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CompletedNCT04652479Updated Jun 9, 2023Results posted

Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

A Phase 2 interventional study of Avexitide in Acquired Hyperinsulinemic Hypoglycemia, sponsored by Dr. Tracey McLaughlin, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-09.

Sponsored by Dr. Tracey McLaughlin, MD · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
  • Post Nissen Fundoplication hypoglycemia
  • Exendin (9-39)
  • Exendin 9-39
03

In context

Congenital Hyperinsulinism

46 studies on the registry are indexed under Congenital Hyperinsulinism; 7 are open to participants now.

This study's enrollment of 25 is close to the median of 23 across 35 interventional studies indexed under Congenital Hyperinsulinism.

Browse Congenital Hyperinsulinism studies →

Lead sponsor

This is the only study on the registry with Dr. Tracey McLaughlin, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Avexitide 45 mg twice daily then avexitide 90 mg once daily

    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

    Drug: Avexitide

  • Experimental
    Avexitide 45 mg once daily then avexitide 90 mg twice daily

    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

    Drug: Avexitide

Interventions

  • DrugAvexitide

    Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

Secondary outcomes

  1. 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.

    Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

  2. 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.

    Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

  3. 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.

    Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

  4. 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.

    Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

  5. Postprandial Glycemia During Standardized Mixed Meal Consumption

    Change from Baseline in glycemia During Standardized Mixed Meal Consumption

    Time frame: 3 Hours Following Standardized Liquid Meal

07

Results

Posted Jun 9, 2023

Participant flow

Run-in Period (14 Days)
Participant flow — Run-in Period (14 Days)
MilestoneRun-in (All Participants)Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once DailyAvexitide 90 mg Once Daily Then Avexitide 45 mg Twice Daily
Started2500
Completed2500
Not completed000
Treatment Period 1 (14 Days)
Participant flow — Treatment Period 1 (14 Days)
MilestoneRun-in (All Participants)Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once DailyAvexitide 90 mg Once Daily Then Avexitide 45 mg Twice Daily
Started089
Completed089
Not completed000
Washout Period (2 Days)
Participant flow — Washout Period (2 Days)
MilestoneRun-in (All Participants)Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once DailyAvexitide 90 mg Once Daily Then Avexitide 45 mg Twice Daily
Started089
Completed089
Not completed000
Treatment Period 2 (14 Days
Participant flow — Treatment Period 2 (14 Days
MilestoneRun-in (All Participants)Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once DailyAvexitide 90 mg Once Daily Then Avexitide 45 mg Twice Daily
Started089
Completed both interventions with no major protocol deviations088
Completed089
Not completed000

Outcome measures

PrimaryDiurnal 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.

Time frame:
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Reported as:
Mean · events per 14 days
Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)
events per 14 daysAvexitide 45 mg Twice DailyAvexitide 90 mg Once Daily
Run-in period5.2 ± 3.525.2 ± 3.52
Treatment period2.7 ± 2.152.1 ± 2.99
Statistical analysis
  • Avexitide 45 mg Twice Daily · Mixed effects model · p = 0.0028 (A p-value of \<0.05 would be considered statistically significant)
  • Avexitide 90 mg Once Daily · Mixed effects model · p = 0.0005 (A p-value of \<0.05 would be considered statistically significant)
SecondaryRate 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.

Time frame:
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Reported as:
Mean · episodes per 14 days
Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG
episodes per 14 daysAvexitide 45 mg Twice DailyAvexitide 90 mg Once Daily
Run-in period2.7 ± 3.12.7 ± 3.1
Treatment period1.2 ± 1.41.3 ± 3.7
Statistical analysis
  • Avexitide 45 mg Twice Daily · Mixed effects model · p = 0.0027 (A p-value of \<0.05 would be considered statistically significant)
  • Avexitide 90 mg Once Daily · Mixed effects model · p = 0.0043 (A p-value of \<0.05 would be considered statistically significant)
SecondaryRate 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.

Time frame:
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Reported as:
Mean · events per 14 days
Rate of Level 3 Hypoglycemia
events per 14 daysAvexitide 45 mg Twice DailyAvexitide 90 mg Once Daily
Run-in period2.5 ± 3.12.5 ± 3.1
Treatment period0.8 ± 1.20.9 ± 2.9
Statistical analysis
  • Avexitide 45 mg Twice Daily · Mixed effects model · p = 0.0003 (A p-value of \<0.05 would be considered statistically significant)
  • Avexitide 90 mg Once Daily · Mixed effects model · p = 0.0003 (A p-value of \<0.05 would be considered statistically significant)
SecondaryPercent 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.

Time frame:
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Reported as:
Mean · percentage of time per 14 days
Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time)
percentage of time per 14 daysAvexitide 45 mg Twice DailyAvexitide 90 mg Once Daily
Run-in period1.50 ± 1.321.50 ± 1.32
Treatment period0.96 ± 0.740.48 ± 0.82
Statistical analysis
  • Avexitide 45 mg Twice Daily vs Avexitide 90 mg Once Daily · t-test, 2 sided · p = 0.161 (A p-value of \<0.05 would be considered statistically significant)
  • Avexitide 45 mg Twice Daily · t-test, 2 sided · p = 0.201 (A p-value of \<0.05 would be considered statistically significant) · Mean difference (net): -35.66
  • Avexitide 90 mg Once Daily · t-test, 2 sided · p = 0.001 (A p-value of \<0.05 would be considered statistically significant) · Mean difference (net): -67.65
SecondaryPercent 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.

Time frame:
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Reported as:
Mean · percentage of time per 14 days
Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time)
percentage of time per 14 daysAvexitide 45 mg Twice DailyAvexitide 90 mg Once Daily
Run-in period4.20 ± 2.754.20 ± 2.75
Treatment period2.86 ± 1.541.96 ± 1.63
Statistical analysis
  • Avexitide 45 mg Twice Daily vs Avexitide 90 mg Once Daily · t-test, 2 sided · p = 0.145 (A p-value of \<0.05 would be considered statistically significant)
  • Avexitide 45 mg Twice Daily · t-test, 2 sided · p = 0.111 (A p-value of \<0.05 would be considered statistically significant) · Mean difference (net): -31.88Change in percentage
  • Avexitide 90 mg Once Daily · t-test, 2 sided · p = 0.001 (A p-value of \<0.05 would be considered statistically significant) · Mean difference (net): -53.37Change in percentage
SecondaryPostprandial Glycemia During Standardized Mixed Meal Consumption

Change from Baseline in glycemia During Standardized Mixed Meal Consumption

Time frame:
3 Hours Following Standardized Liquid Meal

No measurements were reported for this outcome.

Adverse events

Collected over 44 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Run-in Period0/25 (0%)0/25 (0%)0/25 (0%)
Avexitide 45 mg Twice Daily0/17 (0%)0/17 (0%)7/17 (41.2%)
Avexitide 90 mg Once Daily0/17 (0%)0/17 (0%)8/17 (47.1%)
Most frequent other events
Most frequent other events
EventRun-in PeriodAvexitide 45 mg Twice DailyAvexitide 90 mg Once Daily
injection site bruisingSkin and subcutaneous tissue disorders0/256/178/17
loose stoolsGastrointestinal disorders0/255/174/17
headacheNervous system disorders0/252/172/17

Baseline characteristics

Participants with no major protocol deviations who were allocated to treatment.

Age, Continuous
Age, Continuous(years)Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once DailyAvexitide 90 mg Once Daily Then Avexitide 45 mg Twice DailyTotal
Mean48.1 ± 15.247.8 ± 11.247.9 ± 12.8
Sex: Female, Male
Sex: Female, Male(Participants)Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once DailyAvexitide 90 mg Once Daily Then Avexitide 45 mg Twice DailyTotal
Female6814
Male202
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once DailyAvexitide 90 mg Once Daily Then Avexitide 45 mg Twice DailyTotal
Hispanic or Latino213
Not Hispanic or Latino6713
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once DailyAvexitide 90 mg Once Daily Then Avexitide 45 mg Twice DailyTotal
American Indian or Alaska Native022
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White5611
More than one race000
Unknown or Not Reported303
Region of Enrollment
Region of Enrollment(Participants)Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once DailyAvexitide 90 mg Once Daily Then Avexitide 45 mg Twice DailyTotal
United States8816
08

Study locations

1 site
  • Clinical and Translational Research Unit
    Palo Alto, California 94304, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 13, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04652479
Lead sponsor
Dr. Tracey McLaughlin, MD
Collaborators
Eiger BioPharmaceuticals
Responsible party
Marilyn Tan (Clinical Assistant Professor of Medicine, Stanford University) — Principal investigator
First posted
Dec 3, 2020
Start date
Jun 21, 2021
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Results posted
Jun 9, 2023
Last update
Jun 9, 2023

Study contacts

Marilyn Tan, MD
study director · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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