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HomeTrials › NCT06747468

Other · Phase 3 · Active, not recruiting

Avexitide for Treatment of Post-Bariatric Hypoglycemia

NCT06747468 · Sponsor: Amylyx Pharmaceuticals Inc.

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Avexitide for post bariatric hypoglycemia.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeAvexitide
Study length~10 months overall
Planned participants75
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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.

Study sites by state

California

  • Stanford Health Care - Endocrinology Clinic — Stanford

Colorado

  • University of Colorado Health Anschutz Medical Campus — Aurora

Florida

  • East Coast Institute for Research — Jacksonville
  • Hanson Diabetes Center — Port Charlotte

Georgia

  • Georgia Clincal Research — Lawrenceville

Kansas

  • Cotton-O'Neil Diabetes and Endocrinology Center — Topeka

Massachusetts

  • Brigham and Women's Hospital — Boston
  • Joslin Diabetes Center — Boston

New York

  • NYC Health + Hospitals/Queens - BRANY — New Hyde Park

North Carolina

  • Duke Center for Metabolic and Weight Loss Surgery — Durham
  • Centricity Research Morehead City Multispecialty — Morehead City

Ohio

  • Cleveland Clinic — Cleveland

Pennsylvania

  • Penn Medicine University City — Philadelphia

Tennessee

  • Vanderbilt Weight Loss Center — Nashville

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

Wisconsin

  • UWHealth - Junction Rd Medical Center Endocrinology Clinic — Madison

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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