A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight

Last updated: January 28, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

Semaglutide

Placebo

Clinical Study ID

NCT05726227
NN9536-4512
U1111-1266-3808
2022-502922-41
  • Ages 6-18
  • All Genders

Study Summary

This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults.

The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent of parent(s) or legally acceptable representative (LAR) ofparticipant and child assent, as age-appropriate, obtained before any study-relatedactivities. Study-related activities are any procedures that are carried out as partof the study, including activities to determine suitability for the study. a) Theparents or LAR of the child must sign and date the Informed Consent Form (accordingto local requirements) b) The child must sign and date the Child Assent Form orprovide oral assent (according to local requirements)

  • Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years.b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1

  • Body mass index (BMI), at screening and randomisation, corresponding to a) GroupKids: greater than or equal to 95th percentile. b) Group Teens: greater than orequal to 95th percentile or greater than or equal to 85th percentile with thepresence of at least 1 weight-related comorbidity (treated or untreated):hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (T2D)

  • History of at least one unsuccessful effort to lose sufficient body weight afterparticipation in a structured lifestyle modification programme (diet and exercisecounselling) for at least 3 months

  • Body weight of greater than 45 kilogram (kg) at screening and randomisation

  • For participants with T2D at screening, the following additional criterion applies:glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles permole [mmol/mol]) as measured by central laboratory at screening

Exclusion

Exclusion Criteria:

  • Treatment with any medication prescribed for the indication of obesity or weightmanagement within 90 days before screening

  • Previous or planned (during the study period) obesity treatment with surgery or aweight loss device. However, the following are allowed: a) liposuction and/orabdominoplasty, if performed greater than 1 year prior to screening. b) adjustablegastric banding, if the band has been removed greater than 1 year prior toscreening. c) intragastric balloon, if the balloon has been removed greater than 1year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if thesleeve has been removed greater than 1 year prior to screening

  • Type 1 diabetes mellitus or monogenic diabetes

  • Participants with endocrine, hypothalamic, or syndromic obesity

  • For participants with T2D at screening, the following additional key criterionapplies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.Verified by a fundus examination performed within the past 90 days before screeningor in the period between screening and randomisation. Pharmacological pupil-dilationis a requirement unless using a digital fundus photography camera specified fornon-dilated examination

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
July 07, 2023
Estimated Completion Date:
December 07, 2026

Connect with a study center

  • Novo Nordisk Investigational Site

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Universitätsklinik Kinder-Jugendheilkunde

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Universitätsklinik Kinder-Jugendheilkunde Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Salzburg, 5020
    Austria

    Site Not Available

  • Universitätsklinik für Kinder und Jugendheilkunde Haus E

    Salzburg, 5020
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Brussel, 1090
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussel, 1090
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Edegem, 2650
    Belgium

    Active - Recruiting

  • UZ Antwerpen - UZA - Kinderziekenhuis

    Edegem, 2650
    Belgium

    Site Not Available

  • UZA - UZ Antwerpen - Kinderziekenhuis

    Edegem, 2650
    Belgium

    Site Not Available

  • Novo Nordisk Investigational Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000
    Belgium

    Site Not Available

  • Aalborg Universitetshospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Aalborg, 9000
    Denmark

    Site Not Available

  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

    Aarhus, 8200
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Holbæk Sygehus

    Holbæk, 4300
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Holbæk, 4300
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Halle, 06120
    Germany

    Site Not Available

  • Universitätsklinikum Halle (Saale)

    Halle, 06120
    Germany

    Site Not Available

  • Auf der Bult - Klinik für Diabetologie, Endokrinologie, Gastroenterologie und Klinische Forschung

    Hannover, 30173
    Germany

    Site Not Available

  • Kinder- und Jugendkrankenhaus

    Hannover, 30173
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hannover, 30173
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin

    Leipzig, 04103
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Ulm, 89075
    Germany

    Site Not Available

  • Universitätsklinikum Ulm für Kinder- und Jugendmedizin

    Ulm, 89075
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Haifa, 31096
    Israel

    Active - Recruiting

  • Rambam Medical Center Children A Dept.

    Haifa, 31096
    Israel

    Site Not Available

  • Endrocrinology & DM Schneider MC

    Petah Tikva, 49202
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Petah Tikva, 49202
    Israel

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Zerifin, 70300
    Israel

    Active - Recruiting

  • Shamir (Assaf Harofe) Medical Center

    Zerifin, 7033001
    Israel

    Site Not Available

  • Consultorio de Endocrinología y Pediatría

    Puebla, 72190
    Mexico

    Site Not Available

  • Novo Nordisk Investigational Site

    Puebla, 72190
    Mexico

    Site Not Available

  • Hospital da Luz

    Lisboa, 1500-650
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Lisboa, 1500-650
    Portugal

    Active - Recruiting

  • CUF-Porto

    Porto, 4100-180
    Portugal

    Site Not Available

  • Centro Hospitalar do Porto, E.P.E

    Porto, 4050-342
    Portugal

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Porto, 4050-342
    Portugal

    Active - Recruiting

  • Unidade Local de Saúde de Santo António, E.P.E

    Porto, 4050-342
    Portugal

    Site Not Available

  • Drottning Silvias barnsjukhus

    Göteborg, 41650
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Göteborg, 41650
    Sweden

    Site Not Available

  • Hallands sjukhus Halmstad

    Halmstad, 30233
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Halmstad, 30233
    Sweden

    Site Not Available

  • Akademiska sjukhuset Uppsala

    Uppsala, 75185
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Uppsala, 75185
    Sweden

    Active - Recruiting

  • Birmingham Children's Hospital

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, B4 6NH
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, BS2 8BJ
    United Kingdom

    Site Not Available

  • University Hospitals Bristol & Weston NHS Foundation Trust

    Bristol, BS2 8BJ
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Great George Street, Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Leeds Children's Hospital

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Liverpool, L12 2AP
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Neighborhood Healthcare

    Escondido, California 92025
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Escondido, California 92025
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Columbus Research Foundation

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Eastside Bariatric and Gen Surg

    Snellville, Georgia 30078
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Snellville, Georgia 30078
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Meridian, Idaho 83646
    United States

    Active - Recruiting

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • Pennington Biom Res Ctr

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Clinical Trials of America LLC

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Monroe, Louisiana 71201
    United States

    Active - Recruiting

  • Barry J. Reiner, MD LLC

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baltimore, Maryland 21229
    United States

    Active - Recruiting

  • Massachusetts General Hospital_Cary

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota 55414
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Site Not Available

  • Mississippi CTR for ADV MED

    Madison, Mississippi 39110
    United States

    Site Not Available

  • Mississippi Center for Advanced Medicine

    Madison, Mississippi 39110
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Madison, Mississippi 39110
    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, New York 14203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Raleigh, North Carolina 27610
    United States

    Active - Recruiting

  • WakeMed Childn Endo-Dbt_Raleig

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fargo, North Dakota 58104
    United States

    Active - Recruiting

  • Valley Weight Loss Clinic

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Centricity Research - Ohio

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Tullahoma, Tennessee 37388
    United States

    Active - Recruiting

  • Tullahoma Pediatrics PLLC

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Texas Diabetes & Endocrinology

    Austin, Texas 78731
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    San Antonio, Texas 78207
    United States

    Active - Recruiting

  • Univ Of Texas Hlth Science Cntr

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Health Res of Hampton Roads

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • Marshfield Clinic

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

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