A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Condition(s) studied
Investigational drug(s) / intervention(s)
Pegozafermin: Subcutaneous injection
Placebo: Subcutaneous injection
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 \[previously known as nonalcoholic steatohepatitis, NASH\]).
Eligibility
Primary outcome measure(s)
- Proportion of Participants Achieving Fibrosis Regression — Baseline through Month 24
Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy. - Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events — Baseline up to 5 years
Trial sites (330)
| Facility | City | Region | Status |
|---|---|---|---|
| 89bio Clinical Study Site | Birmingham | Alabama | Recruiting |
| 89bio Clinical Study Site | Homewood | Alabama | Recruiting |
| 89bio Clinical Study Site | Chandler | Arizona | Recruiting |
| 89bio Clinical Study Site | Flagstaff | Arizona | Withdrawn |
| 89bio Clinical Study Site | Peoria | Arizona | Recruiting |
| 89bio Clinical Study Site | Phoenix | Arizona | Recruiting |
| 89bio Clinical Study Site | Sun City | Arizona | Recruiting |
| 89bio Clinical Study Site | Tucson | Arizona | Recruiting |
| 89bio Clinical Study Site | Tucson | Arizona | Recruiting |
| 89bio Clinical Study Site | Tucson | Arizona | Recruiting |
| 89bio Clinical Study Site | Little Rock | Arkansas | Recruiting |
| 89bio Clinical Study Site | North Little Rock | Arkansas | Recruiting |
| 89bio Clinical Study Site | Camarillo | California | Recruiting |
| 89bio Clinical Study Site | Canoga Park | California | Recruiting |
| 89bio Clinical Study Site | Coronado | California | Recruiting |
| 89bio Clinical Study Site | Fountain Valley | California | Recruiting |
| 89bio Clinical Study Site | Fresno | California | Recruiting |
| 89bio Clinical Study Site | Huntington Park | California | Withdrawn |
| 89bio Clinical Study Site | La Jolla | California | Recruiting |
| 89bio Clinical Study Site | Los Angeles | California | Recruiting |
| 89bio Clinical Study Site | Los Angeles | California | Recruiting |
| 89bio Clinical Study Site | Pasadena | California | Recruiting |
| 89bio Clinical Study Site | Poway | California | Recruiting |
| 89bio Clinical Study Site | Redwood City | California | Recruiting |
| 89bio Clinical Study Site | Rialto | California | Recruiting |
| 89bio Clinical Study Site | Sacramento | California | Recruiting |
| 89bio Clinical Study Site | Santa Ana | California | Withdrawn |
| 89bio Clinical Study Site | Littleton | Colorado | Recruiting |
| 89bio Clinical Study Site | Clermont | Florida | Recruiting |
| 89bio Clinical Study Site | Fort Myers | Florida | Recruiting |
| 89bio Clinical Study Site | Gainesville | Florida | Recruiting |
| 89bio Clinical Study Site | Hialeah Gardens | Florida | Recruiting |
| 89bio Clinical Study Site | Homestead | Florida | Recruiting |
| 89bio Clinical Study Site | Jacksonville | Florida | Recruiting |
| 89bio Clinical Study Site | Jacksonville | Florida | Recruiting |
| 89bio Clinical Study Site | Lady Lake | Florida | Withdrawn |
| 89bio Clinical Study Site | Lakewood Rch | Florida | Recruiting |
| 89bio Clinical Study Site | Lehigh Acres | Florida | Recruiting |
| 89bio Clinical Study Site | Maitland | Florida | Withdrawn |
| 89bio Clinical Study Site | Miami | Florida | Recruiting |
+ 290 more sites — see the full list on the official registry below.
More 89bio, Inc. trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06419374 on ClinicalTrials.gov ↗ ← All trials in Italy