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NCT Number: NCT07590219

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

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.

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Key information

Conditions

Severe Obesity Body Weight Cardiovascular Function Childhood Obesity Echocardiography Liraglutide Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Speckle Tracking

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Childrens Institute - University of Sao Paulo

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Change in Body Mass Index (BMI)

    Time frame: 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 outcomes

  1. Change in left ventricular global longitudinal strain (LV-GLS) measured by two-dimensional speckle-tracking echocardiography

    Time frame: 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.

  2. Change in left atrial reservoir strain (LASr) measured by two-dimensional speckle-tracking echocardiography

    Time frame: 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

  3. Change in fasting plasma glucose

    Time frame: 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.

  4. Change in fasting insulin levels

    Time frame: 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

  5. Change in triglyceride levels

    Time frame: 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.

  6. Change in total cholesterol levels

    Time frame: 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.

  7. Change in HDL cholesterol levels

    Time frame: 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.

  8. Change in LDL cholesterol levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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