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Amylyx Pharmaceuticals Presents Results from Phase 3 LUCIDITY Clinical Trial of Avexitide in Post-Bariatric Hypoglycemia at ObesityWeek® 2026 Annual Meeting

AMLX
  • Amylyx Pharmaceuticals reported that the Phase 3 LUCIDITY trial met its primary endpoint, showing avexitide reduced the composite Level 2/3 hypoglycemic event rate by 55% compared to placebo (p=0.0000034).
  • Avexitide demonstrated statistically significant reductions across all prespecified secondary endpoints, including a 63% reduction in SMBG-confirmed Level 2 events, 47% in EAC-adjudicated Level 3 events, & 42% in CGM-detected Level 2 events.
  • The drug exhibited a favorable safety profile with mostly mild to moderate adverse events, no treatment-related serious adverse events, & no deaths during the 16-week double-blind period.
  • Participants in the avexitide arm experienced a 72.9% decrease in events from baseline versus a 37.8% decrease in the placebo arm (p=0.000034 for the difference).
  • The trial enrolled 78 adults with post-bariatric hypoglycemia following Roux-en-Y gastric bypass surgery, with 90% of participants completing the double-blind treatment period.
  • Amylyx plans to submit a New Drug Application (NDA) to the FDA by the end of 2026 & aims for a potential commercial launch in 2027 if approved.
  • The company will host an investor key opinion leader event on November 15 at 11:45 AM ET to discuss the LUCIDITY results via in-person & webcast formats.
  • Avexitide holds Breakthrough Therapy, Orphan Drug, & Rare Pediatric Disease designations from the FDA for post-bariatric hypoglycemia & congenital hyperinsulinism.
  • There are currently no FDA-approved therapies for post-bariatric hypoglycemia, a condition affecting approximately 8% of individuals who undergo sleeve gastrectomy or Roux-en-Y gastric bypass.
  • The 32-week open-label extension period & the Expanded Access Program for avexitide remain ongoing for eligible participants.