A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome
- Conditions
- Prader-Willi syndromePWS100274241000301810014067
- Registration Number
- NL-OMON48225
- Lead Sponsor
- Millendo Therapeutics SAS
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
- A confirmed gentic diganosis of PWS. Documentation of PWS subtype. If PWS
subtype is not known, a sample for testing may be obtained
and the patient may continue on to be enrolled into the study if he/she meets
all the other inclusion criteria and non of the
exclusion criteria.
- Male and female patients 4 to 65 years of age.
- Evidence of increased appetite or hyperphagia, as jugded by the investigator
and HQ-CT score.
- Patient must have a single primary caregiver who should be available for the
duration of the study. On average,
approximately 4 (or more) waking hours per day with the patient.
- BMI * 65 kg/m2
- Growth hormone treatment permitted if doses are stable
- History of chronic liver disease
- Type 1 diabetes mellitus
- HbA1c > 10%
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Outcome Measures :<br /><br>Change in hyperphagia and food-related behaviors (Hyperphagia Questionnaire for<br /><br>Clinical Trials; HQ-CT) [ Time Frame: Baseline to month 3 ]<br /><br><br /><br>Change from baseline to the end of the 3-month Core Period for HQ-CT total<br /><br>score. The HQ-CT score range is 0 to 36 where the higher score represents more<br /><br>severe abnormal food related behaviors.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Outcome Measures :<br /><br>Change in fat mass [ Time Frame: Baseline to month 3 ]<br /><br>Percentage change from baseline to the end of the 3-month Core Period in total<br /><br>body fat mass in overweight/obese patients with PWS<br /><br><br /><br>Change in waist circumference [ Time Frame: Baseline to month 3 ]<br /><br>Change from baseline to the end of the 3-month Core Period in waist<br /><br>circumference in overweight/obese patients with PWS<br /><br><br /><br>Change in body weight [ Time Frame: Baseline to month 3 ]<br /><br>Percentage change from baseline to the end of the 3-month Core Period in body<br /><br>weight in overweight/obese patients with PWS</p><br>