Clinical Trials in Germany / NCT06419374
Recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
NCT06419374 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Investigational drug(s) / intervention(s)
Pegozafermin →Placebo
Pegozafermin: Subcutaneous injection
Placebo: Subcutaneous injection
Study summary
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
Eligibility
Key Inclusion Criteria:
* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
* Evidence of both cirrhosis and MASH etiology, either through a historical biopsy or a biopsy at Screening.
* Clinical diagnosis of cirrhosis based on the NIT algorithm.
Key Exclusion Criteria:
* Liver disorder other than MASH.
* History or evidence of hepatic decompensation.
* History or evidence of hepatocellular carcinoma.
* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
* Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.
Other protocol-defined inclusion and exclusion criteria may apply.
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| 89bio Clinical Study Site | Flagstaff | Arizona | Withdrawn |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.
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Official registry record
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 Germany