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

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).

Timeline

Start

2019-03-25

Primary completion

2020-02-26

Completion

2020-05-25

Outcome

Met primary endpoint

Stopped: “Livoletide did not result in a statistically significant improvement in hyperphagia and food-related behaviors”

registry analysis (superiority test); Low-Dose Livoletide vs High-Dose Livoletide vs Placebo; p <0.025; Mean Difference (Net) 4; Mixed Models Analysis NCT03790865 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Livoletide	Protein / enzyme biologic	60 ug/kg	Subcutaneous
Subject	Livoletide	Protein / enzyme biologic	120 ug/kg	Subcutaneous

Indications