A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Metabolism and Nutrition Disorder
Obesity

Treatments

Drug: placebo
Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02696148
NN8022-4181
2014-004454-34 (EudraCT Number)
U1111-1162-9171 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

7 to 11 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups, including a placebo group

Liraglutide
Experimental group
Treatment:
Drug: liraglutide
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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