Clinical trial NCT04652479: Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Official title: A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Post Nissen Fundoplication hypoglycemia
Exendin (9-39)
Exendin 9-39
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eiger BioPharmaceuticals
First posted: 2020-12-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)
timeFrame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary outcomes:
measure: Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG
timeFrame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
measure: Rate of Level 3 Hypoglycemia
timeFrame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
measure: Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time)
timeFrame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
measure: Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time)
timeFrame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
measure: Postprandial Glycemia During Standardized Mixed Meal Consumption
timeFrame: 3 Hours Following Standardized Liquid Meal
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Clinical and Translational Research Unit
state: California
Study officials:
affiliation: Stanford University
name: Marilyn Tan, MD
role: STUDY_DIRECTOR
References: