Effect of liraglutide for weight management in pubertal adolescent subjects with obesity

Phase 1

• Conditions: Obesity; MedDRA version: 19.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-004353-14-BE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-08
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 228

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. Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation
3. 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)
4. Stable body weight during the previous 90 days before screening V2 (<5 kg self-reported weight change)
5. History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject’s medical record

Are the trial subjects under 18? yes
Number of subjects for this age range: 228
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. Pre-pubertal subjects (Tanner stage 1) at screening V2
2. Type 1 diabetes mellitus (T1DM)
3. Family or personal history of multiple endocrine neoplasia type 2 (MEN2)
4. Medullary thyroid carcinoma (MTC)
5. History of pancreatitis (acute or chronic)
6. Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)
7. Treatment with medications within 90 days before screening V2 that, based on the investigator’s judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)
8. Anti-diabetic treatment other than metformin
9. History of major depressive disorder within 2 years before screening V2

Study & Design

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