Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: Placebo

Drug: Liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02918279

U1111-1162-7101 (Other Identifier)

NN8022-4180

2014-004353-14 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.

Enrollment

251 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
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
BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change)
History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record

Exclusion criteria

Pre-pubertal subjects (Tanner stage 1) at screening V2
Type 1 diabetes mellitus (T1DM)
Family or personal history of multiple endocrine neoplasia type 2 (MEN2)
Medullary thyroid carcinoma (MTC)
History of pancreatitis (acute or chronic)
Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)
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)
Anti-diabetic treatment other than metformin
History of major depressive disorder within 2 years before screening V2