Last updated on August 2019

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


Brief description of study

This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).

Detailed Study Description

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.

Clinical Study Identifier: NCT03790865

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