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 - ZEPHYR

Phase 1

• Conditions: Prader-Willi Syndrome; MedDRA version: 20.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-003062-13-IT
• Lead Sponsor: Millendo Therapeutics SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-05-25
• Study Start: 2020-10-07
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Phase 2b and Phase 3 Core
1. Diagnosis of PWS confirmed by deoxyribonucleic acid (DNA) methylation test.
2. Male and female patients 8 to 65 years of age, inclusive.
3. Have evidence of increased appetite or Hyperphagia

Phase 2b and 3 Extension
Patients must have participated in the core period.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Core Period
Phase 2b
1. History of chronic liver disease, such as cirrhosis or chronic hepatitis due to any cause, or suspected alcohol abuse.
2. History of significant cardiovascular disease including history of congestive heart failure CHF, New York Heart Association [NYHA] Class 3 or 4), angina pectoris, or myocardial infarction (MI) within 6 months prior to screening.
3. Type 1 diabetes mellitus.
4. Glycated hemoglobin (HbA1c) >10%.
5. History of frequent hypoglycaemia.

Phase 3
A patient who enrolled in the Phase 2b part is not eligible for recruitment in the Phase 3 part.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified