Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

Completed · Phase 3 · Has a placebo group

Conditions studied: OSA

In brief

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.

Key facts

Study ID

NCT05813275

Run by

Apnimed

People needed

646

Starts

2023-09-16

Expected to finish

2025-03-14

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age at the time of informed consent.
• PSG criteria: AHI of ≥10 and ≤45; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
• PROMIS-Fatigue: raw score ≥17
• PAP intolerance or current PAP refusal.
• BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.

You may not qualify if…

• Narcolepsy, restless leg syndrome, REM sleep behavior disorder
• Insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms.
• Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
• Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. Stable atrial arrhythmia is allowed.
• Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.
• Exclusion Criteria:

Where it is running

• Desert Clinical Research - CCT Research — Mesa, Arizona, United States
• Foothills Research Center - CCT Research — Phoenix, Arizona, United States
• Fiel Family Sports Medicine - PC CCT Research — Tempe, Arizona, United States
• Noble Clinical Research — Tucson, Arizona, United States
• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
• Orange County Research Institute — Anaheim, California, United States
• North County Neurology Associates — Carlsbad, California, United States
• Core Healthcare Group — Cerritos, California, United States
• Exalt Clinical Research — Chula Vista, California, United States
• Catalina Research Institute — Montclair, California, United States
• Probe Clinical Research Corporation — Riverside, California, United States
• Pacific Research Network — San Diego, California, United States
• Sleep Medicine Specialists of California — San Ramon, California, United States
• SDS Clinical Trials Inc. — Santa Ana, California, United States
• Provideré Research Inc. — West Covina, California, United States
• Meris Clinical Research — Brandon, Florida, United States
• Nouvelle Clinical Research — Cutler Bay, Florida, United States
• Accel Research Sites — DeLand, Florida, United States
• Research Centers of America, LLC — Hollywood, Florida, United States
• Canvas Clinical Research — Lake Worth, Florida, United States
• Florida Lung and Sleep Associates — Lehigh Acres, Florida, United States
• Advanced Medical Research Institute — Miami, Florida, United States
• Clinical Site Partners — Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc - Orlando — Orlando, Florida, United States
• Alabama Neurology & Sleep Medicine — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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