Change in Body Mass Index (BMI) (Percentage [%])
| Group | Value (Percentage change of BMI) | Spread |
|---|---|---|
| Semaglutide 2.4 mg | -16.2 | 12.9 |
| Placebo | -0.1 | 8.6 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Austria, Belgium, Croatia, Ireland, Mexico, Russia, United Kingdom
1 trial · 1 completed · 1 with posted results
A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
NCT041021897 Oct 2019 to 28 Mar 2022
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Semaglutide
2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly
Placebo comparator
Placebo
Placebo injected s.c. once weekly .
Outcomes the sponsor listed as primary.
Change in Body Mass Index (BMI) (Percentage [%])
Time frame · 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.
Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)
Time frame · 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 Body Weight (Kilograms [kg])
Time frame · 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 (%)
Time frame · 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)
Time frame · 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)
Time frame · 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)
Time frame · 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}])
Time frame · 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)
Time frame · 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])
Time frame · 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])
Time frame · 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
Time frame · 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)
Time frame · 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
Time frame · 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
Time frame · 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) (%)
Time frame · 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])
Time frame · 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])
Time frame · 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])
Time frame · 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
Time frame · 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.
Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage change of BMI) | Spread |
|---|---|---|
| Semaglutide 2.4 mg | -16.2 | 12.9 |
| Placebo | -0.1 | 8.6 |
| Group | Value (Percentage of participants) |
|---|---|
| Semaglutide 2.4 mg | 72.5 |
| Placebo | 17.7 |
| Group | Value (kg) | Spread |
|---|---|---|
| Semaglutide 2.4 mg | -15.7 | 14.6 |
| Placebo | 2.3 | 9.7 |
| Group | Value (Percentage change of body weight) | Spread |
|---|---|---|
| Semaglutide 2.4 mg | -14.8 | 13.2 |
| Placebo | 2.3 | 9.1 |
| Group | Value (Percentage of participants) |
|---|---|
| Semaglutide 2.4 mg | 61.8 |
| Placebo | 8.1 |
| Group | Value (Percentage of participants) |
|---|---|
| Semaglutide 2.4 mg | 53.4 |
| Placebo | 4.8 |
| Group | Value (Percentage of participants) |
|---|---|
| Semaglutide 2.4 mg | 37.4 |
| Placebo | 3.2 |
| Group | Value (Percentage point of BMI) | Spread |
|---|---|---|
| Semaglutide 2.4 mg | -24.9 | 17.0 |
| Placebo | -4.5 | 10.5 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Semaglutide 2.4 mgParticipants received once weekly s.c. injection of semaglutide for 68 weeks. Participants initially received 0.25 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. | 0 / 133 | 15 / 133 | 90 / 133 |
| PlaceboParticipants 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. | 0 / 67 | 6 / 67 | 40 / 67 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2023
Kelly et al. 2023Obesity (Silver Spring, Md.)cited by 37
PMID 37196421DOI 10.1002/oby.23808PUB-37196421
Indexing hint: Randomized controlled trial · 2022
Weghuber et al. 2022The New England journal of medicinecited by 539
PMID 36322838PMC9997064DOI 10.1056/nejmoa2208601PUB-36322838
2 studies on this page
PubMed tag: none · 2023
Weghuber et al. 2023Journal of comparative effectiveness researchcited by 9
PMID 36534451PMC10288970DOI 10.2217/cer-2022-0187PUB-36534451
Indexing hint: Review · 2022
Cuda et al. 2022Current opinion in pediatricscited by 11
PMID 35797460DOI 10.1097/mop.0000000000001150PUB-35797460
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