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

NCT ID: NCT05726227

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2026-12-07

Brief 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).

Conditions

Obesity

Study Design

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

Study Groups

Group Kids

Participants in the age group 6 to less than (\<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

Semaglutide will be administered subcutaneously once weekly.

Placebo

Intervention Type: DRUG

Placebo will be administered subcutaneously once-weekly.

Group Teens

Participants in the age group 12 to \< 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

Semaglutide will be administered subcutaneously once weekly.

Placebo

Intervention Type: DRUG

Placebo will be administered subcutaneously once-weekly.

Interventions

Semaglutide

Semaglutide will be administered subcutaneously once weekly.

Intervention Type: DRUG

Placebo

Placebo will be administered subcutaneously once-weekly.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. a) The parents or LAR of the child must sign and date the Informed Consent Form (according to local requirements) b) The child must sign and date the Child Assent Form or provide 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) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence 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 after participation in a structured lifestyle modification programme (diet and exercise counselling) 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 per mole [mmol/mol]) as measured by central laboratory at screening

Exclusion Criteria

• Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
• Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve 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 criterion applies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 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 Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Neighborhood Healthcare

Escondido, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

Columbus Research Foundation

Columbus, Georgia, United States

Eastside Bariatric and Gen Surg

Snellville, Georgia, United States

Solaris Clinical Research

Meridian, Idaho, United States

Pennington Biom Res Ctr

Baton Rouge, Louisiana, United States

Clinical Trials of America LLC

Monroe, Louisiana, United States

IMA Clinical Research

Monroe, Louisiana, United States

Barry J. Reiner, MD LLC

Baltimore, Maryland, United States

Massachusetts General Hospital_Cary

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mississippi Center for Advanced Medicine

Madison, Mississippi, United States

Mississippi CTR for ADV MED

Madison, Mississippi, 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

Centricity Research - Ohio

Columbus, Ohio, United States

UPMC Child Hosp-Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Tullahoma Pediatrics PLLC

Tullahoma, Tennessee, United States

Texas Diabetes & Endocrinology

Austin, Texas, United States

Univ Of Texas Hlth Science Cntr

San Antonio, Texas, United States

Health Res of Hampton Roads

Newport News, Virginia, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Universitätsklinik Kinder-Jugendheilkunde Innsbruck

Innsbruck, , Austria

Universitätsklinik für Kinder und Jugendheilkunde Haus E

Salzburg, , Austria

UZ Brussel

Brussels, , Belgium

UZ Antwerpen - UZA - Kinderziekenhuis

Edegem, , Belgium

UZA - UZ Antwerpen - Kinderziekenhuis

Edegem, , Belgium

UZ Leuven - Kindergeneeskunde

Leuven, , Belgium

Aalborg Universitetshospital

Aalborg, , Denmark

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus, , Denmark

Holbæk Sygehus - Børne- og Ungeafdelingen

Holbæk, , Denmark

Universitätsklinikum Halle - Innere Medizin II

Halle, , Germany

Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung

Hanover, , Germany

Kinder- und Jugendkrankenhaus

Hanover, , Germany

Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin

Leipzig, , Germany

Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin

Leipzig, , Germany

Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ)

Ulm, , Germany

Universitätsklinikum Ulm für Kinder- und Jugendmedizin

Ulm, , Germany

Rambam MC - Department of Pediatrics A

Haifa, , Israel

Schneider MC - Endrocrinology and Diabetes

Petah Tikva, , Israel

Shamir MC - Pediatric and Adolescents Endocrinology unit

Ẕerifin, , Israel

Consultorio de Endocrinología y Pediatría

Puebla City, , Mexico

Hospital Da Luz S.A.

Lisbon, , Portugal

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

Porto, , Portugal

Hospital CUF Porto S.A.

Porto, , Portugal

Drottning Silvias barnsjukhus

Gothenburg, , Sweden

Hallands sjukhus Halmstad

Halmstad, , Sweden

Akademiska sjukhuset Uppsala

Uppsala, , Sweden

Uppsala universitetssjukhus

Uppsala, , Sweden

Birmingham Children's Hospital

Birmingham, , United Kingdom

University Hospitals Bristol & Weston NHS Foundation Trust

Bristol, , United Kingdom

Leeds Children's Hospital

Leeds, , United Kingdom

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

Countries

United States; Austria; Belgium; Denmark; Germany; Israel; Mexico; Portugal; Sweden; United Kingdom

Other Identifiers

U1111-1266-3808

Identifier Type: OTHER

Identifier Source: secondary_id

2022-502922-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9536-4512

Identifier Type: -

Identifier Source: org_study_id