Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

NCT05811247 | Completed Phase 3 FDA Drug

• 1 other identifier: APC-APN-304
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 64

Brief 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.

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 \>5; ≤ 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 (64)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Chandler Clinical Trials

Chandler, Arizona, 85224, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Marvel Clinical Research, LLC

Huntington Beach, California, 92647, United States

Location

CenExel CNS

Los Alamitos, California, 90720, United States

Location

Santa Monica Clinical Trials

Los Angeles, California, 90025, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

SDS Clinical Trials Inc.

Santa Ana, California, 92705, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80301, United States

Location

Mountain View Clinical Research, Inc.

Denver, Colorado, 80209, United States

Location

Nuvance Health

Norwalk, Connecticut, 06850, United States

Location

Teradan Clinical trials LLC

Brandon, Florida, 33511, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

Nouvelle Clinical Research

Cutler Bay, Florida, 33189, United States

Location

Arrow Clinical Trials

Daytona Beach, Florida, 32117, United States

Location

Cenexel Research Centers of America - Hollywood

Hollywood, Florida, 33024, United States

Location

Ivetmar Medical Group LLC

Miami, Florida, 33155, United States

Location

PharmaDev Clinical Research Institute, LLC

Miami, Florida, 33176, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Palm Beach Research ClinEdge-PPDS

West Palm Beach, Florida, 33409, United States

Location

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, 32789, United States

Location

NeuroTrials Research

Atlanta, Georgia, 30328, United States

Location

CenExel iResearch

Decatur, Georgia, 30030, United States

Location

Sleep Practitioners, LLC

Macon, Georgia, 31210, United States

Location

Centricity Research Rincon Pulmonology

Rincon, Georgia, 31326, United States

Location

Medster Research

Valdosta, Georgia, 31605, United States

Location

Chicago Research Center Inc

Chicago, Illinois, 60634, United States

Location

Sleep Disorders Centers of the Mid-Atlantic

Glen Burnie, Maryland, 21061, United States

Location

Velocity Clinical Research

Rockville, Maryland, 20854, United States

Location

Neurocare, Inc

Newton, Massachusetts, 02459, United States

Location

Infinity Medical Research

North Dartmouth, Massachusetts, 02747, United States

Location

Baystate Medical Center (BMC) - Baystate Sleep Medicine

Springfield, Massachusetts, 01199, United States

Location

Western Michigan University Homer Stryker M.D. School of Medicine

Kalamazoo, Michigan, 49008, United States

Location

Henry Ford Health (Sleep Research Department)

Novi, Michigan, 48377, United States

Location

Clinical Neurophysiology Services

Sterling Heights, Michigan, 48314, United States

Location

St Lukes Hospital

Chesterfield, Missouri, 63017, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

Great Plains Health

North Platte, Nebraska, 69101, United States

Location

Henderson Clinical Trials

Henderson, Nevada, 89052, United States

Location

Clinilabs, Inc

Eatontown, New Jersey, 07724, United States

Location

Maimonides Sleep Arts and Sciences

Albuquerque, New Mexico, 87107, United States

Location

Northwell Health Physician Partners

New Hyde Park, New York, 11042, United States

Location

Research Carolina Elite

Denver, North Carolina, 28037, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States

Location

Advanced Respiratory and Sleep Medicine, LLC

Huntersville, North Carolina, 28078, United States

Location

Coastal Carolina Health Care

New Bern, North Carolina, 28562, United States

Location

Meridian Clinical Research

Raleigh, North Carolina, 27607, United States

Location

NeuroScience Research Center, LLC

Canton, Ohio, 44718, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Sleep Management Institute

Cincinnati, Ohio, 45245, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Northwest Research Center

Portland, Oregon, 97202, United States

Location

Brian Abaluck, LLC

Malvern, Pennsylvania, 19355, United States

Location

UPMC Comprehensive Lung Center - Sleep Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Lowcountry Lung and Critical Care

Charleston, South Carolina, 29406, United States

Location

Velocity Clinical Research - Greenville

Greenville, South Carolina, 29615, United States

Location

Clinical Neuroscience Solutions - Memphis

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Central Texas Neurology Consultants, PA

Round Rock, Texas, 78681, United States

Location

Sleep Therapy Research Center

San Antonio, Texas, 78229, United States

Location

Sleep Disorders Centers of the Mid-Atlantic

Vienna, Virginia, 22182, United States

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: March 31, 2023
• First Posted: April 13, 2023
• Study Start: August 28, 2023
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (64)