AzTrials
AzTrials

Sleep ApneaPhase 2NCT05814016

A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery

A Phase 2 study testing Danavorexton in people with Sleep Apnea, run by Takeda at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The main aim is to see if danavorexton can help improve people's breathing in the recovery room after abdominal surgery. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Sleep Apnea
What is being tested?
Danavorexton
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
19 sitesUnited States
Study dates
11 May 2023to 25 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant has a body mass index (BMI) within the range of 18.5 to 50 kg/m^2, inclusive.
  • The participant has diagnosed or suspected moderate or severe obstructive sleep apnea (OSA) based on one of the criteria below:
  • 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.
  • 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.
  • The participant is scheduled to undergo a surgery requiring general anesthesia and endotracheal intubation.
  • The participant's surgery, as planned, is anticipated to require use of IV opioids in the postanesthesia care unit (PACU).
  • 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.
  • The participant has an American Society of Anesthesiologists (ASA) Classification of II to III.

Who cannot join

  • 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.
  • The participant is undergoing liver or kidney surgery.
  • The participant has a planned transfer to the intensive care unit (ICU) from the operating room.
  • For the participant, immediate (continuous positive airway pressure [CPAP]/ bilevel positive airway pressure [BiPAP]) use in the PACU is anticipated or planned.
  • The participant has undergone major surgery or donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
  • The participant has received chemotherapy or radiation therapy within 4 weeks before administration of the study drug.
Show all 10Show fewer
  • The participant has poorly controlled diabetes with an episode of ketoacidosis within 6 months of the screening visit.
  • The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), human immunodeficiency virus antibody/antigen at screening.
  • 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.
  • 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).

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115-6110

  • Rush University

    Chicago, Illinois, 60622

  • Fairview Hospital

    Cleveland, Ohio, 44111-5612

  • Cleveland Clinic Hospital

    Cleveland, Ohio, 44195-0001

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210-1240

  • Mayo Clinic Jacksonville - PPDS

    Jacksonville, Florida, 32224-1865

  • UCSD

    La Jolla, California, 92037-1300

  • University of Louisville - Hospital

    Louisville, Kentucky, 40202-3700

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

    Miami, Florida, 33136-1005

  • Medical Research Center - Clinic/Outpatient Facility

    Miami, Florida, 33165

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226-3522

  • NYU Langone

    Mineola, New York, 11501-3893

  • Inspira Health

    Mullica Hill, New Jersey, 09061

  • Mayo Clinic - PPDS - Hospital

    Phoenix, Arizona, 85054-4502

  • Helen Keller Hospital

    Sheffield, Alabama, 35660-6334

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-0001

  • University of South Florida

    Tampa, Florida, 33606-3601

  • Cedars Sinai Medical Hospital

    West Hollywood, California, 90048

  • Cleveland Clinic Florida

    Weston, Florida, 33331-3609

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Infusion of Danavorexton in Participants With Moderate to Severe Obstructive Sleep Apnea Undergoing General Anesthesia for Abdominal Surgery

The main aim is to see if danavorexton can help improve people's breathing in the recovery room after abdominal surgery.

Read the detailed description

The drug being tested in this study is called danavorexton. Danavorexton is being tested in people who have moderate to severe obstructive sleep apnea undergoing general anesthesia for abdominal surgery.

The study will enroll approximately 180 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three groups-which will remain undisclosed/unknown to the participant and study doctor during the study (unless there is an urgent medical need):

  • Danavorexton high dose
  • Danavorexton low dose
  • Placebo All participants will receive an intravenous (IV) infusion on Day 1 of the treatment period.

This multi-center study will be conducted in approximately 20 sites in the United States. The overall time for participants to participate in the study will be up to approximately 12 months.

Conditions
Sleep Apnea
Being tested
Danavorexton, Placebo
Keywords
Drug Therapy, Obstructive Sleep Apnea
Medical subject headings
Sleep Apnea Syndromes, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DanavorextonDrug

    Also called TAK-925

    Danavorexton IV infusion.

  • PlaceboDrug

    Placebo matching danavorexton IV infusion.

Study groups in NCT05814016
Study groupRoleWhat they receive
High Dose DanavorextonExperimentalParticipants will receive danavorexton intravenous (IV) infusion as high dose on Day 1 of the treatment period.
Receives: Drug: Danavorexton
Low Dose DanavorextonExperimentalParticipants will receive danavorexton IV infusion as low dose on Day 1 of the treatment period.
Receives: Drug: Danavorexton
PlaceboPlacebo comparatorParticipants will receive a placebo-matching danavorexton IV infusion on Day 1 of the treatment period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants who Maintain Respiratory Stability for 120 Minutes in the Postanesthesia Care Unit (PACU)

    Respiratory stability in the PACU will be considered as having been achieved if the participant can breathe without problems for 120 minutes in the PACU.

    Measured: Day 1

Secondary outcomes (6)

  1. Number of Episodes of Respiratory Instability per Participant Within 120 Minutes in the PACU

    The number of episodes of respiratory instability during 120 minutes in the PACU will be assessed.

    Measured: Day 1

  2. Plasma Concentration of Danavorexton at the End of Infusion (Ceoi)

    Measured: Pre-dose within 1 hour before surgery and 24 hours post start of the infusion up to Day 2

  3. Number of Participants with At Least One Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

    Measured: Up to 12 months

  4. Number of Participants with At Least One Occurrence of ≥1 Markedly Abnormal Value (MAV) in Post-Study Drug Laboratory Values

    Measured: Up to 12 months

  5. Number of Participants with At Least One Occurrence of ≥1 MAV in Post-Study Drug Vital Signs

    Measured: Up to 12 months

  6. Number of Participants with At Least One Occurrence of ≥1 MAV on Post-Study Drug ECGs

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2023
  2. Study start11 May 2023
  3. Primary completion25 Sep 2024
  4. Study completion25 Sep 2024

Why it stopped: Business decision unrelated to patient safety.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05814016
Sponsor's protocol ID
TAK-925-1501
Status last verified
Sep 2025
First submitted
3 Apr 2023
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Danavorexton in people with Sleep Apnea, run by Takeda at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business decision unrelated to patient safety.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants who Maintain Respiratory Stability for 120 Minutes in the Postanesthesia Care Unit (PACU) (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05814016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in