Acquired Hyperinsulinemic HypoglycemiaPhase 2NCT04652479
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
A Phase 2 study testing Avexitide in people with Acquired Hyperinsulinemic Hypoglycemia, run by Dr. Tracey McLaughlin, MD at 1 site in United States.
Trial summary
The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Hyperinsulinemic Hypoglycemia
- What is being tested?
- Avexitide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy, esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of Screening
- History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as documented in the medical record.
- Body mass index (BMI) of up to 40 kg/m2
- If female, must not be breastfeeding and must have a negative urine pregnancy test result
Who cannot join
- Major surgery within 6 months before randomization.
- History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g., insulin autoimmune hypoglycemia).
- Use of agents that may interfere with glucose metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Research Unit
Palo Alto, California, 94304
About this study
Official title: A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia
The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia.
- Conditions
- Acquired Hyperinsulinemic Hypoglycemia
- Being tested
- Avexitide
- Keywords
- Post Bariatric Hypoglycemia, avexitide, Post-Bariatric Hypoglycemia, Post-gastrectomy hypoglycemia, Post gastrectomy hypoglycemia, Post-esophagectomy hypoglycemia, Post esophagectomy hypoglycemia, Post-Nissen Fundoplication hypoglycemia, Post Nissen Fundoplication hypoglycemia, Exendin (9-39), Exendin 9-39
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvexitideDrug
Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor
| Study group | Role | What they receive |
|---|---|---|
| Avexitide 45 mg twice daily then avexitide 90 mg once daily | Experimental | Patients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days Receives: Drug: Avexitide |
| Avexitide 45 mg once daily then avexitide 90 mg twice daily | Experimental | Patients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days Receives: Drug: Avexitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)
Level 2 hypoglycemia events (ADA, <54 mg/dL) as measured by CGM and defined as the number of events captured by CGM with glucose measures <54 mg/dL during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.
Measured: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary outcomes (5)
Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG
Distinct episodes of Level 2 hypoglycemia (SMBG glucose <54 mg/dL), divided by number of days for run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.
Measured: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Rate of Level 3 Hypoglycemia
Severe events during each treatment period characterized by altered mental and/or physical functioning that requires assistance from another person for recovery; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days. This would apply regardless of whether a patient actually received external assistance.
Measured: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time)
Percentage of time in level 2 hypoglycemia (<54mg/dL by CGM) during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.
Measured: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time)
Percentage of time in level 1 hypoglycemia (<70mg/dL by CGM) during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.
Measured: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Postprandial Glycemia During Standardized Mixed Meal Consumption
Change from Baseline in glycemia During Standardized Mixed Meal Consumption
Measured: 3 Hours Following Standardized Liquid Meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start21 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Hyperinsulinemic 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Tracey McLaughlin, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eiger BioPharmaceuticals
- Responsible party
- Principal investigator, Marilyn Tan, Stanford University
- Investigators
- Marilyn Tan, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652479
- Sponsor's protocol ID
- 52880
- Status last verified
- May 2023
- First submitted
- 27 Oct 2020
- Last updated
- 9 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Craig C, Tan M, Shamloo T, Perelman D, McLaughlin T. Efficacy and safety of avexitide for treatment of hypoglycemia following bariatric and other upper gastrointestinal surgeries: a phase 2b study. Metabolism. 2026 Sep 15:156773. doi: 10.1016/j.metabol.2026.156773. Online ahead of print.
PubMed 42744082
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia
- ClinicalTrials.gov ID
- NCT04652479
- Acronym / sponsor ID
- 52880
- Conditions
- Acquired Hyperinsulinemic Hypoglycemia
- Keywords
- Post Bariatric Hypoglycemia, avexitide, Post-Bariatric Hypoglycemia, Post-gastrectomy hypoglycemia, Post gastrectomy hypoglycemia, Post-esophagectomy hypoglycemia, Post esophagectomy hypoglycemia, Post-Nissen Fundoplication hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dr. Tracey McLaughlin, MDUniversity, hospital or other
- Collaborators
- Eiger BioPharmaceuticals
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 9 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avexitide 45 mg twice daily then avexitide 90 mg once daily | Experimental | Drug: AvexitidePatients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days |
| Avexitide 45 mg once daily then avexitide 90 mg twice daily | Experimental | Drug: AvexitidePatients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy, esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of Screening
- History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as documented in the medical record.
- Body mass index (BMI) of up to 40 kg/m2
- If female, must not be breastfeeding and must have a negative urine pregnancy test result
Key exclusion criteria (3 listed)
- Major surgery within 6 months before randomization.
- History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g., insulin autoimmune hypoglycemia).
- Use of agents that may interfere with glucose metabolism
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 |
|---|---|---|
| AvexitideAvexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor | Drug | Avexitide 45 mg once daily then avexitide 90 mg twice daily, Avexitide 45 mg twice daily then avexitide 90 mg once daily |
Primary outcome
Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)
Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Level 2 hypoglycemia events (ADA, <54 mg/dL) as measured by CGM and defined as the number of events captured by CGM with glucose measures <54 mg/dL during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.
5 secondary outcomes
Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG
Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Rate of Level 3 Hypoglycemia
Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time)
Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time)
Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Postprandial Glycemia During Standardized Mixed Meal Consumption
Time frame: 3 Hours Following Standardized Liquid Meal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42744082Craig C, Tan M, Shamloo T, Perelman D, McLaughlin T. Efficacy and safety of avexitide for treatment of hypoglycemia following bariatric and other upper gastrointestinal surgeries: a phase 2b study. Metabolism. 2026 Sep 15:156773. doi: 10.1016/j.metabol.2026.156773. Online ahead of print.
- Individual participant dataSharing planned: No
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.
Marilyn Tan, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avexitide in people with Acquired Hyperinsulinemic Hypoglycemia, run by Dr. Tracey McLaughlin, MD at 1 site 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) (time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04652479, which also lists 1 linked publication.
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 9 Jun 2023.