Clinical trial NCT02696148: A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-03-02
Enrollment: 24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide in obese children aged 7 to 11 years


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 7-11 years (both inclusive) at the time of signing informed consent
* 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 secondary causes of childhood obesity (i.e., hypothalamic, genetic or endocrine causes)
* 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

Primary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing)
Secondary outcomes:
measure: Area under the liraglutide concentration curve
timeFrame: From 0-24 hours at steady state following the last dose (49-91 days after first dosing)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: New Haven
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Buffalo
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Mineola
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
Study officials:
References:
citation: 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.