Trial · NCT03845023

Trial of AD036 in Obstructive Sleep Apnea

NCT03845023, Phase 2, Completed, Apnimed; results first posted 2023-01-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of AD036 in Obstructive Sleep Apnea. Trials, record NCT03845023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03845023

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of AD036 in Obstructive Sleep Apnea
NCT number: NCT03845023
Status: Completed
Phases: Phase 2
Enrollment: 140 participants, actual
Lead sponsor: Apnimed
Conditions: Obstructive Sleep Apnea
Interventions: AD036 Dose 1, AD036 Dose 2, AD036 Dose 3, Placebo
First posted: 2019-02-19
Last updated: 2023-01-17
Results first posted: 2023-01-17

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Apnea Hypopnea Index (AHI)	10 days	Number of participants with ≥50% reduction in apnea hypopnea index (AHI). AHI is the average number of apneas and hypopneas a person experiences each hour during sleep, to register as an event an apnea or hypopnea must last at least 10 seconds or longer. To measure this, doctors divide the total number of apneic and hypopneic events by the total number of hours the person was asleep.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Apnea Hypopnea Index (AHI)	10 days	All randomized subjects were included in the mITT	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Apnea Hypopnea Index (AHI)	Placebo	Yes (subjects that had a 50% reduction in AHI)	3	Participants
Apnea Hypopnea Index (AHI)	AD036 Dose 1	Yes (subjects that had a 50% reduction in AHI)	2	Participants
Apnea Hypopnea Index (AHI)	AD036 Dose 2	Yes (subjects that had a 50% reduction in AHI)	6	Participants
Apnea Hypopnea Index (AHI)	AD036 Dose 3	Yes (subjects that had a 50% reduction in AHI)	8	Participants
Apnea Hypopnea Index (AHI)	Placebo	No (subjects that did not have a 50% reduction in AHI)	33	Participants
Apnea Hypopnea Index (AHI)	AD036 Dose 1	No (subjects that did not have a 50% reduction in AHI)	34	Participants
Apnea Hypopnea Index (AHI)	AD036 Dose 2	No (subjects that did not have a 50% reduction in AHI)	28	Participants
Apnea Hypopnea Index (AHI)	AD036 Dose 3	No (subjects that did not have a 50% reduction in AHI)	26	Participants

Source ClinicalTrials.gov

Participant flow48

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Placebo Run-In Period (2 Nights)	STARTED	Placebo	36
Placebo Run-In Period (2 Nights)	STARTED	AD036 Dose 1	36
Placebo Run-In Period (2 Nights)	STARTED	AD036 Dose 2	34
Placebo Run-In Period (2 Nights)	STARTED	AD036 Dose 3	34
Placebo Run-In Period (2 Nights)	COMPLETED	Placebo	36
Placebo Run-In Period (2 Nights)	COMPLETED	AD036 Dose 1	36
Placebo Run-In Period (2 Nights)	COMPLETED	AD036 Dose 2	34
Placebo Run-In Period (2 Nights)	COMPLETED	AD036 Dose 3	34
Placebo Run-In Period (2 Nights)	NOT COMPLETED	Placebo	0
Placebo Run-In Period (2 Nights)	NOT COMPLETED	AD036 Dose 1	0

1 to 10 of 48Source ClinicalTrials.gov

See all 48 participant flow

Adverse events92

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dry Mouth	Gastrointestinal disorders	Placebo	2	140	2
other	Dry Mouth	Gastrointestinal disorders	AD036 Dose 1	6	104	6
other	Dry Mouth	Gastrointestinal disorders	AD036 Dose 2	2	34	2
other	Dry Mouth	Gastrointestinal disorders	AD036 Dose 3	8	34	8
other	Constipation	Gastrointestinal disorders	Placebo	0	140	0
other	Constipation	Gastrointestinal disorders	AD036 Dose 1	2	104	2
other	Constipation	Gastrointestinal disorders	AD036 Dose 2	1	34	1
other	Constipation	Gastrointestinal disorders	AD036 Dose 3	5	34	5
other	dyspepsia	Gastrointestinal disorders	Placebo	2	140	2
other	dyspepsia	Gastrointestinal disorders	AD036 Dose 1	1	104	1

1 to 10 of 92Source ClinicalTrials.gov

See all 92 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	140
Total, all-cause mortality	AD036 Dose 1	0	104
Total, all-cause mortality	AD036 Dose 2	0	34
Total, all-cause mortality	AD036 Dose 3	0	34
Total, other adverse events	Placebo	7	140
Total, other adverse events	AD036 Dose 1	13	104
Total, other adverse events	AD036 Dose 2	16	34
Total, other adverse events	AD036 Dose 3	14	34
Total, serious adverse events	Placebo	0	140
Total, serious adverse events	AD036 Dose 1	1	104

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03845023

GET https://conductscience.org/api/trials/v1/NCT03845023/flow?page=2

API reference For AI assistants