SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity
- Registration Number
- NCT04775082
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liraglutide 3.0 mg Liraglutide The treatment duration is 56 weeks and the follow-up period is 26 weeks. Placebo Placebo The treatment duration is 56 weeks and the follow-up period is 26 weeks.
- Primary Outcome Measures
Name Time Method Relative change in BMI (Body mass index) From baseline (week 0) to week 56 Percent
- Secondary Outcome Measures
Name Time Method Change in BMI standard deviation score (WHO.int) From baseline (week 0) to week 56 Unitless
Subjects achieving above or equal to 10 percent reduction of BMI From baseline (week 0) to week 56 Yes/no
Change in HbA1c (glycated haemoglobin) From baseline (week 0) to week 56 Percent point
Treatment emergent adverse events (TEAEs) From baseline (week 0) to week 82 Number
Relative change in body weight From baseline (week 0) to week 56 Percent
Subjects achieving above or equal to 5 percent reduction of BMI From baseline (week 0) to week 56 Yes/no
BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) From baseline (week 0) to week 56 Percent point
Change in waist circumference From baseline (week 0) to week 56 cm
Change in systolic blood pressure From baseline (week 0) to week 56 mmHg
Change in diastolic blood pressure From baseline (week 0) to week 56 mmHg
Treatment emergent serious adverse events (SAEs From baseline (week 0) to week 82 Number
Trial Locations
- Locations (28)
Hospital Da Luz S.A.
🇵🇹Lisboa, Portugal
Unidade Local De Saude De Santa Maria E.P.E.
🇵🇹Lisboa, Portugal
Hospital CUF Porto S.A.
🇵🇹Porto, Portugal
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
UPMC Child Hosp-Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
UZ Brussel
🇧🇪Brussel, Belgium
UZ Leuven - Kindergeneeskunde
🇧🇪Leuven, Belgium
Endolife Specialty Hospitals
🇮🇳Guntur, Andhra Pradesh, India
Mamc & Lnjp
🇮🇳New Delhi, India
Rambam Medical Center Children A Dept.
🇮🇱Haifa, Israel
Endrocrinology & DM Schneider MC
🇮🇱Petah Tikva, Israel
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Consultorio de Endocrinología y Pediatría
🇲🇽Puebla, Mexico
Hospital da Luz
🇵🇹Lisboa, Portugal
Centro Hospitalar Lisboa Norte
🇵🇹Lisboa, Portugal
Unidade Local de Saúde de Santo António, E.P.E
🇵🇹Porto, Portugal
CUF-Porto
🇵🇹Porto, Portugal
National Medical Research Center of Endocrinology
🇷🇺Moscow, Russian Federation
NSMU paediatric clinic
🇷🇺Novosibirsk, Russian Federation
Samara Regional Children Clinical Hospital n.a. N.N. Ivanova
🇷🇺Samara, Russian Federation
Siberian State Medical University
🇷🇺Tomsk, Russian Federation
Kantonsspital Olten
🇨🇭Olten, Switzerland
Kinderspital Endokrinologie, Zürich
🇨🇭Zürich, Switzerland