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

• ClinicalTrials.gov Identifier: NCT04102189
• Recruitment Status: Completed
• First Posted: September 25, 2019
• Last Update Posted: January 25, 2023
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

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
Overweight; Obesity	Drug: Semaglutide; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 229 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

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 .	Other: 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) [ 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

Eligibility Criteria

• 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

Locations

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

• Study Director: Clinical Reporting Anchor and Disclosure (1452); Novo Nordisk A/S

More Information

Publications of Results:

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.

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

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.

• 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
• Last Update Posted: January 25, 2023
• Last Verified: January 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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight