← Back to Search

Other

AD109 for Obstructive Sleep Apnea

Verified Trial
Phase 3
Recruiting
Research Sponsored by Apnimed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age at the time of informed consent
PAP intolerance or current PAP refusal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial tests a drug to treat sleep apnea. It compares the drug to a placebo to see if it's effective.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this summary doesn't provide specific side effects of AD109, generally speaking, possible side effects could include typical drug reactions like nausea, headaches, dizziness or allergic responses. However, details would depend on the nature of AD109.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I cannot tolerate or refuse to use a CPAP machine.
Select...
My BMI is between 18.5 and 40 (if I am a man) or 42 (if I am a woman).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of AD109 on airway obstruction in mild to severe OSA

Side effects data

From 2021 Phase 2 trial • 60 Patients • NCT04580394
4%
Gastroesophageal reflux disease
2%
Cardiac Arrythmia
2%
Headache
2%
Seizure
2%
Atrial Fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
A: AD109
B: Atomoxetine 75 mg + Placebo
C: R-oxybutynin 2.5 mg + Placebo
D:Placebo + Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AD109Experimental Treatment1 Intervention
AD109
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AD109
2021
Completed Phase 2
~360

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP), oral appliances, and pharmacologic agents. CPAP works by providing a steady stream of air through a mask to keep the airway open during sleep, preventing apneas and hypopneas. Oral appliances reposition the jaw or tongue to maintain airway patency. Pharmacologic treatments, such as those being studied in the AD109 trial, often aim to reduce upper airway collapsibility or stimulate respiratory drive. For example, AD109 is a fixed-dose combination that may include agents to enhance airway muscle tone and improve breathing stability. These mechanisms are crucial for OSA patients as they directly address the airway obstruction that characterizes the condition, thereby improving sleep quality, reducing daytime sleepiness, and lowering the risk of associated cardiovascular and metabolic complications.
Effects of hypnotics on obstructive sleep apnea endotypes and severity: Novel insights into pathophysiology and treatment.Effects of opioid, hypnotic and sedating medications on sleep-disordered breathing in adults with obstructive sleep apnoea.Treatment of Obstructive Sleep Apnea. Prospects for Personalized Combined Modality Therapy.

Find a Location

Who is running the clinical trial?

ApnimedLead Sponsor
14 Previous Clinical Trials
1,535 Total Patients Enrolled
~335 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top