Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
NCT ID: NCT03790865
Last Updated: 2021-02-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
158 participants
INTERVENTIONAL
2019-03-25
2020-05-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low-Dose Livoletide
Daily subcutaneous injection of \~ 60 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide
Daily subcutaneous injection
High-Dose Livoletide
Daily subcutaneous injection of \~120 mcg/kg for 3 month double-blind core period and 9 month open label extension period.
Livoletide
Daily subcutaneous injection
Placebo
Daily subcutaneous injection of 0.9% NaCl for the 3 month double-blind core period and then low-dose or high-dose livoletide for 9 month open label extension period.
Placebo
Daily subcutaneous injection
Interventions
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Livoletide
Daily subcutaneous injection
Placebo
Daily subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Type 1 diabetes mellitus
* HbA1c \> 10%
* Body weight \<20 kg
4 Years
65 Years
ALL
No
Sponsors
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Millendo Therapeutics SAS
INDUSTRY
Responsible Party
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Locations
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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
CHU de Toulouse - Hopital des Enfants
Toulouse, , France
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Erasmus University Medical Center
Rotterdam, , Netherlands
Stichting Kind en Groei
Rotterdam, , Netherlands
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital de Cruces
Barakaldo, , Spain
Hospital Sant Joan de Deu
Barcelona, , Spain
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Sabadell, , Spain
NHS Tayside
Dundee, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Imperial College London
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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AZP01-CLI-003
Identifier Type: -
Identifier Source: org_study_id
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