Clinical trial

Use of Liraglutide in Children Aged 6 to 12 Years With Severe Obesity

Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT07590219

Active, not recruitingPhase 4Interventional

What this study is about

This randomized controlled trial evaluates the efficacy, safety, metabolic, and cardiovascular effects of liraglutide in children aged 6 to 12 years with severe obesity. Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone for 6 months. In addition to primary outcomes related to weight loss and metabolic improvement, a predefined subgroup analysis evaluates cardiovascular function in participants receiving liraglutide using advanced echocardiographic techniques, including speckle-tracking-derived myocardial deformation parameters.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 12 Years

SexAll

Healthy volunteersNot accepted

ConditionSevere Obesity, Cardiovascular Function, Liraglutide, Childhood Obesity, Echocardiography, Speckle Tracking

Full registry criteria

Inclusion Criteria: * Children aged 6-12 years * BMI Z-score ≥ +3 * Previous unsuccessful lifestyle intervention Exclusion Criteria: * Severe chronic diseases * Cardiac disease * Dermatological contraindication * Use of interfering medications

Treatments and study arms

Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

Drug

Liraglutide administered as a once-daily subcutaneous injection, starting at 0.6 mg and titrated weekly up to 3.0 mg or maximum tolerated dose, for 6 months, combined with lifestyle intervention.

Primary outcomes

Change in Body Mass Index (BMI)6 months

Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). BMI will be assessed at baseline and after 6 months using standardized anthropometric measurements.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Childrens Institute - University of Sao Paulo🇧🇷 São Paulo, São Paulo, Brazil

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