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

NCT07590219 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 74225723.4.0000.0068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Keywords

severe obesity; Liraglutide; Cardiovascular function; Echocardiography; Speckle tracking; childhood obesity

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (8)

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

  6 months

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

  6 months

• Change in fasting plasma glucose

  Baseline to 6 months

• Change in fasting insulin levels

  6 months

• Change in triglyceride levels

  6 months

Study Arms (2)

Liraglutide + Lifestyle Intervention

EXPERIMENTAL

Participants receive liraglutide with dose escalation (0.6 mg to 3.0 mg daily) plus lifestyle intervention. Intervention: Drug: Liraglutide Behavioral: Lifestyle intervention

Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml

Lifestyle Intervention Alone

NO INTERVENTION

Participants receive standard multidisciplinary lifestyle intervention without pharmacological treatment.

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.

Liraglutide + Lifestyle Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Childrens Institute - University of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (12)

• 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: 27295427 BACKGROUND

• 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: 36322838 BACKGROUND

• 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: 32233338 BACKGROUND

• 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: 29055731 BACKGROUND

• 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: 31963569 BACKGROUND

• 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: 23449553 BACKGROUND

• 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: 23302619 BACKGROUND

• 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: 28359099 BACKGROUND

• 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: 19875556 BACKGROUND

• 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: 8610077 BACKGROUND

• 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: 9614255 BACKGROUND

• 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.

  PMID: 38438626 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Pediatric Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Louise Cominato, PI

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Natalia Bernardes, SI

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 15, 2026
• Study Start: March 30, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

BR (1)