Status:
TERMINATED
Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
Lead Sponsor:
Millendo Therapeutics SAS
Conditions:
Prader-Willi Syndrome
Hyperphagia
Eligibility:
All Genders
4-65 years
Phase:
PHASE2
PHASE3
Brief 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).
Detailed 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 Per...
Eligibility Criteria
Inclusion
- 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
- History of chronic liver disease
- Type 1 diabetes mellitus
- HbA1c \> 10%
- Body weight \<20 kg
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2020
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT03790865
Start Date
March 25 2019
End Date
May 25 2020
Last Update
February 17 2021
Active Locations (37)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California - Irvine Medical Center
Orange, California, United States, 92868
3
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
4
Children's Hospital Colorado
Denver, Colorado, United States, 80045