AD109 for Obstructive Sleep Apnea

No longer recruiting at 79 trial locations

Overseen By Ron Farkas, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Apnimed

Must not be taking: Sedative-hypnotics

Disqualifiers: Narcolepsy, Insomnia, Cardiac disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AD109 for individuals with obstructive sleep apnea, a condition where breathing repeatedly stops and starts during sleep. The goal is to determine if AD109 reduces sleep apnea symptoms compared to a placebo (a substance with no active ingredient). Suitable candidates have tried and do not tolerate CPAP machines or choose not to use them. The trial seeks adults who experience significant fatigue and have a moderate level of sleep apnea. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using sedative-hypnotics or other medications for insomnia, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that AD109 is generally well-tolerated by people with obstructive sleep apnea. In one study, 22.9% of participants who took AD109 achieved complete control of their sleep apnea, experiencing fewer than five instances per hour where their breathing stopped or was reduced during sleep.

Another study examined the safety of AD109 over 12 months in adults with varying levels of sleep apnea severity, including mild, moderate, and severe forms. The results were positive, indicating that AD109 is safe for long-term use.

While some side effects might occur, these studies suggest the treatment is safe. Always consult a healthcare provider for personal advice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for obstructive sleep apnea, which often include CPAP machines and dental appliances, AD109 offers a novel approach by combining two active ingredients to target the condition. Researchers are excited about AD109 because it works through a unique mechanism by modulating neurotransmitters to maintain upper airway muscle tone during sleep. This innovative method could offer a more comfortable and potentially more effective solution for patients who struggle with current treatment options.

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

Research has shown that AD109, which participants in this trial may receive, holds promise for treating obstructive sleep apnea (OSA). In one study, 51.2% of participants taking AD109 experienced a reduction in OSA severity. Additionally, 22.9% of those treated with AD109 achieved complete control of their OSA, with fewer than 5 breathing interruptions per hour. Another study found that AD109 significantly lowered the number of breathing pauses during sleep, while a placebo, another treatment arm in this trial, reduced it by only 6.8%. Overall, the evidence supports that AD109 can effectively reduce symptoms in people with OSA. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Obstructive Sleep Apnea (OSA) who have an AHI of >5, mostly non-central apneas, and low sleep movement-related arousal. Participants should be tired often, not currently using or intolerant to PAP therapy, and have a BMI within set limits.

Inclusion Criteria

My BMI is between 18.5 and 40 (if I am a man) or 42 (if I am a woman).

PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15

PROMIS-Fatigue: raw score ≥17

Exclusion Criteria

I do not have any neuromuscular or neurodegenerative conditions.

I do not have serious heart problems like unstable heart disease or uncontrolled arrhythmias.

I have been diagnosed with narcolepsy, restless leg syndrome, or REM sleep behavior disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a fixed dose combination of AD109 or placebo for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AD109
• Placebo

Trial Overview The study tests AD109 against a placebo in people with OSA. It's a Phase 3 trial where participants are randomly assigned to either the medication or placebo group without knowing which one they're getting. The comparison lasts for six months.

How Is the Trial Designed?

Group I: AD109 Experimental Treatment 1 Intervention

AD109

Group II: Placebo Placebo Group 1 Intervention

Placebo

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. apnimed.com apnimed.com/article/ad109toplinephase3results/

Apnimed Reports Positive Topline Results from Second ... LunAIRo was a 12-month study that evaluated the efficacy and safety of AD109 in adults with mild, moderate and severe OSA, across a wide range of weight ...

3. 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 ...

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. 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, ...

6. apnimed.com apnimed.com/ad109/

AD109: A Novel Approach To Improve Oxygenation in OSA AD109 is designed to target the neurobiology of the hypoglossal motor nucleus (HMN) to increase signals to the upper airway during sleep to limit or prevent ...

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

The Combination of Aroxybutynin and Atomoxetine in the ... In this phase II randomized, double-blind, placebo-controlled study, both doses of AD109 showed clinically meaningful improvement in OSA over a 1-month ...