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Trial · Interventional

Active, not recruitingPhase 4Registry data

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

NCTNCT07590219 (opens ClinicalTrials.gov in a new tab)Other id74225723.4.0000.0068
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
30 participants (estimated)
Sponsor
University of Sao Paulo General Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Brazil

Start
30 Mar 2024
Primary completion
Apr 2027 (estimated)
Completion
Apr 2028 (estimated)
First posted
15 May 2026
Last update posted
15 May 2026
Conditions
Severe Obesity · Cardiovascular Function · Liraglutide · Childhood Obesity · Echocardiography · Speckle Tracking

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026202720282029
  1. Ph 4

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

    NCT07590219

    30 Mar 2024 to est. Apr 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

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

Arms2

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Body Mass Index (BMI)

    Time frame · 6 months

    Registry description

    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(8)

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

    Time frame · 6 months

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    LDL cholesterol levels will be measured from venous blood samples and expressed in mg/dL. Changes between baseline and 6 months will be evaluated.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2022

10 results

Once-Weekly Semaglutide in Adolescents with Obesity.

Weghuber et al. 2022The New England journal of medicinecited by 539

PMID 36322838PMC9997064DOI 10.1056/nejmoa2208601PUB-36322838

Rights unknown10 results
Source linkSee results (10)

Indexing hint: Randomized controlled trial · 2020

11 results

A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity.

Kelly et al. 2020The New England journal of medicinecited by 520

PMID 32233338DOI 10.1056/nejmoa1916038PUB-32233338

Full text at the publisher11 results
Publisher pageSee results (11)

Indexing hint: Randomized controlled trial · 2016

8 results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,535

PMID 27295427PMC4985288DOI 10.1056/nejmoa1603827PUB-27295427

Rights unknown8 results
Source linkSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 12 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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