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

Prader-Willi Syndrome Clinical Trial

Official title: A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi Syndrome

Status Terminated

Clinical Trial Summary

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).

Clinical Trial 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.

A total of approximately 50 patients per group (8 to 65 years of age) will be randomized (approximately 150 patients in total). In addition to this cohort of 150 patients, a separate cohort of patients 4 to 7 years of age will also be randomized.

Note: The 8-65 year old cohort has been fully enrolled. Enrollment into the 4-7 year age cohort remains ongoing. ;

Related Conditions & MeSH terms

• Hyperphagia
• Prader-Willi Syndrome
• Syndrome

• NCT number: NCT03790865
• Study type: Interventional
• Source: Millendo Therapeutics, Inc.
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: March 25, 2019
• Completion date: May 25, 2020