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AD109 for Obstructive Sleep Apnea

Phase 2
Recruiting
Research Sponsored by Apnimed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable individual dose of specified incretin agents over the past 4 weeks without intention to change dosing based on side effects or efficacy
Age between 18-75 years at the time of informed consent
Must not have
Neuromuscular disorder, epilepsy, Parkinson, Alzheimer, or other neurodegenerative disease
Clinically significant or medically uncontrolled cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial will test the safety and effectiveness of a combination of two medications, Aroxybutynin and Atomoxetine (AD109), in patients with obstructive sleep apnea who are also taking

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include dry mouth, constipation due to oxybutynin; increased heart rate, dry mouth, insomnia from atomoxetine; plus any additional reactions from combining these with GLP-1 medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been on a steady dose of certain diabetes medication for the last 4 weeks.
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I am between 18 and 75 years old.
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I have type 2 diabetes or my BMI is within the specified range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a neuromuscular disorder or a neurodegenerative disease like Parkinson's or Alzheimer's.
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I do not have serious heart problems that are not under control.
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I often have severe constipation that bothers me.
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I have narcolepsy, restless leg syndrome needing medication, or REM sleep behavior disorder.
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I have been diagnosed with narrow angle glaucoma.
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I have been on long-term oxygen therapy.
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I have had a condition where my lymphocytes grow abnormally.
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I have been diagnosed with schizophrenia, schizoaffective disorder, generalized anxiety disorder, or bipolar disorder.
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I am experiencing symptoms from a blocked bladder.
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I have used devices like mouthguards or nasal strips for sleep apnea before.
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My kidney function is reduced with an eGFR less than 50 ml/min.
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I work as a commercial driver or vehicle operator.
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I am unwilling to use specified methods of contraception.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Objective (Adverse Events)

Trial Design

2Treatment groups
Active Control
Group I: Arm 1Active Control1 Intervention
Twenty patients who are taking GLP-1 at time of enrollment will be treated with AD109
Group II: Arm 2Active Control1 Intervention
Twenty patients who are not taking a GLP-1 will be treated with AD109 only

Find a Location

Who is running the clinical trial?

ApnimedLead Sponsor
14 Previous Clinical Trials
2,135 Total Patients Enrolled
~20 spots leftby Sep 2024