Study That Tests AD109 in Patients Taking GLP-1 Drugs

NCT06400615 | Completed Phase 2 FDA Drug

• 1 other identifier: APC-APN-201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

OSA

Keywords

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Primary Objective (Adverse Events)

  General safety and tolerability will be assessed between treatment cohorts using the occurrence of spontaneously reported adverse events (AEs) at 6 weeks

  6 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Twenty patients who are taking GLP-1 at time of enrollment will be treated with AD109

Drug: AD109

Arm 2

ACTIVE COMPARATOR

Twenty patients who are not taking a GLP-1 will be treated with AD109 only

Drug: AD109

Interventions

AD109 DRUG

Oral administration at bedtime

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Home Sleep Apnea Testing (HSAT) criteria ( Mean Respiratory Event Index (REI4) (Hypopneas defined by 4% oxygen desaturation) of \>5 and \<45. REI is determined as a mean number collected across 2 nights of testing initiated at Visit 2; ≤ 25% central or mixed apneas (as proportion of total apneas and hypopneas)
• Participants with a history of using devices for OSA treatment, including Continuous Positive Airway Pressure (CPAP), oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first HSAT and are not used during participation in the study.
• Weight
• For the subjects in the incretin arm the following criteria must be met (Patients must have an identified prescriber and adhere to drug labelling considerations; A patient's individual dose is stable over the past 4 weeks without intention to increase to decrease dosing based on side effects or efficacy; Willingness to maintain a medication administration diary during the study.
• 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
• Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the Screening Visit procedures.
• Participant must be able to understand the nature of the study and must have the opportunity to have any questions answered.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions
• Narcolepsy, restless leg syndrome requiring medication, rapid eye movement (REM) sleep behavior disorder
• Current bothersome symptoms of insomnia (difficulty initiating or maintaining sleep, as distinct from unrefreshing sleep or other symptoms attributable to OSA). Participants being treated for insomnia can be enrolled only if the condition is stable and generally controlled.
• Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.
• Clinically significant or medically uncontrolled cardiovascular disease, e.g., ventricular arrhythmia requiring medical or device therapy, unstable atrial fibrillation (including cardioversion, ablation, or change in antiarrhythmic regimen within past 3 months \[patients in whom anticoagulation is indicated must be on such treatment for enrollment\], or resting heart rate \>100), untreated or unstable coronary artery disease (including revascularization within 3 months), cardiac failure, cerebrovascular event or transient ischemic attack or revascularization within 3 months.
• Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy, or myopathy, myasthenic syndrome); epilepsy; Parkinson, Alzheimer, or other neurodegenerative disease.
• Schizophrenia, schizoaffective disorder, generalized anxiety disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) or International Classification of Disease tenth edition criteria.
• Attempted suicide within 1 year prior to screening, or current suicidal ideation.
• Severe or frequent constipation considered currently bothersome by the patient, or symptomatic gastric motility disorder.
• Current bothersome symptoms of bladder outlet obstruction including difficulty initiating or maintaining urinary flow, straining, or sensation of incomplete bladder emptying; participants being treated with alpha-1 adrenergic antagonist for benign prostatic hypertrophy can be enrolled only if the condition is stable and generally controlled.
• Active substance use disorder as defined in DSM-5, or other substance use that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation. Positive screen for drugs with abuse liability is an important but not sole determinant of substance use disorder and study eligibility. Participants who use marijuana daily should be excluded.
• A serious illness or infection in the past 30 days as determined by investigator.
• Clinically significant cognitive dysfunction as determined by investigator.
• Narrow angle glaucoma.

Sponsors & Collaborators

• Apnimed: lead

Study Sites (4)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32256, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Clinical Neuroscience Solutions, Inc

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of approximately 40 participants will be enrolled in the 2 arms: 20 subjects taking GLP-1+ AD109 20 subjects taking AD109 without any GLP-1 Therapy

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: May 6, 2024
• Study Start: May 20, 2024
• Primary Completion: December 26, 2024
• Study Completion: December 26, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

US (4)