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A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 326 → 330 locations Eligibility criteria expanded, about 10 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 10 words
  2. Trial sites expanded: 321 → 326 locationsv26
  3. Trial sites expanded: 317 → 321 locationsv25
  4. Re-verified, no change to tracked fieldsv24
  5. Trial sites expanded: 303 → 317 locationsv23
  6. Trial sites expanded: 296 → 303 locationsv22
  7. Trial sites expanded: 291 → 296 locationsv21
  8. Trial sites expanded: 284 → 291 locationsv20
  9. Study sites: 281 to 284v19
  10. Study sites: 280 to 281v18
  11. Study sites: 278 to 280v17
  12. Study sites: 275 to 278v16
  13. Study sites: 274 to 275v15
  14. Study sites: 250 to 274 Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 4 of 4 entriesv14 Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 4 entries

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 241 to 250v13
  16. Study sites: 213 to 241v12
  17. Study sites: 165 to 213v11
  18. Study sites: 96 to 165v10
  19. Study sites: 82 to 96v9
  20. Study sites: 65 to 82v8
  21. Study sites: 50 to 65v7
  22. Study sites: 14 to 50v6
  23. Study sites: 8 to 14v5
  24. Study sites: 2 to 8 Study title expanded, about 1 wordv4 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  25. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of May 2024 to May 24, 2024v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of May 2024 to May 24, 2024
  26. Primary completion date: Apr 2030 to Jun 2028v2
  27. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
89bio, Inc.
4 trials monitored
See all monitored trials
NASH / MASH
654 trials monitored
See 22 trials at risk
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 \[previously known as nonalcoholic steatohepatitis, NASH\]).
Trial Details
NCT Number NCT06419374
Lead Sponsor 89bio, Inc.
Conditions Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Enrollment 762 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov