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ACTIVE NOT RECRUITING
NCT07590219
PHASE4

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

Sponsor: University of Sao Paulo General Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy, Metabolic and Cardiovascular Effects of Liraglutide in Children Aged 6-12 Years With Severe Obesity: A Randomized Controlled Trial With Advanced Echocardiographic Assessment

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-03-30

Completion Date

2028-04

Last Updated

2026-05-15

Healthy Volunteers

No

Interventions

DRUG

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

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.

Locations (1)

Childrens Institute - University of Sao Paulo

São Paulo, São Paulo, Brazil