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Active, not recruiting Phase 3

Avexitide for Treatment of Post-Bariatric Hypoglycemia

NCT06747468 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2025-04-29
Last updated
2026-08-24

Condition(s) studied

Post Bariatric Hypoglycemia

Investigational drug(s) / intervention(s)

AvexitidePlacebo

Avexitide: Avexitide (also known as exendin 9-39), a first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist, is a 31-amino acid peptide with a free amino group at the N-terminus and an amidated C-terminus. By binding to the GLP-1 receptor, avexitide inhibits GLP-1 receptor signaling, thereby reducing GLP-1 receptor-mediated insulin secretion

Placebo: Matching placebo comparator

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Able to provide written informed consent and understand the purpose and risks of the study * Willing and able to adhere to study requirements, including the use of the study-provided CGM device, SMBG device, and eDiary device as well as the other study evaluations and procedures. * Is male or female, at least 18 years of age (inclusive) at the time of consent. * Body mass index (BMI) of up to 40 kg/m2 and has stable body weight-i.e., not varying by \>5% for at least 2 months prior to Screening * Has undergone documented RYGB performed ≥12 months prior to Screening. * Has clinical diagnosis of PBH-defined as history of recurrent hypoglycemia with onset after surgery and having ruled out other causes of hypoglycemia as per Investigator judgment. * Has recurrent hypoglycemia, as demonstrated by experiencing at least 3 discrete hypoglycemic episodes during the 3-week study Run-in period. * Must agree to consistently follow the dietary management guidance and to maintain consistent exercise and/or physical activity level throughout the Screening period (including the Run-in period), the Double-Blind study treatment period, and Part A of the OLE period. * If female, must meet all of the following: * Is not breastfeeding or lactating; * If of childbearing potential, has negative serum pregnancy test result at Screening and on Day 1 ahead of dosing * If of childbearing potential, must also agree to use a highly effective method of birth control-and agree not to participate in egg (ova) donation or storage, throughout the duration of study participation and for at least 1 month after the last dose of study drug. * If male and engaging in heterosexual intercourse with a female partner of childbearing potential, must utilize a highly effective method of contraception, and agree not to donate sperm, from the time of providing written informed consent until at least 3 months after the last dose of study drug. Exclusion Criteria: * Has received avexitide (exendin 9-39) at any time prior to Screening Visit 1. * Has received another investigational drug, for any indication, within 5 half-lives of that drug prior to Screening Visit 1. * Has participated in another interventional clinical study within 30 days prior to Screening Visit 1. * Presence of gastrostomy tube (G-tube). * Any known or suspected allergy to one of the investigational medicinal products (avexitide or placebo) or any related product (e.g., exenatide). * History or presence of insulinoma or other cause of endogenous hyperinsulinism other than PBH. * Active psychiatric disease or active eating disorder (e.g., uncontrolled major depressive disorder, schizophrenia, bipolar disorder, or other severe mood, anxiety, or eating disorder). Note: prospective participants with stable conditions, per Investigator judgement, may be considered, provided they are not on an excluded medication. * History of major surgery within 6 months prior to Screening. * History of upper GI surgery, other than RYGB. Note that history of vertical sleeve gastrectomy (VSG) with subsequent RYGB conversion may be considered on a case-by-case basis upon discussion with the Medical Monitor. * Current or prior use of agent(s) that may alter glucose metabolism, or promote weight loss, within 5 medication half-lives of Screening Visit 1. Such agents include, but are not limited to, the following: acarbose; calcium channel blockers; diazoxide; dipeptidyl-peptidase-4 (DPP-4) inhibitors; GLP-1 agonists; glucocorticoids; glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 dual agonists; insulin; lithium; meglitinides; metformin; pentamide; sodium-glucose-linked transporter (SGLT)-1 inhibitors; SGLT-2 inhibitors; somatostatin analogs; sulfonylureas; and thiazolidinediones (TZDs). * Use of drugs that interfere with the Dexcom G7 sensor within 5 half-lives of Screening Visit 1. Such drugs include acetaminophen administered at a dosage greater than 1000 mg every 6 hours, and hydroxyurea. * Investigator-assessed evidence of alcohol or drug abuse within 12 months prior to Screening. Unwillingness to restrict alcohol use to no more than 1 drink per day is also exclusionary.

Primary outcome measure(s)

  • Composite rate of Level 2 and Level 3 hypoglycemic events — During the double-blind treatment period (approximately 16 weeks)
    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
  • Safety and Tolerability of avexitide — During the double-blind treatment period (approximately 16 weeks)
    Incidence of adverse events (AEs)-e.g., incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), AEs of special interest (AESIs), and TEAEs leading to discontinuation-and other safety assessments (e.g., clinical laboratory results and vital sign measurements), assessed during the Double-Blind study treatment period
  • Incidence of anti-drug antibodies (ADAb) — During the double-blind treatment period (approximately 16 weeks)
    Incidence of ADAb, assessed during the Double-Blind study treatment period

Trial sites (21)

FacilityCityRegionStatus
Stanford Health Care - Endocrinology Clinic Stanford California
University of Colorado Health Anschutz Medical Campus Aurora Colorado
East Coast Institute for Research Jacksonville Florida
Hanson Diabetes Center Port Charlotte Florida
Georgia Clincal Research Lawrenceville Georgia
Cotton-O'Neil Diabetes and Endocrinology Center Topeka Kansas
Brigham and Women's Hospital Boston Massachusetts
Joslin Diabetes Center Boston Massachusetts
NYC Health + Hospitals/Queens - BRANY New Hyde Park New York
Duke Center for Metabolic and Weight Loss Surgery Durham North Carolina
Centricity Research Morehead City Multispecialty Morehead City North Carolina
Cleveland Clinic Cleveland Ohio
Penn Medicine University City Philadelphia Pennsylvania
Vanderbilt Weight Loss Center Nashville Tennessee
Endocrine and Psychiatry Center Houston Texas
Southern Endocrinology & Diabetes Associates Mesquite Texas
UT Health San Antonio San Antonio Texas
Diabetes and Gandular Disease Clinic San Antonio Texas
Consano Clinical Research Shavano Park Texas
Texas Valley Clinical Research, LLC Weslaco Texas
UWHealth - Junction Rd Medical Center Endocrinology Clinic Madison Wisconsin

More Amylyx Pharmaceuticals Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06747468 on ClinicalTrials.gov ↗ ← All trials in the USA