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New hope for Post-Surgery sugar crashes: avexitide trial underway

NCT ID NCT06747468

Disease control Sponsor: Amylyx Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This study tests a drug called avexitide in 75 adults who have dangerous low blood sugar episodes after gastric bypass surgery. Participants receive either the drug or a placebo for 16 weeks to see if it reduces severe sugar crashes. The goal is to control this long-term condition, not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

dumping syndrome hypoglycemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post bariatric hypoglycemia

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Centricity Research Morehead City Multispecialty

    Morehead City, North Carolina, 28557-3126, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001, United States

  • Consano Clinical Research

    Shavano Park, Texas, 78231-1281, United States

  • Cotton-O'Neil Diabetes and Endocrinology Center

    Topeka, Kansas, 66606-2806, United States

  • Diabetes and Gandular Disease Clinic

    San Antonio, Texas, 78229-4801, United States

  • Duke Center for Metabolic and Weight Loss Surgery

    Durham, North Carolina, 27704-2726, United States

  • East Coast Institute for Research

    Jacksonville, Florida, 32216, United States

  • Endocrine and Psychiatry Center

    Houston, Texas, 77095-2856, United States

  • Georgia Clincal Research

    Lawrenceville, Georgia, 30044, United States

  • Hanson Diabetes Center

    Port Charlotte, Florida, 33952-6722, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215-5306, United States

  • NYC Health + Hospitals/Queens - BRANY

    New Hyde Park, New York, 11042-1214, United States

  • Penn Medicine University City

    Philadelphia, Pennsylvania, 19104, United States

  • Southern Endocrinology & Diabetes Associates

    Mesquite, Texas, 75149, United States

  • Stanford Health Care - Endocrinology Clinic

    Stanford, California, 94304, United States

  • Texas Valley Clinical Research, LLC

    Weslaco, Texas, 78596-7288, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229-3931, United States

  • UWHealth - Junction Rd Medical Center Endocrinology Clinic

    Madison, Wisconsin, 53717-2656, United States

  • University of Colorado Health Anschutz Medical Campus

    Aurora, Colorado, 80045-2541, United States

  • Vanderbilt Weight Loss Center

    Nashville, Tennessee, 37212-3609, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.