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

NCT05813275 | Completed Phase 3 FDA Drug

• 1 other identifier: APC-APN-305
• Study Type: interventional
• Target: 646
• Locations: 2 countries
• Sites: 73

Brief 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.

Conditions

OSA

Keywords

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Apnea-Hypopnea Index (AHI)

  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%.

  6 months

Study Arms (2)

AD109

EXPERIMENTAL

AD109

Drug: AD109

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AD109 DRUG

Oral administration at bedtime

AD109

Placebo DRUG

Oral administration at bedtime

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Apnimed: lead

Study Sites (73)

Alabama Neurology & Sleep Medicine

Tuscaloosa, Alabama, 35406, United States

Location

Desert Clinical Research - CCT Research

Mesa, Arizona, 85213, United States

Location

Foothills Research Center - CCT Research

Phoenix, Arizona, 85044, United States

Location

Fiel Family Sports Medicine - PC CCT Research

Tempe, Arizona, 85283, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

North County Neurology Associates

Carlsbad, California, 92011, United States

Location

Core Healthcare Group

Cerritos, California, 90703, United States

Location

Exalt Clinical Research

Chula Vista, California, 91910, United States

Location

Catalina Research Institute

Montclair, California, 91763, United States

Location

Probe Clinical Research Corporation

Riverside, California, 92501, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

Sleep Medicine Specialists of California

San Ramon, California, 94583, United States

Location

SDS Clinical Trials Inc.

Santa Ana, California, 92705, United States

Location

Provideré Research Inc.

West Covina, California, 91790, United States

Location

Meris Clinical Research

Brandon, Florida, 33511, United States

Location

Nouvelle Clinical Research

Cutler Bay, Florida, 33189, United States

Location

Accel Research Sites

DeLand, Florida, 32720, United States

Location

Research Centers of America, LLC

Hollywood, Florida, 33024, United States

Location

Canvas Clinical Research

Lake Worth, Florida, 33467, United States

Location

Florida Lung and Sleep Associates

Lehigh Acres, Florida, 33971, United States

Location

Advanced Medical Research Institute

Miami, Florida, 33174, United States

Location

Clinical Site Partners

Miami, Florida, 33186, United States

Location

Clinical Neuroscience Solutions, Inc - Orlando

Orlando, Florida, 32801, United States

Location

JSV Clinical Research Study Inc

Tampa, Florida, 33634, United States

Location

Florida Pediatric Research Institute

Winter Park, Florida, 32789, United States

Location

Atlanta Center for Medical Research, LLC

Atlanta, Georgia, 30031, United States

Location

NeuroTrials Research

Atlanta, Georgia, 30342, United States

Location

Georgia Neurology and Sleep Medicine Assoc

Suwanee, Georgia, 30024, United States

Location

Javarra Inc-Privia Medical Group

Thomasville, Georgia, 31792, United States

Location

St. Lukes Clinic - Idaho Pulmonary Associates

Meridian, Idaho, 83642, United States

Location

Chicago Research Center Inc

Chicago, Illinois, 60634, United States

Location

OSF HealthCare Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40220, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

Infinity Medical Research

North Dartmouth, Massachusetts, 02747, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Revive Research Institute

Lathrup Village, Michigan, 48076, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

Neurology Specialists of Monmouth County

West Long Branch, New Jersey, 07764, United States

Location

Javara Inc - Tryon Medical Partners PLCC

Charlotte, North Carolina, 28210, United States

Location

Research Carolina Elite

Denver, North Carolina, 28025, United States

Location

Peters Medical Research, LLC

High Point, North Carolina, 27260, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Sleep Management Institute (Intrepid)

Cincinnati, Ohio, 45245, United States

Location

UC Health Sleep Medicine

Cincinnati, Ohio, 45267, United States

Location

University Hospital of Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Abington Neurological Associate

Abington, Pennsylvania, 19001, United States

Location

Respiratory Specialists

Wyomissing, Pennsylvania, 19610, United States

Location

Tribe Clinical Research LL

Greenville, South Carolina, 29607, United States

Location

OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A

Rock Hill, South Carolina, 29732, United States

Location

Chattanooga Research & Medicine, PLLC

Chattanooga, Tennessee, 37404, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

The Heights Hospital (HD Heights)

Houston, Texas, 77008, United States

Location

Weill Cornell Medical College

Houston, Texas, 77030, United States

Location

Lone Star Lung and Sleep Clinic

Houston, Texas, 77070, United States

Location

Huntsville Research Institute LLC

Huntsville, Texas, 77340, United States

Location

Epic Medical Research

Red Oak, Texas, 75154, United States

Location

Element Research Group

San Antonio, Texas, 78229, United States

Location

South Ogden Family Medicine / CCT Research

South Ogden, Utah, 84405, United States

Location

Canadian Sleep Consultants

Calgary, Alberta, T2Z 3R6, Canada

Location

Medical Arts Health Research

Kelowna, British Columbia, V1Y 9N7, Canada

Location

AMNDX

Markham, Ontario, L3R 1A3, Canada

Location

West Ottawa Sleep Centre

Ottawa, Ontario, K2C 0P7, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3J 0K2, Canada

Location

Toronto Sleep Institute

Toronto, Ontario, M4P 1P2, Canada

Location

Sleep and Alertness Center

Toronto, Ontario, M5S 3A3, Canada

Location

McGill University Health Centre

Montreal, Quebec, QC H4A, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: September 16, 2023
• Primary Completion: March 10, 2025
• Study Completion: March 14, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CA (8); US (65)