DRUG
Liraglutide (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.
Use of Liraglutide in Children Aged 6 to 12 Years With Severe Obesity
Status
Active, not recruiting
Phase
Phase 4
Enrollment
30
Locations
1
Results
Not posted
Publications
12
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
May 15, 2026
Study start
Mar 30, 2024
Primary completion
Apr 2027
Study completion
Apr 2028
Results posted
Not reported
Registry updated
May 15, 2026
Outcomes
What the study measures.
Primary outcomes
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
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.
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
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.
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
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.
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.
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.
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.
Eligibility
Who can take part.
- Minimum age
- 6 Years
- Maximum age
- 12 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
Brazil. Showing up to 24 locations stored in the fast local snapshot.
Childrens Institute - University of Sao Paulo
São Paulo, São Paulo, Brazil
Publications
Results and literature.
PMID 27295427 ↗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.PMID 36322838 ↗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.PMID 32233338 ↗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.PMID 29055731 ↗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.PMID 31963569 ↗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.PMID 23449553 ↗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.PMID 23302619 ↗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.PMID 28359099 ↗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.PMID 19875556 ↗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.PMID 8610077 ↗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.PMID 9614255 ↗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.PMID 38438626 ↗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.
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