ADIPOSA
- Study HIC#:2000033371
- Last Updated:01/27/2026
The purpose of this research is to understand the effects of medication, Bexagliflozin, on obstructive sleep apnea. We are investigating how Bexagliflozin may improve obstructive sleep apnea by evaluating multiple anatomic and non-anatomic physiological traits causing obstructive sleep apnea. We will also investigate how Bexagliflozin may improve other conditions associated with obstructive sleep apnea. Bexagliflozin is under a medication class sodium glucose cotransporter 2 inhibitor (SGLT2i), it is FDA-approved for diabetes and may be a potential therapy for obstructive sleep apnea.
https://clinicaltrials.gov/study/NCT05612594
Contact Us
For more information about this study, including how to volunteer, contact:
Opemipo Olaseni
- Phone Number: 1-203-654-1903
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
The primary objective of this study is to determine whether bexagliflozin 20 mg once daily compared with placebo reduces the apnea hypopnea index (AHI) in adults with overweight or obesity with moderate to severe OSA. Secondary Objectives The secondary objectives of this study are to determine whether bexagliflozin 20 mg mg once daily compared with placebo: a) reduces visceral and neck fat and upper airway soft tissue structure volumes and increases airway caliber b) reduces Pcrit/Vpass c) reduces rostral to caudal fluid shifts (measured by neck circumference) d) improves clinical measures of OSA severity and sleep deficiency including polysomnography, sleep questionnaires, anthropometrics, sleep duration by actigraphy, and blood pressure. Study Design The project is a 2-center mechanistic clinical trial of N=164 overweight or obese adults (BMI 25-40 kg/m2) diagnosed with moderate to severe OSA (with and without T2D) prospectively recruited from University Hospitals Cleveland Medical Center (UH) and Yale New Haven Health (YNHH). Participants will be randomized to bexagliflozin 20 mg once daily or matching placebo in addition to standard routine clinical care for both groups (including clinically prescribed CPAP as appropriate at the discretion of the treating sleep medicine physician) for 6 months. At baseline and at study end, participants will undergo measurements of anatomic traits using MRI imaging (neck and tongue fat, soft tissue structures, airway caliber, visceral and ectopic abdominal fat), critical closing pressure (Pcrit/Vpass), blood-based biomarkers of dysfunctional adiposity, non-anatomic physiologic trait polysomnographic phenotyping (ArTh, LG, Mresp), morning neck circumference (to assess caudal to rostral fluid shifts), clinical measures of sleep apnea severity (apnea hypopnea index [AHI], oxygen desaturation index [ODI], % time with O2sat < 90% [T90]), sleep arousal index [AI]), and measures of sleep deficiency (validated sleep surveys, wrist-wearable actigraphy), to evaluate the effects of SGLT2i on the measured phenotypes. Our working hypothesis is that SGLT2i will reduce anatomic traits, non-anatomic physiologic, and clinical measures of OSA and sleep deficiency in the clinical trial population, and improvement in clinical measures will be mediated by improvement in the anatomic and physiologic traits.
https://clinicaltrials.gov/study/NCT05612594
Eligibility Criteria
- 18 years and above
- Able to provide informed consent
- BMI of 25-40kg/m2
- Diagnosed with moderate to severe obstructive sleep apnea
