A Phase 3 interventional study of Semaglutide and Placebo in Overweight and Obesity, sponsored by Novo Nordisk A/S. Completed at 51 sites in 8 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
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.
3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.
This study's enrollment of 201 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly
Drug: Semaglutide
Placebo injected s.c. once weekly .
Other: Placebo
Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks
Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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:
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
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
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:
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
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
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
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
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
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
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
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
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
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
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
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).
| Milestone | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Started | 134 | 67 |
| Treated | 133 | 67 |
| Full analysis set (fas) | 134 | 67 |
| Safety analysis set | 133 | 67 |
| Completed | 132 | 64 |
| Not completed | 2 | 3 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Withdrawal by parent/guardian | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| Percentage change of BMI | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Body Mass Index (BMI) (Percentage [%]) | -16.2 ± 12.9 | -0.1 ± 8.6 |
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.
| Percentage of participants | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Yes | 72.5 | 17.7 |
| No | 27.5 | 82.3 |
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.
| kg | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Body Weight (Kilograms [kg]) | -15.7 ± 14.6 | 2.3 ± 9.7 |
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 change of body weight | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Body Weight (%) | -14.8 ± 13.2 | 2.3 ± 9.1 |
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 | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Yes | 61.8 | 8.1 |
| No | 38.2 | 91.9 |
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 | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Yes | 53.4 | 4.8 |
| No | 46.6 | 95.2 |
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.
| Percentage of participants | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Yes | 37.4 | 3.2 |
| No | 62.6 | 96.8 |
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 point of BMI | Semaglutide 2.4 mg | 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}]) | -24.9 ± 17.0 | -4.5 ± 10.5 |
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.
| Percentage of participants | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Yes | 71.8 | 21.0 |
| No | 28.2 | 79.0 |
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.
| standard deviation score | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in BMI (Standard Deviation Score [SDS]) | -1.1 ± 0.9 | -0.1 ± 0.5 |
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.
| kg/m^2 | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in BMI (Kilograms Per Meter Square [kg/m^2]) | -5.9 ± 4.9 | 0.0 ± 3.1 |
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.
| cm | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Waist Circumference | -12.7 ± 12.2 | -0.5 ± 6.5 |
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.
| Percentage of participants | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Yes | 75.6 | 22.6 |
| No | 24.4 | 77.4 |
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.
| millimeters of mercury (mmHg) | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Systolic Blood Pressure | -3 ± 12 | -1 ± 9 |
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.
| mmHg | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Diastolic Blood Pressure | -2 ± 9 | -1 ± 8 |
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.
| Percentage of HbA1c | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) (%) | -0.4 ± 0.3 | -0.1 ± 0.3 |
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.
| mmol/mol | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in HbA1c (Millimoles Per Mole [mmol/Mol]) | -4.2 ± 3.5 | -1.2 ± 2.9 |
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.
| mmol/L | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L]) | -0.2 ± 0.5 | 0.0 ± 0.5 |
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.
| mg/dL | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL]) | -4.2 ± 9.6 | 0.0 ± 8.6 |
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.
| Ratio of fasting insulin | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline | 0.64 ± 62.9 | 0.99 ± 58.2 |
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.
| Ratio of fasting insulin | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline | 0.64 ± 62.9 | 0.99 ± 58.2 |
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.
| Ratio of total cholesterol | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Total Cholesterol (mmol/L): Ratio to Baseline | 0.92 ± 14.6 | 0.98 ± 9.4 |
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.
| Ratio of total cholesterol | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Total Cholesterol (mg/dL): Ratio to Baseline | 0.92 ± 14.6 | 0.98 ± 9.4 |
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.
| Ratio of HDL cholesterol | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline | 1.08 ± 17.5 | 1.03 ± 21.5 |
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.
| Ratio of HDL cholesterol | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline | 1.08 ± 17.5 | 1.03 ± 21.5 |
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.
| Ratio of LDL cholesterol | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline | 0.91 ± 20.9 | 0.96 ± 15.4 |
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.
| Ratio of LDL cholesterol | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in LDL Cholesterol (mg/dL): Ratio to Baseline | 0.91 ± 20.9 | 0.96 ± 15.4 |
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.
| Ratio of VLDL cholesterol | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline | 0.71 ± 46.1 | 1.03 ± 40.8 |
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.
| Ratio of VLDL cholesterol | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in VLDL Cholesterol (mg/dL): Ratio to Baseline | 0.71 ± 46.1 | 1.03 ± 40.8 |
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.
| Ratio of triglycerides | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Triglycerides (mmol/L): Ratio to Baseline | 0.71 ± 45.8 | 1.04 ± 40.9 |
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.
| Ratio of triglycerides | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Triglycerides (mg/dL): Ratio to Baseline | 0.71 ± 45.8 | 1.04 ± 40.9 |
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.
| Ratio of ALT | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Alanine Aminotransferase (ALT): Ratio to Baseline | 0.79 ± 63.8 | 1.00 ± 44.3 |
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).
| Events | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) | 792 | 328 |
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).
| Events | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Number of Treatment-emergent Serious Adverse Events (SAEs) | 17 | 7 |
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).
| Beats per minute (beats/min) | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Pulse | 0 ± 13 | -1 ± 13 |
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).
| Ratio of amylase | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Amylase: Ratio to Baseline | 1.15 ± 17.4 | 1.04 ± 18.2 |
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).
| Ratio of lipase | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Lipase: Ratio to Baseline | 1.39 ± 37.3 | 1.12 ± 37.0 |
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).
| Ratio of calcitonin | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| Change in Calcitonin: Ratio to Baseline | 1.14 ± 47.0 | 1.09 ± 36.7 |
Collected over From baseline (week 0) to week 75. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Semaglutide 2.4 mg | 0/133 (0%) | 15/133 (11.3%) | 90/133 (67.7%) |
| Placebo | 0/67 (0%) | 6/67 (9%) | 40/67 (59.7%) |
| Event | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| CholelithiasisHepatobiliary disorders | 3/133 | 0/67 |
| AppendicitisInfections and infestations | 2/133 | 0/67 |
| Abdominal pain upperGastrointestinal disorders | 0/133 | 1/67 |
| Clavicle fractureInjury, poisoning and procedural complications | 0/133 | 1/67 |
| ContusionInjury, poisoning and procedural complications | 0/133 | 1/67 |
| Loss of consciousnessNervous system disorders | 0/133 | 1/67 |
| Ovarian germ cell teratoma benignNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/133 | 1/67 |
| Tension headacheNervous system disorders | 0/133 | 1/67 |
| Transaminases increasedInvestigations | 1/133 | 1/67 |
| Abdominal painGastrointestinal disorders | 1/133 | 0/67 |
| Event | Semaglutide 2.4 mg | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 56/133 | 12/67 |
| VomitingGastrointestinal disorders | 48/133 | 7/67 |
| DiarrhoeaGastrointestinal disorders | 29/133 | 13/67 |
| HeadacheNervous system disorders | 22/133 | 11/67 |
| Abdominal painGastrointestinal disorders | 20/133 | 4/67 |
| COVID-19Infections and infestations | 15/133 | 10/67 |
| NasopharyngitisInfections and infestations | 16/133 | 7/67 |
| Abdominal pain upperGastrointestinal disorders | 11/133 | 8/67 |
| DizzinessNervous system disorders | 10/133 | 2/67 |
| FatigueGeneral disorders | 4/133 | 5/67 |
The full analysis set (FAS) included all randomized participants according to the intention-to-treat principle.
| Age, Continuous(Years) | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|
| Mean | 15.5 ± 1.5 | 15.3 ± 1.6 | 15.4 ± 1.6 |
| Sex: Female, Male(Participants) | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|
| Female | 84 | 41 | 125 |
| Male | 50 | 26 | 76 |
| Ethnicity (NIH/OMB)(Participants) | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 8 | 22 |
| Not Hispanic or Latino | 120 | 59 | 179 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Semaglutide 2.4 mg | Placebo | Total |
|---|---|---|---|
| Race — White | 104 | 55 | 159 |
| Race — Other | 14 | 6 | 20 |
| Race — Black or African American | 11 | 5 | 16 |
| Race — Asian | 3 | 1 | 4 |
| Race — American Indian or Alaska Native | 2 | 0 | 2 |
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