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.
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Composite rate of Level 2 and Level 3 hypoglycemic events
Timeframe: During the double-blind treatment period (approximately 16 weeks)
Safety and Tolerability of avexitide
Timeframe: During the double-blind treatment period (approximately 16 weeks)
Incidence of anti-drug antibodies (ADAb)
Timeframe: During the double-blind treatment period (approximately 16 weeks)