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

University of Sao Paulo General Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Liraglutide; Speckle Tracking; Cardiovascular Function; Childhood Obesity; Echocardiography; Severe Obesity

Treatments: Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

Study type: Interventional

Funder types: Other

Identifiers

NCT07590219

74225723.4.0000.0068

Details and patient eligibility

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.

Full description

Childhood obesity is associated with early structural and functional cardiac alterations, including subclinical myocardial dysfunction. Conventional echocardiographic parameters may not detect early changes.

This is a prospective, randomized, controlled, open-label clinical trial including children aged 6-12 years with severe obesity (BMI Z-score ≥ +3). Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone.

Participants are followed for 6 months with clinical, laboratory, imaging, and functional assessments.

In addition to the primary randomized comparison, a predefined longitudinal subgroup analysis is conducted in participants receiving liraglutide to assess cardiovascular effects using advanced echocardiographic techniques, including speckle-tracking analysis of left ventricular global longitudinal strain and left atrial reservoir strain.

This study was registered retrospectively because participant enrollment began prior to trial registration due to administrative reasons. The study protocol and outcomes were defined prior to participant inclusion.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Liraglutide + Lifestyle Intervention

Experimental group

Description:

Participants receive liraglutide with dose escalation (0.6 mg to 3.0 mg daily) plus lifestyle intervention. Intervention: Drug: Liraglutide Behavioral: Lifestyle intervention

Treatment:

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

Lifestyle Intervention Alone

No Intervention group

Description:

Participants receive standard multidisciplinary lifestyle intervention without pharmacological treatment.