NCT05814016

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DRUG	Danavorexton	Danavorexton IV infusion.
DRUG	Placebo	Placebo matching danavorexton IV infusion.

Timeline

• Start date: 2023-05-11
• Primary completion: 2024-09-25
• Completion: 2024-09-25
• First posted: 2023-04-14
• Last updated: 2025-09-16

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study