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A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 2 entries Study sites: 356 to 357 · Eligibility criteria expanded, about 10 words · Secondary endpoints: 19 to 20 · 1 more Show 4 more changesShow less
    • Study sites: 356 to 357
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 19 to 20
    • Study description expanded, about 8 words
  2. Site details revised at 1 of 356 sitesv26
  3. Site details revised at 1 of 356 sitesv25
  4. Primary and study completion pushed from Nov 2032 to Feb 2033 Secondary endpoints: 20 to 19 · Study description shortened, about 40 wordsv24 Show 2 more changesShow less
    • Secondary endpoints: 20 to 19
    • Study description shortened, about 40 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial sites expanded: 349 → 355 locationsv23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 349 to 355 Eligibility criteria expanded, about 41 words · Secondary endpoints: 16 to 20 · Study description expanded, about 338 wordsv22 Show 3 more changesShow less
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: 16 to 20
    • Study description expanded, about 338 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 347 to 349v21
  3. Study sites: 341 to 347v20
  4. Study sites: 338 to 341v19
  5. Site details revised at 3 of 338 sitesv18
  6. Study sites: 337 to 338v17
  7. Study sites: 332 to 337v16
  8. Study sites: 330 to 332v15
  9. Study sites: 326 to 330v14
  10. Study sites: 321 to 326v13
  11. Study sites: 314 to 321v12
  12. Study sites: 310 to 314v11
  13. Study sites: 292 to 310v10
  14. Study sites: 290 to 292v9
  15. Study sites: 289 to 290v8
  16. Study sites: 288 to 289v7
  17. Study sites: 278 to 288v6
  18. Enrollment target: 1000 to 1650 Primary completion date: Dec 2026 to Nov 2032 · Primary endpoints: 1 to 2 · Study sites: 238 to 278 · 3 morev5 Show 6 more changesShow less
    • Primary completion date: Dec 2026 to Nov 2032
    • Primary endpoints: 1 to 2
    • Study sites: 238 to 278
    • Completion date: Mar 2027 to Nov 2032
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 19 to 16

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 229 to 238v4
  20. Study sites: 169 to 229v3
  21. Study sites: 75 to 169 Secondary endpoints: details revised at 1 of 19 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 19 entries
  1. 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 non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Trial Details
NCT Number NCT06215716
Lead Sponsor Akero Therapeutics, Inc
Conditions NASH With Fibrosis, MASH With Fibrosis
Enrollment 1,650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov