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Weight-Loss drug for kids? new trial tests liraglutide in children as young as 6

NCT ID NCT04775082

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study tests whether a daily injection of liraglutide (3.0 mg) can help children aged 6 to 12 with obesity lose weight. Over 56 weeks, 78 children will receive either liraglutide or a placebo, along with counseling on diet and exercise. The main goal is to see how much their body mass index (BMI) changes.

What this could mean

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

Active substance
liraglutide
What this could lead to
If successful, this could provide a new medication option to help children with obesity lose weight, potentially reducing future health risks.
What could go wrong
This is a relatively small Phase 3 trial (78 children). Liraglutide 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 78 people

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

Started

Mar 2021

Expected to finish

Feb 2027

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 12 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 age-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, aged 6 to below 12 years at the time of signing informed consent * Tanner stage 1-5 pubertal development at the time of signing informed consent * BMI above or equal to 95th percentile, on gender and age-specific growth charts (CDC.gov) * History of failing to lose sufficient weight with lifestyle modification as judged by the investigator For subjects with type 2 diabetes at screening the following inclusion criterion apply in addition: \- Hemoglobin A1c (HbA1c) below or equal to 10.0 percent (86 mmol/mol) as measured by central laboratory at screening Exclusion Criteria: * A self-reported (or by parent(s)/LAR (legally acceptable representative) where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Treatment with any medication for the indication of obesity within the past 90 days before screening * Type 1 diabetes * Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Barry J. Reiner, MD LLC

    Baltimore, Maryland, 21229, United States

  • CUF-Porto

    Porto, 4100-180, Portugal

  • Centro Hospitalar Lisboa Norte

    Lisbon, 1649-035, Portugal

  • Children's Hospital Colorado

    Denver, Colorado, 80045, United States

  • Consultorio de Endocrinología y Pediatría

    Puebla City, 72190, Mexico

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, 522001, India

  • FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia

    Moscow, 117292, Russia

  • Hospital CUF Porto S.A.

    Porto, 4100-180, Portugal

  • Hospital Putrajaya

    Putrajaya, 62250, Malaysia

  • Hospital da Luz

    Lisbon, 1500-650, Portugal

  • Hospital da Luz Lisboa, S.A.

    Lisbon, 1500-650, Portugal

  • Kantonsspital Olten

    Olten, 4600, Switzerland

  • Kinderspital Endokrinologie, Zürich

    Zurich, 8032, Switzerland

  • Mamc & Lnjp

    New Delhi, 110002, India

  • NSMU paediatric clinic

    Novosibirsk, 630048, Russia

  • Pennington Biom Res Ctr

    Baton Rouge, Louisiana, 70808, United States

  • PriMed Clinical Research

    Dayton, Ohio, 45419, United States

  • Rambam MC - Department of Pediatrics A

    Haifa, 31096, Israel

  • Samara Regional Children Clinical Hospital n.a. N.N. Ivanova

    Samara, 443079, Russia

  • Schneider MC - Endrocrinology and Diabetes

    Petah Tikva, 49202, Israel

  • Siberian State Medical University

    Tomsk, 634050, Russia

  • Solaris Clinical Research

    Meridian, Idaho, 83646, United States

  • TMC Hlthcr Clin Res Office

    Tucson, Arizona, 85712, 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, 4099-001, Portugal

  • UPMC Child Hosp-Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • UZ Brussel

    Brussels, 1090, Belgium

  • UZ Leuven - Kindergeneeskunde

    Leuven, 3000, Belgium

  • Unidade De Santa Maria E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

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

    Porto, 4099-001, Portugal

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100, Malaysia

  • University of Minnesota_CPOM

    Minneapolis, Minnesota, 55414, United States

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