Could a diabetes pill help you breathe better at night?
NCT ID NCT05612594
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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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
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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: * 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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Yale New Haven Health
RECRUITINGNew Haven, Connecticut, 06520, United States
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