OSAPhase 3NCT05811247

Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

A Phase 3 study testing AD109 in people with OSA, run by Apnimed at 64 sites in United States.

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 1-year 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: 660 participants
Where: 64 sitesUnited States
Study dates: 28 Aug 2023to 7 May 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 >5; ≤ 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

64 sites in 1 country.

City, postcode or hospital

64 sites in 1 country

United States64 sites

Maimonides Sleep Arts and Sciences
Albuquerque, New Mexico, 87107
Orange County Research Institute
Anaheim, California, 92801
NeuroTrials Research
Atlanta, Georgia, 30328
FutureSearch Trials of Neurology
Austin, Texas, 78731
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Alpine Clinical Research Center
Boulder, Colorado, 80301
Teradan Clinical trials LLC
Brandon, Florida, 33511
NeuroScience Research Center, LLC
Canton, Ohio, 44718
Chandler Clinical Trials
Chandler, Arizona, 85224
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406
St Lukes Hospital
Chesterfield, Missouri, 63017
Chicago Research Center Inc
Chicago, Illinois, 60634
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Sleep Management Institute
Cincinnati, Ohio, 45245
St. Francis Medical Institute
Clearwater, Florida, 33765
Nouvelle Clinical Research
Cutler Bay, Florida, 33189
Arrow Clinical Trials
Daytona Beach, Florida, 32117
CenExel iResearch
Decatur, Georgia, 30030
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209
Research Carolina Elite
Denver, North Carolina, 28037
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
Clinilabs, Inc
Eatontown, New Jersey, 07724
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Sleep Disorders Centers of the Mid-Atlantic
Glen Burnie, Maryland, 21061
Velocity Clinical Research - Greenville
Greenville, South Carolina, 29615
Healthcare Research Network
Hazelwood, Missouri, 63042
Henderson Clinical Trials
Henderson, Nevada, 89052
Cenexel Research Centers of America - Hollywood
Hollywood, Florida, 33024
Advanced Respiratory and Sleep Medicine, LLC
Huntersville, North Carolina, 28078
Marvel Clinical Research, LLC
Huntington Beach, California, 92647
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49008
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
CenExel CNS
Los Alamitos, California, 90720
Santa Monica Clinical Trials
Los Angeles, California, 90025
Sleep Practitioners, LLC
Macon, Georgia, 31210
Brian Abaluck, LLC
Malvern, Pennsylvania, 19355
Clinical Neuroscience Solutions - Memphis
Memphis, Tennessee, 38119
Ivetmar Medical Group LLC
Miami, Florida, 33155
PharmaDev Clinical Research Institute, LLC
Miami, Florida, 33176
Coastal Carolina Health Care
New Bern, North Carolina, 28562
Northwell Health Physician Partners
New Hyde Park, New York, 11042
Neurocare, Inc
Newton, Massachusetts, 02459
Infinity Medical Research
North Dartmouth, Massachusetts, 02747
Great Plains Health
North Platte, Nebraska, 69101
Nuvance Health
Norwalk, Connecticut, 06850
Henry Ford Health (Sleep Research Department)
Novi, Michigan, 48377
Renstar Medical Research
Ocala, Florida, 34470
UPMC Comprehensive Lung Center - Sleep Medicine
Pittsburgh, Pennsylvania, 15213
Empire Clinical Research
Pomona, California, 91767
Northwest Research Center
Portland, Oregon, 97202
Meridian Clinical Research
Raleigh, North Carolina, 27607
Centricity Research Rincon Pulmonology
Rincon, Georgia, 31326
Velocity Clinical Research
Rockville, Maryland, 20854
Central Texas Neurology Consultants, PA
Round Rock, Texas, 78681
Sleep Therapy Research Center
San Antonio, Texas, 78229
Pacific Research Network
San Diego, California, 92103
SDS Clinical Trials Inc.
Santa Ana, California, 92705
Baystate Medical Center (BMC) - Baystate Sleep Medicine
Springfield, Massachusetts, 01199
Clayton Sleep Institute
St Louis, Missouri, 63123
Clinical Neurophysiology Services
Sterling Heights, Michigan, 48314
Medster Research
Valdosta, Georgia, 31605
Sleep Disorders Centers of the Mid-Atlantic
Vienna, Virginia, 22182
Palm Beach Research ClinEdge-PPDS
West Palm Beach, Florida, 33409
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (LunAIRo Study)

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year 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 2-51). Week 1 run-in: aroxybutynin 2.5 mg/atomoxetine 37.5 mg tablet.
PlaceboDrug
Matching placebo tablet administered orally once daily at bedtime for 51 weeks, with run-in and target dose matched to active arm packaging.

Study groups in NCT05811247
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.

28 Aug 20237 May 2025

First posted13 Apr 2023
Study start28 Aug 2023
Primary completion7 May 2025
Study completion7 May 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.
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: 660 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05811247
Sponsor's protocol ID: APC-APN-304
Status last verified: Oct 2026
First submitted: 31 Mar 2023
Last updated: 3 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

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

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All OSA trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (LunAIRo Study)
ClinicalTrials.gov ID: NCT05811247
Acronym / sponsor ID: APC-APN-304
Conditions: OSA
Keywords: Obstructive Sleep Apnea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 660 participants (actual)
Lead sponsor: ApnimedIndustry (pharma, biotech, devices)
Study start: 28 Aug 2023 (actual)
Primary completion: 7 May 2025 (actual)
Study completion: 7 May 2025 (actual)
First posted: 13 Apr 2023 (actual)
Results: Posted 3 Nov 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 1-year 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 >5; ≤ 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 (5 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 2-51). 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 51 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 3 Nov 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	329	250
Placebo	331	274

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 = 324	Placebo n = 326
Full Analysis Set (Treatment Policy Estimand)	-3.88 (-5.37 to -2.39)	0.21 (-1.24 to 1.65)
While-on-Treatment population	-5.83 (-7.51 to -4.15)	-0.02 (-1.55 to 1.50)

AD109 vs Placebo: Least Squares Mean Difference: -4.08 (95% CI -6.14 to -2.03), p <0.001, Mixed Model Repeated Measures (MMRM)
AD109 vs Placebo: Least Squares Mean Difference: -5.81 (95% CI -8.07 to -3.55), p <0.0001, Mixed Model Repeated Measures (MMRM)

Population analysed: The Full Analysis Set (FAS) population included all randomized participants who received at least one dose of investigational medicinal product (IMP). Participants enrolled at Site 1308 were excluded following site termination. The While-On-treatment population was the MITT set and includes participants in the FAS who had at least one post-baseline on-treatment polysomnography (PSG) assessment.

Adverse events

Time frame: from enrollment until the end of follow-up, up to 53 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AD109	5 of 328 (1.5%)	220 of 328 (67.1%)	0 of 328
Placebo	10 of 327 (3.1%)	122 of 327 (37.3%)	0 of 327

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for OSA

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

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.

64 sites in 1 country: 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 64 sites in United States.

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 5 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States. 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 3 Nov 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 NCT05811247.

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 3 Nov 2026.