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A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 367 → 370 locations Eligibility criteria expanded, about 8 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 8 words
  2. Study sites: 365 to 367v27
  3. Trial sites expanded: 361 → 365 locationsv26
  4. Re-verified, no change to tracked fieldsv25
  5. Trial sites expanded: 349 → 361 locationsv24
  6. Trial sites expanded: 342 → 349 locationsv23
  7. Trial sites expanded: 331 → 342 locationsv22
  8. Study sites: 327 to 331v21
  9. Study sites: 313 to 327v20
  10. Study sites: 305 to 313v19
  11. Primary endpoints revised (3) Enrollment target: 1050 to 1350 · Study sites: 239 to 305 · Eligibility criteria shortened, about 66 words · 1 morev18 Show 4 more changesShow less
    • Enrollment target: 1050 to 1350
    • Study sites: 239 to 305
    • Eligibility criteria shortened, about 66 words
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 230 to 239v17
  13. Study sites: 219 to 230v16
  14. Study sites: 209 to 219v15
  15. Study sites: 177 to 209v14
  16. Primary completion date: Dec 2026 to Feb 2029 Primary endpoints: 2 to 3 · Study sites: 141 to 177 · Eligibility criteria expanded, about 20 words · 1 morev13 Show 4 more changesShow less
    • Primary endpoints: 2 to 3
    • Study sites: 141 to 177
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  17. Study sites: 115 to 141v12
  18. Study sites: 93 to 115v11
  19. Study sites: 87 to 93v10
  20. Study sites: 77 to 87v9
  21. Study sites: 69 to 77v8
  22. Study sites: 58 to 69v7
  23. Study sites: 47 to 58v6
  24. Study sites: 24 to 47v5
  25. Study sites: 5 to 24v4
  26. Start date changed from estimate of Mar 2024 to Mar 13, 2024v3
  27. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 5v2 Show 1 more changeShow less
    • Study sites: 0 to 5
  28. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
Trial Details
NCT Number NCT06318169
Lead Sponsor 89bio, Inc.
Conditions Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Enrollment 1,350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov