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

Status Not yet 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	Not yet recruiting
Phase	Phase 2
Start date	May 15, 2024
Completion date	December 31, 2024

View Details

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