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NCT05811247 · ClinicalTrials.gov registry record · Phase 3
Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
A Phase 3 study of OSA, sponsored by Apnimed.
- Completed
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
- 20
- Study locations
NCT05811247: Completed Phase 3 study of OSA, sponsored by Apnimed.
NCT05811247 is a Phase 3 study of OSA that has completed, run by Apnimed. The registered enrollment target is 660 participants, above the 118-participant average among 14 other OSA trials with a reported enrollment target (459% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05811247, a Phase 3 study of OSA, has completed, sponsored by Apnimed.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Primary Outcome
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%.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AD109
Study Locations (20)
California
- Orange County Research Institute - Anaheim
- Marvel Clinical Research, LLC - Huntington Beach
- CenExel CNS - Los Alamitos
- Santa Monica Clinical Trials - Los Angeles
- Empire Clinical Research - Pomona
- Pacific Research Network - San Diego
- SDS Clinical Trials Inc. - Santa Ana
Florida
- Teradan Clinical trials LLC - Brandon
- St. Francis Medical Institute - Clearwater
- Nouvelle Clinical Research - Cutler Bay
- Arrow Clinical Trials - Daytona Beach
- Cenexel Research Centers of America - Hollywood - Hollywood
- Ivetmar Medical Group LLC - Miami
- PharmaDev Clinical Research Institute, LLC - Miami
Colorado
- Alpine Clinical Research Center - Boulder
- Mountain View Clinical Research, Inc. - Denver
Alabama
- Sleep Disorders Center of Alabama - Birmingham
Arizona
- Chandler Clinical Trials - Chandler
Arkansas
- Preferred Research Partners, Inc. - Little Rock
Connecticut
- Nuvance Health - Norwalk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2023-08-28 |
| Est. Completion | 2025-05-07 |
| Phase | Phase 3 |
What the finished NCT05811247 record still lists
NCT05811247 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, above the 118-participant average among 14 other OSA trials with a reported enrollment target (459% higher).
The record links to 1 condition, with OSA appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05811247 names 20 study sites across 7 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT05811247 about?
NCT05811247 is a clinical study titled "Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)". This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
What is the current status of trial NCT05811247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2023-08-28. Estimated completion is 2025-05-07.
What conditions does trial NCT05811247 study?
This clinical trial studies the following conditions: OSA.
What interventions are being tested in trial NCT05811247?
The interventions under investigation include: Placebo (DRUG), AD109 (DRUG).
Who is sponsoring clinical trial NCT05811247?
This trial is sponsored by Apnimed, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05811247 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for OSA
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05811247's enrollment target sits among peer trials
660 1st of 14 higher than 14 of 14 other OSA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other OSA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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