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A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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

NCT05814016•Takeda

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

30 - 75 years

Sex

ALL

Healthy Volunteers

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.

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).

Locations (19)

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

Key Dates

Start Date

May 11, 2023

Primary Completion Date

September 25, 2024

Completion Date

September 25, 2024

Last Updated

September 16, 2025

Enrollment

ACTUAL participants

Conditions

Sleep Apnea

Interventions

Danavorexton

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Digital-supported Orofacial Myofunctional Therapy in OSA

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

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