A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years
NCT ID: NCT02696148
Last Updated: 2019-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2016-03-14
2017-04-13
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
For subcutaneous (s.c., under the skin) injection once daily.
Placebo
placebo
For subcutaneous (s.c., under the skin) injection once daily.
Interventions
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liraglutide
For subcutaneous (s.c., under the skin) injection once daily.
placebo
For subcutaneous (s.c., under the skin) injection once daily.
Eligibility Criteria
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Inclusion Criteria
* Tanner stage 1 (including subjects with premature adrenarche) at the time of signing informed consent
* BMI (body mass index) corresponding to above or equal to 30 kg/m\^2 for adults by international cut-off points (Cole et al 2000)1 and BMI below or equal to 45 kg/m\^2 as well as BMI above or equal to 95th percentile for age and gender
Exclusion Criteria
* Subjects with confirmed bulimia nervosa disorder
* Diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus as defined by glycosylated haemoglobin (HbA1C) Above or equal to 6.5 %
* History of pancreatitis (acute or chronic)
* Presence of severe co-morbidities as judged by the investigator
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC)
* History of major depressive disorder within 2 years before randomisation
7 Years
11 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
New Haven, Connecticut, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, United States
Novo Nordisk Investigational Site
Pensacola, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Buffalo, New York, United States
Novo Nordisk Investigational Site
Mineola, New York, United States
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States
Novo Nordisk Investigational Site
Memphis, Tennessee, United States
Countries
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References
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Mastrandrea LD, Witten L, Carlsson Petri KC, Hale PM, Hedman HK, Riesenberg RA. Liraglutide effects in a paediatric (7-11 y) population with obesity: A randomized, double-blind, placebo-controlled, short-term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Pediatr Obes. 2019 May;14(5):e12495. doi: 10.1111/ijpo.12495. Epub 2019 Jan 17.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1162-9171
Identifier Type: OTHER
Identifier Source: secondary_id
2014-004454-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN8022-4181
Identifier Type: -
Identifier Source: org_study_id
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