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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metabolism and Nutrition Disorder, Obesity

In brief

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.

Key facts

Study ID

NCT02918279

Run by

Novo Nordisk A/S

People needed

251

Starts

2016-09-29

Expected to finish

2019-08-08

Last updated by the study team

2020-04-27

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Meridian, Idaho, United States
• Novo Nordisk Investigational Site — Baton Rouge, Louisiana, United States
• Novo Nordisk Investigational Site — Baltimore, Maryland, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — Buffalo, New York, United States
• Novo Nordisk Investigational Site — Columbus, Ohio, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Dayton, Ohio, United States
• Novo Nordisk Investigational Site — Pittsburgh, Pennsylvania, United States
• Novo Nordisk Investigational Site — Charleston, South Carolina, United States
• Novo Nordisk Investigational Site — Goose Creek, South Carolina, United States
• Novo Nordisk Investigational Site — Greenville, South Carolina, United States
• Novo Nordisk Investigational Site — Memphis, Tennessee, United States
• Novo Nordisk Investigational Site — Brussels, Belgium
• Novo Nordisk Investigational Site — Brussels, Belgium
• Novo Nordisk Investigational Site — Edegem, Belgium
• Novo Nordisk Investigational Site — Hasselt, Belgium
• Novo Nordisk Investigational Site — Leuven, Belgium
• Novo Nordisk Investigational Site — Namur, Belgium
• Novo Nordisk Investigational Site — Ciudad Madero, Tamaulipas, Mexico
• Novo Nordisk Investigational Site — Puebla City, Mexico
• Novo Nordisk Investigational Site — Moscow, Russia
• Novo Nordisk Investigational Site — Novosibirsk, Russia
• Novo Nordisk Investigational Site — Rostov-on-Don, Russia
• Novo Nordisk Investigational Site — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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