Effect of liraglutide for weight management in children with Prader-Willi Syndrome

Phase 1

• Conditions: Obesity(Prader-Willi syndrome); MedDRA version: 18.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-004415-37-NL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-17
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
2. Confirmed diagnosis of PWS (by genetic testing)
3. Male or female, age at the time of signing informed consent:
– Part A: = 12 and < 18 years
– Part B: = 6 and < 12 years
4. Tanner stage 2-5 pubertal development for part A, and Tanner stage 1 for part B
5. BMI corresponding to = 30 kg/m^2 for adults by international cut-off points and = the 95th percentile for age and sex (for diagnosis of obesity)
6. Stable body weight during the previous 90 days before screening (< 10 kg self-reported weight change)
7. Testing has been performed to evaluate for adrenal insufficiency and documented in medical record
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Type 1 diabetes mellitus (T1DM)
2. Type 2 diabetes mellitus (T2DM)
3. Calcitonin = 50 ng/L
4. No change in treatment plan with growth hormone (GH) from randomisation to the end of the open-label period patients on growth hormone to stay on, patients off GH to stay off during this period. Adjustments in doses of growth hormone will be permitted)
5. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroids Carcinoma (MTC)
6. History of pancreatitis (acute or chronic)
7. Treatment with any medication prescribed for weight loss within 90 days before screening (e.g. orlistat, zonisamide, topiramate/phentermine, lorcaserin, phentermine, bupropion/naltrexone, liraglutide, metformin)
8. Untreated adrenal insufficiency
9. Suggestive history of, or significant risk of gastroparesis (e.g. marked abdominalbloating post-meal, history of vomiting, severe constipation), as judged by the investigator

Study & Design

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