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

NCT07590219 · Active, not recruiting

Last updated 2026-05-28

This clinical trial tests whether the medication liraglutide helps reduce body weight in children aged 6 to 12 who have severe obesity.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 30 people Planned (estimated).

Who can join Ages 6–12 · all sexes

Timeline Started 2024-03 · est. completion 2028-04

Where 1 site · Brazil

What this study is testing ClinicalTrials.gov NCT07590219 ↗

Description as written by the study sponsor.

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.

Treatments tested

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.

Main thing measured	Change in Body Mass Index (BMI)
Sponsor	University of Sao Paulo General Hospital
Conditions studied	Severe Obesity, Cardiovascular Function, Liraglutide, Childhood Obesity, Echocardiography, Speckle Tracking
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07590219 ↗