- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04102189
A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
December 29, 2023 updated by: Novo Nordisk A/S
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
201
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint Stefan, Austria, 8511
- Novo Nordisk Investigational Site
-
Salzburg, Austria, 5020
- Novo Nordisk Investigational Site
-
Wien, Austria, 1060
- Novo Nordisk Investigational Site
-
-
-
-
-
Brussel, Belgium, 1090
- Novo Nordisk Investigational Site
-
Bruxelles, Belgium, 1200
- Novo Nordisk Investigational Site
-
Edegem, Belgium, 2650
- Novo Nordisk Investigational Site
-
Leuven, Belgium, 3000
- Novo Nordisk Investigational Site
-
-
-
-
-
Rijeka, Croatia, 51000
- Novo Nordisk Investigational Site
-
Zagreb, Croatia, 10 000
- Novo Nordisk Investigational Site
-
Zagreb, Croatia, 10000
- Novo Nordisk Investigational Site
-
-
-
-
Leinster
-
Dublin, Leinster, Ireland, D04 T6F4
- Novo Nordisk Investigational Site
-
-
-
-
-
Puebla, Mexico, 72190
- Novo Nordisk Investigational Site
-
-
-
-
-
Izhevsk, Russian Federation, 426009
- Novo Nordisk Investigational Site
-
Moscow, Russian Federation, 125373
- Novo Nordisk Investigational Site
-
Novosibirsk, Russian Federation, 630048
- Novo Nordisk Investigational Site
-
Rostov-on-Don, Russian Federation, 344013
- Novo Nordisk Investigational Site
-
Saint-Petersburg, Russian Federation, 191144
- Novo Nordisk Investigational Site
-
Saint-Petersburg, Russian Federation, 191036
- Novo Nordisk Investigational Site
-
Tomsk, Russian Federation, 634050
- Novo Nordisk Investigational Site
-
-
-
-
-
Birmingham, United Kingdom, B4 6NH
- Novo Nordisk Investigational Site
-
Bristol, United Kingdom, BS2 8AE
- Novo Nordisk Investigational Site
-
London, United Kingdom, WC1E 6DB
- Novo Nordisk Investigational Site
-
Sheffield, United Kingdom, S35 9XQ
- Novo Nordisk Investigational Site
-
Southampton, United Kingdom, SO16 6YD
- Novo Nordisk Investigational Site
-
-
South Yorkshire
-
Rotherham, South Yorkshire, United Kingdom, S65 1DA
- Novo Nordisk Investigational Site
-
-
-
-
Idaho
-
Meridian, Idaho, United States, 83646
- Novo Nordisk Investigational Site
-
-
Maryland
-
Baltimore, Maryland, United States, 21229
- Novo Nordisk Investigational Site
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114-2621
- Novo Nordisk Investigational Site
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- Novo Nordisk Investigational Site
-
-
New York
-
Buffalo, New York, United States, 14203
- Novo Nordisk Investigational Site
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27610
- Novo Nordisk Investigational Site
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- Novo Nordisk Investigational Site
-
-
Ohio
-
Columbus, Ohio, United States, 43213
- Novo Nordisk Investigational Site
-
Dayton, Ohio, United States, 45419
- Novo Nordisk Investigational Site
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15224
- Novo Nordisk Investigational Site
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- Novo Nordisk Investigational Site
-
-
Wisconsin
-
Marshfield, Wisconsin, United States, 54449
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Semaglutide
2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly
|
Participants will receive semaglutide s.c.
once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks
|
Placebo Comparator: Placebo
Placebo injected s.c.
once weekly .
|
Participants will receive semaglutide placebo s.c.
once weekly for a total of 68 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (week 0), week 68
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At week 68
|
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.
|
Baseline (week 0), week 68
|
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.
|
Baseline (week 0), week 68
|
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.
|
At week 68
|
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.
|
At week 68
|
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.
|
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
|
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.
|
Baseline (week 0), week 68
|
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.
|
At week 68
|
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.
|
Baseline (week 0), week 68
|
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.
|
Baseline (week 0), week 68
|
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.
|
Baseline (week 0), week 68
|
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.
|
At week 68
|
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.
|
Baseline (week 0), week 68
|
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.
|
Baseline (week 0), week 68
|
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.
|
Baseline (week 0), week 68
|
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.
|
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 (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.
|
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 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.
|
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 (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.
|
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 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.
|
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 (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.
|
Baseline (week 0), week 68
|
Change in Total Cholesterol (mg/dL): Ratio to Baseline
Time Frame: Baseline (week 0), week 68
|
Change in total cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
|
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 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.
|
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 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.
|
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 (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.
|
Baseline (week 0), week 68
|
Change in LDL Cholesterol (mg/dL): Ratio to Baseline
Time Frame: Baseline (week 0), week 68:
|
Change in LDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
|
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 (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.
|
Baseline (week 0), week 68
|
Change in VLDL Cholesterol (mg/dL): Ratio to Baseline
Time Frame: Baseline (week 0), week 68
|
Change in VLDL cholesterol (mg/dL) from baseline to week 68 is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
|
Baseline (week 0), week 68
|
Change in Triglycerides (mmol/L): Ratio to Baseline
Time Frame: Baseline (week 0), week 68
|
Change in triglycerides (mmol/L) from baseline to week 68 is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
|
Baseline (week 0), week 68
|
Change in Triglycerides (mg/dL): Ratio to Baseline
Time Frame: Baseline (week 0), week 68
|
Change in triglycerides (mg/dL) from baseline to week 68 is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
|
Baseline (week 0), week 68
|
Change in Alanine Aminotransferase (ALT): Ratio to Baseline
Time Frame: Baseline (week 0), week 68
|
Change in ALT (units per liter [U/L]) from baseline to week 68 is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.
|
Baseline (week 0), week 68
|
Number of Treatment-emergent Adverse Events (TEAEs)
Time Frame: From baseline (week 0) to week 75
|
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage.
All AEs reported here are TEAEs.
TEAE is defined as an event that had onset date during the on-treatment period.
The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as greater than (>) 7 consecutive missed doses (corresponding to >7 weeks off-treatment).
|
From baseline (week 0) to week 75
|
Number of Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: From baseline (week 0) to week 75
|
An SAE is an AE that fulfils at least one of the following criteria: 1) results in death; 2) is life-threatening; 3) requires inpatient hospitalisation or prolongation of existing hospitalisation; 4) results in persistent disability/incapacity; 5) is a congenital anomaly/birth defect; 6) important medical event.
All AEs reported here are TEAEs.
TEAE is defined as an event that had onset date during the on-treatment period.
The on-treatment period was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).
|
From baseline (week 0) to week 75
|
Change in Pulse
Time Frame: Baseline (week 0), week 68
|
Change in pulse from baseline to week 68 is presented.
Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
|
Baseline (week 0), week 68
|
Change in Amylase: Ratio to Baseline
Time Frame: Baseline (week 0), week 68
|
Change in amylase (U/L) from baseline to week 68 is presented as ratio to baseline.
Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
|
Baseline (week 0), week 68
|
Change in Lipase: Ratio to Baseline
Time Frame: Baseline (week 0), week 68
|
Change in lipase (U/L) from baseline to week 68 is presented as ratio to baseline.
Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
|
Baseline (week 0), week 68
|
Change in Calcitonin: Ratio to Baseline
Time Frame: Baseline (week 0), week 68
|
Change in calcitonin (nanograms per liter [ng/L]) from baseline to week 68 is presented as ratio to baseline.
Data is reported for on-treatment period: the on-treatment period was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
|
Baseline (week 0), week 68
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Cuda 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2019
Primary Completion (Actual)
March 25, 2022
Study Completion (Actual)
March 28, 2022
Study Registration Dates
First Submitted
September 23, 2019
First Submitted That Met QC Criteria
September 23, 2019
First Posted (Actual)
September 25, 2019
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9536-4451
- U1111-1215-7560 (Other Identifier: World Health Organization (WHO))
- 2018-002431-18 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Semaglutide
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2Germany
-
Novo Nordisk A/SCompletedType 2 Diabetes | Healthy VolunteersUnited States, Canada
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States, India, Japan, Russian Federation, United Kingdom, Canada, Spain, South Africa, Germany, Greece, United Arab Emirates, Argentina, Puerto Rico
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States, Italy, Spain, Canada, Hungary
-
Novo Nordisk A/SCompletedObesity | OverweightJapan, Korea, Republic of
-
Novo Nordisk A/SCompletedOverweight or Obesity | Metabolism and Nutrition DisorderUnited States, India, Mexico, Russian Federation, United Kingdom, Canada, Denmark, Finland, Belgium, Japan, Taiwan, France, Poland, Germany, Bulgaria, Argentina, Puerto Rico
-
Novo Nordisk A/SCompletedObesityUnited States, Israel, United Kingdom, Denmark, Germany, Netherlands, Canada, Argentina, Czechia, Hungary, Poland, Spain, Australia
-
Novo Nordisk A/SCompletedObesity | Diabetes Mellitus, Type 2 | OverweightKorea, Republic of, Hong Kong, Brazil, China
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States
-
Novo Nordisk A/SRecruiting