Monroe Biomedical Research | Monroe, NC
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Phase 2 Safety, Efficacy and, Tolerability of Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) in Obstructive Sleep Apnea Patients Taking Tirzepatide, Semaglutide or Liraglutide
Full 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.
Enrollment
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Ages
Volunteers
Inclusion criteria
• Age and Sex Between 18-75 years of age at the time of informed consent.
Body Mass Index (BMI) • BMI between 27 and 43 kg/m2 for men, or 45 kg/m2 for women, inclusive.
Obstructive Sleep Apnea (OSA) History and Measures
Weight
Other doses prescribed by a physician are acceptable if a stable dose is maintained for 4 weeks or more.
Male participants:
• If male and sexually active with female partner(s) of childbearing potential, participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception (see Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information).
Female participants:
• If a woman of childbearing potential (WOCBP), the participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception (See Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information). All WOCBP must have negative result of a serum pregnancy test performed at screening ( Females of non-childbearing potential include postmenopausal or permanently sterile.)
Informed Consent
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
Prior/Concurrent Clinical Study Experience
• Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
Diagnostic Assessments
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
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Central trial contact
John Cronin, MD
Data sourced from clinicaltrials.gov
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