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

Last updated: September 30, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Semaglutide

Placebo

Clinical Study ID

NCT04102189
NN9536-4451
2018-002431-18
U1111-1215-7560
  • Ages 12-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent of parent(s) or legally acceptable representative of subject andchild assent, as appropriate obtained before any trial-related activities.Trial-related activities are any procedures that are carried out as part of thetrial, 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 (ongender and age-specific growth charts (CDC.gov)) with 1 or more weight relatedcomorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleepapnoea 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

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 screeningirrespective of medical records

  • Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic orendocrine causes)

  • For subjects with type 2 diabetes only: Uncontrolled and potentially unstablediabetic retinopathy or maculopathy. Verified by a fundus examination performedwithin the past 90 days prior to screening. Pharmacological pupil-dilation is arequirement unless using a digital fundus photography camera specified fornon-dilated examination

Study Design

Total Participants: 201
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
October 07, 2019
Estimated Completion Date:
March 28, 2022

Connect with a study center

  • Fließer-Görzer [Ordination]

    Saint Stefan, 8511
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Stefan, 8511
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Salzburg, 5020
    Austria

    Site Not Available

  • Universitätsklinik für Kinder und Jugendheilkunde Haus E

    Salzburg 2766824, 5020
    Austria

    Site Not Available

  • Ordination Dr. Hanusch

    Vienna 2761369, 1060
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Wien, 1060
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Brussel, 1090
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Brussels, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

    Brussels 2800866, 1200
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels 2800866, 1090
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Edegem, 2650
    Belgium

    Site Not Available

  • UZA - UZ Antwerpen - Kinderziekenhuis

    Edegem 2799007, 2650
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven - Kindergeneeskunde

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Rijeka, 51000
    Croatia

    Site Not Available

  • Klinički bolnički centar Rijeka, pedijatrija

    Rijeka 3191648, 51000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Zagreb, 10 000
    Croatia

    Site Not Available

  • KBC "Sestre Milosrdnice"

    Zagreb 3186886, 10 000
    Croatia

    Site Not Available

  • KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes

    Zagreb 3186886, 10000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Dublin, Leinster D04 T6F4
    Ireland

    Site Not Available

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

    Dublin 2964574, Leinster 7521314 D04 T6F4
    Ireland

    Site Not Available

  • Novo Nordisk Investigational Site

    Puebla, 72190
    Mexico

    Site Not Available

  • Consultorio de Endocrinología y Pediatría

    Puebla City 3521081, 72190
    Mexico

    Site Not Available

  • Republic Children's Hospital of Ministry of Health of Udmurt

    Izhevsk 554840, 426009
    Russia

    Site Not Available

  • RMAPE

    Moscow 524901, 125373
    Russia

    Site Not Available

  • NSMU paediatric clinic

    Novosibirsk 1496747, 630048
    Russia

    Site Not Available

  • FSBEI of Higher Education "Rostov State Medical University"

    Rostov-on-Don 501175, 344013
    Russia

    Site Not Available

  • City Children Endocrinology Center n.a. Raukhfus

    Saint Petersburg 498817, 191036
    Russia

    Site Not Available

  • SPSBHI City Children out-patient clinic #44

    Saint Petersburg 498817, 191144
    Russia

    Site Not Available

  • Siberian State Medical University

    Tomsk 1489425, 634050
    Russia

    Site Not Available

  • Novo Nordisk Investigational Site

    Izhevsk, 426009
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 125373
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Novosibirsk, 630048
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Rostov-on-Don, 344013
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint-Petersburg, 191036
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Rotherham, South Yorkshire S65 1DA
    United Kingdom

    Site Not Available

  • Clifton Medical Centre

    Rotherham 2639093, South Yorkshire S65 1DA
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Birmingham Children's Hospital

    Birmingham 2655603, B4 6NH
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, BS2 8AE
    United Kingdom

    Site Not Available

  • University Hospitals Bristol & Weston NHS Foundation Trust

    Bristol 2654675, BS2 8AE
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    London, WC1E 6DB
    United Kingdom

    Site Not Available

  • Paediatric Services - UCL

    London 2643743, WC1E 6DB
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Sheffield, S35 9XQ
    United Kingdom

    Site Not Available

  • Ecclesfield Group Practice

    Sheffield 2638077, S35 9XQ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton 2637487, SO16 6YD
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian 5600685, Idaho 5596512 83646
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Barry J. Reiner, MD LLC

    Baltimore 4347778, Maryland 4361885 21229
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Boston, Massachusetts 02114-2621
    United States

    Site Not Available

  • Massachusetts General Hospital_Cary

    Boston 4930956, Massachusetts 6254926 02114-2621
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota 55414
    United States

    Site Not Available

  • University of Minnesota_CPOM

    Minneapolis 5037649, Minnesota 5037779 55414
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buffalo, New York 14203
    United States

    Site Not Available

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo 5110629, New York 5128638 14203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • WakeMed Childn Endo-Dbt_Raleig

    Raleigh 4487042, North Carolina 4482348 27610
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Valley Weight Loss Clinic

    Fargo 5059163, North Dakota 5690763 58104
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dayton, Ohio 45419
    United States

    Site Not Available

  • Aventiv Research Inc

    Columbus 4509177, Ohio 5165418 43213
    United States

    Site Not Available

  • PriMed Clinical Research

    Dayton 4509884, Ohio 5165418 45419
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh 5206379, Pennsylvania 6254927 15224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Goose Creek, South Carolina 29445
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Monument Health Clinical Rsrch

    Rapid City 5768233, South Dakota 5769223 57701
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Marshfield Clinic

    Marshfield 5261969, Wisconsin 5279468 54449
    United States

    Site Not Available

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