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

Sponsor
University of Sao Paulo General Hospital
Study ID
NCT07590219
Phase
PHASE4
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 30, 2024
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide + Lifestyle Intervention
    Participants receive liraglutide with dose escalation (0.6 mg to 3.0 mg daily) plus lifestyle intervention. Intervention: Drug: Liraglutide Behavioral: Lifestyle intervention
  • No Intervention: Lifestyle Intervention Alone
    Participants receive standard multidisciplinary lifestyle intervention without pharmacological treatment.

Primary Outcome Measure

Change in Body Mass Index (BMI) [ Time Frame: 6 months ]

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