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Adipose Dysfunction, Imaging, Physiology, and Outcomes With Sodium Glucose Cotransporter 2 Inhibitor (SGLT2i) for Sleep Apnea: The ADIPOSA Study

NCT05612594 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-09-11

No results posted yet for this study

Summary

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).

The main question it aims to answer is:

* If SGLT2i will reduce anatomic and physiologic traits, clinical measures of OSA and sleep deficiency in participants
* If improvement in clinical measures are because of improvement in the anatomic and physiologic traits.

Participants will be placed on either drug or placebo and get routine normal care for 6 months. At the start and end of the study, participants will undergo different clinical measurements to see if the drug makes the sleep apnea better.

Conditions

Interventions

DRUG

Bexagliflozin 20 mg

15mg once daily

DRUG

Placebo

matching placebo once daily

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Henry K Yaggi, M.D. · Yale University

  • Ian J Neeland, M.D. · Case Western Reserve University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05612594 on ClinicalTrials.gov