Clinical Trial

Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome

Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
Prospective observational study developed to generate more evidence of the safety profile, clinical characteristics and outcomes of patients with PWS treated with VYKAT XR.
Protocol Amendment History 4 changes
notable Trial sites expanded: 15 -> 23 locations 2026-08-14
notable Trial sites expanded: 11 -> 15 locations 2026-05-20
notable Trial sites expanded: 6 -> 11 locations 2026-04-17
notable Trial sites expanded: 2 -> 6 locations 2026-04-08
Trial Details
NCT Number NCT07450664
Lead Sponsor Soleno Therapeutics, Inc.
Conditions Prader-Willi Syndrome
Enrollment 200 participants
Start Date 2025-11-26
Primary Completion 2028-03 (estimated)
Study Completion 2028-03-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-13