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

Last updated: February 8, 2021
Sponsor: Millendo Therapeutics SAS
Overall Status: Terminated

Phase

2/3

Condition

Bulimia

Hypogonadism

Severe Short Stature

Treatment

N/A

Clinical Study ID

NCT03790865
AZP01-CLI-003
  • Ages 4-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 certaindurations of the study
  • BMI ≤ 65 kg/m2
  • Growth hormone treatment permitted if doses have been stable for at least 1 monthprior to screening

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 158
Study Start date:
March 25, 2019
Estimated Completion Date:
May 25, 2020

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.

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.

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, 2050
    Australia

    Site Not Available

  • Austin Health

    Melbourne, 3084
    Australia

    Site Not Available

  • Perth Children's Hospital

    Nedlands, 6009
    Australia

    Site Not Available

  • The Childrens Hospital at Westmead

    Westmead, 2145
    Australia

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49100
    France

    Site Not Available

  • CHU Lyon - Hopital Femmes Mere Enfant

    Bron, 69677
    France

    Site Not Available

  • Hopital Necker-Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • Hospital Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • CHU de Toulouse - Hopital des Enfants

    Toulouse,
    France

    Site Not Available

  • CHU de Toulouse - Hospital Rangueil

    Toulouse, 31059
    France

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165
    Italy

    Site Not Available

  • Erasmus University Medical Center

    Rotterdam, 3015
    Netherlands

    Site Not Available

  • Stichting Kind en Groei

    Rotterdam, 3016
    Netherlands

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital de Cruces

    Barakaldo, 48903
    Spain

    Site Not Available

  • Hospital Sant Joan de Deu

    Barcelona, 08950
    Spain

    Site Not Available

  • Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

    Sabadell, 08208
    Spain

    Site Not Available

  • Hospital de Cruces

    Vizcaya, 48903
    Spain

    Site Not Available

  • NHS Tayside

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital

    London, SW109NH
    United Kingdom

    Site Not Available

  • Imperial College London

    London, W12 0NN
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of California - Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • Rady Children's Hospital - San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • Children's Hospital Colorado

    Denver, Colorado 80045
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Children's Hospitals and Clinics of Minnesota-Minneapolis

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • New York Presbyterian Morgan Stanley Children's Hospital

    New York, New York 10032
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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