AD109 for Obstructive Sleep Apnea

No longer recruiting at 64 trial locations

Overseen By Luigi Taranto, 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: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AD109 for obstructive sleep apnea, a condition where breathing stops and starts during sleep. The study compares AD109 to a placebo (a pill with no active medicine) to determine its effectiveness in reducing symptoms. Participants should have sleep apnea and have tried or refused treatments like CPAP (a machine that aids breathing during sleep). Participants must also experience regular fatigue and meet specific body weight and height ratio (BMI) criteria. This research could lead to new ways to improve sleep quality and restfulness. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance 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 AD109 is likely to be safe for humans?

Research has shown that AD109 is generally safe for people with obstructive sleep apnea (OSA). In a previous study, about 22.9% of participants using AD109 achieved full control of their OSA. Most participants did not experience serious side effects, indicating that AD109 is generally well-tolerated. While all treatments can have side effects, evidence suggests that AD109 is a safe option for many people with OSA. ^{1 2 3 4 5}

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

Researchers are excited about AD109 for obstructive sleep apnea because it offers a unique approach compared to current treatments like CPAP machines and oral appliances. Unlike these standard options, which primarily focus on keeping airways open mechanically, AD109 works by targeting the brain’s neurotransmitters to improve breathing during sleep. This innovative mechanism of action could lead to better compliance and effectiveness for patients who struggle with existing therapies. Additionally, AD109 is taken orally, which provides a more convenient and less intrusive treatment option.

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, can help treat obstructive sleep apnea (OSA). In one study, 51.2% of people taking AD109 experienced less severe OSA. Additionally, 22.9% of those treated with AD109 achieved complete control of their OSA, with fewer than five breathing interruptions per hour. The treatment significantly reduced sleep disruptions, and this improvement lasted for almost a year. These findings suggest that AD109 can help people with OSA breathe better while they sleep. ^{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 >5, don't respond well to PAP therapy, and feel very tired. They should not be too overweight (BMI limits apply differently for men and women). People with certain sleep disorders, severe heart issues, or significant neurological diseases cannot join.

Inclusion Criteria

PROMIS-Fatigue: raw score ≥17

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

Exclusion Criteria

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

I have trouble falling or staying asleep, or I've used sleep medication in the last month.

I have a craniofacial syndrome or very large tonsils.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AD109 or placebo in a double-blind manner

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

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 year-long test where participants are randomly chosen to receive either the real drug or a fake one without knowing which they're getting. The goal is to see if AD109 helps better than the placebo.

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+

Published Research Related to This Trial

In a study involving 104 participants with mild to moderate obstructive sleep apnea, the use of sham-CPAP showed statistically significant but small changes in sleep quality, indicating it can serve as an effective placebo in clinical trials.

The differences observed in sleep metrics, such as decreased sleep efficiency and increased arousal, suggest that while sham-CPAP impacts sleep, these effects are minimal and clinically insignificant, supporting its use in evaluating true CPAP treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Rodway, GW., Weaver, TE., Mancini, C., et al.[2022]

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 ...