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COMPLETED Phase 3

Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)

NCT05811247 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG AD109

Study Locations (20)

California

  • Orange County Research Institute — Anaheim
  • Marvel Clinical Research, LLC — Huntington Beach
  • CenExel CNS — Los Alamitos
  • Santa Monica Clinical Trials — Los Angeles
  • Empire Clinical Research — Pomona
  • Pacific Research Network — San Diego
  • SDS Clinical Trials Inc. — Santa Ana

Florida

  • Teradan Clinical trials LLC — Brandon
  • St. Francis Medical Institute — Clearwater
  • Nouvelle Clinical Research — Cutler Bay
  • Arrow Clinical Trials — Daytona Beach
  • Cenexel Research Centers of America - Hollywood — Hollywood
  • Ivetmar Medical Group LLC — Miami
  • PharmaDev Clinical Research Institute, LLC — Miami

Colorado

  • Alpine Clinical Research Center — Boulder
  • Mountain View Clinical Research, Inc. — Denver

Alabama

  • Sleep Disorders Center of Alabama — Birmingham

Arizona

  • Chandler Clinical Trials — Chandler

Arkansas

  • Preferred Research Partners, Inc. — Little Rock

Connecticut

  • Nuvance Health — Norwalk

Trial Details

FieldValue
Enrollment Target 660 participants
Start Date 2023-08-28
Est. Completion 2025-05-07
Phase Phase 3

Sponsor

Apnimed

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05811247

The ClinicalTrials.gov registry entry for NCT05811247 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Apnimed, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with OSA appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05811247 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05811247 about?

NCT05811247 is a clinical study titled "Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)". This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

What is the current status of trial NCT05811247?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2023-08-28. Estimated completion is 2025-05-07.

What conditions does trial NCT05811247 study?

This clinical trial studies the following conditions: OSA. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05811247?

The interventions under investigation include: Placebo (DRUG), AD109 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05811247?

This trial is sponsored by Apnimed, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05811247 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial