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Could a diabetes pill help you breathe better at night?

NCT ID NCT05612594

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests whether bexagliflozin, a drug used for diabetes, can reduce the severity of obstructive sleep apnea in overweight or obese adults. Over 6 months, participants will take either the drug or a placebo and undergo sleep tests and body scans. The goal is to see if the drug improves breathing during sleep and reduces related health risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bexagliflozin
What this could lead to
If it works, this could offer a new medication option to reduce sleep apnea severity in people who are overweight.
What could go wrong
This is a relatively small, early-phase trial, and the drug may not significantly improve sleep apnea. Side effects from SGLT2 inhibitors are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 164 people

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

Started

Mar 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Able to provide informed consent and stated willingness to comply with all study procedures and availability for the duration of the study * Overweight or obese (body mass index 25-40 kg/m2) * Clinically confirmed diagnosis of obstructive sleep apnea by one of the following methods: a. Polysomnography: AHI ≥15/hour sleep or b. Home sleep apnea testing: Respiratory event index (REI) ≥15/hour sleep * AHI: apnea-hypopnea index (apneas + hypopneas / total sleep time in hours) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Known non-OSA related conditions associated with sleep disordered breathing (e.g., central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder) * Use of sleep-inducing medications (e.g. benzodiazepines, opiates, barbiturates) * Type 1 diabetes mellitus * History of diabetic ketoacidosis * Known hypersensitivity reaction to bexagliflozin or any of its constituents or any contraindication to bexagliflozin use * Severe, recurrent urinary tract or genital mycotic infections * eGFR\<30mL/min/1.73m2 at time of or within 4 weeks of enrollment in the study * Unable to complete/tolerate magnetic resonance imaging (MRI) due to severe claustrophobia or metallic implants. * Language barrier, mental incapacity, unwillingness or inability to understand. * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant. * Currently or planning to take a SGLT2i prior to or during enrollment in the study * Currently or planning to follow a ketogenic diet pattern ("keto diet) prior to or during enrollment in the study * Currently or planning to follow an active weight loss program (including but not limited to use of supplements, medications, or surgery) prior to or during enrollment in the study * Currently or planning to follow an intermittent fasting diet plan prior to or during enrollment in the study * Currently or planning to take a GLP-1 receptor agonist prior to or during enrollment in the study . * Existing lower limb ulcer (due to diabetes or any cause) * Existing severe peripheral arterial disease with intermittent claudication and/or prior lower limb revascularization procedure * Concomitant administration of UGT inducers * Severe liver disease

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Yale New Haven Health

    RECRUITING

    New Haven, Connecticut, 06520, United States

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