Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome

The protocol includes 2 consecutive parts:

1. The first part is a Phase 2b dose-response study consisting of a 3-month double-blind,
placebo-controlled Core Period followed by a 9-month Extension Period.

2. The second part is a Phase 3 study consisting of a 6-month double-blind,
placebo-controlled Core Period followed by a 6-month Extension Period. Phase 3 may be
initiated following review of safety and efficacy results at the completion of the Phase
2b Core Period.

Inclusion Criteria:

- Diagnosis of PWS confirmed by DNA methylation test

- Evidence of increased appetite or hyperphagia

- Patient must have a single primary caregiver who should be available for the duration
of the study

- BMI ≤ 65 kg/m2

- Growth hormone treatment permitted if doses are stable

Exclusion Criteria:

- History of chronic liver disease

- Type 1 diabetes mellitus

- HbA1c > 10%