OSAPhase 3NCT05813275

Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

A Phase 3 study testing AD109 in people with OSA, run by Apnimed at 73 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: OSA
What is being tested?: AD109
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 646 participants
Where: 73 sitesin 2 countries
Study dates: 16 Sep 2023to 14 Mar 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥18 years of age at the time of informed consent.
PSG criteria: AHI of ≥10 and ≤45; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
PROMIS-Fatigue: raw score ≥17
PAP intolerance or current PAP refusal.
BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.

Who cannot join

Narcolepsy, restless leg syndrome, REM sleep behavior disorder
Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms.
Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.
Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.
-

Trial locations and contacts

73 sites in 2 countries.

Country

City, postcode or hospital

73 sites in 2 countries

United States65 sites

Abington Neurological Associate
Abington, Pennsylvania, 19001
Orange County Research Institute
Anaheim, California, 92801
University of Michigan
Ann Arbor, Michigan, 48109
Atlanta Center for Medical Research, LLC
Atlanta, Georgia, 30031
NeuroTrials Research
Atlanta, Georgia, 30342
FutureSearch Trials of Neurology
Austin, Texas, 78731
Meris Clinical Research
Brandon, Florida, 33511
North County Neurology Associates
Carlsbad, California, 92011
Core Healthcare Group
Cerritos, California, 90703
Javara Inc - Tryon Medical Partners PLCC
Charlotte, North Carolina, 28210
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, 37404
Chicago Research Center Inc
Chicago, Illinois, 60634
Exalt Clinical Research
Chula Vista, California, 91910
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Sleep Management Institute (Intrepid)
Cincinnati, Ohio, 45245
UC Health Sleep Medicine
Cincinnati, Ohio, 45267
University Hospital of Cleveland Medical Center
Cleveland, Ohio, 44106
Nouvelle Clinical Research
Cutler Bay, Florida, 33189
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Accel Research Sites
DeLand, Florida, 32720
Research Carolina Elite
Denver, North Carolina, 28025
Centennial Medical Group
Elkridge, Maryland, 21075
Lillestol Research LLC
Fargo, North Dakota, 58104
Tribe Clinical Research LL
Greenville, South Carolina, 29607
Peters Medical Research, LLC
High Point, North Carolina, 27260
Research Centers of America, LLC
Hollywood, Florida, 33024
The Heights Hospital (HD Heights)
Houston, Texas, 77008
Weill Cornell Medical College
Houston, Texas, 77030
Lone Star Lung and Sleep Clinic
Houston, Texas, 77070
Huntsville Research Institute LLC
Huntsville, Texas, 77340
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Canvas Clinical Research
Lake Worth, Florida, 33467
Revive Research Institute
Lathrup Village, Michigan, 48076
Florida Lung and Sleep Associates
Lehigh Acres, Florida, 33971
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Advanced ENT and Allergy
Louisville, Kentucky, 40220
St. Lukes Clinic - Idaho Pulmonary Associates
Meridian, Idaho, 83642
Desert Clinical Research - CCT Research
Mesa, Arizona, 85213
Advanced Medical Research Institute
Miami, Florida, 33174
Clinical Site Partners
Miami, Florida, 33186
Catalina Research Institute
Montclair, California, 91763
Infinity Medical Research
North Dartmouth, Massachusetts, 02747
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
Clinical Neuroscience Solutions, Inc - Orlando
Orlando, Florida, 32801
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, 61637
Foothills Research Center - CCT Research
Phoenix, Arizona, 85044
Epic Medical Research
Red Oak, Texas, 75154
Probe Clinical Research Corporation
Riverside, California, 92501
OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A
Rock Hill, South Carolina, 29732
Element Research Group
San Antonio, Texas, 78229
Pacific Research Network
San Diego, California, 92103
Sleep Medicine Specialists of California
San Ramon, California, 94583
SDS Clinical Trials Inc.
Santa Ana, California, 92705
South Ogden Family Medicine / CCT Research
South Ogden, Utah, 84405
Georgia Neurology and Sleep Medicine Assoc
Suwanee, Georgia, 30024
JSV Clinical Research Study Inc
Tampa, Florida, 33634
Fiel Family Sports Medicine - PC CCT Research
Tempe, Arizona, 85283
Javarra Inc-Privia Medical Group
Thomasville, Georgia, 31792
Noble Clinical Research
Tucson, Arizona, 85704
Alabama Neurology & Sleep Medicine
Tuscaloosa, Alabama, 35406
Provideré Research Inc.
West Covina, California, 91790
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, 07764
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Florida Pediatric Research Institute
Winter Park, Florida, 32789
Respiratory Specialists
Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada8 sites

Canadian Sleep Consultants
Calgary, Alberta, T2Z 3R6
Medical Arts Health Research
Kelowna, British Columbia, V1Y 9N7
AMNDX
Markham, Ontario, L3R 1A3
McGill University Health Centre
Montreal, Quebec, QC H4A
West Ottawa Sleep Centre
Ottawa, Ontario, K2C 0P7
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
Toronto Sleep Institute
Toronto, Ontario, M4P 1P2
Sleep and Alertness Center
Toronto, Ontario, M5S 3A3

Other trials in Canada

About this study

Official title: Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Conditions: OSA
Being tested: AD109, Placebo
Keywords: Obstructive Sleep Apnea
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AD109Drug
Aroxybutynin 2.5 mg/atomoxetine 75 mg tablet, administered orally once daily at bedtime (Weeks 2-26). Week 1 run-in: aroxybutynin 2.5 mg/atomoxetine 37.5 mg tablet.
PlaceboDrug
Matching placebo tablet administered orally once daily at bedtime for 26 weeks, with run-in and target dose matched to active arm packaging

Study groups in NCT05813275
Study group	Role	What they receive
AD109	Experimental	Not described Receives: Drug: AD109
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Apnea-Hypopnea Index (AHI)
AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO2) by at least 4%.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 202314 Mar 2025

First posted14 Apr 2023
Study start16 Sep 2023
Primary completion10 Mar 2025
Study completion14 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OSAStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 646 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05813275
Sponsor's protocol ID: APC-APN-305
Status last verified: Aug 2026
First submitted: 3 Apr 2023
Last updated: 11 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Strollo PJ Jr, Farkas R, Taranto-Montemurro L, Cronin J, Patel SR; SynAIRgy Investigators. Aroxybutynin and atomoxetine (AD109) for obstructive sleep apnea: a randomized phase 3 trial (SynAIRgy). Am J Respir Crit Care Med. 2026 Jul 1;212(7):1569-1584. doi: 10.1093/ajrccm/aamag215.
PubMed 42148495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
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Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
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All OSA trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)
ClinicalTrials.gov ID: NCT05813275
Acronym / sponsor ID: APC-APN-305
Conditions: OSA
Keywords: Obstructive Sleep Apnea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 646 participants (actual)
Lead sponsor: ApnimedIndustry (pharma, biotech, devices)
Study start: 16 Sep 2023 (actual)
Primary completion: 10 Mar 2025 (actual)
Study completion: 14 Mar 2025 (actual)
First posted: 14 Apr 2023 (actual)
Results: Posted 11 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AD109	Experimental	Drug: AD109
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

≥18 years of age at the time of informed consent.
PSG criteria: AHI of ≥10 and ≤45; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
PROMIS-Fatigue: raw score ≥17
PAP intolerance or current PAP refusal.
BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.

Key exclusion criteria (6 listed)

Narcolepsy, restless leg syndrome, REM sleep behavior disorder
Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms.
Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.
Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AD109Aroxybutynin 2.5 mg/atomoxetine 75 mg tablet, administered orally once daily at bedtime (Weeks 2-26). Week 1 run-in: aroxybutynin 2.5 mg/atomoxetine 37.5 mg tablet.	Drug	AD109
PlaceboMatching placebo tablet administered orally once daily at bedtime for 26 weeks, with run-in and target dose matched to active arm packaging	Drug	Placebo

Primary outcome

Change From Baseline in Apnea-Hypopnea Index (AHI)
Time frame: 6 months
AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO2) by at least 4%.

Results and safety

Results posted to the registry on 11 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AD109	324	269
Placebo	322	276

Primary outcome: Change From Baseline in Apnea-Hypopnea Index (AHI)

Time frame: 6 months. Least squares mean (95% Confidence Interval). Unit: events/hr

Measure	AD109 n = 302	Placebo n = 313
Primary Full Analysis Set (Treatment Policy Estimand)	-3.28 (-5.05 to -1.51)	0.71 (-1.01 to 2.44)
While-on-Treatment population	-6.11 (-7.80 to -4.41)	0.44 (-1.15 to 2.02)

AD109 vs Placebo: Least Squares Mean Difference: -3.99 (95% CI -6.40 to -1.59), p = 0.001, Mixed Model Repeated Measures (MMRM)
AD109 vs Placebo: Least Squares Mean Difference: -6.54 (95% CI -8.80 to -4.28), p <0.0001, Mixed Model Repeated Measures (MMRM)

Population analysed: The Primary Full Analysis Set (PFAS) population included all randomized participants in the main cohort who received at least one dose of investigational medicinal product (IMP). Participants enrolled at Site 1416 were excluded following site termination. The While-on-Treatment population is the MITT set, which includes participants in the PFAS who had at least one post-baseline on-treatment polysomnography (PSG) assessment.

Adverse events

Time frame: from enrollment until end of follow-up, up to 28 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AD109	5 of 325 (1.5%)	176 of 325 (54.2%)	0 of 325
Placebo	8 of 319 (2.5%)	50 of 319 (15.7%)	0 of 319

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42148495Strollo PJ Jr, Farkas R, Taranto-Montemurro L, Cronin J, Patel SR; SynAIRgy Investigators. Aroxybutynin and atomoxetine (AD109) for obstructive sleep apnea: a randomized phase 3 trial (SynAIRgy). Am J Respir Crit Care Med. 2026 Jul 1;212(7):1569-1584. doi: 10.1093/ajrccm/aamag215.

Related trials for OSA

Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Not yet recruiting
Comparing Two Types of Breathing Support in People With COPD, High Carbon Dioxide Levels, and Sleep Apnea
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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

73 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AD109 in people with OSA, run by Apnimed at 73 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Apnea-Hypopnea Index (AHI) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05813275, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.