Post-bariatric HypoglycemiaNCT07582874
An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia
A study testing Avexitide in people with Post-bariatric Hypoglycemia, run by Amylyx Pharmaceuticals Inc. at 4 sites in United States.
Trial summary
The Expanded Access Program will provide access to avexitide for people with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) who meet the eligibility criteria for this program. The safety of avexitide and patient treatment experience will be monitored during this program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-bariatric Hypoglycemia
- What is being tested?
- Avexitide
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Applicable to all patients:
- Male or female, at least 18 years of age; able to understand the purpose and risks of the program, and provides written informed consent to participate.
- Not eligible for or otherwise able to obtain access to avexitide via a clinical trial, and does not have access to satisfactory, alternative treatment options.
- If female, cannot be breastfeeding or lactating, and if of childbearing potential must agree to use a highly effective method of birth control during EAP participation. A negative urine pregnancy test is required at time of entry.
- If male, must agree to use a highly effective method of birth control during EAP participation.
- For Category A:
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- Have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.
- For Category B:
- Have clinical diagnosis of PBH, and underwent documented RYGB ≥ 12 months prior to EAP eligibility assessment.
- Has body mass index (BMI) of up to 40 kg/m2.
- Treating physician confirmation of either participation in previous avexitide clinical trials conducted in PBH following RYGB; or documented LUCIDITY participant who signed ICF and was eligible for LUCIDITY based on screening and run-in, but was unable to be randomized due to completion of recruitment.
Who cannot join
- Applicable to all patients:
- Use of GLP-1 receptor agonists, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor dual agonists, and other GLP-1 receptor agonist combination therapies.
- Presence of any clinically relevant condition which, per the judgment of the treating physician, may preclude the patient from safe treatment.
- For Category B:
- Have received another investigational drug for any indication within 5 half-lives of that drug or have participated in another interventional clinical study within 30 days prior to entry visit.
- History of upper GI surgery affecting RYGB anatomy or function, other than RYGB.
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- Any known or suspected allergy to the investigational medicinal product (avexitide) or any related product (e.g., exenatide).
- Abnormal liver function defined as AST and/or ALT > 5 times the upper limit of the normal and/or bilirubin level >3 times the upper limit of the normal within 12 weeks from entry.
- Renal impairment, defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 within 12 weeks from entry.
- History or presence of insulinoma or other cause of endogenous hyperinsulinism other than PBH.
- Presence of acute or chronic pancreatitis, history of idiopathic acute pancreatitis, or pancreatic cancer.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
- Available
Joslin Diabetes Center
Boston, Massachusetts, 02215-5306
- Available
Southern Endocrinology and Diabetes Associates
Mesquite, Texas, 75149
- Available
Centricity Research Morehead City Multispecialty
Morehead City, North Carolina, 28557-3126
- Available
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229-4801
About this study
The Expanded Access Program will provide access to avexitide for people with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) who meet the eligibility criteria for this program. The safety of avexitide and patient treatment experience will be monitored during this program.
- Conditions
- Post-bariatric Hypoglycemia
- Being tested
- Avexitide
- Keywords
- AVX, avexitide, PBH, post-bariatric hypoglycemia, hypoglycemia post bariatric surgery, reactive hypoglycemia, hypoglycemia, low blood sugar, Roux-en-Y gastric bypass (RYGB), Roux-en-Y gastric bypass, Roux-en-Y, RYGB, gastric bypass, LUCIDITY, PREVENT, exendin, exendin 9-39, exendin 939
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvexitideDrug
90 mg subcutaneous injection once per day at least one hour prior to first meal of the day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-bariatric HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Amylyx Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582874
- Sponsor's protocol ID
- AVX-002
- Status last verified
- Jul 2026
- First submitted
- 5 May 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia
- ClinicalTrials.gov ID
- NCT07582874
- Acronym / sponsor ID
- AVX-002
- Conditions
- Post-bariatric Hypoglycemia
- Keywords
- AVX, avexitide, PBH, post-bariatric hypoglycemia, hypoglycemia post bariatric surgery, reactive hypoglycemia, hypoglycemia, low blood sugar
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Amylyx Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Expanded Access Program will provide access to avexitide for people with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) who meet the eligibility criteria for this program. The safety of avexitide and patient treatment experience will be monitored during this program.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, at least 18 years of age; able to understand the purpose and risks of the program, and provides written informed consent to participate.
- Not eligible for or otherwise able to obtain access to avexitide via a clinical trial, and does not have access to satisfactory, alternative treatment options.
- If female, cannot be breastfeeding or lactating, and if of childbearing potential must agree to use a highly effective method of birth control during EAP participation. A negative urine pregnancy test is required at time of entry.
- If male, must agree to use a highly effective method of birth control during EAP participation.
- Have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.
Key exclusion criteria (11 listed)
- Use of GLP-1 receptor agonists, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor dual agonists, and other GLP-1 receptor agonist combination therapies.
- Presence of any clinically relevant condition which, per the judgment of the treating physician, may preclude the patient from safe treatment.
- Have received another investigational drug for any indication within 5 half-lives of that drug or have participated in another interventional clinical study within 30 days prior to entry visit.
- History of upper GI surgery affecting RYGB anatomy or function, other than RYGB.
- Any known or suspected allergy to the investigational medicinal product (avexitide) or any related product (e.g., exenatide).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avexitide90 mg subcutaneous injection once per day at least one hour prior to first meal of the day. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avexitide in people with Post-bariatric Hypoglycemia, run by Amylyx Pharmaceuticals Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medical Director, Amylyx Pharmaceuticals (1-857-575-7007, MedInfo@amylyx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.