Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:8 - 65
Updated:4/4/2019
Start Date:March 2019
End Date:March 2021
Contact:Nadège Tremel
Email:tremel@millendo.com
Phone:+33 472 18 09 30

Use our guide to learn which trials are right for you!

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

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).

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 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.

Inclusion Criteria:

- Diagnosis of PWS confirmed by DNA methylation test

- Evidence of increased appetite or hyperphagia

- Patient must have a single primary caregiver who should be available for the duration
of the study

- BMI ≤ 65 kg/m2

- Growth hormone treatment permitted if doses are stable

Exclusion Criteria:

- History of chronic liver disease

- Type 1 diabetes mellitus

- HbA1c > 10%
We found this trial at
5
sites
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Angers,
Click here to add this to my saved trials