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A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Apr 2026 to Mar 3, 2026 Completion date: Oct 2026 to Jun 19, 2026v17 Show 1 more changeShow less
    • Completion date: Oct 2026 to Jun 19, 2026
  2. Re-verified, no change to tracked fieldsv16
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting Secondary endpoints: 10 to 12 · Eligibility criteria shortened, about 4 wordsv15 Show 2 more changesShow less
    • Secondary endpoints: 10 to 12
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Recruiting to Enrolling by Invitation Study sites: 218 to 211v14 Show 1 more changeShow less
    • Study sites: 218 to 211
  5. Study sites: 217 to 218v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 216 to 217v12
  2. Study sites: 215 to 216v11
  3. Study sites: 189 to 215v10
  4. Study sites: 173 to 189v9
  5. Study sites: 163 to 173v8
  6. Study sites: 144 to 163v7
  7. Study sites: 137 to 144v6
  8. Enrollment target: 600 to 700 Study sites: 126 to 137v5 Show 1 more changeShow less
    • Study sites: 126 to 137
  9. Study sites: 89 to 126v4
  10. Primary endpoints: 1 to 4 Study sites: 73 to 89 · Eligibility criteria expanded, about 55 words · Secondary endpoints: 5 to 10v3 Show 3 more changesShow less
    • Study sites: 73 to 89
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: 5 to 10

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 50 to 73 Start date: Nov 9, 2023 to Nov 10, 2023v2 Show 1 more changeShow less
    • Start date: Nov 9, 2023 to Nov 10, 2023
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
Trial Details
NCT Number NCT06161571
Lead Sponsor Akero Therapeutics, Inc
Conditions NASH/MASH, NAFLD/MASLD
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov