Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia
ConditionPostbariatric Hypoglycemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVogenx, Inc.
About this trial
VGX-001-013 (EMERGE) is a Phase 2b study to evaluate an investigational new drug, mizagliflozin, for safety, tolerability and its ability to prevent low blood sugar in patients with post-bariatric hypoglycemia.
Eligibility criteria
Qualifiers
Males and nonpregnant females, ages ≥18 years old, having had Roux-en-Y bariatric surgery more than 12 months prior to signing the ICF.
History of reactive hypoglycemia with Whipple's triad: the occurrence of hypoglycemic symptoms associated with blood glucose of <54 mg/dL, and resolution with glucose or carbohydrate administration. Symptoms associated with reactive hypoglycemia include neuroglycopenic symptoms (e.g., behavioral changes, confusion or impaired cognitive function, seizure, loss of consciousness).
Willing and able to give informed consent and follow all study procedures and requirements.
Participants (male and female) must agree to use an adequate method of contraception
Disqualifiers
History of current medical conditions excluding PBH which may result in hypoglycemia).
Current use of insulin or insulin secretagogues.
Current use of GLP-1 agonists, GLP-1/GIP dual agonists, or GLP-1 antagonists. Unless participants have been through a 'wash-out' period
Current use of drugs that may affect CGM function (e.g., acetaminophen/paracetamol).
Trial design
Treatments tested in this trial
- Mizagliflozin 5 mg
- Mizagliflozin 10 mg
- Placebo
Treatment groups
36 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov