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

NCT05612594 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2000033371
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

Brief 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

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change in Apnea hypopnea index (AHI) measured by full ambulatory polysomnography (aPSG)

  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.

  Baseline and 6 months

Secondary Outcomes (27)

• Change in Neck and body fat and lean volume by MRI

  Baseline and 6 months

• Change in Airway caliber by MRI

  Baseline and 6 months

• Change in Critical closing pressure (Pcrit)/normal ventilatory drive (Vpass) by aPSG

  Baseline and 6 months

• Change in neck circumference

  Baseline and 6 months

• Change in Oxygen desaturation index (ODI) measured by aPSG

  Baseline and 6 months

Study Arms (2)

Bexagliflozin

EXPERIMENTAL

Bexagliflozin once daily for 6 months

Drug: Bexagliflozin 20 mg

Placebo

PLACEBO COMPARATOR

Placebo once daily for 6 months

Drug: Placebo

Interventions

Bexagliflozin 20 mg DRUG

15mg once daily

Bexagliflozin

Placebo DRUG

matching placebo once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Case Western Reserve University: collaborator

Study Sites (2)

Yale New Haven Health

New Haven, Connecticut, 06520, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

bexagliflozin

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Henry K Yaggi, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Ian J Neeland, M.D.

  Case Western Reserve University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry K Yaggi, M.D.

CONTACT

203-785-4163; henry.yaggi@yale.edu

Ian J Neeland, M.D.

CONTACT

216-844-5965; Ian.Neeland@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, study personnel, and outcomes adjudicators will be blinded to the treatment assignment until the end of study procedures and database lock. Blinding codes will be broken at the end of the trial. Blinding codes will only be broken before the end of trial if a participant develops a serious adverse event requiring knowledge of the treatment allocation. At such time, the participant will be considered to have completed the trial and will not undergo any further trial treatment but may be asked to undergo assessment of trial endpoints when feasible. Whenever a code is broken, the person breaking the code must complete the unblinding form in Redcap. If the participant should be withdrawn following a code break, a withdrawal session should be completed in the computerized randomization system.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: March 27, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)