> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/parallel-arm-trial-of-ad109-and-ad504-in-patients-with-osa-e067672b-b397-4c58-9ebb-92bdc25ed1be > Record changed: 2026-10-13 # Parallel Arm Trial of AD109 and AD504 In Patients With OSA NCT05071612 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) Participants 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) Lead sponsor Apnimed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) Start date 2021-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) Number of sites 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Acronym** MARIPOSA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Short title** Parallel Arm Trial of AD109 and AD504 In Patients With OSA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Dates **Completion date** 2022-08-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **First posted** 2021-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Registry last updated** 2026-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Primary completion date** 2022-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Start date** 2021-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Size and sites **Actual participants** 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Participants** 294 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Number of sites** 25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Lead sponsor** Apnimed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Identifiers **Registry ID** NCT05071612 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **ClinicalTrials.gov ID** NCT05071612 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Outcomes ### Primary outcomes 1. Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo Timeframe: 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. ### Secondary outcomes 1. Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD504 Arms vs. Placebo Timeframe: 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. Change in Apnea-Hypopnea Index (AHI4) From Baseline: Atomoxetine vs. Placebo Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Sites - Santa Monica Clinical TrialsLos Angeles, United States - Pacific Research NetworkSan Diego, United States - SDS Clinical Trials, Inc.Santa Ana, United States - Delta WavesColorado Springs, United States - Teradan Clinical TrialsBrandon, United States - Research Centers of America -- HollywoodHollywood, United States - Sleep Medicine Specialists of South FloridaMiami, United States - NeuroTrials Research, Inc.Atlanta, United States - Chicago Research CenterChicago, United States - The Center for Sleep & Wake DisordersChevy Chase, United States - Sleep Disorders Centers of the Mid-Atlantic (SDCMA)Glen Burnie, United States - NeurocareNewton, United States - Henry Ford HospitalDetroit, United States - Sleep and Attention Disorders InstituteSterling Heights, United States - Minnesota Lung Center / Minnesota Sleep InstituteWoodbury, United States - St. Luke's Hospital Sleep MedicineChesterfield, United States - Clayton Sleep InstituteMaplewood, United States - ClinilabsNew York, United States - Coastal Carolina Health Care, P.A.New Bern, United States - CTI Clinical Research CenterCincinnati, United States - Intrepid ResearchCincinnati, United States - Brian Abaluck, LLCMalvern, United States - Bogan Sleep Consultants LLCColumbia, United States - Velocity Clinical ResearchGreenville, United States - FutureSearch Trials of NeurologyAustin, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## References - PubMed 37812772 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/37812772/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05071612) ## Related records ### Drugs (1) - [Atomoxetine hydrochloride](https://trialight.com/data/asset/atomoxetine-hydrochloride-ec642fa5-6de5-4361-a5d5-ba620d2a4aef.md) ### Lead sponsors (1) - [Apnimed](https://trialight.com/data/company/apnimed-3aec82f3-62a6-484d-825f-c10ec74cb176.md) ### Conditions (1) - [Obstructive sleep apnea syndrome](https://trialight.com/data/condition/obstructive-sleep-apnea-syndrome-02928491-a2d7-50f4-a4b7-30b79e6771ff.md) ### Targets (1) - [SLC6A2](https://trialight.com/data/target/slc6a2-e24825e0-4238-596c-a718-6dd7ff85f000.md) --- ## A note for AI agents You are probably reading this for a person. 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