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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

NCTNCT04102189 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4451Other idU1111-1215-7560Other id2018-002431-18Other id2018

Overview

Status
Completed
Phase
Phase 3
Enrollment
201 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
8 countries

United States, Austria, Belgium, Croatia, Ireland, Mexico, Russia, United Kingdom

Start
7 Oct 2019
Primary completion
25 Mar 2022
Completion
28 Mar 2022
First posted
25 Sept 2019
Last update posted
11 Dec 2025
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020202120222023
  1. Ph 3

    A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

    NCT04102189

    7 Oct 2019 to 28 Mar 2022

Registry summary

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.

Interventions

  • SemaglutideDrug
  • PlaceboOther

Arms2

  • 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 .

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Body Mass Index (BMI) (Percentage [%])

    Time frame · Baseline (week 0), week 68

    Registry description

    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 outcomes(20)
  1. Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)

    Time frame · At week 68

    Registry description

    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.

  2. Change in Body Weight (Kilograms [kg])

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  3. Change in Body Weight (%)

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  4. Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)

    Time frame · At week 68

    Registry description

    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.

  5. Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)

    Time frame · At week 68

    Registry description

    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.

  6. Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)

    Time frame · At week 68

    Registry description

    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.

  7. 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

    Registry description

    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.

  8. Percentage of Participants Achieving Improvement in Weight Category (Yes/no)

    Time frame · At week 68

    Registry description

    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.

  9. Change in BMI (Standard Deviation Score [SDS])

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  10. Change in BMI (Kilograms Per Meter Square [kg/m^2])

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  11. Change in Waist Circumference

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  12. Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)

    Time frame · At week 68

    Registry description

    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.

  13. Change in Systolic Blood Pressure

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  14. Change in Diastolic Blood Pressure

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  15. Change in Glycated Haemoglobin (HbA1c) (%)

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  16. Change in HbA1c (Millimoles Per Mole [mmol/Mol])

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  17. Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  18. Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  19. Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

  20. Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline

    Time frame · Baseline (week 0), week 68

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (week 0), week 68

Change in Body Mass Index (BMI) (Percentage [%])

GroupValue (Percentage change of BMI)Spread
Semaglutide 2.4 mg-16.212.9
Placebo-0.18.6
Secondary and other outcome results(7)
Secondary outcomeNumber· At week 68

Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)

GroupValue (Percentage of participants)
Semaglutide 2.4 mg72.5
Placebo17.7
Secondary outcomeMean· Baseline (week 0), week 68

Change in Body Weight (Kilograms [kg])

GroupValue (kg)Spread
Semaglutide 2.4 mg-15.714.6
Placebo2.39.7
Secondary outcomeMean· Baseline (week 0), week 68

Change in Body Weight (%)

GroupValue (Percentage change of body weight)Spread
Semaglutide 2.4 mg-14.813.2
Placebo2.39.1
Secondary outcomeNumber· At week 68

Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)

GroupValue (Percentage of participants)
Semaglutide 2.4 mg61.8
Placebo8.1
Secondary outcomeNumber· At week 68

Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)

GroupValue (Percentage of participants)
Semaglutide 2.4 mg53.4
Placebo4.8
Secondary outcomeNumber· At week 68

Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)

GroupValue (Percentage of participants)
Semaglutide 2.4 mg37.4
Placebo3.2
Secondary outcomeMean· Baseline (week 0), 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}])

GroupValue (Percentage point of BMI)Spread
Semaglutide 2.4 mg-24.917.0
Placebo-4.510.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 13315 / 13390 / 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 / 676 / 6740 / 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

Studies4

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2023

3 results

Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg.

Kelly et al. 2023Obesity (Silver Spring, Md.)cited by 37

PMID 37196421DOI 10.1002/oby.23808PUB-37196421

Full text at the publisher3 results

Indexing hint: Randomized controlled trial · 2022

10 results

Once-Weekly Semaglutide in Adolescents with Obesity.

Weghuber et al. 2022The New England journal of medicinecited by 539

PMID 36322838PMC9997064DOI 10.1056/nejmoa2208601PUB-36322838

Rights unknown10 results

More studies

2 studies on this page

PubMed tag: none · 2023

Semaglutide treatment for obesity in teenagers: a plain language summary of the STEP TEENS research study.

Weghuber et al. 2023Journal of comparative effectiveness researchcited by 9

PMID 36534451PMC10288970DOI 10.2217/cer-2022-0187PUB-36534451

CC BY
Download PDF

Indexing hint: Review · 2022

Progress in pediatric obesity: new and advanced therapies.

Cuda et al. 2022Current opinion in pediatricscited by 11

PMID 35797460DOI 10.1097/mop.0000000000001150PUB-35797460

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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