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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
NCT03790865 |
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Date of registration:
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28/12/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
ZEPHYR |
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Scientific title:
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A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi Syndrome |
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Date of first enrolment:
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March 25, 2019 |
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Target sample size:
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158 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03790865 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Australia
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Belgium
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France
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Italy
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Netherlands
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Spain
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
4 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hyperphagia
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Prader-Willi Syndrome
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Intervention(s)
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Drug: Livoletide
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Drug: Placebo
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Primary Outcome(s)
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Change in Hyperphagia and Food-related Behaviors (Hyperphagia Questionnaire for Clinical Trials; HQ-CT)
[Time Frame: Baseline to month 3]
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Secondary Outcome(s)
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Change From Baseline to Month 3 in Waist Circumference in Patients Eight to 65 Years of Age Defined as Overweight/Obese
[Time Frame: Baseline to month 3]
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Percentage Change From Baseline to Month 3 in Total Body Fat Mass in Patients Eight to 65 Years of Age Defined as Overweight/Obese
[Time Frame: Baseline to month 3]
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Percentage Change From Baseline to Month 3 in Body Weight in Patients Eight to 65 Years of Age Defined as Overweight/Obese
[Time Frame: Baseline to month 3]
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Secondary ID(s)
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AZP01-CLI-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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