The study looks at how liraglutide works on participant's body weight. Researchers will look at how liraglutide can help children with obesity to lose weight. They will look at how much weight the children will lose, and if there are any side effects. Participants will either get liraglutide or placebo. Which treatment the participants get is decided by chance. Liraglutide is a new medicine for children, but it can already be prescribed by doctors to adults with overweight or obesity. The participant will get 1 injection every day. In addition to taking the medicine, the participants will have talks with the study staff about healthy food choices, how they can be more physically active and what can be done to help the participants to lose weight. The study will last for about 96 weeks (almost 2 years). The participants will have 18 clinic visits and 10 phone or video calls with the study doctor/staff. Participant will have blood samples taken, have 1 test to check the heart, 1 hand X-ray taken and must fill in a diary between some of the visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily. The dose will increase each week over 4 or 5 weeks until the final dose is reached.
The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.
TMC Hlthcr Clin Res Office
Tucson, Arizona, United States
Children's Hospital Colorado
Denver, Colorado, United States
Solaris Clinical Research
Meridian, Idaho, United States
Pennington Biom Res Ctr
Baton Rouge, Louisiana, United States
Barry J. Reiner, MD LLC
Baltimore, Maryland, United States
Relative change in BMI (Body mass index)
Percent
Time frame: From baseline (week 0) to week 56
Relative change in body weight
Percent
Time frame: From baseline (week 0) to week 56
Change in BMI standard deviation score (WHO.int)
Unitless
Time frame: From baseline (week 0) to week 56
Subjects achieving above or equal to 5 percent reduction of BMI
Yes/no
Time frame: From baseline (week 0) to week 56
Subjects achieving above or equal to 10 percent reduction of BMI
Yes/no
Time frame: From baseline (week 0) to week 56
BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)
Percent point
Time frame: From baseline (week 0) to week 56
Change in waist circumference
cm
Time frame: From baseline (week 0) to week 56
Change in systolic blood pressure
mmHg
Time frame: From baseline (week 0) to week 56
Change in diastolic blood pressure
mmHg
Time frame: From baseline (week 0) to week 56
Change in HbA1c (glycated haemoglobin)
Percent point
Time frame: From baseline (week 0) to week 56
Treatment emergent adverse events (TEAEs)
Number
Time frame: From baseline (week 0) to week 82
Treatment emergent serious adverse events (SAEs
Number
Time frame: From baseline (week 0) to week 82
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University of Minnesota_CPOM
Minneapolis, Minnesota, United States
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, United States
PriMed Clinical Research
Dayton, Ohio, United States
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, United States
UZ Brussel
Brussels, Belgium
...and 22 more locations