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NCT06747468 · ClinicalTrials.gov registry record · Phase 3
Avexitide for Treatment of Post-Bariatric Hypoglycemia
A Phase 3 study of Post-Bariatric Hypoglycemia, sponsored by Amylyx Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT06747468: Active Phase 3 study of Post-Bariatric Hypoglycemia, sponsored by Amylyx Pharmaceuticals.
NCT06747468 is a Phase 3 study of Post-Bariatric Hypoglycemia that is active but no longer recruiting, run by Amylyx Pharmaceuticals. The registered enrollment target is 75 participants, above the 42-participant average among 4 other Post-Bariatric Hypoglycemia trials with a reported enrollment target (79% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06747468, a Phase 3 study of Post-Bariatric Hypoglycemia, is active but no longer recruiting, sponsored by Amylyx Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Composite rate of Level 2 hypoglycemia (as measured by self-monitoring of blood glucose \[SMBG\]) and Level 3 hypoglycemia (per American Diabetes Association \[ADA\], European Association for the Study of Diabetes \[EASD\]; adjudicated by independent Event Adjudication Committee \[EAC\]), assessed during the Double-Blind study treatment period
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Avexitide
Study Locations (20)
Texas
- Endocrine and Psychiatry Center - Houston
- Southern Endocrinology & Diabetes Associates - Mesquite
- UT Health San Antonio - San Antonio
- Diabetes and Gandular Disease Clinic - San Antonio
- Consano Clinical Research - Shavano Park
- Texas Valley Clinical Research, LLC - Weslaco
Florida
- East Coast Institute for Research - Jacksonville
- Hanson Diabetes Center - Port Charlotte
Massachusetts
- Brigham and Women's Hospital - Boston
- Joslin Diabetes Center - Boston
North Carolina
- Duke Center for Metabolic and Weight Loss Surgery - Durham
- Centricity Research Morehead City Multispecialty - Morehead City
California
- Stanford Health Care - Endocrinology Clinic - Stanford
Colorado
- University of Colorado Health Anschutz Medical Campus - Aurora
Georgia
- Georgia Clincal Research - Lawrenceville
Kansas
- Cotton-O'Neil Diabetes and Endocrinology Center - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2025-04-29 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
What the registry record for NCT06747468 still lists
NCT06747468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 42-participant average among 4 other Post-Bariatric Hypoglycemia trials with a reported enrollment target (79% higher).
The record links to 1 condition, with Post-Bariatric Hypoglycemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06747468 names 20 study sites across 12 states, led by Texas, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06747468 about?
NCT06747468 is a clinical study titled "Avexitide for Treatment of Post-Bariatric Hypoglycemia". 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...
What is the current status of trial NCT06747468?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2025-04-29. Estimated completion is 2026-10.
What conditions does trial NCT06747468 study?
This clinical trial studies the following conditions: Post-Bariatric Hypoglycemia.
What interventions are being tested in trial NCT06747468?
The interventions under investigation include: Placebo (OTHER), Avexitide (DRUG).
Who is sponsoring clinical trial NCT06747468?
This trial is sponsored by Amylyx Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06747468 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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