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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102189
Recruitment Status : Completed
First Posted : September 25, 2019
Results First Posted : April 18, 2023
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Drug: Semaglutide Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
Official Title: Effect and Safety of Semaglutide 2.4 mg Once Weekly on Weight Management in Adolescents With Overweight or Obesity
Actual Study Start Date : October 7, 2019
Actual Primary Completion Date : March 25, 2022
Actual Study Completion Date : March 28, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide
2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly
 Drug: Semaglutide
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 .
 Other: Placebo
Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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).

  33. 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).

  34. 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).

  35. 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).

  36. 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).

  37. 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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102189


Locations
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United States, Idaho
Novo Nordisk Investigational Site
Meridian, Idaho, United States, 83646
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02114-2621
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55414
United States, New York
Novo Nordisk Investigational Site
Buffalo, New York, United States, 14203
United States, North Carolina
Novo Nordisk Investigational Site
Raleigh, North Carolina, United States, 27610
United States, North Dakota
Novo Nordisk Investigational Site
Fargo, North Dakota, United States, 58104
United States, Ohio
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43213
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45419
United States, Pennsylvania
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
United States, South Dakota
Novo Nordisk Investigational Site
Rapid City, South Dakota, United States, 57701
United States, Wisconsin
Novo Nordisk Investigational Site
Marshfield, Wisconsin, United States, 54449
Austria
Novo Nordisk Investigational Site
Saint Stefan, Austria, 8511
Novo Nordisk Investigational Site
Salzburg, Austria, 5020
Novo Nordisk Investigational Site
Wien, Austria, 1060
Belgium
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
Croatia
Novo Nordisk Investigational Site
Rijeka, Croatia, 51000
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
Novo Nordisk Investigational Site
Zagreb, Croatia, 10000
Ireland
Novo Nordisk Investigational Site
Dublin, Leinster, Ireland, DUBLIN 4
Mexico
Novo Nordisk Investigational Site
Puebla, Mexico, 72190
Russian Federation
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, 191036
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 191144
Novo Nordisk Investigational Site
Tomsk, Russian Federation, 634050
United Kingdom
Novo Nordisk Investigational Site
Rotherham, South Yorkshire, United Kingdom, S65 1DA
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Study Protocol  [PDF] February 3, 2021
Statistical Analysis Plan  [PDF] December 16, 2021

More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04102189    
Other Study ID Numbers: NN9536-4451
U1111-1215-7560 ( Other Identifier: World Health Organization (WHO) )
2018-002431-18 ( EudraCT Number )
First Posted: September 25, 2019    Key Record Dates
Results First Posted: April 18, 2023
Last Update Posted: April 18, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight