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

NCT ID: NCT04102189

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2022-03-28

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Semaglutide

2.4 mg or maximum tolerated dose (MTD) injected subcutaneously (under the skin, s.c.) once weekly

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks

Placebo

Placebo injected s.c. once weekly .

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Semaglutide

Participants will receive semaglutide s.c. once weekly for a dose escalation period of 16 weeks and a maintenance period of 52 weeks

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility 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

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, United States

Solaris Clinical Research

Meridian, Idaho, United States

Pennington Biomed Res Ctr

Baton Rouge, Louisiana, United States

DelRicht Research

Gretna, Louisiana, United States

Barry J. Reiner, MD LLC

Baltimore, Maryland, United States

Massachusetts General Hospital_Cary

Boston, Massachusetts, United States

University of Minnesota_CPOM

Minneapolis, Minnesota, United States

University of Minnesota_Minneapolis

Minneapolis, Minnesota, United States

UBMD Peds-Div of Endo/Diabetes

Buffalo, New York, United States

WakeMed Childn Endo-Dbt_Raleig

Raleigh, North Carolina, United States

Valley Weight Loss Clinic

Fargo, North Dakota, United States

Aventiv Research Inc

Columbus, Ohio, United States

PriMed Clinical Research

Dayton, Ohio, United States

Geisinger Clinic

Danville, Pennsylvania, United States

Children's Hosptl Philadelphia

Philadelphia, Pennsylvania, United States

UPMC Child Hosp-Pittsburgh

Pittsburgh, Pennsylvania, United States

Medical Research South, LLC_Cary

Goose Creek, South Carolina, United States

Greenville Hospital System Pediatric Endo

Greenville, South Carolina, United States

Monument Health Clinical Rsrch

Rapid City, South Dakota, United States

Discovery MM Services, Inc

Houston, Texas, United States

Univ Of Texas Hlth Science Cntr

San Antonio, Texas, United States

National Clin Res Inc.

Richmond, Virginia, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Fließer-Görzer [Ordination]

Saint Stefan, , Austria

Universitätsklinik für Kinder und Jugendheilkunde Haus E

Salzburg, , Austria

Ordination Dr. Hanusch

Vienna, , Austria

UZ Brussel

Brussels, , Belgium

Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

Brussels, , Belgium

UZA - UZ Antwerpen - Kinderziekenhuis

Edegem, , Belgium

UZ Leuven - Kindergeneeskunde

Leuven, , Belgium

Klinički bolnički centar Rijeka, pedijatrija

Rijeka, , Croatia

KBC "Sestre Milosrdnice"

Zagreb, , Croatia

KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes

Zagreb, , Croatia

Clinical Research Centre, St. Vincent's University Hospital,

Dublin, Leinster, Ireland

CHI Crumlin Dept of Endocrinology

Dublin, , Ireland

CRF HRB - Galway

Galway, , Ireland

Wexford General Hospital - UCD CRC

Wexford, , Ireland

Consultorio de Endocrinología y Pediatría

Puebla City, , Mexico

Republic Children's Hospital of Ministry of Health of Udmurt

Izhevsk, , Russia

RMAPE

Moscow, , Russia

NSMU paediatric clinic

Novosibirsk, , Russia

FSBEI of Higher Education "Rostov State Medical University"

Rostov-on-Don, , Russia

City Children Endocrinology Center n.a. Raukhfus

Saint Petersburg, , Russia

SPSBHI City Children out-patient clinic #44

Saint Petersburg, , Russia

Siberian State Medical University

Tomsk, , Russia

Clifton Medical Centre

Rotherham, South Yorkshire, United Kingdom

Birmingham Children's Hospital

Birmingham, , United Kingdom

University Hospitals Bristol & Weston NHS Foundation Trust

Bristol, , United Kingdom

University College Hospital Hospital - Paediatric Services

London, , United Kingdom

Ecclesfield Group Practice

Sheffield, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Countries

United States; Austria; Belgium; Croatia; Ireland; Mexico; Russia; United Kingdom

References

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.

Reference Type: RESULT

PMID: 36322838 (View on PubMed)

Kelly AS, Arslanian S, Hesse D, Iversen AT, Korner A, Schmidt S, Sorrig R, Weghuber D, Jastreboff AM. Reducing BMI below the obesity threshold in adolescents treated with once-weekly subcutaneous semaglutide 2.4 mg. Obesity (Silver Spring). 2023 Aug;31(8):2139-2149. doi: 10.1002/oby.23808. Epub 2023 Jul 9.

Reference Type: DERIVED

PMID: 37196421 (View on PubMed)

Weghuber D, Boberg K, Hesse D, Jeppesen OK, Sorrig R, Kelly AS; STEP TEENS Investigators. Semaglutide treatment for obesity in teenagers: a plain language summary of the STEP TEENS research study. J Comp Eff Res. 2023 Feb;12(2):e220187. doi: 10.2217/cer-2022-0187. Epub 2022 Dec 19.

Reference Type: DERIVED

PMID: 36534451 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35797460 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1215-7560

Identifier Type: OTHER

Identifier Source: secondary_id

2018-002431-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9536-4451

Identifier Type: -

Identifier Source: org_study_id