NCT06400615

Study That Tests AD109 in Patients Taking GLP-1 Drugs

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Apnimed · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Study APC-APN-201 is an open-label, parallel-arm, 6 weeks study of AD109 in participants with OSA and obesity. One arm consists of patients concomitantly taking tirzepatide, semaglutide or liraglutide, 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., 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.

Conditions

• OSA

Interventions

Type	Name	Description
DRUG	AD109	Oral administration at bedtime

Timeline

• Start date: 2024-05-20
• Primary completion: 2024-12-26
• Completion: 2024-12-26
• First posted: 2024-05-06
• Last updated: 2025-02-19

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study