DRUG
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.
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
Status
Active, not recruiting
Phase
Phase 3
Enrollment
78
Locations
32
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
The study medicine must be injected in a skin fold in the stomach, thigh or upper arm once daily.
Timeline
From registration to results.
First posted
Mar 1, 2021
Study start
Mar 4, 2021
Primary completion
Aug 1, 2023
Study completion
Feb 8, 2027
Results posted
Not reported
Registry updated
Jul 9, 2026
Outcomes
What the study measures.
Primary outcomes
Relative change in BMI (Body mass index)
Time frame · From baseline (week 0) to week 56
Percent
Secondary outcomes
Relative change in body weight
Time frame · From baseline (week 0) to week 56
Percent
Change in BMI standard deviation score (WHO.int)
Time frame · From baseline (week 0) to week 56
Unitless
Subjects achieving above or equal to 5 percent reduction of BMI
Time frame · From baseline (week 0) to week 56
Yes/no
Subjects achieving above or equal to 10 percent reduction of BMI
Time frame · From baseline (week 0) to week 56
Yes/no
BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov)
Time frame · From baseline (week 0) to week 56
Percent point
Change in waist circumference
Time frame · From baseline (week 0) to week 56
cm
Change in systolic blood pressure
Time frame · From baseline (week 0) to week 56
mmHg
Change in diastolic blood pressure
Time frame · From baseline (week 0) to week 56
mmHg
Change in HbA1c (glycated haemoglobin)
Time frame · From baseline (week 0) to week 56
Percent point
Treatment emergent adverse events (TEAEs)
Time frame · From baseline (week 0) to week 82
Number
Eligibility
Who can take part.
- Minimum age
- 6 Years
- Maximum age
- 12 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Informed consent of parent(s) or legally acceptable representative 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 * Male or female, aged 6 to below 12 years at the time of signing informed consent * Tanner stage 1-5 pubertal development at the time of signing informed consent * BMI above or equal to 95th percentile, on gender and age-specific growth charts (CDC.gov) * History of failing to lose sufficient weight with lifestyle modification as judged by the investigator For subjects with type 2 diabetes at screening the following inclusion criterion apply in addition: \- Hemoglobin A1c (HbA1c) below or equal to 10.0 percent (86 mmol/mol) as measured by central laboratory at screening Exclusion Criteria: * A self-reported (or by parent(s)/LAR (legally acceptable representative) where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Treatment with any medication for the indication of obesity within the past 90 days before screening * Type 1 diabetes * Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)
Study locations
32 registered sites.
Belgium · India · Israel · Malaysia · Mexico · Portugal · Russia · Switzerland · United States. Showing up to 24 locations stored in the fast local snapshot.
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 Lisboa, S.A.
Lisbon, Portugal
Hospital da Luz
Lisbon, Portugal
Centro Hospitalar Lisboa Norte
Lisbon, Portugal
Unidade De Santa Maria E.P.E. - Hospital de Santa Maria
Lisbon, Portugal
ULS De Santo António, E.P.E. - Hospital de Santo António
Porto, Portugal
Unidade Local de Saúde de Santo António, E.P.E
Porto, Portugal
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