ESPE2024 Poster Category 2 Late Breaking (107 abstracts)
Reducing BMI below the obesity threshold in children aged 6 to <12 years treated with once-daily liraglutide 3.0 mg: A secondary analysis of the SCALE Kids study
Claudia K. Fox 1 , Margarita Barrientos-Pérez 2 , Eric M. Bomberg 1,3 , John Dcruz 4 , Inge Gies 5 , Nina Majlund Harder-Lauridsen 6 , Muhammad Yazid Jalaludin 7 , Kushal Sahu 4 , Petra Weimers 6 , Thomas Zueger 8,9 & Silva Arslanian 10
1Department of Pediatrics, Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis, MN, USA. 2Pediatric Endocrinology, Hospital Angeles Puebla, Puebla City, Mexico. 3Department of Pediatrics, Division of Endocrinology, University of Minnesota Medical School, Minneapolis, MN, USA. 4Novo Nordisk Global Business Services, Bangalore, India. 5Department of Pediatrics, Division of Pediatric Endocrinology, Universitair Ziekenhuis Brussel, Brussels, Belgium. 6Novo Nordisk A/S, Søborg, Denmark. 7Department of Paediatrics, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia. 8Department of Endocrinology and Metabolic Diseases, Kantonsspital Olten, Olten, Switzerland. 9Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. 10Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
Childhood obesity is associated with present and future complications, including type 2 diabetes and cardiovascular disease. Although lifestyle interventions (i.e. dietary and physical activity counselling) are the cornerstone of therapy, their impact on body mass index (BMI) is limited. The phase 3a SCALE Kids study (NCT04775082) demonstrated superiority of liraglutide 3.0 mg versus placebo, plus lifestyle interventions, for BMI reduction in children with general (i.e. non-monogenic, non-syndromic) obesity aged 6–<12 years. This post hoc analysis evaluated changes in weight categories based on BMI growth charts according to CDC.gov. Participants were randomised 2:1 to once-daily, subcutaneous liraglutide 3.0 mg (n = 56) or placebo (n = 26), plus lifestyle interventions, for 56 weeks. Weight categories included: normal weight (NW; BMI <85th percentile); overweight (OW; BMI ≥85th–<95th percentile); obesity class I (OC-I; BMI ≥95th–<120% of the 95th percentile); OC-II (BMI ≥120–<140% of the 95th percentile); and OC-III (BMI ≥140% of the 95th percentile). Analyses used the treatment policy estimand, assessing treatment effect regardless of adherence to treatment or rescue interventions. Weight category data at week 56 were available for 52 liraglutide recipients and 23 placebo recipients. Improvement in BMI categories at week 56 occurred in 30/52 (57.7%) liraglutide recipients and 2/23 (8.7%) placebo recipients, with 8/52 (15.4%) and 1/23 (4.3%), respectively, reaching a BMI below the obesity threshold (OW or NW) (Table:). Among liraglutide recipients, 8/19 (42%), 2/19 (11%), and 2/19 (11%) improved from OC-III to OC-II, OC-I, and OW, respectively; 12/23 (52%) and 1/23 (4%) improved from OC-II to OC-I and NW, respectively; and 3/10 (30%) and 2/10 (20%) improved from OC-I to OW and NW, respectively. These findings support the use of liraglutide for treating general obesity in children aged 6–<12 years and demonstrate the potential of liraglutide to reduce BMI, even below the obesity threshold.
| N | Baseline OW | Baseline OC-I | Baseline OC-II | Baseline OC-III | |
| Week 56 | |||||
| Liraglutide, n (%) NW OW OC-I OC-II OC-III |
52 | 2 (20.0) ↓ 3 (30.0) ↓ 5 (50.0) ↔ |
1 (4.3) ↓ 12 (52.2) ↓ 10 (43.5) ↔ |
2 (10.5) ↓ 2 (10.5) ↓ 8 (42.1) ↓ 7 (36.8) ↔ |
|
| Placebo, n (%) NW OW OC-I OC-II OC-III |
23 | 1 (14.3) ↔ | 1 (14.3) ↓ 5 (71.4) ↔ 1 (14.3) ↑ |
4 (100.0) ↔ | 1 (9.1) ↓ 10 (90.9) ↔ |
| ↓Improvement in weight category; ↑Worsening; ↔Unchanged. | |||||
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