NL-OMON48225
Completed
Phase 2
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 - Millendo AZP531PWS Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Millendo Therapeutics SAS
- Enrollment
- 23
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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,
Exclusion Criteria
- •\- History of chronic liver disease
- •\- Type 1 diabetes mellitus
- •\- HbA1c \> 10%
Outcomes
Primary Outcomes
Not specified
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