An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001)

Exclusion Criteria

• •1. Body weight \<12 kg or \>100 kg at Baseline.
• •2. HbA1c values above 7% at the Screening visit.
• •3. Clinically significant abnormalities in safety laboratory tests and vital signs at Screening.
• •4. Positive pregnancy test at the Screening visit.
• •5. Positive drugs of abuse screen not explained by concomitant medications.
• •6. Abnormal QTcF interval or prolongation at Screening.
• •7. Any other clinically significant finding on ECG at the Screening visit.
• •8. Positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening or Baseline.
• •9. Previous COVID 19 infection with last 12 months that required hospitalization.
• •10. Previous COVD-19 infection involving multi-organ systems, resulting in Multisystem Inflammatory Syndrome in Children (MIS-C) or with clinically significant long term effects.
• •11. COVID-19 infection associated with acute kidney injury (AKI) or renal conditions.
• •12. Renal conditions or abnormalities identified in laboratory testing, imaging or medical history.
• •13. Liver conditions and Hepatic abnormalities.
• •14. Vision abnormalities and Ocular conditions.
• •15. Excluded concomitant treatments.
• •16. Unstable seizure profile.
• •17. Current clinically significant cardiovascular, gastrointestinal, or respiratory disease, or clinically significant organ impairment, or endocrine disease with the exception of obesity and controlled hypothyroidism.
• •18. Current clinically significant hypo or hyperthyroidism, Type 1 or Type 2 diabetes mellitus requiring insulin (whether well controlled or uncontrolled), or uncontrolled Type 1 or Type 2 diabetes.
• •19. Has planned surgery during the study.
• •20. History of, or current, cerebrovascular disease or brain trauma.
• •21. History of, or current catatonia or catatonia-like symptoms.
• •22. History of, or current, malignancy.
• •23. Current major or persistent depressive disorder (including bipolar depression).
• •24. Significant uncorrected hearing impairment.
• •25. Allergy to strawberry.
• •26. Has participated in another interventional clinical study within 30 days prior to start of Screening.
• •27. Subject is judged by the Investigator or Medical Monitor to be inappropriate for the study.