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Avexitide for Treatment of Post-Bariatric Hypoglycemia

Study acronym: LUCIDITY
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Mar 2026 → Jul 8, 2026
See other at-risk trials from Amylyx Pharmaceuticals Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 2026 to Jul 8, 2026
    • Study completion pushed from Oct 2026 to Feb 2027
    v13
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (21)
    v12
  3. Site details revised at 8 of 21 sitesv11
  4. Site details revised at 1 of 21 sitesv10
  5. Site details revised at 1 of 21 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 1 of 21 sitesv8
  2. Site details revised at 3 of 21 sitesv7
  3. Site details revised at 2 of 21 sitesv6
  4. Site details revised at 1 of 21 sitesv5
  5. Site details revised at 1 of 21 sitesv4
  6. Study sites: 19 to 21
    • Start date changed from estimate of Feb 2025 to Apr 29, 2025
    v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 19
    • Start date: Jan 2025 to Feb 2025
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB). The study will assess avexitide compared to placebo for safety and efficacy, measured by reduction of hypoglycemic events. The study includes a Screening period with a Run-in period (of up to 6- and 3-weeks, respectively); a randomized, double-blind, placebo-controlled study treatment period of 16 weeks; and a two-part open-label extension (OLE) period with a duration of approximately 32 weeks.
Trial Details
NCT Number NCT06747468
Lead Sponsor Amylyx Pharmaceuticals Inc.
Conditions
(from sponsor)		 Post Bariatric Hypoglycemia
Related terms Hypoglycemia
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov