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Can a daily pill stop dangerous sugar drops after Weight-Loss surgery?

NCT ID NCT07760961

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. 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.

    Open the record ↗

  2. A doctor treating you

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