Trial Outcomes & Findings for Parallel Arm Trial of AD109 and AD504 In Patients With OSA (NCT NCT05071612)

Last Updated: 2026-08-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

294 participants

Primary outcome timeframe

Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)

Results posted on

2026-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	AD109 75/5mg AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 5 mg tablet following a 1-week titration with Atomoxetine 37.5 mg/Aroxybutynin 2.5 mg tablet.	AD109 75/2.5mg AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 2.5 mg tablet following a 1-week titration with Atomoxetine 37.5 mg/Aroxybutynin 2.5 mg tablet.	AD504 75/100mg AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg tablet /Trazodone 100 mg capsule following a 1-week titration with Atomoxetine 37.5 mg tablet /Trazodone 50 mg capsule	AD504 75/50mg AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg tablet / Trazodone 50 mg capsule following a 1-week titration with Atomoxetine 37.5 mg tablet /Trazodone 50 mg capsule	Atomoxetine 75mg Atomoxetine Hydrochloride: Oral administration at bedtime. Dose: Atomoxetine 75 mg tablet alone or Atomoxetine 75 mg tablet plus placebo capsule, following a 1-week titration with Atomoxetine 37.5 mg tablet alone or Atomoxetine 37.5 mg tablet plus placebo capsule. Regimens were pooled for analysis.	Placebo Placebo: Oral administration at bedtime. Dose: Matching placebo tablet alone or matching placebo tablet plus matching placebo capsule. Regimens were pooled for analysis.
Overall Study STARTED	41	42	43	40	64	64
Overall Study COMPLETED	35	33	38	38	49	59
Overall Study NOT COMPLETED	6	9	5	2	15	5

Reasons for withdrawal

Reasons for withdrawal
Measure	AD109 75/5mg AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 5 mg tablet following a 1-week titration with Atomoxetine 37.5 mg/Aroxybutynin 2.5 mg tablet.	AD109 75/2.5mg AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 2.5 mg tablet following a 1-week titration with Atomoxetine 37.5 mg/Aroxybutynin 2.5 mg tablet.	AD504 75/100mg AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg tablet /Trazodone 100 mg capsule following a 1-week titration with Atomoxetine 37.5 mg tablet /Trazodone 50 mg capsule	AD504 75/50mg AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg tablet / Trazodone 50 mg capsule following a 1-week titration with Atomoxetine 37.5 mg tablet /Trazodone 50 mg capsule	Atomoxetine 75mg Atomoxetine Hydrochloride: Oral administration at bedtime. Dose: Atomoxetine 75 mg tablet alone or Atomoxetine 75 mg tablet plus placebo capsule, following a 1-week titration with Atomoxetine 37.5 mg tablet alone or Atomoxetine 37.5 mg tablet plus placebo capsule. Regimens were pooled for analysis.	Placebo Placebo: Oral administration at bedtime. Dose: Matching placebo tablet alone or matching placebo tablet plus matching placebo capsule. Regimens were pooled for analysis.
Overall Study Other/Unknown	0	1	1	0	1	1
Overall Study Adverse Event	5	5	3	1	12	1
Overall Study Withdrawal by Subject	1	2	0	1	0	1
Overall Study Lost to Follow-up	0	0	0	0	2	0
Overall Study Protocol Violation	0	0	1	0	0	2
Overall Study Non-Compliance with Study Drug	0	1	0	0	0	0

Baseline Characteristics

Parallel Arm Trial of AD109 and AD504 In Patients With OSA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atomoxetine 75mg n=63 Participants Atomoxetine Hydrochloride: Oral administration at bedtime. Dose: Atomoxetine 75 mg	Placebo n=63 Participants Placebo: Oral administration at bedtime	Total n=292 Participants Total of all reporting groups	AD504 75/50mg n=40 Participants AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Trazodone 50 mg	AD109 75/5mg n=41 Participants AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 5 mg	AD109 75/2.5mg n=42 Participants AD109: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Aroxybutynin 2.5 mg	AD504 75/100mg n=43 Participants AD504: Oral administration at bedtime. Dose: Atomoxetine 75 mg/Trazodone 100 mg
Age, Categorical <=18 years	0 Participants	0 Participants n=5 Participants	0 Participants n=11 Participants	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	56 Participants	58 Participants n=5 Participants	262 Participants n=11 Participants	37 Participants n=2 Participants	37 Participants n=1 Participants	40 Participants n=1 Participants	34 Participants n=1 Participants
Age, Categorical >=65 years	7 Participants	5 Participants n=5 Participants	30 Participants n=11 Participants	3 Participants n=2 Participants	4 Participants n=1 Participants	2 Participants n=1 Participants	9 Participants n=1 Participants
Age, Continuous	52.8 years STANDARD_DEVIATION 10.95	54.9 years STANDARD_DEVIATION 9.03 • n=5 Participants	54.2 years STANDARD_DEVIATION 9.49 • n=11 Participants	53.9 years STANDARD_DEVIATION 8.81 • n=2 Participants	54.2 years STANDARD_DEVIATION 9.24 • n=1 Participants	51.5 years STANDARD_DEVIATION 9.22 • n=1 Participants	57.8 years STANDARD_DEVIATION 8.20 • n=1 Participants
Sex: Female, Male Female	22 Participants	27 Participants n=5 Participants	121 Participants n=11 Participants	14 Participants n=2 Participants	19 Participants n=1 Participants	17 Participants n=1 Participants	22 Participants n=1 Participants
Sex: Female, Male Male	41 Participants	36 Participants n=5 Participants	171 Participants n=11 Participants	26 Participants n=2 Participants	22 Participants n=1 Participants	25 Participants n=1 Participants	21 Participants n=1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants n=5 Participants	1 Participants n=11 Participants	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	1 Participants n=1 Participants
Race (NIH/OMB) Asian	3 Participants	5 Participants n=5 Participants	15 Participants n=11 Participants	2 Participants n=2 Participants	2 Participants n=1 Participants	2 Participants n=1 Participants	1 Participants n=1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=5 Participants	0 Participants n=11 Participants	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Black or African American	5 Participants	9 Participants n=5 Participants	41 Participants n=11 Participants	5 Participants n=2 Participants	6 Participants n=1 Participants	11 Participants n=1 Participants	5 Participants n=1 Participants
Race (NIH/OMB) White	52 Participants	48 Participants n=5 Participants	226 Participants n=11 Participants	31 Participants n=2 Participants	33 Participants n=1 Participants	28 Participants n=1 Participants	34 Participants n=1 Participants
Race (NIH/OMB) More than one race	1 Participants	0 Participants n=5 Participants	4 Participants n=11 Participants	0 Participants n=2 Participants	0 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=1 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	1 Participants n=5 Participants	5 Participants n=11 Participants	2 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants	11 Participants n=5 Participants	53 Participants n=11 Participants	8 Participants n=2 Participants	9 Participants n=1 Participants	8 Participants n=1 Participants	5 Participants n=1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants	52 Participants n=5 Participants	239 Participants n=11 Participants	32 Participants n=2 Participants	32 Participants n=1 Participants	34 Participants n=1 Participants	38 Participants n=1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants n=5 Participants	0 Participants n=11 Participants	0 Participants n=2 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Region of Enrollment United States	63 participants	63 participants n=5 Participants	292 participants n=11 Participants	40 participants n=2 Participants	41 participants n=1 Participants	42 participants n=1 Participants	43 participants n=1 Participants
Body Mass Index (BMI)	31.16 kg/m2 STANDARD_DEVIATION 4.716	31.17 kg/m2 STANDARD_DEVIATION 4.719 • n=5 Participants	31.65 kg/m2 STANDARD_DEVIATION 4.389 • n=11 Participants	32.68 kg/m2 STANDARD_DEVIATION 3.537 • n=2 Participants	31.12 kg/m2 STANDARD_DEVIATION 4.085 • n=1 Participants	33.43 kg/m2 STANDARD_DEVIATION 4.352 • n=1 Participants	30.89 kg/m2 STANDARD_DEVIATION 3.999 • n=1 Participants

PRIMARY outcome

Timeframe: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)

Population: 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.

Outcome measures

Outcome measures
Measure	AD109 Combined Dose Arms n=69 Participants Prespecified AD109 combined analysis group includes n=35 participants taking Atomoxetine 75mg / Aroxybutynin 5mg, and n=34 participants taking Atomoxetine 75 mg / Aroxybutynin 2.5 mg	AD109 75/5mg n=35 Participants Dose: Atomoxetine 75 mg/Aroxybutynin 5 mg	AD109 75/2.5mg n=34 Participants Dose: Atomoxetine 75 mg/Aroxybutynin 2.5 mg	Placebo n=62 Participants Participants received matching placebo
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD109 Arms vs. Placebo	-7.38 events/hr Interval -9.53 to -5.23	-7.40 events/hr Interval -10.41 to -4.38	-7.37 events/hr Interval -10.44 to -4.3	-0.21 events/hr Interval -2.49 to 2.07

SECONDARY outcome

Timeframe: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)

Population: mITT set: all randomized participants who received ≥1 dose and had ≥1 primary endpoint measurement. The two AD504 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 AD504 versus placebo rather than to compare individual dose levels. Results for the individual AD504 dose groups are presented descriptively to provide arm-level data.

Outcome measures

Outcome measures
Measure	AD109 Combined Dose Arms n=76 Participants Prespecified AD109 combined analysis group includes n=35 participants taking Atomoxetine 75mg / Aroxybutynin 5mg, and n=34 participants taking Atomoxetine 75 mg / Aroxybutynin 2.5 mg	AD109 75/5mg n=38 Participants Dose: Atomoxetine 75 mg/Aroxybutynin 5 mg	AD109 75/2.5mg n=38 Participants Dose: Atomoxetine 75 mg/Aroxybutynin 2.5 mg	Placebo n=62 Participants Participants received matching placebo
Change in Apnea-Hypopnea Index (AHI4) From Baseline: Combined AD504 Arms vs. Placebo	-8.02 events/hr Interval -9.98 to -6.05	-8.53 events/hr Interval -11.31 to -5.74	-7.50 events/hr Interval -10.29 to -4.72	-0.33 events/hr Interval -2.52 to 1.86

SECONDARY outcome

Timeframe: Baseline (mean of PSG Visits 2 and 3) to Day 21 and Day 28 (PSG Visits 5 and 6)

Population: mITT set: all randomized participants who received ≥1 dose and had ≥1 primary endpoint measurement.