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

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.

Timeline

Start

2024-03-30

Primary completion

2027-04

Completion

2028-04

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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