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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT04102189
Collaborator
(none)
163
38
2
29.7
4.3
0.1

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

Study Type:
Interventional
Actual Enrollment :
163 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 :
Oct 7, 2019
Actual Primary Completion Date :
Feb 11, 2022
Actual Study Completion Date :
Mar 28, 2022

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

  1. Change in Body Mass Index (BMI) [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 [From baseline (week 0) to week 68]

    Yes/no

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

    Kg

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

    Percent

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

    Score

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

    Cm

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

    mmHg

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

    mmHg

  9. Change in glycosylated haemoglobin (HbA1c) [From baseline (week 0) to week 68]

    Percentage points

  10. Subjects achieving a reduction of BMI equal to or above 5 percent [From baseline (week 0) to week 68]

    Yes/no

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

    Count

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

    Count

  13. Change in pulse [From baseline (week 0) to week 68]

    Bpm

  14. Change in amylase [From baseline (week 0) to week 68]

    U/L

  15. Change in lipase [From baseline (week 0) to week 68]

    U/L

  16. Change in calcitonin [From baseline (week 0) to week 68]

    ng/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04102189
Other Study ID Numbers:
  • NN9536-4451
  • U1111-1215-7560
  • 2018-002431-18
First Posted:
Sep 25, 2019
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2022