Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity
NCT ID: NCT02918279
Last Updated: 2020-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
251 participants
INTERVENTIONAL
2016-09-29
2019-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Liraglutide
Liraglutide
Administered once daily subcutaneously (s.c., under the skin)
Placebo
Placebo
Administered once daily subcutaneously (s.c., under the skin)
Interventions
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Liraglutide
Administered once daily subcutaneously (s.c., under the skin)
Placebo
Administered once daily subcutaneously (s.c., under the skin)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
17 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
Novo Nordisk Investigational Site
Samara, , Russia
Novo Nordisk Investigational Site
Stavropol, , Russia
Novo Nordisk Investigational Site
Tomsk, , Russia
Novo Nordisk Investigational Site
Ufa, , Russia
Novo Nordisk Investigational Site
Gothenburg, , Sweden
Novo Nordisk Investigational Site
Huddinge, , Sweden
Novo Nordisk Investigational Site
Malmo, , Sweden
Novo Nordisk Investigational Site
Uppsala, , Sweden
Countries
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References
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Kelly AS, Auerbach P, Barrientos-Perez M, Gies I, Hale PM, Marcus C, Mastrandrea LD, Prabhu N, Arslanian S; NN8022-4180 Trial Investigators. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020 May 28;382(22):2117-2128. doi: 10.1056/NEJMoa1916038. Epub 2020 Mar 31.
Bensignor MO, Bramante CT, Bomberg EM, Fox CK, Hale PM, Kelly AS, Mamadi R, Prabhu N, Harder-Lauridsen NM, Gross AC. Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial. Pediatr Obes. 2023 Sep;18(9):e13061. doi: 10.1111/ijpo.13061. Epub 2023 Jun 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-004353-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1162-7101
Identifier Type: OTHER
Identifier Source: secondary_id
NN8022-4180
Identifier Type: -
Identifier Source: org_study_id
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