Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
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.
Timeline
- Start
- 2023-08-28
- Primary completion
- 2025-05-07
- Completion
- 2025-05-07
Outcome
Met primary endpoint
release “The LunAIRo trial met its primary endpoint, demonstrating clinically meaningful and statistically significant reductions in airway obstruction at 26 weeks.” apnimed.com ↗
release “Select LunAIRo Phase 3 Results In the mITT population, AD109 achieved a significant reduction in mean AHI from baseline (46.8%, p<0.001)” apnimed.com ↗
release “The additional data built on previously reported topline results show that both studies met their primary endpoint, reduction in apnea-hypopnea index (AHI) at 26 weeks” apnimed.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AD109 | Unknown | — | Oral |