Weight-Loss drug for kids? new trial tests liraglutide in children as young as 6
NCT ID NCT04775082
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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6 to 12 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Barry J. Reiner, MD LLC
Baltimore, Maryland, 21229, United States
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CUF-Porto
Porto, 4100-180, Portugal
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Centro Hospitalar Lisboa Norte
Lisbon, 1649-035, Portugal
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Children's Hospital Colorado
Denver, Colorado, 80045, United States
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Consultorio de Endocrinología y Pediatría
Puebla City, 72190, Mexico
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Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001, India
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FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
Moscow, 117292, Russia
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Hospital CUF Porto S.A.
Porto, 4100-180, Portugal
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Hospital Putrajaya
Putrajaya, 62250, Malaysia
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Hospital da Luz
Lisbon, 1500-650, Portugal
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Hospital da Luz Lisboa, S.A.
Lisbon, 1500-650, Portugal
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Kantonsspital Olten
Olten, 4600, Switzerland
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Kinderspital Endokrinologie, Zürich
Zurich, 8032, Switzerland
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Mamc & Lnjp
New Delhi, 110002, India
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NSMU paediatric clinic
Novosibirsk, 630048, Russia
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Pennington Biom Res Ctr
Baton Rouge, Louisiana, 70808, United States
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PriMed Clinical Research
Dayton, Ohio, 45419, United States
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Rambam MC - Department of Pediatrics A
Haifa, 31096, Israel
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Samara Regional Children Clinical Hospital n.a. N.N. Ivanova
Samara, 443079, Russia
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Schneider MC - Endrocrinology and Diabetes
Petah Tikva, 49202, Israel
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Siberian State Medical University
Tomsk, 634050, Russia
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Solaris Clinical Research
Meridian, Idaho, 83646, United States
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TMC Hlthcr Clin Res Office
Tucson, Arizona, 85712, United States
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UBMD Peds-Div of Endo/Diabetes
Buffalo, New York, 14203, United States
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ULS De Santo António, E.P.E. - Hospital de Santo António
Porto, 4099-001, Portugal
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UPMC Child Hosp-Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
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UZ Brussel
Brussels, 1090, Belgium
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UZ Leuven - Kindergeneeskunde
Leuven, 3000, Belgium
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Unidade De Santa Maria E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
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Unidade Local de Saúde de Santo António, E.P.E
Porto, 4099-001, Portugal
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University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
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University of Minnesota_CPOM
Minneapolis, Minnesota, 55414, United States
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