NCT05811247Phase 3Completed

Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

Study sponsor: Apnimed

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-05-07Actual

Enrollment · participants660Actual

Source updated2025-11-21Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-11-21 · 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: ~~Efficacy~~ of ~~AD109 on airway obstruction~~ in ~~mild~~ to ~~severe OSA~~

+ After

Measure: Change from Baseline in Apnea-Hypopnea Index (AHI)

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Study details

Conditions studied

OSA

Treatments or interventions studied

AD109Drug
PlaceboDrug

Primary outcomes · main study measures

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measure: Change from Baseline in Apnea-Hypopnea Index (AHI); description: AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO2) by at least 4%.; timeFrame: 6 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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