Clinical Trial

Avexitide for Treatment of Post-Bariatric Hypoglycemia

Study acronym: LUCIDITY
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2024-12-18; most recent amendment 2026-03-03.
Status change: Recruiting → Active, Not Recruiting 2026-03-03
Status change: Not Yet Recruiting → Recruiting 2025-02-06
Trial Details
NCT Number NCT06747468
Lead Sponsor Amylyx Pharmaceuticals Inc.
Conditions Post Bariatric Hypoglycemia
Enrollment 75 participants
Start Date 2025-04-29
Primary Completion 2026-03 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-04