OverweightPhase 3NCT04102189
A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 51 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 51 sitesin 8 countries
- Study dates
- 7 Oct 2019to 28 Mar 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
51 sites in 8 countries.
51 sites in 8 countries
United States23 sites
Barry J. Reiner, MD LLC
Baltimore, Maryland, 21229
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, 70808-4124
Massachusetts General Hospital_Cary
Boston, Massachusetts, 02114-2621
UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, 14203
Aventiv Research Inc
Columbus, Ohio, 43213
Geisinger Clinic
Danville, Pennsylvania, 17822-2111
PriMed Clinical Research
Dayton, Ohio, 45419
Valley Weight Loss Clinic
Fargo, North Dakota, 58104
Medical Research South, LLC_Cary
Goose Creek, South Carolina, 29445
Greenville Hospital System Pediatric Endo
Greenville, South Carolina, 29615
DelRicht Research
Gretna, Louisiana, 70053
Discovery MM Services, Inc
Houston, Texas, 77061
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, 90027
Marshfield Clinic
Marshfield, Wisconsin, 54449
Solaris Clinical Research
Meridian, Idaho, 83646
University of Minnesota_CPOM
Minneapolis, Minnesota, 55414
University of Minnesota_Minneapolis
Minneapolis, Minnesota, 55455
Children's Hosptl Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, 15224
WakeMed Childn Endo-Dbt_Raleig
Raleigh, North Carolina, 27610
Monument Health Clinical Rsrch
Rapid City, South Dakota, 57701
National Clin Res Inc.
Richmond, Virginia, 23294
Univ Of Texas Hlth Science Cntr
San Antonio, Texas, 78229
Russia7 sites
Republic Children's Hospital of Ministry of Health of Udmurt
Izhevsk, 426009
RMAPE
Moscow, 125373
NSMU paediatric clinic
Novosibirsk, 630048
FSBEI of Higher Education "Rostov State Medical University"
Rostov-on-Don, 344013
City Children Endocrinology Center n.a. Raukhfus
Saint Petersburg, 191036
SPSBHI City Children out-patient clinic #44
Saint Petersburg, 191144
Siberian State Medical University
Tomsk, 634050
United Kingdom6 sites
Birmingham Children's Hospital
Birmingham, B4 6NH
University Hospitals Bristol & Weston NHS Foundation Trust
Bristol, BS2 8AE
University College Hospital Hospital - Paediatric Services
London, WC1E 6DB
Clifton Medical Centre
Rotherham, South Yorkshire, S65 1DA
Ecclesfield Group Practice
Sheffield, S35 9XQ
Southampton General Hospital
Southampton, SO16 6YD
Belgium4 sites
UZ Brussel
Brussels, 1090
Cliniques Universitaires Saint-Luc - Serv. Pédiatrie
Brussels, 1200
UZA - UZ Antwerpen - Kinderziekenhuis
Edegem, 2650
UZ Leuven - Kindergeneeskunde
Leuven, 3000
Ireland4 sites
Clinical Research Centre, St. Vincent's University Hospital,
Dublin, Leinster, D04 T6F4
CHI Crumlin Dept of Endocrinology
Dublin, D12 N512
CRF HRB - Galway
Galway, H91 YR71
Wexford General Hospital - UCD CRC
Wexford, Y35 Y17D
Austria3 sites
Fließer-Görzer [Ordination]
Saint Stefan, 8511
Universitätsklinik für Kinder und Jugendheilkunde Haus E
Salzburg, 5020
Ordination Dr. Hanusch
Vienna, 1060
Croatia3 sites
Klinički bolnički centar Rijeka, pedijatrija
Rijeka, 51000
KBC "Sestre Milosrdnice"
Zagreb, 10 000
KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes
Zagreb, 10000
About this study
Official title: Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity
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.
- Conditions
- Overweight, Obesity
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks
PlaceboOther
Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | 2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Placebo injected s.c. once weekly . Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0), week 68
Secondary outcomes (37)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (week 0), week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start7 Oct 2019
- Primary completion25 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102189
- Sponsor's protocol ID
- NN9536-4451
- Other IDs
- U1111-1215-7560, 2018-002431-18, 2018
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2019
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Weghuber D, Barrett T, Barrientos-Perez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sorrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Dec 15;387(24):2245-2257. doi: 10.1056/NEJMoa2208601. Epub 2022 Nov 2.
PubMed 36322838Kelly AS, Arslanian S, Hesse D, Iversen AT, Korner A, Schmidt S, Sorrig R, Weghuber D, Jastreboff AM. Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg. Obesity (Silver Spring). 2023 Aug;31(8):2139-2149. doi: 10.1002/oby.23808. Epub 2023 Jul 9.
PubMed 37196421Weghuber D, Boberg K, Hesse D, Jeppesen OK, Sorrig R, Kelly AS; STEP TEENS Investigators. Semaglutide treatment for obesity in teenagers: a plain language summary of the STEP TEENS research study. J Comp Eff Res. 2023 Feb;12(2):e220187. doi: 10.2217/cer-2022-0187. Epub 2022 Dec 19.
PubMed 36534451Cuda S, Censani M. Progress in pediatric obesity: new and advanced therapies. Curr Opin Pediatr. 2022 Aug 1;34(4):407-413. doi: 10.1097/MOP.0000000000001150. Epub 2022 Jul 5.
PubMed 35797460
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT04102189
- Acronym / sponsor ID
- NN9536-4451
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly |
| Placebo | Placebo comparator | Other: PlaceboPlacebo injected s.c. once weekly . |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideParticipants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks | Drug | Semaglutide |
| PlaceboParticipants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks | Other | Placebo |
Primary outcome
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.
37 secondary outcomes
Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)
Time frame: At week 68
Change in Body Weight (Kilograms [kg])
Time frame: Baseline (week 0), week 68
Change in Body Weight (%)
Time frame: Baseline (week 0), week 68
Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)
Time frame: At week 68
Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)
Time frame: At week 68
Percentage of Participants Achieving >=20% Reduction of Body Weight (Yes/no)
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}])
Time frame: Baseline (week 0), week 68
Percentage of Participants Achieving Improvement in Weight Category (Yes/no)
Time frame: At week 68
Change in BMI (Standard Deviation Score [SDS])
Time frame: Baseline (week 0), week 68
Change in BMI (Kilograms Per Meter Square [kg/m^2])
Time frame: Baseline (week 0), week 68
Change in Waist Circumference
Time frame: Baseline (week 0), week 68
Percentage of Participants Achieving >=5% Reduction of BMI (Yes/no)
Time frame: At week 68
Change in Systolic Blood Pressure
Time frame: Baseline (week 0), week 68
Change in Diastolic Blood Pressure
Time frame: Baseline (week 0), week 68
Change in Glycated Haemoglobin (HbA1c) (%)
Time frame: Baseline (week 0), week 68
Change in HbA1c (Millimoles Per Mole [mmol/Mol])
Time frame: Baseline (week 0), week 68
Change in Fasting Plasma Glucose (Millimoles Per Liter [mmol/L])
Time frame: Baseline (week 0), week 68
Change in Fasting Plasma Glucose (Milligrams Per Deciliter [mg/dL])
Time frame: Baseline (week 0), week 68
Change in Fasting Insulin (Picomoles Per Liter [Pmol/L]): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in Fasting Insulin (Milli International Units Per Milliliter [mIU/mL]): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in Total Cholesterol (mmol/L): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in Total Cholesterol (mg/dL): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L): Ratio to Baseline
Time frame: Baseline (week 0), week 68:
Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in LDL Cholesterol (mg/dL): Ratio to Baseline
Time frame: Baseline (week 0), week 68:
Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in VLDL Cholesterol (mg/dL): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in Triglycerides (mmol/L): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in Triglycerides (mg/dL): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in Alanine Aminotransferase (ALT): Ratio to Baseline
Time frame: Baseline (week 0), week 68
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: From baseline (week 0) to week 75
Number of Treatment-emergent Serious Adverse Events (SAEs)
Time frame: From baseline (week 0) to week 75
Change in Pulse
Time frame: Baseline (week 0), week 68
Change in Amylase: Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in Lipase: Ratio to Baseline
Time frame: Baseline (week 0), week 68
Change in Calcitonin: Ratio to Baseline
Time frame: Baseline (week 0), week 68
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36322838Weghuber D, Barrett T, Barrientos-Perez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sorrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Dec 15;387(24):2245-2257. doi: 10.1056/NEJMoa2208601. Epub 2022 Nov 2.
- Derived from this study: PubMed 37196421Kelly AS, Arslanian S, Hesse D, Iversen AT, Korner A, Schmidt S, Sorrig R, Weghuber D, Jastreboff AM. Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg. Obesity (Silver Spring). 2023 Aug;31(8):2139-2149. doi: 10.1002/oby.23808. Epub 2023 Jul 9.
- Derived from this study: PubMed 36534451Weghuber D, Boberg K, Hesse D, Jeppesen OK, Sorrig R, Kelly AS; STEP TEENS Investigators. Semaglutide treatment for obesity in teenagers: a plain language summary of the STEP TEENS research study. J Comp Eff Res. 2023 Feb;12(2):e220187. doi: 10.2217/cer-2022-0187. Epub 2022 Dec 19.
- Derived from this study: PubMed 35797460Cuda S, Censani M. Progress in pediatric obesity: new and advanced therapies. Curr Opin Pediatr. 2022 Aug 1;34(4):407-413. doi: 10.1097/MOP.0000000000001150. Epub 2022 Jul 5.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
51 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 51 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Russia, United Kingdom, Belgium, Ireland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (Percentage [%]) (time frame: Baseline (week 0), week 68). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102189, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.