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



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:12 - 17
Updated:3/17/2019
Start Date:September 29, 2016
End Date:August 8, 2019

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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

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.


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
We found this trial at
12
sites
5603
mi
from 91732
Brussels,
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Baltimore, Maryland 21229
2297
mi
from 91732
Baltimore, MD
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Baton Rouge, Louisiana 70808
1585
mi
from 91732
Baton Rouge, LA
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Buffalo, New York 14222
2181
mi
from 91732
Buffalo, NY
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Charleston, South Carolina 29407
2180
mi
from 91732
Charleston, SC
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Columbus, Ohio 43205
1960
mi
from 91732
Columbus, OH
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1894
mi
from 91732
Dayton, OH
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Greenville, South Carolina 29607
2019
mi
from 91732
Greenville, SC
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Memphis, Tennessee 38119
1598
mi
from 91732
Memphis, TN
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Meridian, Idaho 83646
666
mi
from 91732
Meridian, ID
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Minneapolis, Minnesota 55404
1509
mi
from 91732
Minneapolis, MN
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Pittsburgh, Pennsylvania 15224
2119
mi
from 91732
Pittsburgh, PA
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