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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02696148
• Collaborator: (none)
• Enrollment: 24
• Locations: 9
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Metabolism and Nutrition Disorder; Obesity	Drug: liraglutide; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 14, 2016
• Actual Primary Completion Date: Apr 13, 2017
• Actual Study Completion Date: Apr 13, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liraglutide	Drug: liraglutide; For subcutaneous (s.c., under the skin) injection once daily.
Placebo Comparator: Placebo	Drug: placebo; For subcutaneous (s.c., under the skin) injection once daily.

Outcome Measures

Primary Outcome Measures

1. Number of treatment emergent adverse events [From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing)]

Secondary Outcome Measures

1. Area under the liraglutide concentration curve [From 0-24 hours at steady state following the last dose (49-91 days after first dosing)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Anaheim	California	United States	92801
2	Novo Nordisk Investigational Site	New Haven	Connecticut	United States	06520
3	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32207
4	Novo Nordisk Investigational Site	Pensacola	Florida	United States	32504
5	Novo Nordisk Investigational Site	Atlanta	Georgia	United States	30331
6	Novo Nordisk Investigational Site	Buffalo	New York	United States	14203
7	Novo Nordisk Investigational Site	Mineola	New York	United States	11501
8	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania	United States	15224
9	Novo Nordisk Investigational Site	Memphis	Tennessee	United States	38119

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02696148
• Other Study ID Numbers: NN8022-4181; U1111-1162-9171; 2014-004454-34
• First Posted: Mar 2, 2016
• Last Update Posted: Mar 18, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nutrition Disorders; Liraglutide

Study Results

No Results Posted as of Mar 18, 2019