NCT05612594 · Yale University
Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study
(ADIPOSA)
What this study is about
The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug).
View original scientific description
The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug).
Interventions
DRUG
Bexagliflozin 20 mg
15mg once daily
DRUG
Placebo
matching placebo once daily
Primary outcome measures
Change in Apnea hypopnea index (AHI) measured by full ambulatory polysomnography (aPSG)
Time frame: Baseline and 6 months
All participants will undergo a full in-home aPSG with a Nox-A1 system, which collects sleep EEG required to determine the physiologic traits and measures of sleep apnea. This is an unattended sleep monitor. The AHI is the number of apneas or hypopneas recorded during the sleep study per hour of sleep. Higher AHI indicates the severity of sleep apnea.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Haven, Connecticut
- Cleveland, Ohio
Collaborators
Case Western Reserve University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations