Parallel Arm Trial of AD109 and AD504 In Patients With OSA (MARIPOSA)

August 7, 2026 updated by: Apnimed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

294

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo tablet
Drug: Placebo
Oral administration at bedtime
Experimental: AD109 75/5mg
Atomoxetine 75 mg/Aroxybutynin 5 mg tablet
Drug: AD109
Oral administration at bedtime
Experimental: AD109 75/2.5mg
Atomoxetine 75 mg/Aroxybutynin 2.5 mg tablet
Drug: AD109
Oral administration at bedtime
Experimental: AD504 75/100mg
Atomoxetine 75 mg tablet/Trazodone 100 mg capsule
Drug: AD504
Oral administration at bedtime
Experimental: AD504 75/50mg
Atomoxetine 75 mg tablet/Trazodone 50 mg capsule
Drug: AD504
Oral administration at bedtime
Active Comparator: Atomoxetine 75mg
Atomoxetine 75 mg tablet
Drug: Atomoxetine Hydrochloride
Oral administration at bedtime
Active Comparator: Atomoxetine 75mg plus placebo
Atomoxetine 75 mg tablet/placebo capsule
Drug: Atomoxetine Hydrochloride
Oral administration at bedtime
Placebo Comparator: Placebo tablet plus placebo capsule
Drug: Placebo
Oral administration at bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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.
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)
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.
Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apnimed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2021

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

August 3, 2022

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARIPOSA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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