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

NCT05726227 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: NN9536-4512U1111-1266-38082022-502922-41
• Study Type: interventional
• Target: 210
• Locations: 10 countries
• Sites: 56

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

Outcome Measures

Primary Outcomes (1)

• Group Kids: Change in body mass index (BMI)

  Measured in percentage (%)

  From baseline (week 0) to week 68

Secondary Outcomes (69)

• Group Kids: Improvement in weight category

  From baseline (week 0) to week 68

• Group Teens: Change in BMI

  From week 0 to week 68

• Group Kids and Group Teens: Change in BMI

  From week 0 to week 104

• Group Teens: Improvement in weight category

  From week 0 to week 68

• Group Kids and Group Teens: Improvement in weight category

  From week 0 to week 104

Study Arms (2)

Group Kids

EXPERIMENTAL

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.

Drug: Semaglutide; Drug: Placebo

Group Teens

EXPERIMENTAL

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.

Drug: Semaglutide; Drug: Placebo

Interventions

Semaglutide DRUG

Semaglutide will be administered subcutaneously once weekly.

Group Kids; Group Teens

Placebo DRUG

Placebo will be administered subcutaneously once-weekly.

Group Kids; Group Teens

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (56)

Neighborhood Healthcare

Escondido, California, 92025, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

Columbus Research Foundation

Columbus, Georgia, 31904, United States

Location

Eastside Bariatric and Gen Surg

Snellville, Georgia, 30078, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Pennington Biom Res Ctr

Baton Rouge, Louisiana, 70808, United States

Location

Clinical Trials of America LLC

Monroe, Louisiana, 71201, United States

Location

IMA Clinical Research

Monroe, Louisiana, 71201, United States

Location

Barry J. Reiner, MD LLC

Baltimore, Maryland, 21229, United States

Location

Massachusetts General Hospital_Cary

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Mississippi Center for Advanced Medicine

Madison, Mississippi, 39110, United States

Location

Mississippi CTR for ADV MED

Madison, Mississippi, 39110, 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

Centricity Research - Ohio

Columbus, Ohio, 43213, United States

Location

UPMC Child Hosp-Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Pediatric Clinical Trials, LLC

Tullahoma, Tennessee, 37388, United States

Location

Texas Diabetes & Endocrinology

Austin, Texas, 78731, United States

Location

Univ Of Texas Hlth Science Cntr

San Antonio, Texas, 78207, United States

Location

Health Res of Hampton Roads

Newport News, Virginia, 23606, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Universitätsklinik Kinder-Jugendheilkunde Innsbruck

Innsbruck, 6020, Austria

Location

Universitätsklinik für Kinder und Jugendheilkunde Haus E

Salzburg, 5020, Austria

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UZ Antwerpen - UZA - Kinderziekenhuis

Edegem, 2650, Belgium

Location

UZA - UZ Antwerpen - Kinderziekenhuis

Edegem, 2650, Belgium

Location

UZ Leuven - Kindergeneeskunde

Leuven, 3000, Belgium

Location

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

Location

Aalborg Universitetshospital - Børne og Ungeafdelingen

Gistrup, 9260, Denmark

Location

Holbæk Sygehus - Børne- og Ungeafdelingen

Holbæk, 4300, Denmark

Location

Universitätsklinikum Halle - Innere Medizin II

Halle, 06120, Germany

Location

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

Hanover, 30173, Germany

Location

Kinder- und Jugendkrankenhaus

Hanover, 30173, Germany

Location

Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin

Leipzig, 04103, Germany

Location

Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin

Leipzig, 04103, Germany

Location

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

Ulm, 89075, Germany

Location

Universitätsklinikum Ulm für Kinder- und Jugendmedizin

Ulm, 89075, Germany

Location

Rambam MC - Department of Pediatrics A

Haifa, 31096, Israel

Location

Schneider MC - Endrocrinology and Diabetes

Petah Tikva, 49202, Israel

Location

Shamir MC - Pediatric and Adolescents Endocrinology unit

Ẕerifin, 7033001, Israel

Location

Consultorio de Endocrinología y Pediatría

Puebla City, 72190, Mexico

Location

Hospital da Luz Lisboa, S.A.

Lisbon, 1500-650, Portugal

Location

ULS De Santo António, E.P.E. - Hospital de Santo António

Porto, 4050-342, Portugal

Location

Hospital CUF Porto S.A.

Porto, 4100-180, Portugal

Location

Drottning Silvias barnsjukhus

Gothenburg, 41650, Sweden

Location

Hallands sjukhus Halmstad

Halmstad, 30233, Sweden

Location

Akademiska sjukhuset Uppsala

Uppsala, 75185, Sweden

Location

Uppsala universitetssjukhus

Uppsala, 75185, Sweden

Location

Birmingham Children's Hospital

Birmingham, B4 6NH, United Kingdom

Location

University Hospitals Bristol & Weston NHS Foundation Trust

Bristol, BS2 8BJ, United Kingdom

Location

Leeds Children's Hospital

Leeds, LS1 3EX, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, L12 2AP, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 13, 2023
• Study Start: July 7, 2023
• Primary Completion: October 15, 2025
• Study Completion (Estimated): December 7, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (4); PT (3); SE (4); DE (7); DK (3); ME (1); GB (5); IL (3); AU (2); US (24)