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Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug

NCT02918279•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

No

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

Locations (33)

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

Key Dates

Start Date

September 29, 2016

Primary Completion Date

February 14, 2019

Completion Date

August 8, 2019

Last Updated

April 27, 2020

Enrollment

251

ACTUAL participants

Conditions

Metabolism and Nutrition DisorderObesity

Interventions

Liraglutide

DRUG

Placebo

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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