Obesity
Conditions
Brief summary
The study is testing how well semaglutide can help adolescents with excess body weight to lose weight and to maintain weight loss. All participants in the study will receive semaglutide as a weekly injection. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. All participants will get semaglutide treatment for a minimum of 3 years.
Interventions
DRUGSemaglutide
Participants will receive semaglutide s.c(under the skin) once weekly.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent 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: 1. The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements 2. The participant must sign and date the Child Assent Form or provide oral assent, according to local requirements * Age 12 to less than 15 years at the time of signing the informed consent * BMI greater than or equal to 95th percentile at screening * Body weight greater than 60 kg at screening
Exclusion criteria
* Prepubertal status (Tanner stage 1) * 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: 1. Liposuction and/or abdominoplasty, if performed more than 1 year prior to screening 2. Adjustable gastric banding, if the band has been removed more than 1 year prior to screening 3. Intragastric balloon, if the balloon has been removed more than 1 year prior to screening 4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed more than 1 year prior to screening * Endocrine, hypothalamic, or syndromic obesity * History of type 1 or type 2 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Body Mass Index (BMI) below obesity threshold | From 1.5 years to 3 years | Measures as count of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of improved Body Mass Index (BMI) category | From 1.5 years to 3 years and end of continued treatment phase (up to 6 years) | Measured as count of participants |
| Tapering to zero dose | From 1.5 years to 3 years | Measured as count of participants |
| Time/dose steps before ending dose tapering | From 1.5 years to 3 years | Measured in weeks, count of dose steps |
| Achieving Body Mass Index (BMI) below obesity threshold | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) | Measured as count of participants |
| Achieving any improvement in Body Mass Index (BMI) category | From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years) | Measured as count of participants |
| Change in Body Mass Index (BMI) | From baseline (day 0) to 1.5 and 3 years | Measured in percentage (%) |
| Body Mass Index (BMI) percentage of the 95th percentile | From baseline (day 0) to 1.5 and 3 years | Measured in percentage (%) |
| Change in Body Mass Index Standard Deviation Score (BMI SDS) | From baseline (day 0) to 1.5 and 3 years | Unitless |
| Change in waist-to-height ratio (waist [cm]/ height [cm]) | From baseline (day 0) to 1.5 and 3 years | Unitless |
| Change in waist circumference | From baseline (day 0) to 1.5 and 3 years | Measured in centimeters (cm) |
| Change in HbA1c | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) | Measured in percentage (%) points |
| Change in fasting plasma glucose | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) | Measured in millimol per liter (mmol/L), milligram per deciliter (mg/dL) |
| Change in fasting insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) | Measured in percentage (%) |
| Change in high sensitivity C-reactive protein (hsCRP) | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) | Measured in percentage (%) |
| Change in alanine aminotransferase (ALT), total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), very low-density lipoprotein (VLDL) and triglycerides | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) | Measured in percentage (%) |
| Change in systolic and diastolic blood pressure | From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years) | Measured in millimetres of mercury (mmHg) |
| Change in fat mass, by dual X-ray absorptiometry (DXA) relative to total body mass | From baseline (day 0) to 1.5 and 3 years | Measured in percentage (%) points |
| Change in lean body mass, by dual X-ray absorptiometry (DXA) relative to total body mass | From baseline (day 0) to 1.5 and 3 years | Measured in percentage (%) points |
| Relative change in visceral fat mass, by dual X-ray absorptiometry (DXA) | From baseline (day 0) to 1.5 and 3 years | Measured in percentage (%) |
| Serious Adverse Event (SAE) | From baseline (day 0) to 1.5 years, from 1.5 to 3 years, and from 3 years to end of continued treatment phase (up to 6 years) | Count |
Countries
Belgium, Canada, Denmark, France, Germany, Greece, Italy, Mexico, Poland, Saudi Arabia, Sweden, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed