepatitis, NASH\]).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 762 participants |
| Start Date | 2024-05-24 |
| Est. Completion | 2031-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06419374
The ClinicalTrials.gov registry entry for NCT06419374 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 762 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 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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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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