Clinical trial to access the effect and safety of liraglutide 3.0 mg on weight management in children with obesity aged 6 to12 years.
- Conditions
- Health Condition 1: E669- Obesity, unspecified
- Registration Number
- CTRI/2021/06/034501
- Lead Sponsor
- ovo Nordisk India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Informed consent of parents or LAR of subject and child assent,as age-appropriate, obtained
before any trial-related activities. Trial-related activities are any procedures that are carried out
as part of the trial, including activities to determine suitability for the trial
a The parents or LAR of the child must sign and date the Informed Consent Form according to local requirements
b The child must sign and date the Child Assent Form or provide oral assent according to local requirements
2.Male or female,aged 6 to <12 years at the time of signing informed consent
3.Tanner stage 1-5 pubertal development at the time of signing informed consent
4.BMI =95th percentile
5.History of failing to lose sufficient weight with lifestyle modification as judged by the
investigator
For subjects with T2D at screening the following inclusion criteria apply in addition to criteria 1-5:
6.Subject with T2D treated with either diet and exercise alone or stable treatment with metformin
for at least 90 days prior to screening
7.HbA1c =10.0% (86 mmol/mol) as measured by central laboratory at screening
Obesity related
1.A self-reported or by parents or LAR where applicable change in body weight >5 kg 11 lbs
within 90 days before screening irrespective of medical records
2.Treatment with any medication for the indication of obesity within the past 90 days before
screening
3.Uncontrolled thyroid disease at screening, in the opinion of the investigator
4.Subjects with secondary causes of obesity for example hypothalamic, monogenic or endocrine
causes
Mental health
5.History of major depressive disorder within 2 years before screening
6.Diagnosis of other severe psychiatric disorders e.g., schizophrenia, bipolar disorder
7.A lifetime history of suicidal attempt
8.Subjects with confirmed diagnosis of bulimia nervosa disorder
General Safety
9.History or presence of pancreatitis acute or chronic
10.Calcitonin =50 ng/L
11.Personal or first degree relatives history of multiple endocrine neoplasia type 2 or medullary
thyroid carcinoma
12.Type 1 diabetes
13.Impaired renal function defined as serum-creatinine >UNR for age in children unless renal
function is proven normal by further assessments at the discretion of the investigator
14.History of malignant neoplasms within the past 5 years prior to the day of screening
15.Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator
16.Known or suspected abuse of alcohol or recreational drugs
17.Known or suspected hypersensitivity to trial products or related products
18.Previous participation in this trial. Participation is defined as signed informed consent
19.Participation in any clinical trial of an approved or non-approved investigational medicinal
product within 90 days before screening
20.Other subjects from the same household participating in any liraglutide trial
21.Female who is of child-bearing potential and not using an adequate contraceptive method
adequate contraceptive measure as required by local regulation or practice
22.Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria,
which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol
Glycaemia-related
23.Treatment with glucose-lowering agents within 90 days before screening except for
metformin
24.Treatment with a GLP-1 receptor agonist within 180 days before screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of liraglutide 3.0 mg s.c. once daily versus placebo on weight management in <br/ ><br>children aged 6 to 12 years with obesityTimepoint: 56 weeks
- Secondary Outcome Measures
Name Time Method To compare the effect of liraglutide 3.0 mg s.c. once daily versus placebo in children aged 6 to 12 <br/ ><br>years with obesity on: <br/ ><br>1.Cardiovascular risk factors <br/ ><br>2.Glucose metabolism <br/ ><br>To evaluate the safety and tolerability of liraglutide 3.0 mg s.c. once daily versus placebo in <br/ ><br>children aged 6 to 12 years with obesityTimepoint: 56 weeks