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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Prader-Willi Syndrome, Hyperphagia

In brief

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).

Key facts

Study ID

NCT03790865

Run by

Millendo Therapeutics SAS

People needed

158

Starts

2019-03-25

Expected to finish

2020-05-25

Last updated by the study team

2021-02-17

Who can join

Age: 4 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of chronic liver disease
• Type 1 diabetes mellitus
• HbA1c > 10%
• Body weight <20 kg

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California - Irvine Medical Center — Orange, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• Children's Hospital Colorado — Denver, Colorado, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Children's Hospitals and Clinics of Minnesota-Minneapolis — Saint Paul, Minnesota, United States
• Winthrop University Hospital — Mineola, New York, United States
• New York Presbyterian Morgan Stanley Children's Hospital — New York, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Royal Prince Alfred Hospital — Camperdown, Australia
• Austin Health — Melbourne, Australia
• Perth Children's Hospital — Nedlands, Australia
• The Childrens Hospital at Westmead — Westmead, Australia
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• Centre Hospitalier Universitaire d'Angers — Angers, France
• CHU Lyon - Hopital Femmes Mere Enfant — Bron, France
• Hospital Pitie Salpetriere — Paris, France
• Hopital Necker-Enfants Malades — Paris, France
• CHU de Toulouse - Hospital Rangueil — Toulouse, France

Full record on ClinicalTrials.gov

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