Obesity
Conditions
Brief summary
This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults. The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).
Interventions
DRUGSemaglutide
Semaglutide will be administered subcutaneously once weekly.
DRUGPlacebo
Placebo will be administered subcutaneously once-weekly.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 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) * Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years. b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1 * Body mass index (BMI), at screening and randomisation, corresponding to a) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (T2D) * History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months * Body weight of greater than 45 kilogram (kg) at screening and randomisation * For participants with T2D at screening, the following additional criterion applies: glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles per mole \[mmol/mol\]) as measured by central laboratory at screening
Exclusion criteria
* Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve has been removed greater than 1 year prior to screening * Type 1 diabetes mellitus or monogenic diabetes * Participants with endocrine, hypothalamic, or syndromic obesity * For participants with T2D at screening, the following additional key criterion applies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group Kids: Change in body mass index (BMI) | From baseline (week 0) to week 68 | Measured in percentage (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass | From week 0 to week 68 | Measured in % points |
| Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass | From week 0 to week 68 | Measured in % points |
| Group Kids and Group Teens: Relative change in visceral fat mass by DXA | From week 0 to week 68 | Measured in % |
| Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no) | From week 0 to week 68 | Measured in count of participants |
| Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no) | From week 0 to week 68 | Measured in count of participants |
| Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no) | From week 0 to week 68 | Measured in count of participants |
| Group Kids and Group Teens: Number of treatment emergent adverse events (AEs) | From week 0 to week 68 | Measured as count of events |
| Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs) | From week 0 to week 68 | Measured as count of events |
| Group Kids and Group Teens: Change in pulse | From week 0 to week 68 | Measured as beats per minute |
| Group Kids and Group Teens: Change in amylase | From week 0 to week 68 | Measured as units per liter (U/L) |
| Group Kids and Group Teens: Change in lipase | From week 0 to week 68 | Measured as U/L |
| Group Kids and Group Teens: Change in calcitonin | From week 0 to week 68 | Measured as nanograms per liter (ng/L) |
| Group Kids and Group Teens: Change in bone mineral density, by DXA | From week 0 to week 68 | Measured as grams per square centimeter (g/cm\^2) |
| Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only) | From week 0 to week 68 | Measured as count of episodes |
| Group Kids and Group Teens: Change in fasting insulin | From week 0 to week 68 | Measured in % |
| Group Kids: Improvement in weight category | From baseline (week 0) to week 68 | Measured as count of participants. Weight categories based on growth charts from Center for Disease Control (CDC).gov: Normal weight= BMI less than (\<) 85th percentile, Overweight= BMI greater than or equal to (\>=) 85th - \<95th percentile, Obesity class I= BMI \>=95th - \<120% of the 95th percentile, Obesity class II= BMI \>=120% - \<140% of the 95th percentile, Obesity class III= BMI \>=140% of the 95th percentile. |
| Group Teens: Change in BMI | From week 0 to week 68 | Measured in % |
| Group Kids and Group Teens: Change in BMI | From week 0 to week 104 | Measured in % |
| Group Teens: Improvement in weight category | From week 0 to week 68 | Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (\<) 85th percentile, Overweight= BMI greater than or equal to (\>=) 85th - \<95th percentile, Obesity class I= BMI \>=95th - \<120% of the 95th percentile, Obesity class II= BMI \>=120% - \<140% of the 95th percentile, Obesity class III= BMI \>=140% of the 95th percentile. |
| Group Kids and Group Teens: Improvement in weight category | From week 0 to week 104 | Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (\<) 85th percentile, Overweight= BMI greater than or equal to (\>=) 85th - \<95th percentile, Obesity class I= BMI \>=95th - \<120% of the 95th percentile, Obesity class II= BMI \>=120% - \<140% of the 95th percentile, Obesity class III= BMI \>=140% of the 95th percentile. |
| Group Kids and Group Teens: Change in body weight | From week 0 to week 68 | Measured in percentage |
| Group Kids and Group Teens: Change in BMI percentage of the 95th percentile | From week 0 to week 68 | Measured in percentage points |
| Group Kids and Group Teens: Change in BMI Standard deviation score (SDS) | From week 0 to week 68 | Measured as score on a scale. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. |
| Group Kids and Group Teens: Change in BMI SDS | From week 0 to week 104 | Measured as score in a scale. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. |
| Group Kids and Group Teens: Change in waist circumference | From week 0 to week 68 | Measured in centimeters (cm) |
| Group Kids and Group Teens: Change in systolic blood pressure | From week 0 to week 68 | Measured in millimeters of mercury (mmHg) |
| Group Kids and Group Teens: Change in diastolic blood pressure | From week 0 to week 68 | Measured in mmHg |
| Group Kids and Group Teens: Change in total cholesterol | From week 0 to week 68 | Measured in % |
| Group Kids and Group Teens: Change in high density lipoprotein (HDL) | From week 0 to week 68 | Measured in % |
| Group Kids and Group Teens: Change in low density lipoprotein (LDL) | From week 0 to week 68 | Measured in % |
| Group Kids and Group Teens: Change in very low density lipoprotein (VLDL) | From week 0 to week 68 | Measured in % |
| Group Kids and Group Teens: Change in triglycerides | From week 0 to week 68 | Measured in % |
| Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP) | From week 0 to week 68 | Measured in % |
| Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c) | From week 0 to week 68 | Measured in % point |
| Group Kids and Group Teens: Change in alanine transaminase (ALT) | From week 0 to week 68 | Measured in milliunits per liter (mU/L) |
| Group Kids and Group Teens: Change in fasting plasma glucose | From week 0 to week 68 | Measured in millimoles per liter (mmol/L) |
Countries
Austria, Belgium, Denmark, Germany, Israel, Mexico, Portugal, Sweden, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed