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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102189
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 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
Estimated Primary Completion Date : October 20, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

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 .
Drug: Placebo
Participants will receive semaglutide placebo s.c. once weekly for a total of 68 weeks




Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) [ Time Frame: From baseline (week 0) to week 68 ]
    Percent


Secondary Outcome Measures :
  1. Subjects achieving a reduction of body weight equal to or above 5 percent [ Time Frame: From baseline (week 0) to week 68 ]
    Yes/no

  2. Change in body weight [ Time Frame: From baseline (week 0) to week 68 ]
    Kg

  3. Change in body weight [ Time Frame: From baseline (week 0) to week 68 ]
    Percent

  4. Change in BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) [ Time Frame: From baseline (week 0) to week 68 ]
    Percent

  5. Change in BMI (standard deviation score) (WHO.int) [ Time Frame: From baseline (week 0) to week 68 ]
    Score

  6. Change in waist circumference [ Time Frame: From baseline (week 0) to week 68 ]
    Cm

  7. Change in systolic blood pressure [ Time Frame: From baseline (week 0) to week 68 ]
    mmHg

  8. Change in diastolic blood pressure [ Time Frame: From baseline (week 0) to week 68 ]
    mmHg

  9. Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 68 ]
    Percentage points

  10. Subjects achieving a reduction of BMI equal to or above 5 percent [ Time Frame: From baseline (week 0) to week 68 ]
    Yes/no

  11. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: From baseline (week 0) to week 75 ]
    Count

  12. Number of treatment-emergent serious adverse events (SAEs) [ Time Frame: From baseline (week 0) to week 75 ]
    Count

  13. Change in pulse [ Time Frame: From baseline (week 0) to week 68 ]
    Bpm

  14. Change in amylase [ Time Frame: From baseline (week 0) to week 68 ]
    U/L

  15. Change in lipase [ Time Frame: From baseline (week 0) to week 68 ]
    U/L

  16. Change in calcitonin [ Time Frame: From baseline (week 0) to week 68 ]
    ng/L



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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United States, Idaho
Novo Nordisk Investigational Site Recruiting
Meridian, Idaho, United States, 83646
United States, Maryland
Novo Nordisk Investigational Site Recruiting
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Novo Nordisk Investigational Site Recruiting
Boston, Massachusetts, United States, 02114-2621
United States, Minnesota
Novo Nordisk Investigational Site Recruiting
Minneapolis, Minnesota, United States, 55414
United States, New York
Novo Nordisk Investigational Site Recruiting
Buffalo, New York, United States, 14203
United States, North Carolina
Novo Nordisk Investigational Site Recruiting
Raleigh, North Carolina, United States, 27610
United States, North Dakota
Novo Nordisk Investigational Site Recruiting
Fargo, North Dakota, United States, 58104
United States, Ohio
Novo Nordisk Investigational Site Recruiting
Columbus, Ohio, United States, 43213
Novo Nordisk Investigational Site Recruiting
Dayton, Ohio, United States, 45419
United States, Pennsylvania
Novo Nordisk Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Novo Nordisk Investigational Site Not yet recruiting
Goose Creek, South Carolina, United States, 29445
United States, South Dakota
Novo Nordisk Investigational Site Recruiting
Rapid City, South Dakota, United States, 57701
United States, Wisconsin
Novo Nordisk Investigational Site Recruiting
Marshfield, Wisconsin, United States, 54449
Austria
Novo Nordisk Investigational Site Recruiting
Saint Stefan, Austria, 8511
Novo Nordisk Investigational Site Recruiting
Salzburg, Austria, 5020
Novo Nordisk Investigational Site Recruiting
Wien, Austria, 1060
Belgium
Novo Nordisk Investigational Site Recruiting
Brussels, Belgium, 1090
Novo Nordisk Investigational Site Recruiting
Brussels, Belgium, 1200
Novo Nordisk Investigational Site Recruiting
Edegem, Belgium, 2650
Novo Nordisk Investigational Site Recruiting
Leuven, Belgium, 3000
Croatia
Novo Nordisk Investigational Site Recruiting
Zagreb, Croatia, 10 000
Novo Nordisk Investigational Site Recruiting
Zagreb, Croatia, 10000
Ireland
Novo Nordisk Investigational Site Recruiting
Dublin, Ireland, DUBLIN 4
Mexico
Novo Nordisk Investigational Site Recruiting
Puebla, Mexico, 72190
Russian Federation
Novo Nordisk Investigational Site Recruiting
Izhevsk, Russian Federation, 426009
Novo Nordisk Investigational Site Recruiting
Moscow, Russian Federation, 125373
Novo Nordisk Investigational Site Recruiting
Novosibirsk, Russian Federation, 630048
Novo Nordisk Investigational Site Recruiting
Rostov-on-Don, Russian Federation, 344013
Novo Nordisk Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 191036
Novo Nordisk Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 191144
Novo Nordisk Investigational Site Recruiting
Tomsk, Russian Federation, 634050
United Kingdom
Novo Nordisk Investigational Site Recruiting
Birmingham, United Kingdom, B4 6NH
Novo Nordisk Investigational Site Recruiting
Bristol, United Kingdom, BS2 8AE
Novo Nordisk Investigational Site Recruiting
London, United Kingdom, WC1E 6DB
Novo Nordisk Investigational Site Recruiting
Rotherham, United Kingdom, S65 1DA
Novo Nordisk Investigational Site Recruiting
Sheffield, United Kingdom, S35 9XQ
Novo Nordisk Investigational Site Recruiting
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

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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
Last Update Posted: March 31, 2020
Last Verified: March 2020
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
Signs and Symptoms