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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07590219

Enrollment

Registered

2026-05-15

Start date

2024-03-30

Completion date

2028-04-01

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

severe obesity, Liraglutide, Cardiovascular function, Echocardiography, Speckle tracking, childhood obesity

Brief 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.

Detailed 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.

Interventions

DRUGLiraglutide (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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Change in left ventricular global longitudinal strain (LV-GLS) measured by two-dimensional speckle-tracking echocardiography	6 months	LV-GLS will be obtained by transthoracic echocardiography using two-dimensional speckle-tracking analysis according to current American Society of Echocardiography recommendations. Measurements will be expressed as percentage (%) and evaluated at baseline and after 6 months.
Change in left atrial reservoir strain (LASr) measured by two-dimensional speckle-tracking echocardiography	6 months	LASr will be obtained from apical four-chamber views using two-dimensional speckle-tracking echocardiography and expressed as percentage (%). Measurements will be performed at baseline and after 6 months according to current American Society of Echocardiography recommendations
Change in fasting plasma glucose	Baseline to 6 months	Fasting plasma glucose levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.
Change in fasting insulin levels	6 months	Fasting insulin levels will be measured from venous blood samples and expressed in µIU/mL. Changes between baseline and 6 months will be evaluated
Change in triglyceride levels	6 months	Serum triglyceride levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.
Change in total cholesterol levels	6 months	Total cholesterol levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.
Change in HDL cholesterol levels	6 months	HDL cholesterol levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.
Change in LDL cholesterol levels	6 months	LDL cholesterol levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.

Countries

Brazil

Contacts

PRINCIPAL_INVESTIGATORLouise Cominato, PI

University of Sao Paulo

STUDY_CHAIRNatalia Bernardes, SI