Obesity, Overweight
Conditions
Brief summary
This study will look at the change in teenagers' body weight from the start to the end of the study. This is to compare the effect on body weight in teenagers taking semaglutide (a new medicine) and teenagers taking dummy medicine. The teenagers in the study and their parents will also have talks with study staff about healthy food choices, how to be more physically active and what they can do to help the teenagers lose weight. The teenagers will either get semaglutide or dummy medicine - which treatment is decided by chance. The teenagers will take 1 injection every week, on the same day of the week for about 15 months. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The teenagers will have 17 clinic visits, will have blood samples taken and will have to complete questionnaires and keep a diary. All this will be explained before study start.
Interventions
DRUGSemaglutide
Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks
OTHERPlacebo
Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent of parent(s) or legally acceptable representative of subject and child assent, as 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, ages 12 to below 18 years at the time of signing informed consent * BMI equal to or above 95th percentile OR equal to or above 85th percentile (on gender and age-specific growth charts (CDC.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes * History of at least one self-reported unsuccessful dietary effort to lose weight For subjects with type 2 diabetes at screening the following inclusion criteria apply in addition: \- HbA1c equal to or below 10.0% (86 mmol/mol) as measured by central laboratory at screening
Exclusion criteria
* Prepubertal subjects (Tanner stage 1) * History of type 1 diabetes * A self-reported (or by parent(s)/legally acceptable representative where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes) * For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. 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 |
|---|---|---|
| Change in Body Mass Index (BMI) (Percentage [%]) | Baseline (week 0), week 68 | Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (Kilograms [kg]) | Baseline (week 0), week 68 | Change in body weight (kg) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Body Weight (%) | Baseline (week 0), week 68 | Change in body weight (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no) | At week 68 | Percentage of participants who achieved \>= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 10% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site. |
| Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no) | At week 68 | Percentage of participants who achieved \>= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 15% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site. |
| Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no) | At week 68 | Percentage of participants who achieved \>= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 20% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site. |
| Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}]) | Baseline (week 0), week 68 | Change from baseline in BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) at week 68 is presented. CDC gender and age-specific growth charts: normal (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% of the 95th percentile - \<140% of the 95th percentile) and obesity class III (BMI \>=140% of the 95th percentile). Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Percentage of Participants Achieving Improvement in Weight Category (Yes/no) | At week 68 | Percentage of participants who achieved improvement in weight category from baseline (week 0) to week 68 is presented. Improvement in weight category was defined as being in a lower weight category at week 68 compared to baseline according to CDC gender and age-specific growth charts: normal (BMI \<85th percentile), overweight (BMI \>=85th - \<95th percentile), obesity class I (BMI \>=95th - \<120% of the 95th percentile), obesity class II (BMI \>=120% of the 95th percentile - \<140% of the 95th percentile) and obesity class III (BMI \>=140% of the 95th percentile). In the reported data, 'Yes' infers the percentage of participants who have achieved improvement in weight category, whereas 'No' infers the percentage of participants who did not achieve improvement in weight category. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site. |
| Change in BMI (Standard Deviation Score [SDS]) | Baseline (week 0), week 68 | Change in BMI SDS from baseline to week 68 is presented. The SDS scores are also called as z-scores. 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 standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (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. Possible values range from -3 to +3, a negative score being beneficial. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in BMI (Kilograms Per Meter Square [kg/m^2]) | Baseline (week 0), week 68 | Change in BMI (kg/m\^2) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Waist Circumference | Baseline (week 0), week 68 | Change in waist circumference (centimeters \[cm\]) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no) | At week 68 | Percentage of participants who achieved \>= 5% reduction of BMI from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 5% BMI reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 5% BMI reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site. |
| Change in Systolic Blood Pressure | Baseline (week 0), week 68 | Change in systolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Diastolic Blood Pressure | Baseline (week 0), week 68 | Change in diastolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Glycated Haemoglobin (HbA1c) (%) | Baseline (week 0), week 68 | Change in HbA1c (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in HbA1c (Millimoles Per Mole [mmol/Mol]) | Baseline (week 0), week 68 | Change in HbA1c (mmol/mol) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L]) | Baseline (week 0), week 68 | Change in fasting plasma glucose (mmol/L) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL]) | Baseline (week 0), week 68 | Change in fasting plasma glucose (mg/dL) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline | Baseline (week 0), week 68 | Change in fasting insulin (pmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no) | At week 68 | Percentage of participants who achieved \>= 5% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 5% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 5% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site. |
| Change in Total Cholesterol (mmol/L): Ratio to Baseline | Baseline (week 0), week 68 | Change in total cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Total Cholesterol (mg/dL): Ratio to Baseline | Baseline (week 0), week 68 | Change in total cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline | Baseline (week 0), week 68: | Change in HDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline | Baseline (week 0), week 68 | Change in HDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline | Baseline (week 0), week 68 | Change in LDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in LDL Cholesterol (mg/dL): Ratio to Baseline | Baseline (week 0), week 68: | Change in LDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline | Baseline (week 0), week 68 | Change in VLDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in VLDL Cholesterol (mg/dL): Ratio to Baseline | Baseline (week 0), week 68 | Change in VLDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Triglycerides (mmol/L): Ratio to Baseline | Baseline (week 0), week 68 | Change in triglycerides (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Number of Treatment-emergent Adverse Events (TEAEs) | From baseline (week 0) to week 75 | An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as greater than (\>) 7 consecutive missed doses (corresponding to \>7 weeks off-treatment). |
| Change in Triglycerides (mg/dL): Ratio to Baseline | Baseline (week 0), week 68 | Change in triglycerides (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Change in Alanine Aminotransferase (ALT): Ratio to Baseline | Baseline (week 0), week 68 | Change in ALT (units per liter \[U/L\]) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
| Number of Treatment-emergent Serious Adverse Events (SAEs) | From baseline (week 0) to week 75 | An SAE is an AE that fulfils at least one of the following criteria: 1) results in death; 2) is life-threatening; 3) requires inpatient hospitalisation or prolongation of existing hospitalisation; 4) results in persistent disability/incapacity; 5) is a congenital anomaly/birth defect; 6) important medical event. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment). |
| Change in Pulse | Baseline (week 0), week 68 | Change in pulse from baseline to week 68 is presented. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment). |
| Change in Amylase: Ratio to Baseline | Baseline (week 0), week 68 | Change in amylase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment). |
| Change in Lipase: Ratio to Baseline | Baseline (week 0), week 68 | Change in lipase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment). |
| Change in Calcitonin: Ratio to Baseline | Baseline (week 0), week 68 | Change in calcitonin (nanograms per liter \[ng/L\]) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment). |
| Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline | Baseline (week 0), week 68 | Change in fasting insulin (mIU/mL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site. |
Countries
Austria, Belgium, Croatia, Ireland, Mexico, Russia, United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 37 sites in 8 countries, as follows: Austria (3), Belgium (4), Croatia (3), Ireland (1), Mexico (1), Russia (7), Great Britain (6), United States (12).
Pre-assignment details
Participants were randomized 2:1 to receive either semaglutide subcutaneously (s.c.) once weekly or semaglutide placebo s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks. This was followed by a 7-week follow-up period after 'end of treatment' due to the long half-life of semaglutide.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 2.4 mg Participants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks for 16 weeks until the target dose of 2.4 mg was reached which was maintained for a period of 52 weeks: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16) and 2.4 mg (week 17 to week 68). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 134 |
| Placebo Participants received once weekly s.c. injection of placebo matched to semaglutide for 68 weeks. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 67 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by parent/guardian | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 15.5 Years STANDARD_DEVIATION 1.5 | 15.3 Years STANDARD_DEVIATION 1.6 | 15.4 Years STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 8 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 120 Participants | 59 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black or African American | 11 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized Race Other | 14 Participants | 6 Participants | 20 Participants |
| Race/Ethnicity, Customized Race White | 104 Participants | 55 Participants | 159 Participants |
| Sex: Female, Male Female | 84 Participants | 41 Participants | 125 Participants |
| Sex: Female, Male Male | 50 Participants | 26 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 133 | 0 / 67 |
| other Total, other adverse events | 90 / 133 | 40 / 67 |
| serious Total, serious adverse events | 15 / 133 | 6 / 67 |
Outcome results
Primary
Change in Body Mass Index (BMI) (Percentage [%])
Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: The full analysis set (FAS) included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Mass Index (BMI) (Percentage [%]) | -16.2 Percentage change of BMI | Standard Deviation 12.9 |
| Placebo | Change in Body Mass Index (BMI) (Percentage [%]) | -0.1 Percentage change of BMI | Standard Deviation 8.6 |
Comparison: Responses were analyzed using an analysis of covariance model with randomized treatment, stratification groups (sex and Tanner stage at baseline) and the interaction between stratification groups as factors and baseline BMI as covariate.p-value: <0.000195% CI: [-20.27, -13.23]ANCOVA
Secondary
Change in Alanine Aminotransferase (ALT): Ratio to Baseline
Change in ALT (units per liter \[U/L\]) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Alanine Aminotransferase (ALT): Ratio to Baseline | 0.79 Ratio of ALT | Geometric Coefficient of Variation 63.8 |
| Placebo | Change in Alanine Aminotransferase (ALT): Ratio to Baseline | 1.00 Ratio of ALT | Geometric Coefficient of Variation 44.3 |
Secondary
Change in Amylase: Ratio to Baseline
Change in amylase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).
Time frame: Baseline (week 0), week 68
Population: SAS included all randomized participants exposed to at least one dose of randomized treatment.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Amylase: Ratio to Baseline | 1.15 Ratio of amylase | Geometric Coefficient of Variation 17.4 |
| Placebo | Change in Amylase: Ratio to Baseline | 1.04 Ratio of amylase | Geometric Coefficient of Variation 18.2 |
Secondary
Change in BMI (Kilograms Per Meter Square [kg/m^2])
Change in BMI (kg/m\^2) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in BMI (Kilograms Per Meter Square [kg/m^2]) | -5.9 kg/m^2 | Standard Deviation 4.9 |
| Placebo | Change in BMI (Kilograms Per Meter Square [kg/m^2]) | 0.0 kg/m^2 | Standard Deviation 3.1 |
Secondary
Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}])
Change from baseline in BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) at week 68 is presented. CDC gender and age-specific growth charts: normal (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% of the 95th percentile - \<140% of the 95th percentile) and obesity class III (BMI \>=140% of the 95th percentile). Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}]) | -24.9 Percentage point of BMI | Standard Deviation 17 |
| Placebo | Change in BMI Percentage of the 95th Percentile on Gender and Age-specific Growth Charts (CDC.Gov [CDC: {Centers for Disease Control and Prevention}]) | -4.5 Percentage point of BMI | Standard Deviation 10.5 |
Secondary
Change in BMI (Standard Deviation Score [SDS])
Change in BMI SDS from baseline to week 68 is presented. The SDS scores are also called as z-scores. 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 standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (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. Possible values range from -3 to +3, a negative score being beneficial. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in BMI (Standard Deviation Score [SDS]) | -1.1 standard deviation score | Standard Deviation 0.9 |
| Placebo | Change in BMI (Standard Deviation Score [SDS]) | -0.1 standard deviation score | Standard Deviation 0.5 |
Secondary
Change in Body Weight (%)
Change in body weight (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Weight (%) | -14.8 Percentage change of body weight | Standard Deviation 13.2 |
| Placebo | Change in Body Weight (%) | 2.3 Percentage change of body weight | Standard Deviation 9.1 |
Secondary
Change in Body Weight (Kilograms [kg])
Change in body weight (kg) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Body Weight (Kilograms [kg]) | -15.7 kg | Standard Deviation 14.6 |
| Placebo | Change in Body Weight (Kilograms [kg]) | 2.3 kg | Standard Deviation 9.7 |
Secondary
Change in Calcitonin: Ratio to Baseline
Change in calcitonin (nanograms per liter \[ng/L\]) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).
Time frame: Baseline (week 0), week 68
Population: SAS included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Calcitonin: Ratio to Baseline | 1.14 Ratio of calcitonin | Geometric Coefficient of Variation 47 |
| Placebo | Change in Calcitonin: Ratio to Baseline | 1.09 Ratio of calcitonin | Geometric Coefficient of Variation 36.7 |
Secondary
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Diastolic Blood Pressure | -2 mmHg | Standard Deviation 9 |
| Placebo | Change in Diastolic Blood Pressure | -1 mmHg | Standard Deviation 8 |
Secondary
Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline
Change in fasting insulin (mIU/mL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline | 0.64 Ratio of fasting insulin | Geometric Coefficient of Variation 62.9 |
| Placebo | Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline | 0.99 Ratio of fasting insulin | Geometric Coefficient of Variation 58.2 |
Secondary
Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline
Change in fasting insulin (pmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline | 0.64 Ratio of fasting insulin | Geometric Coefficient of Variation 62.9 |
| Placebo | Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline | 0.99 Ratio of fasting insulin | Geometric Coefficient of Variation 58.2 |
Secondary
Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])
Change in fasting plasma glucose (mg/dL) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL]) | -4.2 mg/dL | Standard Deviation 9.6 |
| Placebo | Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL]) | 0.0 mg/dL | Standard Deviation 8.6 |
Secondary
Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])
Change in fasting plasma glucose (mmol/L) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L]) | -0.2 mmol/L | Standard Deviation 0.5 |
| Placebo | Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L]) | 0.0 mmol/L | Standard Deviation 0.5 |
Secondary
Change in Glycated Haemoglobin (HbA1c) (%)
Change in HbA1c (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Glycated Haemoglobin (HbA1c) (%) | -0.4 Percentage of HbA1c | Standard Deviation 0.3 |
| Placebo | Change in Glycated Haemoglobin (HbA1c) (%) | -0.1 Percentage of HbA1c | Standard Deviation 0.3 |
Secondary
Change in HbA1c (Millimoles Per Mole [mmol/Mol])
Change in HbA1c (mmol/mol) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in HbA1c (Millimoles Per Mole [mmol/Mol]) | -4.2 mmol/mol | Standard Deviation 3.5 |
| Placebo | Change in HbA1c (Millimoles Per Mole [mmol/Mol]) | -1.2 mmol/mol | Standard Deviation 2.9 |
Secondary
Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline
Change in HDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline | 1.08 Ratio of HDL cholesterol | Geometric Coefficient of Variation 17.5 |
| Placebo | Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline | 1.03 Ratio of HDL cholesterol | Geometric Coefficient of Variation 21.5 |
Secondary
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline
Change in HDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68:
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline | 1.08 Ratio of HDL cholesterol | Geometric Coefficient of Variation 17.5 |
| Placebo | Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline | 1.03 Ratio of HDL cholesterol | Geometric Coefficient of Variation 21.5 |
Secondary
Change in LDL Cholesterol (mg/dL): Ratio to Baseline
Change in LDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68:
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in LDL Cholesterol (mg/dL): Ratio to Baseline | 0.91 Ratio of LDL cholesterol | Geometric Coefficient of Variation 20.9 |
| Placebo | Change in LDL Cholesterol (mg/dL): Ratio to Baseline | 0.96 Ratio of LDL cholesterol | Geometric Coefficient of Variation 15.4 |
Secondary
Change in Lipase: Ratio to Baseline
Change in lipase (U/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).
Time frame: Baseline (week 0), week 68
Population: SAS included all randomized participants exposed to at least one dose of randomized treatment.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Lipase: Ratio to Baseline | 1.39 Ratio of lipase | Geometric Coefficient of Variation 37.3 |
| Placebo | Change in Lipase: Ratio to Baseline | 1.12 Ratio of lipase | Geometric Coefficient of Variation 37 |
Secondary
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline
Change in LDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline | 0.91 Ratio of LDL cholesterol | Geometric Coefficient of Variation 20.9 |
| Placebo | Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline | 0.96 Ratio of LDL cholesterol | Geometric Coefficient of Variation 15.4 |
Secondary
Change in Pulse
Change in pulse from baseline to week 68 is presented. Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>2 consecutive missed doses (corresponding to \>2 weeks off-treatment).
Time frame: Baseline (week 0), week 68
Population: SAS included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Pulse | 0 Beats per minute (beats/min) | Standard Deviation 13 |
| Placebo | Change in Pulse | -1 Beats per minute (beats/min) | Standard Deviation 13 |
Secondary
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Systolic Blood Pressure | -3 millimeters of mercury (mmHg) | Standard Deviation 12 |
| Placebo | Change in Systolic Blood Pressure | -1 millimeters of mercury (mmHg) | Standard Deviation 9 |
Secondary
Change in Total Cholesterol (mg/dL): Ratio to Baseline
Change in total cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Total Cholesterol (mg/dL): Ratio to Baseline | 0.92 Ratio of total cholesterol | Geometric Coefficient of Variation 14.6 |
| Placebo | Change in Total Cholesterol (mg/dL): Ratio to Baseline | 0.98 Ratio of total cholesterol | Geometric Coefficient of Variation 9.4 |
Secondary
Change in Total Cholesterol (mmol/L): Ratio to Baseline
Change in total cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Total Cholesterol (mmol/L): Ratio to Baseline | 0.92 Ratio of total cholesterol | Geometric Coefficient of Variation 14.6 |
| Placebo | Change in Total Cholesterol (mmol/L): Ratio to Baseline | 0.98 Ratio of total cholesterol | Geometric Coefficient of Variation 9.4 |
Secondary
Change in Triglycerides (mg/dL): Ratio to Baseline
Change in triglycerides (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Triglycerides (mg/dL): Ratio to Baseline | 0.71 Ratio of triglycerides | Geometric Coefficient of Variation 45.8 |
| Placebo | Change in Triglycerides (mg/dL): Ratio to Baseline | 1.04 Ratio of triglycerides | Geometric Coefficient of Variation 40.9 |
Secondary
Change in Triglycerides (mmol/L): Ratio to Baseline
Change in triglycerides (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Triglycerides (mmol/L): Ratio to Baseline | 0.71 Ratio of triglycerides | Geometric Coefficient of Variation 45.8 |
| Placebo | Change in Triglycerides (mmol/L): Ratio to Baseline | 1.04 Ratio of triglycerides | Geometric Coefficient of Variation 40.9 |
Secondary
Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline
Change in VLDL cholesterol (mmol/L) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline | 0.71 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 46.1 |
| Placebo | Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline | 1.03 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 40.8 |
Secondary
Change in VLDL Cholesterol (mg/dL): Ratio to Baseline
Change in VLDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in VLDL Cholesterol (mg/dL): Ratio to Baseline | 0.71 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 46.1 |
| Placebo | Change in VLDL Cholesterol (mg/dL): Ratio to Baseline | 1.03 Ratio of VLDL cholesterol | Geometric Coefficient of Variation 40.8 |
Secondary
Change in Waist Circumference
Change in waist circumference (centimeters \[cm\]) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
Time frame: Baseline (week 0), week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Waist Circumference | -12.7 cm | Standard Deviation 12.2 |
| Placebo | Change in Waist Circumference | -0.5 cm | Standard Deviation 6.5 |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as greater than (\>) 7 consecutive missed doses (corresponding to \>7 weeks off-treatment).
Time frame: From baseline (week 0) to week 75
Population: The safety analysis set (SAS) included all randomized participants exposed to at least one dose of randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 2.4 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 792 Events |
| Placebo | Number of Treatment-emergent Adverse Events (TEAEs) | 328 Events |
Secondary
Number of Treatment-emergent Serious Adverse Events (SAEs)
An SAE is an AE that fulfils at least one of the following criteria: 1) results in death; 2) is life-threatening; 3) requires inpatient hospitalisation or prolongation of existing hospitalisation; 4) results in persistent disability/incapacity; 5) is a congenital anomaly/birth defect; 6) important medical event. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as \>7 consecutive missed doses (corresponding to \>7 weeks off-treatment).
Time frame: From baseline (week 0) to week 75
Population: SAS included all randomized participants exposed to at least one dose of randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Semaglutide 2.4 mg | Number of Treatment-emergent Serious Adverse Events (SAEs) | 17 Events |
| Placebo | Number of Treatment-emergent Serious Adverse Events (SAEs) | 7 Events |
Secondary
Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)
Percentage of participants who achieved \>= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 10% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.
Time frame: At week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 2.4 mg | Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no) | Yes | 61.8 Percentage of participants |
| Semaglutide 2.4 mg | Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no) | No | 38.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no) | Yes | 8.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no) | No | 91.9 Percentage of participants |
Secondary
Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)
Percentage of participants who achieved \>= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 15% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.
Time frame: At week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 2.4 mg | Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no) | Yes | 53.4 Percentage of participants |
| Semaglutide 2.4 mg | Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no) | No | 46.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no) | Yes | 4.8 Percentage of participants |
| Placebo | Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no) | No | 95.2 Percentage of participants |
Secondary
Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)
Percentage of participants who achieved \>= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 20% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.
Time frame: At week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 2.4 mg | Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no) | Yes | 37.4 Percentage of participants |
| Semaglutide 2.4 mg | Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no) | No | 62.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no) | Yes | 3.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no) | No | 96.8 Percentage of participants |
Secondary
Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)
Percentage of participants who achieved \>= 5% reduction of BMI from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 5% BMI reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 5% BMI reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.
Time frame: At week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 2.4 mg | Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no) | Yes | 75.6 Percentage of participants |
| Semaglutide 2.4 mg | Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no) | No | 24.4 Percentage of participants |
| Placebo | Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no) | Yes | 22.6 Percentage of participants |
| Placebo | Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no) | No | 77.4 Percentage of participants |
Secondary
Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)
Percentage of participants who achieved \>= 5% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the percentage of participants who have achieved \>= 5% weight reduction, whereas 'No' infers the percentage of participants who did not achieve \>= 5% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to last contact with trial site.
Time frame: At week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 2.4 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no) | Yes | 72.5 Percentage of participants |
| Semaglutide 2.4 mg | Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no) | No | 27.5 Percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no) | Yes | 17.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no) | No | 82.3 Percentage of participants |
Secondary
Percentage of Participants Achieving Improvement in Weight Category (Yes/no)
Percentage of participants who achieved improvement in weight category from baseline (week 0) to week 68 is presented. Improvement in weight category was defined as being in a lower weight category at week 68 compared to baseline according to CDC gender and age-specific growth charts: normal (BMI \<85th percentile), overweight (BMI \>=85th - \<95th percentile), obesity class I (BMI \>=95th - \<120% of the 95th percentile), obesity class II (BMI \>=120% of the 95th percentile - \<140% of the 95th percentile) and obesity class III (BMI \>=140% of the 95th percentile). In the reported data, 'Yes' infers the percentage of participants who have achieved improvement in weight category, whereas 'No' infers the percentage of participants who did not achieve improvement in weight category. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
Time frame: At week 68
Population: FAS included all randomized participants according to the intention-to-treat principle. Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Semaglutide 2.4 mg | Percentage of Participants Achieving Improvement in Weight Category (Yes/no) | Yes | 71.8 Percentage of participants |
| Semaglutide 2.4 mg | Percentage of Participants Achieving Improvement in Weight Category (Yes/no) | No | 28.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement in Weight Category (Yes/no) | Yes | 21.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Improvement in Weight Category (Yes/no) | No | 79.0 Percentage of participants |