A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.

Phase 1

• Conditions: Prader-Willi Syndrome; MedDRA version: 20.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-06
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Phase 2b and Phase 3 Core
1. A confirmed genetic diagnosis of PWS
2. Male and female patients 4 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: 0
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 0

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