OSA Clinical Trial - Study That Tests AD109 in Patients Taking GLP-1 Drugs

Status Recruiting

Clinical Trial Summary

Phase 2 Safety, Efficacy and, Tolerability of Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) in Obstructive Sleep Apnea Patients Taking Tirzepatide or Semaglutide

Clinical Trial Description

Study APC-APN-201 is an open-label, parallel-arm, 6 weeks study of AD109 in participants with OSA and type 2 diabetes or obesity. One arm consists of patients concomitantly taking tirzepatide or semaglutide, and a second comparator arm consists of patients not taking any GLP drug but who otherwise would meet the criteria for prescribing a GLP-1 (i.e., presence of type 2 diabetes and/or BMI≥27). Each arm is composed of approximately 20 participants. The participants on GLP-1 must be on a stable maintenance dose that has remained unchanged for at least four weeks prior to enrollment. All study procedures, including open-label dosing of AD109, are the same for both arms; the arms differ only in concomitant GLP-1 use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06400615
Study type	Interventional
Source	Apnimed
Contact	John Cronin, MD
Phone	617-500-8880
Email	jcronin@apnimed.com
Status	Recruiting
Phase	Phase 2
Start date	May 30, 2024
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05404438` - Mouth Breathing Habits Improvement Intervention	N/A
Recruiting	`NCT05960175` - Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP	N/A
Recruiting	`NCT05813275` - Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)	Phase 3
Completed	`NCT05075668` - Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA	N/A
Completed	`NCT05881512` - Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea	N/A
Completed	`NCT03336515` - Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)	N/A
Not yet recruiting	`NCT05944965` - Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea	Phase 1/Phase 2
Completed	`NCT02387476` - Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea	N/A
Not yet recruiting	`NCT06058052` - Prevalence of OSA in Patients of ILD
Recruiting	`NCT03721445` - Could HRV be a Valuable Predictor for CPAP Adherence?
Completed	`NCT03172130` - Sham CPAP vs. Straight CPAP for Chronic Cough	N/A
Recruiting	`NCT06320795` - Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device	N/A
Completed	`NCT01717339` - Sleep Apnea and Vascular Function	N/A
Completed	`NCT00772044` - Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea	Phase 4
Completed	`NCT02438137` - Dimethyl Fumarate for Obstructive Sleep Apnea	N/A
Completed	`NCT01672606` - Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea	N/A
Not yet recruiting	`NCT06110962` - Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor
Completed	`NCT05060133` - Changes of the Upper Airway Volume After Orthognathic Surgery
Completed	`NCT03196583` - Efficacy of a Novel MAD in OSA	N/A
Not yet recruiting	`NCT03933046` - The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children	N/A