Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)

Exclusion Criteria

• •1. BP:
• •1. Step 1: Adults with \>140/90
• •2. Step 2: Adolescents with ≥95th percentile for gender, age, and height
• •2. Heart Rate (HR) ≥ 90, \<50 bpm
• •3. Hypersensitivity to tesofensine/metoprolol
• •4. Type 1 diabetes
• •5. Heart failure New York Heart Association (NYHA) level II or greater, decompensated heart failure
• •6. Previous myocardial infarction or stroke
• •7. Diagnosis of schizophrenia, bipolar disorder, personality disorder or other DSM-III disorders, or any other psychiatric condition, which in the investigator's opinion will interfere significantly with study compliance
• •8. History of major depressive disorder or suicidality
• •9. Any clinically significant cardiac arrhythmia
• •10. Treatment with calcium channel blockers and beta blockers
• •11. Concomitant use of monoaminooxidase inhibitors
• •12. Bulimia or anorexia nervosa
• •13. Any agent used for weight loss in the past 3 months
• •14. Untreated hypo- or hyperthyroidism
• •15. Clinically significant liver (\>3x ULN (Upper Limit of Normal range)) and/or kidney impairment
• •16. More than 5% weight loss within the last 3 months
• •17. Any other clinically meaningful condition, in the opinion of the investigator, which would make participation potentially unsafe
• •18. Contraindications to administration of metoprolol per current Summary of Product Characteristics