AzTrials
AzTrials

Severe ObesityPhase 4NCT07590219

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

A Phase 4 study testing Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml in people with Severe Obesity and Cardiovascular Function, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
What is being tested?
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
30 Mar 2024to Apr 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 6-12 years
  • BMI Z-score ≥ +3
  • Previous unsuccessful lifestyle intervention

Who cannot join

  • Severe chronic diseases
  • Cardiac disease
  • Dermatological contraindication
  • Use of interfering medications

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Childrens Institute - University of Sao Paulo

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

About this study

Official 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

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.

Read the 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.

Being tested
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Keywords
severe obesity, Liraglutide, Cardiovascular function, Echocardiography, Speckle tracking, childhood obesity
Medical subject headings
Obesity, Morbid, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 groups in NCT07590219
Study groupRoleWhat they receive
Liraglutide + Lifestyle InterventionExperimentalParticipants receive liraglutide with dose escalation (0.6 mg to 3.0 mg daily) plus lifestyle intervention. Intervention: Drug: Liraglutide Behavioral: Lifestyle intervention
Receives: Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Lifestyle Intervention AloneNo interventionParticipants receive standard multidisciplinary lifestyle intervention without pharmacological treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Mass Index (BMI)

    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.

    Measured: 6 months

Secondary outcomes (8)

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

    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.

    Measured: 6 months

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

    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

    Measured: 6 months

  3. Change in fasting plasma glucose

    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.

    Measured: Baseline to 6 months

  4. Change in fasting insulin levels

    Fasting insulin levels will be measured from venous blood samples and expressed in µIU/mL. Changes between baseline and 6 months will be evaluated

    Measured: 6 months

  5. Change in triglyceride levels

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

    Measured: 6 months

  6. Change in total cholesterol levels

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

    Measured: 6 months

  7. Change in HDL cholesterol levels

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

    Measured: 6 months

  8. Change in LDL cholesterol levels

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start30 Mar 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07590219
Sponsor's protocol ID
74225723.4.0000.0068
Status last verified
May 2026
First submitted
22 Apr 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

    PubMed 27295427

  • Weghuber D, Barrett T, Barrientos-Perez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sorrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Dec 15;387(24):2245-2257. doi: 10.1056/NEJMoa2208601. Epub 2022 Nov 2.

    PubMed 36322838

  • Kelly AS, Auerbach P, Barrientos-Perez M, Gies I, Hale PM, Marcus C, Mastrandrea LD, Prabhu N, Arslanian S; NN8022-4180 Trial Investigators. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020 May 28;382(22):2117-2128. doi: 10.1056/NEJMoa1916038. Epub 2020 Mar 31.

    PubMed 32233338

  • Harchali S, Zarrouki M, Elyadari M, Azenoud S, Elmerrouni S, Abdellah E, Berraho A. [Malignant conjunctival melanoma arising from conjunctival melanosis of Reese]. J Fr Ophtalmol. 2017 Nov;40(9):817-818. doi: 10.1016/j.jfo.2017.01.020. Epub 2017 Oct 19. No abstract available. French.

    PubMed 29055731

  • Provenzano M, Andreucci M, Garofalo C, Faga T, Michael A, Ielapi N, Grande R, Sapienza P, Franciscis S, Mastroroberto P, Serra R. The Association of Matrix Metalloproteinases with Chronic Kidney Disease and Peripheral Vascular Disease: A Light at the End of the Tunnel? Biomolecules. 2020 Jan 17;10(1):154. doi: 10.3390/biom10010154.

    PubMed 31963569

  • Erdivanli OC, Coskun ZO, Kazikdas KC, Demirci M. Prevalence of Otitis Media with Effusion among Primary School Children in Eastern Black Sea, in Turkey and the Effect of Smoking in the Development of Otitis Media with Effusion. Indian J Otolaryngol Head Neck Surg. 2012 Mar;64(1):17-21. doi: 10.1007/s12070-011-0131-z. Epub 2011 Feb 4.

    PubMed 23449553

  • Wang HY, Sun LZ, Yue ZH, Yang J, Jiang XY, Mo Y. [Clinical and pathological features of Denys-Drash syndrome: report of 3 cases]. Zhonghua Er Ke Za Zhi. 2012 Nov;50(11):855-8. Chinese.

    PubMed 23302619

  • Styne DM, Arslanian SA, Connor EL, Farooqi IS, Murad MH, Silverstein JH, Yanovski JA. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017 Mar 1;102(3):709-757. doi: 10.1210/jc.2016-2573.

    PubMed 28359099

  • Nauck MA, Vilsboll T, Gallwitz B, Garber A, Madsbad S. Incretin-based therapies: viewpoints on the way to consensus. Diabetes Care. 2009 Nov;32 Suppl 2(Suppl 2):S223-31. doi: 10.2337/dc09-S315. No abstract available.

    PubMed 19875556

  • Caplan LS, Lane DS, Grimson R. The use of cohort vs repeated cross-sectional sample survey data in monitoring changing breast cancer screening practices. Prev Med. 1995 Nov;24(6):553-6. doi: 10.1006/pmed.1995.1088.

    PubMed 8610077

  • Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.

    PubMed 9614255

  • Ferreira SRG, Macotela Y, Velloso LA, Mori MA. Determinants of obesity in Latin America. Nat Metab. 2024 Mar;6(3):409-432. doi: 10.1038/s42255-024-00977-1. Epub 2024 Mar 4.

    PubMed 38438626

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml in people with Severe Obesity and Cardiovascular Function, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Mass Index (BMI) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07590219, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in