Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Avexitide for Treatment of Post-Bariatric Hypoglycemia
NCT06747468 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06747468
The ClinicalTrials.gov registry entry for NCT06747468 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amylyx Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06747468 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06747468?
The interventions under investigation include: Placebo (OTHER), Avexitide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06747468?
This trial is sponsored by Amylyx Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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