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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.

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

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

Sponsor

89bio

7 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.