AD109 for Obstructive Sleep Apnea

Recruiting at 3 trial locations

Overseen By John Cronin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Apnimed

Must be taking: Tirzepatide, Semaglutide, Liraglutide

Disqualifiers: Narcolepsy, Insomnia, Cardiovascular disease, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Phase 2 Safety, Efficacy and, Tolerability of Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) in Obstructive Sleep Apnea Patients Taking Tirzepatide, Semaglutide or Liraglutide

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with obstructive sleep apnea who are not using OSA devices but are taking GLP-1 drugs like Tirzepatide or Semaglutide. Participants should have a certain range of respiratory event index, type 2 diabetes and/or specific BMI ranges. Exclusions include severe constipation, recent suicide attempts, substance abuse, significant heart or liver issues, among others.

Inclusion Criteria

Willingness to maintain a medication administration diary during the study

Mean Respiratory Event Index (REI4) of >5 and <45 with ≤ 25% central or mixed apneas

History of using devices for OSA treatment, not used for at least 2 weeks prior to first HSAT and not used during study participation

Exclusion Criteria

Living outside the US

I often have severe constipation that bothers me.

Attempted suicide within 1 year prior to screening, or current suicidal ideation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label dosing of AD109 for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AD109

Trial Overview The study tests the safety and effectiveness of AD109 in patients with obstructive sleep apnea already on GLP-1 drugs. It's a phase 2 trial focusing on how well people tolerate this fixed-dose combination therapy and its impact on their condition.

How Is the Trial Designed?

Group I: Arm 1 Active Control 1 Intervention

Twenty patients who are taking GLP-1 at time of enrollment will be treated with AD109

Group II: Arm 2 Active Control 1 Intervention

Twenty patients who are not taking a GLP-1 will be treated with AD109 only

Who Is Running the Clinical Trial?

Apnimed

Lead Sponsor

Trials

17

Recruited

3,400+