OSAPhase 2NCT06400615
Study That Tests AD109 in Patients Taking GLP-1 Drugs
A Phase 2 study testing AD109 in people with OSA, run by Apnimed at 4 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- OSA
- What is being tested?
- AD109
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 May 2024to 26 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- The following agents and doses are acceptable to meet inclusion criteria: ( Tirzepatide (Mounjaro®, Zepbound®): doses of 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, 15mg can be given once weekly by subcutaneous injection; Semagultide (Ozempic®, Wegovy®): doses of 0.25mg, 0.5mg, 1mg, 1.7mg, 2.0, or 2.4mg; Liraglutide (Saxenda®) doses of 0.6 mg, 1.2m mg, 1.8 mg, 2.4 mg, 3.0 mg can be given once weekly by subcutaneous injection)
- 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.
Who cannot join
- 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.
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- 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.
- Women who are pregnant or nursing. Prior/Concomitant Therapy
- Participants with prior use of mandibular advancement devices, nasal devices, or sleeping position devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
- Participants with history of chronic oxygen therapy are excluded.
- Participants with implanted devices for the treatment of OSA are excluded (e.g., hypoglossal nerve stimulator, or investigational devices).
- 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
- Montgomery-Asberg Depression Rating Scale (MADRS) "Suicidal Thoughts question response of thinking of or planning suicide.
- Systolic blood pressure up to 140 mm Hg or diastolic blood pressure up to 90 mm Hg is allowed in participants not currently treated with antihypertensives. If the participant is under the care of a healthcare provider managing blood pressure and on stable (at least 1 month) antihypertensive therapy, systolic blood pressure up to 145/90 is allowed at enrollment. If initial blood pressure (measured in triplicate, use average of final two readings) is above this enrollment threshold, it may be repeated up to a total of 3 times (each in triplicate) to confirm that the reading was not due to measurement technique or transient factors, with selection of the lowest repeated measure. The determination that blood pressure meets enrollment criteria involves the clinical judgment of the investigator interpreting blood pressure readings.
- Unexplained or new identification of hepatic transaminases (AST or ALT) >2X the upper limit of normal (ULN) generally is exclusionary. However, elevation between 2-2.5 may be allowed with prior consent of the sponsor if evidence suggests it is due to nonalcoholic fatty liver disease (NAFLD) or other condition that would not be expected to acutely worsen or require medical intervention during the course of the study.
- Total bilirubin >1.5X ULN (unless confirmed Gilbert syndrome).
- Estimated glomerular filtration rate < 50 ml/min.
- ECG abnormality indicative of clinically significant cardiac disease that may be adversely affected by AD109 Other Exclusions
- Night- or shift-work sleep schedule which causes the major sleep period to be during the day, including on a rotating basis.
- Frequent travel or jet lag is likely to interfere with study procedures or evaluations.
- Employment as a commercial driver or other vehicle operator (includes independent contractors and ride-share services).
- History of sleepiness-related motor vehicle accident (MVA).
- Unwilling to use specified contraception.
- Any condition that in the investigator's opinion would present an unreasonable risk to the participant, including nature or severity of OSA symptoms, or which would interfere with their participation in the study or confound study interpretation.
- Participant considered by the investigator, for any reason, an unsuitable candidate to receive AD109 or unable or unlikely to understand or comply with the dosing schedule or study evaluations.
- Subjects with a history of gastric weight loss surgery (i.e., sleeve gastrectomy, gastric bypass, adjustable gastric banding, biliopancreatic diversion)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 32256
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, 38119
Monroe Biomedical Research
Monroe, North Carolina, 28112
About this study
Official title: Phase 2 Safety, Efficacy and, Tolerability of Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) in Obstructive Sleep Apnea Patients Taking Tirzepatide, Semaglutide or Liraglutide
Phase 2 Safety, Efficacy and, Tolerability of Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) in Obstructive Sleep Apnea Patients Taking Tirzepatide, Semaglutide or Liraglutide
Read the 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
- Being tested
- AD109
- Keywords
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD109Drug
Oral administration at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Twenty patients who are taking GLP-1 at time of enrollment will be treated with AD109 Receives: Drug: AD109 |
| Arm 2 | Active comparator | Twenty patients who are not taking a GLP-1 will be treated with AD109 only Receives: Drug: AD109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start20 May 2024
- Primary completion26 Dec 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apnimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400615
- Sponsor's protocol ID
- APC-APN-201
- Status last verified
- Feb 2025
- First submitted
- 12 Apr 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Safety, Efficacy and, Tolerability of Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) in Obstructive Sleep Apnea Patients Taking Tirzepatide, Semaglutide or Liraglutide
- ClinicalTrials.gov ID
- NCT06400615
- Acronym / sponsor ID
- APC-APN-201
- Conditions
- OSA
- Keywords
- Obstructive Sleep Apnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ApnimedIndustry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: AD109Twenty patients who are taking GLP-1 at time of enrollment will be treated with AD109 |
| Arm 2 | Active comparator | Drug: AD109Twenty patients who are not taking a GLP-1 will be treated with AD109 only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (36 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD109Oral administration at bedtime | Drug | Arm 1, Arm 2 |
Primary outcome
Primary Objective (Adverse Events)
Time frame: 6 weeks
General safety and tolerability will be assessed between treatment cohorts using the occurrence of spontaneously reported adverse events (AEs) at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AD109 in people with OSA, run by Apnimed at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (Adverse Events) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.