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Active, not recruiting Phase 3 Interventional

Avexitide for Treatment of Post-Bariatric Hypoglycemia

ClinicalTrials.gov ID: NCT06747468

Public ClinicalTrials.gov record NCT06747468. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Avexitide in Participants With Post-Bariatric Hypoglycemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06747468
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amylyx Pharmaceuticals Inc.
Industry
Enrollment
75 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 29, 2025 (Actual)
Primary completion
Jul 8, 2026 (Actual)
Completion
Feb 2027 (Estimated)
Last update posted
Aug 24, 2026

2025 – 2027

United States locations

U.S. sites
21
U.S. states
13
U.S. cities
19
Facility City State ZIP Site status
Stanford Health Care - Endocrinology Clinic Stanford California 94304 —
University of Colorado Health Anschutz Medical Campus Aurora Colorado 80045-2541 —
East Coast Institute for Research Jacksonville Florida 32216 —
Hanson Diabetes Center Port Charlotte Florida 33952-6722 —
Georgia Clincal Research Lawrenceville Georgia 30044 —
Cotton-O'Neil Diabetes and Endocrinology Center Topeka Kansas 66606-2806 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Joslin Diabetes Center Boston Massachusetts 02215-5306 —
NYC Health + Hospitals/Queens - BRANY New Hyde Park New York 11042-1214 —
Duke Center for Metabolic and Weight Loss Surgery Durham North Carolina 27704-2726 —
Centricity Research Morehead City Multispecialty Morehead City North Carolina 28557-3126 —
Cleveland Clinic Cleveland Ohio 44195-0001 —
Penn Medicine University City Philadelphia Pennsylvania 19104 —
Vanderbilt Weight Loss Center Nashville Tennessee 37212-3609 —
Endocrine and Psychiatry Center Houston Texas 77095-2856 —
Southern Endocrinology & Diabetes Associates Mesquite Texas 75149 —
UT Health San Antonio San Antonio Texas 78229-3931 —
Diabetes and Gandular Disease Clinic San Antonio Texas 78229-4801 —
Consano Clinical Research Shavano Park Texas 78231-1281 —
Texas Valley Clinical Research, LLC Weslaco Texas 78596-7288 —
UWHealth - Junction Rd Medical Center Endocrinology Clinic Madison Wisconsin 53717-2656 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06747468, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 24, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06747468 live on ClinicalTrials.gov.

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