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SGLT2 Inhibitor

Ertugliflozin for Sleep Apnea (ADIPOSA Trial)

Phase 4
Recruiting
Led By Ian J Neeland, M.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months and 6 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests if a drug can reduce sleep apnea severity in overweight/obese adults w/ moderate-severe OSA vs. a placebo. Participants will get routine care and undergo tests to check drug effectiveness.

Who is the study for?
The ADIPOSA study is for overweight or obese adults with moderate to severe obstructive sleep apnea (OSA). Participants must be able to consent, follow the study plan for 6 months, and have a confirmed OSA diagnosis. Excluded are those planning certain weight loss treatments, with hypersensitivity to the drug tested, pregnant women, users of sleep-inducing meds, and individuals with specific medical conditions or inability to undergo MRI.
What is being tested?
This trial tests if Ertugliflozin can reduce the severity of sleep apnea in comparison to a placebo. It examines whether improvements in clinical measures of OSA result from changes in anatomic and physiologic traits. Participants will receive either the drug or placebo alongside routine care for six months while undergoing various clinical measurements.
What are the potential side effects?
Potential side effects may include urinary tract infections, genital mycotic infections due to SGLT2 inhibitors like Ertugliflozin. The exact side effects will be monitored throughout the trial as participants' reactions can vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Apnea hypopnea index (AHI) measured by full ambulatory polysomnography (aPSG)
Secondary study objectives
Change in 24 hour ambulatory average diastolic blood pressure
Change in 24 hour ambulatory average systolic blood pressure
Change in 24 hour ambulatory blood pressure variability
+24 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BexagliflozinExperimental Treatment1 Intervention
Bexagliflozin once daily for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo once daily for 6 months

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,031,319 Total Patients Enrolled
2 Trials studying Sleep Apnea
117 Patients Enrolled for Sleep Apnea
Case Western Reserve UniversityOTHER
307 Previous Clinical Trials
250,469 Total Patients Enrolled
Ian J Neeland, M.D.Principal InvestigatorCase Western Reserve University School of Medicine

Media Library

Ertugliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05612594 — Phase 4
Sleep Apnea Research Study Groups: Bexagliflozin, Placebo
Sleep Apnea Clinical Trial 2023: Ertugliflozin Highlights & Side Effects. Trial Name: NCT05612594 — Phase 4
Ertugliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05612594 — Phase 4
~109 spots leftby Sep 2027
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