AD109 for Obstructive Sleep Apnea

No longer recruiting at 3 trial locations

Overseen By John Cronin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Apnimed

Must be taking: Tirzepatide, Semaglutide, Liraglutide

Disqualifiers: Narcolepsy, Insomnia, Cardiovascular disease, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AD109 to determine its safety and effectiveness for people with obstructive sleep apnea (OSA). The study examines how AD109 works for individuals currently taking medications like Tirzepatide, Semaglutide, or Liraglutide, as well as those not using these drugs. It suits those with a history of OSA, who may have used devices like CPAP in the past, and who are either using or not using specific medications for weight management. Participants should not use their OSA devices during the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that if you are taking Tirzepatide, Semaglutide, or Liraglutide, your dose must be stable for at least 4 weeks before joining. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that AD109 is likely to be safe for humans?

Research has shown that AD109, a combination of aroxybutynin and atomoxetine, has undergone testing in over 15 clinical trials to assess its safety and effectiveness. These studies indicate that AD109 is generally well-tolerated. For instance, one study found that 22.9% of participants completely controlled their obstructive sleep apnea (OSA), highlighting its potential effectiveness with a good safety record.

Additionally, earlier trials with AD109 demonstrated significant improvements in OSA patients over a month. This suggests that the treatment is not only effective but also safe for short-term use. While side effects can occur with any treatment, current data suggests that AD109 is well-tolerated in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obstructive sleep apnea?

Researchers are excited about AD109 for obstructive sleep apnea because it offers a novel approach compared to standard treatments like CPAP machines and oral appliances. Unlike these mechanical solutions, AD109 is a medication that combines two active ingredients: a norepinephrine reuptake inhibitor and a selective serotonin reuptake inhibitor. This combination aims to enhance muscle tone in the airway during sleep, potentially reducing the collapsibility of the airway, which is a key problem in sleep apnea. By targeting the condition's root cause pharmacologically, AD109 has the potential to provide relief with more convenience and possibly fewer disruptions to daily life.

What evidence suggests that AD109 might be an effective treatment for obstructive sleep apnea?

Research has shown that AD109, a combination of aroxybutynin and atomoxetine, can significantly impact obstructive sleep apnea (OSA). In one study, 51.2% of participants using AD109 experienced a reduction in OSA severity. Additionally, 22.9% of participants showed major improvement, with a significant decrease in OSA events. The treatment also lowered the apnea-hypopnea index (AHI), which measures sleep disturbances, more effectively than a placebo. These results suggest that AD109 could be a promising option for managing OSA. Participants in this trial will be divided into two groups: those taking GLP-1 at enrollment and those not taking GLP-1, with both groups receiving AD109. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with obstructive sleep apnea who are not using OSA devices but are taking GLP-1 drugs like Tirzepatide or Semaglutide. Participants should have a certain range of respiratory event index, type 2 diabetes and/or specific BMI ranges. Exclusions include severe constipation, recent suicide attempts, substance abuse, significant heart or liver issues, among others.

Inclusion Criteria

Willingness to maintain a medication administration diary during the study

Mean Respiratory Event Index (REI4) of >5 and <45 with ≤ 25% central or mixed apneas

History of using devices for OSA treatment, not used for at least 2 weeks prior to first HSAT and not used during study participation

Exclusion Criteria

Living outside the US

I often have severe constipation that bothers me.

Attempted suicide within 1 year prior to screening, or current suicidal ideation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label dosing of AD109 for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AD109

Trial Overview The study tests the safety and effectiveness of AD109 in patients with obstructive sleep apnea already on GLP-1 drugs. It's a phase 2 trial focusing on how well people tolerate this fixed-dose combination therapy and its impact on their condition.

How Is the Trial Designed?

Group I: Arm 1 Active Control 1 Intervention

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

Group II: Arm 2 Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Apnimed

Lead Sponsor

Trials

17

Recruited

3,400+

Citations

1. apnimed.com apnimed.com/article/apnimed-to-present-additional-phase-3-data-for-ad109-an-investigational-oral-pill-for-obstructive-sleep-apnea-at-chest-2025-annual-meeting/

Apnimed To Present Additional Phase 3 Data for AD109, ... 51.2% of participants treated with AD109 showed a reduction in OSA disease severity category; 22.3% of participants treated with AD109 achieved ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425001127

Aroxybutynin and atomoxetine (AD109) for the treatment of ... We hypothesize that AD109 will significantly reduce AHI4 and symptomatic fatigue compared to placebo in people with OSA. The primary outcome for both trials is ...

3. aasm.org aasm.org/apnimed-second-clinical-trial-sleep-apnea-medication/

Apnimed announces results from second study of sleep ... In contrast, the AHI was reduced by only 6.8% in those who took a placebo. The reduction in AHI with AD109 remained significant after 51 weeks, ...

4. prnewswire.com prnewswire.com/news-releases/apnimed-to-present-additional-phase-3-data-for-ad109-an-investigational-oral-pill-for-obstructive-sleep-apnea-at-chest-2025-annual-meeting-302587042.html

Apnimed To Present Additional Phase 3 Data for AD109 ... 22.9% of participants treated with AD109 achieved complete OSA disease control (defined as AHI <5 events/hour); AD109 was generally well- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10765395/

The Combination of Aroxybutynin and Atomoxetine in the ... In this randomized, placebo-controlled trial, AD109, a combination of aroxybutynin and atomoxetine, demonstrated a clinically significant improvement in OSA ...

6. apnimed.com apnimed.com/ad109/

AD109: A Novel Approach To Improve Oxygenation in OSA We have conducted more than 15 Phase 1 and 2 clinical trials that inform various aspects of the AD109 program and have amassed efficacy, safety, and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04580394

Crossover Trial of AD109 in Obstructive Sleep Apnea This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual ...