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

NCT04102189 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: NN9536-4451U1111-1215-75602018-002431-18
• Study Type: interventional
• Target: 201
• Locations: 8 countries
• Sites: 51

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

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI) (Percentage [%])

  Change in BMI (%) from baseline to week 68 is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from randomization to last contact with trial site.

  Baseline (week 0), week 68

Secondary Outcomes (37)

• Percentage of Participants Achieving Greater Than or Equal to (>=) 5% Reduction of Body Weight (Yes/no)

  At week 68

• Change in Body Weight (Kilograms [kg])

  Baseline (week 0), week 68

• Change in Body Weight (%)

  Baseline (week 0), week 68

• Percentage of Participants Achieving >=10% Reduction of Body Weight (Yes/no)

  At week 68

• Percentage of Participants Achieving >=15% Reduction of Body Weight (Yes/no)

  At week 68

Study Arms (2)

Semaglutide

EXPERIMENTAL

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

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Placebo injected s.c. once weekly .

Other: Placebo

Interventions

Semaglutide DRUG

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

Semaglutide

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (51)

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, 90027, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Pennington Biomed Res Ctr

Baton Rouge, Louisiana, 70808-4124, United States

Location

DelRicht Research

Gretna, Louisiana, 70053, United States

Location

Barry J. Reiner, MD LLC

Baltimore, Maryland, 21229, United States

Location

Massachusetts General Hospital_Cary

Boston, Massachusetts, 02114-2621, United States

Location

University of Minnesota_CPOM

Minneapolis, Minnesota, 55414, United States

Location

University of Minnesota_Minneapolis

Minneapolis, Minnesota, 55455, United States

Location

UBMD Peds-Div of Endo/Diabetes

Buffalo, New York, 14203, United States

Location

WakeMed Childn Endo-Dbt_Raleig

Raleigh, North Carolina, 27610, United States

Location

Valley Weight Loss Clinic

Fargo, North Dakota, 58104, United States

Location

Aventiv Research Inc

Columbus, Ohio, 43213, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45419, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822-2111, United States

Location

Children's Hosptl Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Child Hosp-Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical Research South, LLC_Cary

Goose Creek, South Carolina, 29445, United States

Location

Greenville Hospital System Pediatric Endo

Greenville, South Carolina, 29615, United States

Location

Monument Health Clinical Rsrch

Rapid City, South Dakota, 57701, United States

Location

Discovery MM Services, Inc

Houston, Texas, 77061, United States

Location

Univ Of Texas Hlth Science Cntr

San Antonio, Texas, 78229, United States

Location

National Clin Res Inc.

Richmond, Virginia, 23294, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Fließer-Görzer [Ordination]

Saint Stefan, 8511, Austria

Location

Universitätsklinik für Kinder und Jugendheilkunde Haus E

Salzburg, 5020, Austria

Location

Ordination Dr. Hanusch

Vienna, 1060, Austria

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

Brussels, 1200, Belgium

Location

UZA - UZ Antwerpen - Kinderziekenhuis

Edegem, 2650, Belgium

Location

UZ Leuven - Kindergeneeskunde

Leuven, 3000, Belgium

Location

Klinički bolnički centar Rijeka, pedijatrija

Rijeka, 51000, Croatia

Location

KBC "Sestre Milosrdnice"

Zagreb, 10 000, Croatia

Location

KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes

Zagreb, 10000, Croatia

Location

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

Dublin, Leinster, D04 T6F4, Ireland

Location

CHI Crumlin Dept of Endocrinology

Dublin, D12 N512, Ireland

Location

CRF HRB - Galway

Galway, H91 YR71, Ireland

Location

Wexford General Hospital - UCD CRC

Wexford, Y35 Y17D, Ireland

Location

Consultorio de Endocrinología y Pediatría

Puebla City, 72190, Mexico

Location

Republic Children's Hospital of Ministry of Health of Udmurt

Izhevsk, 426009, Russia

Location

RMAPE

Moscow, 125373, Russia

Location

NSMU paediatric clinic

Novosibirsk, 630048, Russia

Location

FSBEI of Higher Education "Rostov State Medical University"

Rostov-on-Don, 344013, Russia

Location

City Children Endocrinology Center n.a. Raukhfus

Saint Petersburg, 191036, Russia

Location

SPSBHI City Children out-patient clinic #44

Saint Petersburg, 191144, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

Clifton Medical Centre

Rotherham, South Yorkshire, S65 1DA, United Kingdom

Location

Birmingham Children's Hospital

Birmingham, B4 6NH, United Kingdom

Location

University Hospitals Bristol & Weston NHS Foundation Trust

Bristol, BS2 8AE, United Kingdom

Location

University College Hospital Hospital - Paediatric Services

London, WC1E 6DB, United Kingdom

Location

Ecclesfield Group Practice

Sheffield, S35 9XQ, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 36322838 RESULT

• 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.

  PMID: 37196421 DERIVED

• 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.

  PMID: 36534451 DERIVED

• 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.

  PMID: 35797460 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: October 7, 2019
• Primary Completion: March 25, 2022
• Study Completion: March 28, 2022
• Last Updated: December 11, 2025
• Results First Posted: April 18, 2023

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

GB (6); RU (7); AU (3); US (23); CR (3); IE (4); ME (1); BE (4)