Mizagliflozin for post-bariatric hypoglycemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2b randomized, double-blind, placebo-controlled trial in adults with post-bariatric hypoglycemia. Participants will receive Mizagliflozin at 5 mg or 10 mg or placebo in a parallel-group design to assess safety, tolerability, and effects on postprandial glucose and hypoglycemic events. The study includes a run-in period to identify eligible participants with recurrent hypoglycemia and Whipple’s triad. Primary aims focus on safety and the drug's impact on glucose variability and hypoglycemia frequency. The trial is conducted at multiple sites in California and Colorado with a lead sponsor of Vogenx, Inc.

Why it matters

Who can join: the full rules

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.

Where it's running

• Exalt Clinical Research
  Chula Vista, California, United States Recruiting
• Centricity Research
  Morehead City, North Carolina, United States Recruiting
• Texas Valley Clinical Research
  Weslaco, Texas, United States Recruiting
• Stanford
  Palo Alto, California, United States Not yet recruiting
• U Colorado- Anschutz Medical Campus
  Aurora, Colorado, United States Not yet recruiting
• DM Clinical- Miami
  Doral, Florida, United States Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting Esbjerg Hospital - University Hospital of Southern Denmark · Esbjerg · NCT06896682

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.