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

• Status: Terminated
• Trial end date: 2020-05-25
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millendo Therapeutics SAS; Millendo Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Confirmed genetic diagnosis of PWS

• Evidence of increased appetite or hyperphagia

• Patient must have a single primary caregiver who should be available for certain durations of the study

• BMI ≤ 65 kg/m2

• Growth hormone treatment permitted if doses have been stable for at least 1 month prior to screening

Exclusion Criteria:

• History of chronic liver disease

• Type 1 diabetes mellitus

• HbA1c > 10%

• Body weight <20 kg