Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea
← catalyst calendarNCT06776432 · readout in 134 d
Sponsored by Shionogi (industry) · 4507.T — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
60actual
Sites
9
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-04-02 | actual | When the study began enrolling |
| Primary completion | 2026-12-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Sleep Apnea
Interventions
- Drug: Sivopixant
- Drug: Placebo
- Drug: Acetazolamide
- Drug: SASS-001
Primary outcome
what the primary-completion date above is the date OFPrimary Endpoint - Change in apnea-hypopnea index (SASS-001 arm vs baseline at Visit 7 polysomnography). Scale is minimum -60 to max 60. Lower scores mean improvement from baseline.
measured up to 6 weeks
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