OSA - Obstructive Sleep ApneaPhase 2MARIPOSANCT05071612

Parallel Arm Trial of AD109 and AD504 In Patients With OSA

A Phase 2 study testing AD109, AD504 and Atomoxetine Hydrochloride in people with OSA - Obstructive Sleep Apnea, run by Apnimed at 25 sites in United States.

Completed

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

Official record

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Trial summary

This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: OSA - Obstructive Sleep Apnea
What is being tested?: AD109, AD504 and Atomoxetine Hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 294 participants
Where: 25 sitesUnited States
Study dates: 29 Nov 2021to 3 Aug 2022
Phase: Phase 2
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.
Mean AHI 10 to 45 events/h, inclusive
PGI-S: >1
BMI between 18.5 and 38 kg/m2 for men and 40 kg/m2 for women, inclusive.

Who cannot join

Current clinically significant sleep disorder other than OSA
Clinically significant craniofacial malformation.
Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

NeuroTrials Research, Inc.
Atlanta, Georgia, 30328
FutureSearch Trials of Neurology
Austin, Texas, 78731
Teradan Clinical Trials
Brandon, Florida, 33511
St. Luke's Hospital Sleep Medicine
Chesterfield, Missouri, 63017
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Chicago Research Center
Chicago, Illinois, 60634
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Intrepid Research
Cincinnati, Ohio, 45245
Delta Waves
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants LLC
Columbia, South Carolina, 29201
Henry Ford Hospital
Detroit, Michigan, 48377
Sleep Disorders Centers of the Mid-Atlantic (SDCMA)
Glen Burnie, Maryland, 21061
Velocity Clinical Research
Greenville, South Carolina, 29615
Research Centers of America -- Hollywood
Hollywood, Florida, 33024
Santa Monica Clinical Trials
Los Angeles, California, 90025
Brian Abaluck, LLC
Malvern, Pennsylvania, 19355
Clayton Sleep Institute
Maplewood, Missouri, 63143
Sleep Medicine Specialists of South Florida
Miami, Florida, 33176
Coastal Carolina Health Care, P.A.
New Bern, North Carolina, 28562
Clinilabs
New York, New York, 10016
Neurocare
Newton, Massachusetts, 02459
Pacific Research Network
San Diego, California, 92103
SDS Clinical Trials, Inc.
Santa Ana, California, 92705
Sleep and Attention Disorders Institute
Sterling Heights, Michigan, 48314
Minnesota Lung Center / Minnesota Sleep Institute
Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea

Conditions: OSA - Obstructive Sleep Apnea
Being tested: AD109, AD504, Atomoxetine Hydrochloride, Placebo
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
Oral administration at bedtime
AD504Drug
Oral administration at bedtime
Atomoxetine HydrochlorideDrug
Oral administration at bedtime
PlaceboDrug
Oral administration at bedtime

Study groups in NCT05071612
Study group	Role	What they receive
AD109 75/5mg	Experimental	Atomoxetine 75 mg/Aroxybutynin 5 mg tablet Receives: Drug: AD109
AD109 75/2.5mg	Experimental	Atomoxetine 75 mg/Aroxybutynin 2.5 mg tablet Receives: Drug: AD109
AD504 75/100mg	Experimental	Atomoxetine 75 mg tablet/Trazodone 100 mg capsule Receives: Drug: AD504
AD504 75/50mg	Experimental	Atomoxetine 75 mg tablet/Trazodone 50 mg capsule Receives: Drug: AD504
Atomoxetine 75mg	Active comparator	Atomoxetine 75 mg tablet Receives: Drug: Atomoxetine Hydrochloride
Atomoxetine 75mg plus placebo	Active comparator	Atomoxetine 75 mg tablet/placebo capsule Receives: Drug: Atomoxetine Hydrochloride
Placebo tablet	Placebo comparator	Not described Receives: Drug: Placebo
Placebo tablet plus placebo capsule	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 in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo
Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.
Measured: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)

Secondary outcomes (2)

Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD504 Arms vs. Placebo
Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.
Measured: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Atomoxetine vs. Placebo
Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.
Measured: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)

Timeline

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

29 Nov 20213 Aug 2022

First posted8 Oct 2021
Study start29 Nov 2021
Primary completion20 Jul 2022
Study completion3 Aug 2022

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 OSA - Obstructive Sleep ApneaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05071612
Sponsor's protocol ID: MARIPOSA
Acronym: MARIPOSA
Status last verified: Aug 2026
First submitted: 27 Sep 2021
Last updated: 12 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Schweitzer PK, Taranto-Montemurro L, Ojile JM, Thein SG, Drake CL, Rosenberg R, Corser B, Abaluck B, Sangal RB, Maynard J. The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial. Am J Respir Crit Care Med. 2023 Dec 15;208(12):1316-1327. doi: 10.1164/rccm.202306-1036OC.
PubMed 37812772

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 - Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT05071612
Acronym / sponsor ID: MARIPOSA / MARIPOSA
Conditions: OSA - Obstructive Sleep Apnea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 294 participants (actual)
Lead sponsor: ApnimedIndustry (pharma, biotech, devices)
Study start: 29 Nov 2021 (actual)
Primary completion: 20 Jul 2022 (actual)
Study completion: 3 Aug 2022 (actual)
First posted: 8 Oct 2021 (actual)
Results: Posted 12 Aug 2026

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
AD109 75/5mg	Experimental	Drug: AD109Atomoxetine 75 mg/Aroxybutynin 5 mg tablet
AD109 75/2.5mg	Experimental	Drug: AD109Atomoxetine 75 mg/Aroxybutynin 2.5 mg tablet
AD504 75/100mg	Experimental	Drug: AD504Atomoxetine 75 mg tablet/Trazodone 100 mg capsule
AD504 75/50mg	Experimental	Drug: AD504Atomoxetine 75 mg tablet/Trazodone 50 mg capsule
Atomoxetine 75mg	Active comparator	Drug: Atomoxetine HydrochlorideAtomoxetine 75 mg tablet
Atomoxetine 75mg plus placebo	Active comparator	Drug: Atomoxetine HydrochlorideAtomoxetine 75 mg tablet/placebo capsule
Placebo tablet	Placebo comparator	Drug: Placebo
Placebo tablet plus placebo capsule	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.
Mean AHI 10 to 45 events/h, inclusive
PGI-S: >1
BMI between 18.5 and 38 kg/m2 for men and 40 kg/m2 for women, inclusive.

Key exclusion criteria (4 listed)

Current clinically significant sleep disorder other than OSA
Clinically significant craniofacial malformation.
Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study

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
AD109Oral administration at bedtime	Drug	AD109 75/2.5mg, AD109 75/5mg
AD504Oral administration at bedtime	Drug	AD504 75/100mg, AD504 75/50mg
Atomoxetine HydrochlorideOral administration at bedtime	Drug	Atomoxetine 75mg, Atomoxetine 75mg plus placebo
PlaceboOral administration at bedtime	Drug	Placebo tablet, Placebo tablet plus placebo capsule

Primary outcome

Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo
Time frame: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
Change in AHI4 (apnea-hypopnea index, 4% oxygen desaturation criterion; average respiratory events per hour of sleep) measured by in-lab polysomnography. Baseline was the mean of two pre-treatment PSG nights (Visits 2 and 3). Change from baseline was assessed at treatment PSG nights at approximately Day 21 (Visit 5) and Day 28 (Visit 6), modeled as repeated measures, with the reported value representing the model-based LS mean using equal (0.5/0.5) weighting between the Day 21 and Day 28 visits.

2 secondary outcomes

Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD504 Arms vs. Placebo
Time frame: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Atomoxetine vs. Placebo
Time frame: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)

Results and safety

Results posted to the registry on 12 Aug 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 75/5mg	41	35
AD109 75/2.5mg	42	33
AD504 75/100mg	43	38
AD504 75/50mg	40	38
Atomoxetine 75mg	64	49
Placebo	64	59

Primary outcome: Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo

Time frame: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6). Least squares mean (95% Confidence Interval). Unit: events/hr

Measure	AD109 Combined Dose Arms n = 69	AD109 75/5mg n = 35	AD109 75/2.5mg n = 34	Placebo n = 62
Value	-7.38 (-9.53 to -5.23)	-7.40 (-10.41 to -4.38)	-7.37 (-10.44 to -4.30)	-0.21 (-2.49 to 2.07)

AD109 Combined Dose Arms vs Placebo: Least Squares Mean Difference: -7.17 (95% CI -10.31 to -4.04), p <0.0001, Mixed Models Analysis

Population analysed: mITT set: all randomized participants who received ≥1 dose and had ≥1 primary endpoint measurement. The two AD109 dose arms were combined as the primary analysis group per the pre-specified SAP (v1.0, April 2022), as the study was designed and powered to evaluate the overall effect of AD109 versus placebo rather than to compare individual dose levels. Results for the individual AD109 dose groups are presented descriptively to provide arm-level data.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: from randomization until end of study visit, up to 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AD109 75/5mg	0 of 41 (0%)	32 of 41 (78%)	0 of 41
AD109 75/2.5mg	0 of 42 (0%)	26 of 42 (61.9%)	0 of 42
AD504 75/100mg	0 of 43 (0%)	33 of 43 (76.7%)	0 of 43
AD504 75/50mg	0 of 40 (0%)	24 of 40 (60%)	0 of 40
Atomoxetine 75mg	0 of 63 (0%)	51 of 63 (81%)	0 of 63
Placebo	0 of 63 (0%)	25 of 63 (39.7%)	0 of 63

Limitations and caveats (from the sponsor): This Phase 2 study was not powered to compare individual dose groups. Primary efficacy analyses evaluated prespecified pooled treatment groups, and results for individual dose arms should be interpreted descriptively.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37812772Schweitzer PK, Taranto-Montemurro L, Ojile JM, Thein SG, Drake CL, Rosenberg R, Corser B, Abaluck B, Sangal RB, Maynard J. The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial. Am J Respir Crit Care Med. 2023 Dec 15;208(12):1316-1327. doi: 10.1164/rccm.202306-1036OC.

Related trials for OSA - Obstructive Sleep Apnea

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)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AD109, AD504 and Atomoxetine Hydrochloride in people with OSA - Obstructive Sleep Apnea, run by Apnimed at 25 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 4 inclusion and 4 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 12 Aug 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 in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo (time frame: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)). 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 NCT05071612, 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 12 Aug 2026.