Can a daily pill stop dangerous sugar drops after Weight-Loss surgery?
NCT ID NCT07760961
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial is testing an investigational drug called mizagliflozin to see if it can prevent low blood sugar (hypoglycemia) in people who experience this condition after bariatric surgery. The study will include adults who had Roux-en-Y bariatric surgery more than a year ago and have a history of reactive hypoglycemia. Participants will take either a low dose, a higher dose, or a placebo capsule three times a day for 28 days, and researchers will track how many low blood sugar episodes occur.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mizagliflozin (an investigational drug taken as a capsule)
- What this could lead to
- If successful, this could lead to a new treatment option to prevent dangerous low blood sugar episodes in people who have had bariatric surgery.
- What could go wrong
- This is an early-stage trial with a small number of participants, so results may not be conclusive. The drug may not work as hoped or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.