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A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 30, 2027 → Dec 31, 2027
Primary endpoint added 2 → 3 primary endpoints
See other at-risk trials from Vertex Pharmaceuticals

Record History

  1. Primary completion pushed from Jun 30, 2027 to Dec 31, 2027 Primary endpoint(s) modified · Completion pushed from Jun 30, 2030 to Dec 31, 2031 · Interventions modified · 6 morev32 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Completion pushed from Jun 30, 2030 to Dec 31, 2031
    • Interventions modified
    • Trial arms changed: 1 → 2
    • Enrollment target: 52 to 57
    • Secondary endpoints: 5 to 6
    • Site details revised at 1 of 29 sites
    • Eligibility criteria shortened, about 2 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 1 of 29 sitesv31
  3. 2 versions Re-verified since Jul 29, 2025, no change to tracked fieldsv29-v30
  4. Study sites: 27 to 29v28
  5. Study sites: 25 to 27v27
Show 25 earlier versionsHide 25 earlier versions
  1. Study sites: 24 to 25v26
  2. Study sites: 23 to 24 Primary completion date: Jun 2027 to Jun 30, 2027 · Completion date: Jun 2030 to Jun 30, 2030 · Eligibility criteria revisedv25 Show 3 more changesShow less
    • Primary completion date: Jun 2027 to Jun 30, 2027
    • Completion date: Jun 2030 to Jun 30, 2030
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  3. Phase: Phase 1/2 to Phase 3 Primary completion date: Feb 2026 to Jun 2027 · Primary endpoints: 3 to 2 · Enrollment target: 37 to 52 · 3 morev24 Show 6 more changesShow less
    • Primary completion date: Feb 2026 to Jun 2027
    • Primary endpoints: 3 to 2
    • Enrollment target: 37 to 52
    • Completion date: Feb 2030 to Jun 2030
    • Secondary endpoints: 3 to 5
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv23
  5. Enrollment target: 17 to 37 Primary completion date: Jan 2024 to Feb 2026 · Primary endpoints: 2 to 3 · Study sites: 22 to 23 · 2 morev22 Show 5 more changesShow less
    • Primary completion date: Jan 2024 to Feb 2026
    • Primary endpoints: 2 to 3
    • Study sites: 22 to 23
    • Completion date: Jan 2028 to Feb 2030
    • Secondary endpoints: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 21 to 22v21
  7. Re-verified, no change to tracked fieldsv20
  8. Study sites: 18 to 21v19
  9. Study sites: 17 to 18v18
  10. Study sites: 16 to 17v17
  11. Study sites: 15 to 16v16
  12. Study sites: 14 to 15v15
  13. Study sites: 13 to 14v14
  14. Study sites: 12 to 13v13
  15. Study sites: 11 to 12v12
  16. Study sites: 10 to 11v11
  17. Study description shortened, about 44 wordsv10 See this version in full on ClinicalTrials.gov ↗
  18. Study description expanded, about 44 words Site details revised at 9 of 10 sitesv9 Show 1 more changeShow less
    • Site details revised at 9 of 10 sites

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 9 to 10v8
  20. Study sites: 8 to 9v7
  21. Study sites: 6 to 8v6
  22. Study sites: 5 to 6v5
  23. Study sites: 3 to 5v4
  24. Start date changed from estimate of Mar 2021 to Mar 29, 2021v3
  25. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3v2 Show 1 more changeShow less
    • Study sites: 0 to 3
  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 study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
Trial Details
NCT Number NCT04786262
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov