A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery
NCT ID: NCT05814016
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
41 participants
INTERVENTIONAL
2023-05-11
2024-09-25
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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High Dose Danavorexton
Participants will receive danavorexton intravenous (IV) infusion as high dose on Day 1 of the treatment period.
Danavorexton
Danavorexton IV infusion.
Low Dose Danavorexton
Participants will receive danavorexton IV infusion as low dose on Day 1 of the treatment period.
Danavorexton
Danavorexton IV infusion.
Placebo
Participants will receive a placebo-matching danavorexton IV infusion on Day 1 of the treatment period.
Placebo
Placebo matching danavorexton IV infusion.
Interventions
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Danavorexton
Danavorexton IV infusion.
Placebo
Placebo matching danavorexton IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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).
30 Years
75 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Helen Keller Hospital
Sheffield, Alabama, United States
Mayo Clinic - PPDS - Hospital
Phoenix, Arizona, United States
UCSD
La Jolla, California, United States
Cedars Sinai Medical Hospital
West Hollywood, California, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, United States
University of Miami - Leonard M. Miller School of Medicine
Miami, Florida, United States
Medical Research Center - Clinic/Outpatient Facility
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Rush University
Chicago, Illinois, United States
University of Louisville - Hospital
Louisville, Kentucky, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Inspira Health
Mullica Hill, New Jersey, United States
NYU Langone
Mineola, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Hospital
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
Countries
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Related Links
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To obtain more information on the study, click here/on this link.
Other Identifiers
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TAK-925-1501
Identifier Type: -
Identifier Source: org_study_id
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