Effect of Mizagliflozin on Hypoglycemia in Patients With Post-Bariatric Hypoglycemia

Inclusion Criteria

• 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
• Has recurrent hypoglycemia of at least 4 episodes during a 3-week Run-In period.

Exclusion Criteria

• 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).
• History of recent fasting hypoglycemia.
• Participants with rectal prolapse or pelvic floor dysfunction within 6 months of Screening.
• Congestive heart failure, New York Heart Association class II, III or IV within 6 months of Screening.
• History of myocardial infarction, unstable angina, or revascularization within 6 months of Screening.
• History of a cerebrovascular accident within 6 months of Screening.
• Active malignancy, except basal cell or squamous cell skin cancers.
• Major surgical operation within 30 days of Screening.
• Active alcohol abuse or substance abuse.
• Pregnancy and/or lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study.
• Other participants considered by the investigator to be inappropriate.