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OpenTrials
Completed

NCT Number: NCT02696148

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

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

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Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

For subcutaneous (s.c., under the skin) injection once daily.

Placebo

Drug

For subcutaneous (s.c., under the skin) injection once daily.

Primary outcomes

  1. Number of treatment emergent adverse events

    Time frame: From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing)

Secondary outcomes

  1. Area under the liraglutide concentration curve

    Time frame: From 0-24 hours at steady state following the last dose (49-91 days after first dosing)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 2, 2016
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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