A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
Study Details
Study Description
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 |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- Change in Body Mass Index (BMI) [From baseline (week 0) to week 68]
Percent
Secondary Outcome Measures
- Subjects achieving a reduction of body weight equal to or above 5 percent [From baseline (week 0) to week 68]
Yes/no
- Change in body weight [From baseline (week 0) to week 68]
Kg
- Change in body weight [From baseline (week 0) to week 68]
Percent
- Change in BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov) [From baseline (week 0) to week 68]
Percent
- Change in BMI (standard deviation score) (WHO.int) [From baseline (week 0) to week 68]
Score
- Change in waist circumference [From baseline (week 0) to week 68]
Cm
- Change in systolic blood pressure [From baseline (week 0) to week 68]
mmHg
- Change in diastolic blood pressure [From baseline (week 0) to week 68]
mmHg
- Change in glycosylated haemoglobin (HbA1c) [From baseline (week 0) to week 68]
Percentage points
- Subjects achieving a reduction of BMI equal to or above 5 percent [From baseline (week 0) to week 68]
Yes/no
- Number of treatment-emergent adverse events (TEAEs) [From baseline (week 0) to week 75]
Count
- Number of treatment-emergent serious adverse events (SAEs) [From baseline (week 0) to week 75]
Count
- Change in pulse [From baseline (week 0) to week 68]
Bpm
- Change in amylase [From baseline (week 0) to week 68]
U/L
- Change in lipase [From baseline (week 0) to week 68]
U/L
- Change in calcitonin [From baseline (week 0) to week 68]
ng/L
Eligibility Criteria
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novo Nordisk Investigational Site | Meridian | Idaho | United States | 83646 |
2 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21229 |
3 | Novo Nordisk Investigational Site | Boston | Massachusetts | United States | 02114-2621 |
4 | Novo Nordisk Investigational Site | Minneapolis | Minnesota | United States | 55414 |
5 | Novo Nordisk Investigational Site | Buffalo | New York | United States | 14203 |
6 | Novo Nordisk Investigational Site | Raleigh | North Carolina | United States | 27610 |
7 | Novo Nordisk Investigational Site | Fargo | North Dakota | United States | 58104 |
8 | Novo Nordisk Investigational Site | Columbus | Ohio | United States | 43213 |
9 | Novo Nordisk Investigational Site | Dayton | Ohio | United States | 45419 |
10 | Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | United States | 15224 |
11 | Novo Nordisk Investigational Site | Goose Creek | South Carolina | United States | 29445 |
12 | Novo Nordisk Investigational Site | Rapid City | South Dakota | United States | 57701 |
13 | Novo Nordisk Investigational Site | Marshfield | Wisconsin | United States | 54449 |
14 | Novo Nordisk Investigational Site | Saint Stefan | Austria | 8511 | |
15 | Novo Nordisk Investigational Site | Salzburg | Austria | 5020 | |
16 | Novo Nordisk Investigational Site | Wien | Austria | 1060 | |
17 | Novo Nordisk Investigational Site | Brussel | Belgium | 1090 | |
18 | Novo Nordisk Investigational Site | Bruxelles | Belgium | 1200 | |
19 | Novo Nordisk Investigational Site | Edegem | Belgium | 2650 | |
20 | Novo Nordisk Investigational Site | Leuven | Belgium | 3000 | |
21 | Novo Nordisk Investigational Site | Rijeka | Croatia | 51000 | |
22 | Novo Nordisk Investigational Site | Zagreb | Croatia | 10 000 | |
23 | Novo Nordisk Investigational Site | Zagreb | Croatia | 10000 | |
24 | Novo Nordisk Investigational Site | Dublin | Ireland | DUBLIN 4 | |
25 | Novo Nordisk Investigational Site | Puebla | Mexico | 72190 | |
26 | Novo Nordisk Investigational Site | Izhevsk | Russian Federation | 426009 | |
27 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 125373 | |
28 | Novo Nordisk Investigational Site | Novosibirsk | Russian Federation | 630048 | |
29 | Novo Nordisk Investigational Site | Rostov-on-Don | Russian Federation | 344013 | |
30 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 191036 | |
31 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 191144 | |
32 | Novo Nordisk Investigational Site | Tomsk | Russian Federation | 634050 | |
33 | Novo Nordisk Investigational Site | Birmingham | United Kingdom | B4 6NH | |
34 | Novo Nordisk Investigational Site | Bristol | United Kingdom | BS2 8AE | |
35 | Novo Nordisk Investigational Site | London | United Kingdom | WC1E 6DB | |
36 | Novo Nordisk Investigational Site | Rotherham | United Kingdom | S65 1DA | |
37 | Novo Nordisk Investigational Site | Sheffield | United Kingdom | S35 9XQ | |
38 | Novo Nordisk Investigational Site | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9536-4451
- U1111-1215-7560
- 2018-002431-18