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Weight-Loss drug semaglutide tested in teens – could it help?

NCT ID NCT04102189

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether a weekly injection of semaglutide (2.4 mg) helps teenagers with overweight or obesity lose weight. 201 teens aged 12 to 18 took part, receiving either semaglutide or a placebo for about 15 months, along with lifestyle counseling. The main goal was to see how much their body mass index (BMI) changed from start to end of the study.

What this could mean

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

Active substance
semaglutide
What this could lead to
If it works, this could offer a new weight management option for teenagers with overweight or obesity.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all teens. Side effects like nausea or vomiting are possible, and weight regain may occur after stopping the drug.

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

201 people

The number who actually took part.

Started

Oct 2019

Finished

Mar 2022

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

12 to 17 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 of subject and child assent, as appropriate obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, 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 (on gender and age-specific growth charts (CDC.gov)) with 1 or more weight related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea 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 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 screening irrespective of medical records * Subjects with secondary causes of obesity (i.e., hypothalamic, monogenic or endocrine causes) * For subjects with type 2 diabetes only: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening. 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 Overweight

As listed by the trial registrant

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

Obesity Overweight

Contacts and locations

Locations

  • Aventiv Research Inc

    Columbus, Ohio, 43213, United States

  • Barry J. Reiner, MD LLC

    Baltimore, Maryland, 21229, United States

  • Birmingham Children's Hospital

    Birmingham, B4 6NH, United Kingdom

  • CHI Crumlin Dept of Endocrinology

    Dublin, D12 N512, Ireland

  • CRF HRB - Galway

    Galway, H91 YR71, Ireland

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027, United States

  • Children's Hosptl Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • City Children Endocrinology Center n.a. Raukhfus

    Saint Petersburg, 191036, Russia

  • Clifton Medical Centre

    Rotherham, South Yorkshire, S65 1DA, United Kingdom

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

    Dublin, Leinster, D04 T6F4, Ireland

  • Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

    Brussels, 1200, Belgium

  • Consultorio de Endocrinología y Pediatría

    Puebla City, 72190, Mexico

  • DelRicht Research

    Gretna, Louisiana, 70053, United States

  • Discovery MM Services, Inc

    Houston, Texas, 77061, United States

  • Ecclesfield Group Practice

    Sheffield, S35 9XQ, United Kingdom

  • FSBEI of Higher Education "Rostov State Medical University"

    Rostov-on-Don, 344013, Russia

  • Fließer-Görzer [Ordination]

    Saint Stefan, 8511, Austria

  • Geisinger Clinic

    Danville, Pennsylvania, 17822-2111, United States

  • Greenville Hospital System Pediatric Endo

    Greenville, South Carolina, 29615, United States

  • KBC "Sestre Milosrdnice"

    Zagreb, 10 000, Croatia

  • KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes

    Zagreb, 10000, Croatia

  • Klinički bolnički centar Rijeka, pedijatrija

    Rijeka, 51000, Croatia

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449, United States

  • Massachusetts General Hospital_Cary

    Boston, Massachusetts, 02114-2621, United States

  • Medical Research South, LLC_Cary

    Goose Creek, South Carolina, 29445, United States

  • Monument Health Clinical Rsrch

    Rapid City, South Dakota, 57701, United States

  • NSMU paediatric clinic

    Novosibirsk, 630048, Russia

  • National Clin Res Inc.

    Richmond, Virginia, 23294, United States

  • Ordination Dr. Hanusch

    Vienna, 1060, Austria

  • Pennington Biomed Res Ctr

    Baton Rouge, Louisiana, 70808-4124, United States

  • PriMed Clinical Research

    Dayton, Ohio, 45419, United States

  • RMAPE

    Moscow, 125373, Russia

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

    Izhevsk, 426009, Russia

  • SPSBHI City Children out-patient clinic #44

    Saint Petersburg, 191144, Russia

  • Siberian State Medical University

    Tomsk, 634050, Russia

  • Solaris Clinical Research

    Meridian, Idaho, 83646, United States

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • UBMD Peds-Div of Endo/Diabetes

    Buffalo, New York, 14203, United States

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • UZ Brussel

    Brussels, 1090, Belgium

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000, Belgium

  • UZA - UZ Antwerpen - Kinderziekenhuis

    Edegem, 2650, Belgium

  • Univ Of Texas Hlth Science Cntr

    San Antonio, Texas, 78229, United States

  • University College Hospital Hospital - Paediatric Services

    London, WC1E 6DB, United Kingdom

  • University Hospitals Bristol & Weston NHS Foundation Trust

    Bristol, BS2 8AE, United Kingdom

  • University of Minnesota_CPOM

    Minneapolis, Minnesota, 55414, United States

  • University of Minnesota_Minneapolis

    Minneapolis, Minnesota, 55455, United States

  • Universitätsklinik für Kinder und Jugendheilkunde Haus E

    Salzburg, 5020, Austria

  • Valley Weight Loss Clinic

    Fargo, North Dakota, 58104, United States

  • WakeMed Childn Endo-Dbt_Raleig

    Raleigh, North Carolina, 27610, United States

  • Wexford General Hospital - UCD CRC

    Wexford, Y35 Y17D, Ireland

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