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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Sleep Apnea

In brief

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.

Key facts

Study ID

NCT06776432

Run by

Shionogi

People needed

60

Starts

2025-04-02

Expected to finish

2026-12-31

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To enroll, subjects need to have a previous diagnosis of at least one or more of the following comorbidities:
• Stable heart failure with reduced ejection fraction (NYHA class 1-3 inclusive) with or without atrial fibrillation
• Heart failure with preserved ejection fraction (NYHA class 1-3 inclusive) and hypertension (BP>120/80 mmHg at screening visit despite the treatment with ≥2 antihypertensives) with or without atrial fibrillation
• Persistent atrial fibrillation (continuous and sustained for more than 7 days, rate controlled with resting HR<100bpm)1 without heart failure
• History of primary (essential) hypertension with BP at screening visit >130/80 mmHg despite the treatment with >2 antihypertensives
• Evidence of complex sleep apnea (CPAP-emergent central sleep apnea with documented CAI>5 events/h on CPAP within 1 year from screening)
• Standard care for heart failure and atrial fibrillation for at least 3 weeks before the screening visit
• OSA measures Average ODI4 between 7 and 55 events/h, inclusive, and average SpO2 ≥88% from continuous home pulse oximetry recordings at screening.
• AHI4 (Hypopneas defined by 4% oxygen desaturation) of >10 to ≤60 events/h
• At minimum of 25% central or mixed apneas (as proportion of total apneas) with a minimum of 2.5 central or mixed apneas/hour of sleep
• OR evidence of clear Cheyne-Stokes breathing pattern during the baseline PSG (regardless of central apnea component).
• OR evidence of OSA with LGn >0.5 at the baseline PSG (regardless of central apnea component) Average SpO2 during sleep ≥88%
• Weight BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive
• Male participants If male and sexually active with female partner(s) of childbearing potential, participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception. Male participants must refrain from donating sperm for the duration of the study and for 3 months after the last dose of study treatment.
• Female participants If a woman of childbearing potential (WOCBP), the participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception. All WOCBP must have negative result of a serum pregnancy test performed at screening.
• If female and of non-childbearing potential, the participant must be either postmenopausal or permanently sterile (e.g. bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
• Informed Consent Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the Screening Visit procedures.
• Participant must be able to understand the nature of the study and must have the opportunity to have any questions answered.
• Patients currently using PAP will be eligible for inclusion in the study if they express willingness to discontinue treatment for a minimum of 7 days before baseline SpO2 assessments, until the study completion.
• Exclusion criteria Vital signs and symptoms
• Sustained SpO2<93% during wakefulness or mean SpO2<88% during sleep, calculated from PSG at screening
• Dyspnea at rest or patients with heart failure class IV NYHA
• Blood pressure <90/50 mmHg or >160/100 mmHg at V1.
• Medical Conditions Recent (<3 months) episode of acute myocardial infarction or acute decompensated heart failure.
• History of stroke.

Where it is running

• Altman Clinical and Translational Research Institute (ACTRI) — La Jolla, California, United States
• Teradan Clinical Trials — Brandon, Florida, United States
• PharmaDev Clinical Research Institute, LLC — Miami, Florida, United States
• Infinity Medical Research — North Dartmouth, Massachusetts, United States
• John D. Dingell VA Medical Center — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Intrepid Research, LLC — Cincinnati, Ohio, United States
• OnSite Clinical Solutions — Rock Hill, South Carolina, United States
• Huntsville Research Institute LLC — Huntsville, Texas, United States

Full record on ClinicalTrials.gov

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