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Weekly shot could help kids lose weight – major trial underway

NCT ID NCT05726227

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study tests whether a once-weekly injection of semaglutide helps children and teenagers (ages 6 to 17) with obesity or overweight lose weight. About 210 participants will receive either the drug or a placebo for up to 2.5 years, along with healthy lifestyle counseling. The main goal is to see if the drug reduces body mass index (BMI) compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
semaglutide (a once-weekly injection, also used for diabetes and weight loss in adults)
What this could lead to
If it works, this could provide a new, effective weight-management option for children and teenagers with obesity.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The drug may cause side effects like nausea or vomiting, and weight loss may not be sustained long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Aalborg Universitetshospital - Børne og Ungeafdelingen

    Gistrup, 9260, Denmark

  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

    Aarhus, 8200, Denmark

  • Akademiska sjukhuset Uppsala

    Uppsala, 75185, Sweden

  • Alder Hey Children's Hospital

    Liverpool, L12 2AP, United Kingdom

  • Barry J. Reiner, MD LLC

    Baltimore, Maryland, 21229, United States

  • Birmingham Children's Hospital

    Birmingham, B4 6NH, United Kingdom

  • Centricity Research - Ohio

    Columbus, Ohio, 43213, United States

  • Clinical Trials of America LLC

    Monroe, Louisiana, 71201, United States

  • Columbus Research Foundation

    Columbus, Georgia, 31904, United States

  • Consultorio de Endocrinología y Pediatría

    Puebla City, 72190, Mexico

  • Drottning Silvias barnsjukhus

    Gothenburg, 41650, Sweden

  • Eastside Bariatric and Gen Surg

    Snellville, Georgia, 30078, United States

  • Hallands sjukhus Halmstad

    Halmstad, 30233, Sweden

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

    Hanover, 30173, Germany

  • Health Res of Hampton Roads

    Newport News, Virginia, 23606, United States

  • Holbæk Sygehus - Børne- og Ungeafdelingen

    Holbæk, 4300, Denmark

  • Hospital CUF Porto S.A.

    Porto, 4100-180, Portugal

  • Hospital da Luz Lisboa, S.A.

    Lisbon, 1500-650, Portugal

  • IMA Clinical Research

    Monroe, Louisiana, 71201, United States

  • Kinder- und Jugendkrankenhaus

    Hanover, 30173, Germany

  • Leeds Children's Hospital

    Leeds, LS1 3EX, United Kingdom

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449, United States

  • Massachusetts General Hospital_Cary

    Boston, Massachusetts, 02114, United States

  • Mississippi CTR for ADV MED

    Madison, Mississippi, 39110, United States

  • Mississippi Center for Advanced Medicine

    Madison, Mississippi, 39110, United States

  • Neighborhood Healthcare

    Escondido, California, 92025, United States

  • Pediatric Clinical Trials, LLC

    Tullahoma, Tennessee, 37388, United States

  • Pennington Biom Res Ctr

    Baton Rouge, Louisiana, 70808, United States

  • Rambam MC - Department of Pediatrics A

    Haifa, 31096, Israel

  • Schneider MC - Endrocrinology and Diabetes

    Petah Tikva, 49202, Israel

  • Shamir MC - Pediatric and Adolescents Endocrinology unit

    Ẕerifin, 7033001, Israel

  • Solaris Clinical Research

    Meridian, Idaho, 83646, United States

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731, United States

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York, 14203, United States

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

    Porto, 4050-342, Portugal

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • UZ Antwerpen - UZA - Kinderziekenhuis

    Edegem, 2650, Belgium

  • UZ Brussel

    Brussels, 1090, Belgium

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000, Belgium

  • UZA - UZ Antwerpen - Kinderziekenhuis

    Edegem, 2650, Belgium

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

    Leipzig, 04103, Germany

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

    Ulm, 89075, Germany

  • Univ Of Texas Hlth Science Cntr

    San Antonio, Texas, 78207, United States

  • University Hospitals Bristol & Weston NHS Foundation Trust

    Bristol, BS2 8BJ, United Kingdom

  • University of Minnesota

    Minneapolis, Minnesota, 55414, United States

  • Universitätsklinik Kinder-Jugendheilkunde Innsbruck

    Innsbruck, 6020, Austria

  • Universitätsklinik für Kinder und Jugendheilkunde Haus E

    Salzburg, 5020, Austria

  • Universitätsklinikum Halle - Innere Medizin II

    Halle, 06120, Germany

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

    Leipzig, 04103, Germany

  • Universitätsklinikum Ulm für Kinder- und Jugendmedizin

    Ulm, 89075, Germany

  • Uppsala universitetssjukhus

    Uppsala, 75185, Sweden

  • Valley Weight Loss Clinic

    Fargo, North Dakota, 58104, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

  • WakeMed Childn Endo-Dbt_Raleig

    Raleigh, North Carolina, 27610, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06519, United States

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