Avexitide Phase 3 trial meets primary endpoint in Post-Bariatric Hypoglycemia (Amylyx Pharmaceuticals)

Trial details

Drug

AvexitideType Drug · Route subcutaneous

Treats

Studied as a treatment for Post-Bariatric hypoglycemia (registry condition: Post Bariatric Hypoglycemia).Condition Post Bariatric Hypoglycemia

Patients

75 patients (anticipated enrollment)2 arms · 21 sites in 1 country

Phase

Phase 3

Design

Randomized, double-blind, placebo-controlled, parallel-group

Primary endpoint

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

Key secondary endpoints

• Further evaluate the efficacy of avexitide compared to placebo for reduction of hypoglycemia

Result

Met endpointLUCIDITY met the FDA-agreed-upon primary endpoint demonstrating a 55% reduction in the composite rate of Level 2 and Level 3 hypoglycemic events compared to placebo (p=0.000003).p-value p=0.000003Figures as reported by the sponsor or registry; not calculated by DrugTrials.org.

Safety

LUCIDITY also met all secondary endpoints demonstrating consistent, highly statistically significant, and clinically meaningful reductions across SMBG-measured Level 2 events, CGM-measured Level 2 events, and independently adjudicated Level 3 events. 1 Avexitide was generally well-tolerated…

Sponsor

Amylyx Pharmaceuticals Nasdaq: AMLX

Dates

Study start Apr 29, 2025Primary completion Jul 8, 2026Announced Aug 18, 2026, 7:09 AM ET (SEC 8-K filing time)

Trial ID

NCT06747468 ClinicalTrials.gov