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

NCT05814016 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: TAK-925-1501
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Sleep Apnea

Keywords

Drug Therapy; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (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.

  Day 1

Secondary Outcomes (6)

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

  Day 1

• Plasma Concentration of Danavorexton at the End of Infusion (Ceoi)

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

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

  Up to 12 months

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

  Up to 12 months

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

  Up to 12 months

Study Arms (3)

High Dose Danavorexton

EXPERIMENTAL

Participants will receive danavorexton intravenous (IV) infusion as high dose on Day 1 of the treatment period.

Drug: Danavorexton

Low Dose Danavorexton

EXPERIMENTAL

Participants will receive danavorexton IV infusion as low dose on Day 1 of the treatment period.

Drug: Danavorexton

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo-matching danavorexton IV infusion on Day 1 of the treatment period.

Drug: Placebo

Interventions

Danavorexton DRUG

Danavorexton IV infusion.

Also known as: TAK-925

High Dose Danavorexton; Low Dose Danavorexton

Placebo DRUG

Placebo matching danavorexton IV infusion.

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (19)

Helen Keller Hospital

Sheffield, Alabama, 35660-6334, United States

Location

Mayo Clinic - PPDS - Hospital

Phoenix, Arizona, 85054-4502, United States

Location

UCSD

La Jolla, California, 92037-1300, United States

Location

Cedars Sinai Medical Hospital

West Hollywood, California, 90048, United States

Location

Mayo Clinic Jacksonville - PPDS

Jacksonville, Florida, 32224-1865, United States

Location

University of Miami - Leonard M. Miller School of Medicine

Miami, Florida, 33136-1005, United States

Location

Medical Research Center - Clinic/Outpatient Facility

Miami, Florida, 33165, United States

Location

University of South Florida

Tampa, Florida, 33606-3601, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331-3609, United States

Location

Rush University

Chicago, Illinois, 60622, United States

Location

University of Louisville - Hospital

Louisville, Kentucky, 40202-3700, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115-6110, United States

Location

Inspira Health

Mullica Hill, New Jersey, 09061, United States

Location

NYU Langone

Mineola, New York, 11501-3893, United States

Location

Stony Brook University Medical Center

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

Location

Fairview Hospital

Cleveland, Ohio, 44111-5612, United States

Location

Cleveland Clinic Hospital

Cleveland, Ohio, 44195-0001, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210-1240, United States

Location

The Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53226-3522, United States

Location

Related Links

• To obtain more information on the study, click here/on this link.

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Interventions

TAK-925

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: May 11, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (19)