NCT06776432

Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea

A Phase 2A Double-Blind Randomized, Controlled, Dose Escalation, Parallel- Arm, Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Apnimed · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the effectiveness of sivopixant, acetazolamide and SASS-001 in adults with sleep apnea with a central component.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DRUG	Sivopixant	Administered as specified in the treatment arm
DRUG	Placebo	Administered as specified in the treatment arm.
DRUG	Acetazolamide	Administered as specified in the treatment arm
DRUG	SASS-001	Administered as specified in the treatment arm

Timeline

• Start date: 2025-04-02
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-01-15
• Last updated: 2025-10-16

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study