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A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 8 of 19 entries Site details revised at 3 of 331 sites · Eligibility criteria expanded, about 5 words Show 2 more changesShow less
    • Site details revised at 3 of 331 sites
    • Eligibility criteria expanded, about 5 words
  2. Study sites: 329 to 331v25
  3. Trial sites expanded: 323 → 329 locationsv24
  4. Study sites: 322 to 323v23
  5. Study sites: 321 to 322v22
  6. Trial sites expanded: 318 → 321 locationsv21
  7. Primary endpoint(s) modified Enrollment increased: 1150 → 2150 participants · Primary completion pushed from Sep 2029 to Feb 2030 · Completion pushed from Oct 2029 to Mar 2030 · 3 morev20 Show 6 more changesShow less
    • Enrollment increased: 1150 → 2150 participants
    • Primary completion pushed from Sep 2029 to Feb 2030
    • Completion pushed from Oct 2029 to Mar 2030
    • Study sites: 316 to 318
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 20 to 19

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 312 to 316v19
  9. Study sites: 308 to 312v18
  10. Study sites: 302 to 308v17
  11. Study sites: 291 to 302v16
  12. Study sites: 285 to 291v15
  13. Study sites: 275 to 285v14
  14. Study sites: 262 to 275v13
  15. Re-verified, no change to tracked fieldsv12
  16. Study sites: 241 to 262v11
  17. Study sites: 224 to 241v10
  18. Study sites: 209 to 224v9
  19. Study sites: 180 to 209v8
  20. Study sites: 155 to 180v7
  21. Study sites: 139 to 155v6
  22. Study sites: 105 to 139v5
  23. Study sites: 62 to 105v4
  24. Start date: Jun 10, 2024 to Sep 4, 2024 Study sites: 40 to 62v3 Show 1 more changeShow less
    • Study sites: 40 to 62
  25. Study sites: 7 to 40v2
  26. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
Trial Details
NCT Number NCT06528314
Lead Sponsor Akero Therapeutics, Inc
Conditions NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Enrollment 2,150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov