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Sleep apnea drug trial halted: can danavorexton still help after surgery?

NCT ID NCT05814016

Symptom relief Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a single dose of danavorexton in 41 people with moderate to severe sleep apnea who were having abdominal surgery. The goal was to see if the drug could help them breathe steadily in the recovery room. The trial was terminated early, so results are incomplete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
danavorexton
What this could lead to
If it works, this could help people with sleep apnea breathe more easily after surgery, reducing complications.
What could go wrong
This was a small, early-phase trial that was terminated, so results are limited. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

41 people

The number who actually took part.

Started

May 2023

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. The participant has a body mass index (BMI) within the range of 18.5 to 50 kg/m\^2, inclusive. 2. The participant has diagnosed or suspected moderate or severe obstructive sleep apnea (OSA) based on one of the criteria below: a. The participant has a snoring, tiredness, observed apnea, high blood pressure, body mass index, age, neck circumference, and gender questionnaire (STOP-Bang) score ≥5 at the screening visit. OR b. The participant has a diagnosis of moderate or severe OSA based on an in-clinic polysomnography (PSG) or home sleep test with an apnea-hypopnea index (AHI) or respiratory event index (REI) score of ≥15 and they have not had significant weight loss since their diagnostic test, in the judgment of the investigator. 3. The participant is scheduled for major abdominal surgery invading the intraperitoneal or retroperitoneal space (open or laparoscopic) that will require at least 1 inpatient overnight stay. 4. The participant is scheduled to undergo a surgery requiring general anesthesia and endotracheal intubation. 5. The participant's surgery, as planned, is anticipated to require use of IV opioids in the postanesthesia care unit (PACU). 6. The duration of the participant's surgery (i.e., incision to last stitch) is expected to be at least 2 hours and up to approximately 8 hours. 7. The participant has an American Society of Anesthesiologists (ASA) Classification of II to III. Key Exclusion Criteria: 1. The participant has an AHI or REI score \<15 based on in-clinic PSG test or at-home sleep test within 2 years before screening. 2. The participant is undergoing liver or kidney surgery. 3. The participant has a planned transfer to the intensive care unit (ICU) from the operating room. 4. For the participant, immediate (continuous positive airway pressure \[CPAP\]/ bilevel positive airway pressure \[BiPAP\]) use in the PACU is anticipated or planned. 5. The participant has undergone major surgery or donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit. 6. The participant has received chemotherapy or radiation therapy within 4 weeks before administration of the study drug. 7. The participant has poorly controlled diabetes with an episode of ketoacidosis within 6 months of the screening visit. 8. The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), human immunodeficiency virus antibody/antigen at screening. 9. The participant has uncontrolled hypertension or unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, myocardial infarction \<3 months, severe valvular disease, or severe structural heart disease), severe heart failure, or any condition requiring a pacemaker or defibrillator. 10. The participant has a screening electrocardiogram (ECG) with a QT interval with Fridericia correction method (QTcF) \>450 milliseconds \[ms\] (for men) or \>470 ms (for women).

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep apnea

Contacts and locations

Locations

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115-6110, United States

  • Cedars Sinai Medical Hospital

    West Hollywood, California, 90048, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331-3609, United States

  • Cleveland Clinic Hospital

    Cleveland, Ohio, 44195-0001, United States

  • Fairview Hospital

    Cleveland, Ohio, 44111-5612, United States

  • Helen Keller Hospital

    Sheffield, Alabama, 35660-6334, United States

  • Inspira Health

    Mullica Hill, New Jersey, 09061, United States

  • Mayo Clinic - PPDS - Hospital

    Phoenix, Arizona, 85054-4502, United States

  • Mayo Clinic Jacksonville - PPDS

    Jacksonville, Florida, 32224-1865, United States

  • Medical Research Center - Clinic/Outpatient Facility

    Miami, Florida, 33165, United States

  • NYU Langone

    Mineola, New York, 11501-3893, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210-1240, United States

  • Rush University

    Chicago, Illinois, 60622, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-0001, United States

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226-3522, United States

  • UCSD

    La Jolla, California, 92037-1300, United States

  • University of Louisville - Hospital

    Louisville, Kentucky, 40202-3700, United States

  • University of Miami - Leonard M. Miller School of Medicine

    Miami, Florida, 33136-1005, United States

  • University of South Florida

    Tampa, Florida, 33606-3601, United States

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Other studies related to the condition(s) this trial covers.