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Avexitide treatment for post-bariatric hypoglycemia

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

PHASE3 · Amylyx Pharmaceuticals Inc. · NCT06747468

This study is testing if a new treatment called avexitide can help people who have low blood sugar after weight loss surgery feel better compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment75 (estimated)
Ages18 Years and up
SexAll
SponsorAmylyx Pharmaceuticals Inc. (industry)
Locations21 sites (Stanford, California and 20 other locations)
Trial IDNCT06747468 on ClinicalTrials.gov

What this trial studies

This Phase 3 study evaluates the efficacy and safety of avexitide compared to a placebo in individuals experiencing post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass surgery. Participants will undergo a screening period, followed by a randomized, double-blind treatment phase lasting 16 weeks, where they will receive either avexitide or placebo. The study also includes a two-part open-label extension period of approximately 32 weeks to further assess the treatment's effects. Participants will utilize continuous glucose monitoring and self-monitoring blood glucose devices throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone Roux-en-Y gastric bypass at least one year prior and have experienced recurrent hypoglycemia.

Not a fit: Patients who have not undergone Roux-en-Y gastric bypass or those with hypoglycemia due to other causes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce hypoglycemic events in patients suffering from post-bariatric hypoglycemia.

How similar studies have performed: Other studies have shown promise in treating post-bariatric hypoglycemia, but the specific use of avexitide in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Stanford, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Post Bariatric Hypoglycemia, avexitide, post bariatric hypoglycemia, PBH, hypoglycemia, hypoglycemia post bariatric surgery, Roux-en-Y gastric bypass, RYGB

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.