
    fda clinical hold
  
['prader-willi syndrome', 'obesity']
['zgn-440 for injectable suspension', 'zgn-440 placebo for injectable suspension']

        Inclusion Criteria:

          -  Confirmed genetic diagnosis of Prader-Willi Syndrome

          -  Age 12-65

          -  Obesity

          -  Age 12-17: BMI ≥ 95th percentile for age and gender

          -  Age 18-65: BMI ≥27 to ≤60 kg/m2

        Exclusion Criteria:

          -  Subjects living in a group home ≥ 50% of the time

          -  Recent use (within 3 months) of weight loss agents including herbal medication

          -  Poorly controlled severe psychiatric disorders
      