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NCT05813275 · ClinicalTrials.gov registry record · Phase 3
Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)
A Phase 3 study, sponsored by Apnimed.
- Completed
- Registry status
- Phase 3
- Development phase
- 646
- Enrollment target
NCT05813275: Completed Phase 3 study, sponsored by Apnimed.
NCT05813275 is a Phase 3 study that has completed, run by Apnimed. The registered enrollment target is 646 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05813275, a Phase 3 study, has completed, sponsored by Apnimed.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 646 participants
- Enrollment target
Study Summary
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month 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%.
Interventions
- DRUG Placebo
- DRUG AD109
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 646 participants |
| Start Date | 2023-09-16 |
| Est. Completion | 2025-03-14 |
| Phase | Phase 3 |
What the finished NCT05813275 record still lists
NCT05813275 is an interventional study that assigns participants to a tested intervention. The registered 646 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05813275 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05813275 about?
NCT05813275 is a clinical study titled "Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)". This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
What is the current status of trial NCT05813275?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 646 participants. The study started on 2023-09-16. Estimated completion is 2025-03-14.
What interventions are being tested in trial NCT05813275?
The interventions under investigation include: Placebo (DRUG), AD109 (DRUG).
Who is sponsoring clinical trial NCT05813275?
This trial is sponsored by Apnimed, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05813275's enrollment target sits among peer trials
646 572nd of 2000 higher than 1,429 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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