Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400615
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-04-12
Brief Title:
Study That Tests AD109 in Patients Taking GLP-1 Drugs
Sponsor:
Apnimed
Organization:
Apnimed
Study Overview
Official Title:
Phase 2 Safety Efficacy and Tolerability of Fixed Dose Combination of AroxybutyninAtomoxetine AD109 in Obstructive Sleep Apnea Patients Taking Tirzepatide Semaglutide or Liraglutide
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 2 Safety Efficacy and Tolerability of Fixed Dose Combination of AroxybutyninAtomoxetine 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 ie BMI27 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None