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SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
Sponsor: Novo Nordisk A/S
Summary
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.
Official title: Effect and Safety of Liraglutide 3.0 mg on Weight Management in Children With Obesity Aged 6 to Below 12 Years: 56-week, Double-blind, Randomised, Placebo-controlled Trial
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2021-03-04
Completion Date
2027-01-15
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
Liraglutide
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.
Placebo
The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.
Locations (31)
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
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
UZ Leuven - Kindergeneeskunde
Leuven, Belgium
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, India
Mamc & Lnjp
New Delhi, India
Rambam MC - Department of Pediatrics A
Haifa, Israel
Schneider MC - Endrocrinology and Diabetes
Petah Tikva, Israel
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Putrajaya
Putrajaya, Malaysia
Consultorio de Endocrinología y Pediatría
Puebla City, Mexico
Hospital Da Luz S.A.
Lisbon, Portugal
Hospital da Luz
Lisbon, Portugal
Centro Hospitalar Lisboa Norte
Lisbon, Portugal
Unidade Local De Saude De Santa Maria E.P.E.
Lisbon, Portugal
Unidade Local de Saúde de Santo António, E.P.E
Porto, Portugal
CUF-Porto
Porto, Portugal
Hospital CUF Porto S.A.
Porto, Portugal
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
Moscow, Russia
NSMU paediatric clinic
Novosibirsk, Russia
Samara Regional Children Clinical Hospital n.a. N.N. Ivanova
Samara, Russia
Siberian State Medical University
Tomsk, Russia
Kantonsspital Olten
Olten, Switzerland
Kinderspital Endokrinologie, Zürich
Zurich, Switzerland