Preview

Pediatric pharmacology

Advanced search

Efficacy and Safety of Liraglutide in Adolescents Aged 12–15 Years with Obesity: a Prospective 24-week Observational

https://doi.org/10.15690/pf.v22i2.2871

Abstract

Background. The problem of childhood obesity remains relevant for modern healthcare. Effective treatment models for this disease are needed with the inclusion of new therapeutic agents, including GLP-1 receptor agonists such as liraglutide (approved from the age of 12). However, its safety and efficacy in pediatrics have not yet been sufficiently studied and require further research.

The aim of the study is to evaluate the efficacy and safety of the GLP-1 receptor agonist liraglutide, a solution for subcutaneous administration in pediatric practice for body weight correction in children with obesity aged 12–15 years in combination with a personalized diet and increased physical activity.

Methods. The cohort study conducted on the basis of Children’s City Hospital No. 11 (Yekaterinburg) from March to October 2024 included children aged 12–15 years with an exogenously constitutional form of obesity (SDS BMI ≥ 2.0) with confirmed ineffectiveness of lifestyle correction for more than a year. The follow-up period was 24 weeks and included 9 visits. The main criterion of effectiveness is the change in SDS BMI by the 24th week. Safety was assessed by the frequency and severity of adverse events, as well as by the effect on linear growth.

Results. The children of the study groups were comparable in all characteristics (p > 0.05). The main group was prescribed liraglutide — an analog of GLP-1— at a dose of 3.0 mg subcutaneously daily. During the first month, the dose was titrated to the maximum according to the instructions, then the drug was used for another 20 weeks. At week 24, a significant decrease in SDS BMI was recorded in the main group compared with the control (therapeutic effect): –0.343 (95% CI: –0.501 to –0.185), p < 0.001.

Conclusion. The results obtained confirm the potential of usage of the liraglutide as part of complex therapy in adolescents with obesity and substantiate the expediency of its further study in pediatric practice.

About the Authors

Olga P. Kovtun
Ural State Medical University
Russian Federation

Olga P. Kovtun - MD, PhD, Professor, corresponding member of the RAS.

Yekaterinburg


Disclosure of interest:

Not declared



Margarita A. Ustiuzhanina
Ural State Medical University
Russian Federation

Margarita A. Ustiuzhanina - MD, PhD.

3, Repina Str., Yekaterinburg, 620028


Disclosure of interest:

Not declared



Svyatoslav I. Solodushkin
Ural State Medical University; Ural Federal University, named after the first President of Russia, B.N. Yeltsin
Russian Federation

Svyatoslav I. Solodushkin – PhD.

Yekaterinburg


Disclosure of interest:

Not declared



Lyudmila V. Kovalchuk
PROMOMED DM LLC
Russian Federation

Lyudmila V. Kovalchuk

Moscow


Disclosure of interest:

Not declared



Kira Ya. Zaslavskaya
N.P. Ogarev Mordovia State University
Russian Federation

Kira Ya. Zaslavskaya

Saransk


Disclosure of interest:

Not declared



References

1. Hampl SE, Hassink SG, Skinner AC, et al. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics. 2023;151(2):e2022060640. doi: https://doi.org/10.1542/peds.2022-060640

2. Ozhirenie u detei: Clinical guidelines. Russian Association of Endocrinologists; Society of Bariatric Surgeons. Ministry of Health of Russian Federation; 2024. 79 p. (In Russ). Доступно по: https://cr.minzdrav.gov.ru/previewcr/229_3. Ссылка активна на 18.01.2025.

3. Jastreboff AM, Kotz CM, Kahan S, et al. Obesity as a Disease: The Obesity Society 2018 Position Statement. Obesity. 2019;27(1):7–9. doi: https://doi.org/10.1002/oby.22378

4. Ward ZJ, Long MW, Resch SC, et al. Simulation of Growth Trajectories of Childhood Obesity into Adulthood. N Engl J Med. 2017;377(22):2145–2153. doi: https://doi.org/10.1056/NEJMoa1703860

5. Kelly AS, Auerbach P, Barrientos-Perez M, et al. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020;382(22):2117–2128. doi: https://doi.org/10.1056/NEJMoa1916038

6. Instructions for medical use of the medicinal product Enligria, Registration No. ЛП-008822. (In Russ). Доступно по: https://www.vidal.ru/drugs/enligriya. Ссылка активна на 18.01.2025.

7. Knudsen LB, Lau J. The Discovery and Development of Liraglutide and Semaglutide. Front Endocrinol. 2019;10:155. doi: https://doi.org/10.3389/fendo.2019.00155

8. Van Can J, Sloth B, Jensen CB, et al. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults. Int J Obes. 2014;38(6):784–793. doi: https://doi.org/10.1038/ijo.2013.162

9. Mastrandrea LD, Witten L, Carlsson Petri KC, et al. Liraglutide effects in a paediatric (7–11 y) population with obesity: A randomized, double-blind, placebo-controlled, short-term trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Pediatr Obes. 2019;14(5):e12495. doi: https://doi.org/10.1111/ijpo.12495

10. Danne T, Biester T, Kapitzke K, et al. Liraglutide in an Adolescent Population with Obesity: A Randomized, Double-Blind, Placebo-Controlled 5-Week Trial to Assess Safety, Tolerability, and Pharmacokinetics of Liraglutide in Adolescents Aged 12–17 Years. J Pediatr. 2017;181:146–153.e3. doi: https://doi.org/10.1016/j.jpeds.2016.10.076

11. Fox CK, Barrientos-Pérez M, Bomberg EM, et al. Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial. N Engl J Med. 2025;392(6):555–565. doi: https://doi.org/10.1056/NEJMoa2407379

12. Ozhirenie u detei: Clinical guidelines. Russian Association of Endocrinologists. Ministry of Health of Russian Federation; 2021. 70 p. (In Russ).]Доступно по: https://cr.minzdrav.gov.ru/recomend/229_2. Ссылка активна на 10.12.2024.

13. Ametov AS, Shokhin IE, Rogozhina EA, et al. Russian development for drug independence in endocrinology: comparative analysis of bioequivalence, safety and tolerability of the first domestic liraglutide. Pharmacy & Pharmacology. 2023;11(3):255–276. (In Russ). doi: https://doi.org/10.19163/2307-9266-2023-11-3-255-276

14. De Onis M. Development of a WHO growth reference for school-aged children and adolescents. Bull World Health Organ. 2007;85(09):660– 667. doi: https://doi.org/10.2471/BLT.07.043497

15. WHO. Global recommendations on physical activity for health. Geneva: World Health Organization; 2010. 60 p. (In Russ).] Доступно по: https://iris.who.int/handle/10665/90814. Ссылка активна на 16.12.2024.

16. Wiegand S, Keller KM, Lob-Corzilius T, et al. Predicting Weight Loss and Maintenance in Overweight/Obese Pediatric Patients. Horm Res Paediatr. 2014;82(6):380–387. doi: https://doi.org/10.1159/000368963

17. O’Connor EA, Evans CV, Burda BU, et al. Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017;317(23):2427. doi: https://doi.org/10.1001/jama.2017.0332

18. Spiga F, Tomlinson E, Davies AL, et al. Interventions to prevent obesity in children aged 12 to 18 years old. Cochrane Public Health Group, ed. Cochrane Database Syst Rev. 2024;2024(7):CD015330. doi: https://doi.org/10.1002/14651858.CD015330.pub2

19. Evdokimova NV. Role of liraglutide in the treatment of obesity in children. University Therapeutic Journal (St. Petersburg). 2023;5(2):96–104. (In Russ). doi: https://doi.org/10.56871/UTJ.2023.36.20.009

20. Freedman DS, Butte NF, Taveras EM, et al. The Limitations of Transforming Very High Body Mass Indexes into z -Scores among 8.7 Million 2to 4-Year-Old Children. J Pediatr. 2017;188:50–56.e1. doi: https://doi.org/10.1016/j.jpeds.2017.03.039

21. Pi-Sunyer X, Astrup A, Fujioka K, et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015;373(1):11–22. doi: https://doi.org/10.1056/NEJMoa1411892

22. Sharshova OG, Chubarov TV, Peterkova VA, Zhdanova OA. The effect of liraglutide therapy on body weight and carbohydrate metabolism and lipid profile in obese children. Meditsinskiy sovet = Medical Council. 2024;(19):131–137. (In Russ). doi: https://doi.org/10.21518/ms2024-476

23. Jøns C, Porta-Sánchez A, Lai PFH, et al. Mechanism of and strategy to mitigate liraglutide-mediated positive chronotropy. Life Sci. 2021;282:119815. doi: https://doi.org/10.1016/j.lfs.2021.119815


Review

For citations:


Kovtun O.P., Ustiuzhanina M.A., Solodushkin S.I., Kovalchuk L.V., Zaslavskaya K.Ya. Efficacy and Safety of Liraglutide in Adolescents Aged 12–15 Years with Obesity: a Prospective 24-week Observational. Pediatric pharmacology. 2025;22(2):117-128. (In Russ.) https://doi.org/10.15690/pf.v22i2.2871

Views: 222


ISSN 1727-5776 (Print)
ISSN 2500-3089 (Online)