Table 2: Summary of paediatric clinical trial results of glucagon-like peptide-1 receptor agonist use in paediatric obesity.
| Study | Design | Sample size | Age in years | Main inclusion criteria | Dose | Duration | Efficacy | Safety |
|---|---|---|---|---|---|---|---|---|
| Liraglutide | ||||||||
| Kelly etal. (2020)63 | RCT | 251 | 12-17 | BMI >95th percentile, did not exclude if T2D | 3.0 mg daily | 56 weeks + 26 weeks follow up | zBMI change (SD): ETD of -0.22, favouring intervention (p=0.002) Reduction in BMI of >5%: 43.3% of intervention versus 18.7% of placebo Reduction in BMI of >10%: 26.1% of intervention versus 8.1% of placebo |
Gl AEs more frequent in intervention (64.8% versus 36.5%) AEs leading to discontinuation more frequent in intervention (10.4% versus 0.0%) Few SAEs (2.4% versus 4.0%) |
| Bensignor et al. (202 D69 | RCT | 134 | 10-16 | BMI >85th percentile andT2D | 0.6 mg daily 1.2 mg daily 1.8 mg daily |
52 weeks | BMI change: ETD of -0.89 (kg/m2), favouring intervention (p=0.036) % change in BMI: ETD of -2.73%, favouring intervention (p=0.028) %BMIp95 change: ETD of -4.42%, favouring intervention (p=0.038) Findings are significant at 52 weeks, not at 26 weeks |
Not evaluated |
| Exenatide | ||||||||
| Kelly etal. (2012)70 | Randomized, open-label, crossover | 12 | 9-16 | BMI >1.2 times the 95th%, or BMI >35 kg/m2 | 10 pg twice daily DE: 5 pg twice daily, 10 pg twice daily | 3 months | BMI change: ETD of -1.71 (kg/m2), favouring intervention (p=0.01) % change in BMI: ETD of -4.92%, favouring intervention (p=0.009) Total body weight change: ETD of -3.9 kg, favouring intervention (p=0.02) Insulin-related findings: Fasting insulin change: ETD of -7.5 mU/L, favouring intervention (p=0.02) Insulin sensitivity: ETD of +6.1, favouring intervention (p=0.02) p-cell function: ETD of +17.97, favouring intervention (p=0.03) |
Mild nausea in 36%, vomiting in 27%, headache in 27%, abdominal pain in 27%, injection site bruising in one participant No hypoglycaemia or pancreatitis |
| Fox etal. (2022)71 | RCT | 100 | 12-18 | BMI >1.2 times the 95th percentile | 2.0 mg extended release, weekly | 52 weeks | % change in BMI: ETD of -4.1%, favouring intervention, did not reach significance (p=0.078) Cardiometabolic findings: TG/HDL ratio: ETD of -0.61, favouring intervention (p=0.05) |
AE frequency similar between groups (96.9% of intervention versus 90.9% of placebo) Gl AEs more common in intervention No serious adverse event directly related to the study drug |
| Semaglutide | ||||||||
| Weghuber et al. (2022)72 | RCT | 201 | 12-17 | BMI >95th percentile or BMI >85th percentile + weight-related coexisting condition | 2.4 mg weekly | 68 weeks | % change in BMI: ETD of -16.7%, favouring intervention group (p=<0.001) Weight loss of >5%: 73% of intervention versus 18% of placebo Cardiometabolic findings: Improved waist circumference, HbA1c, lipids, AST were greater in intervention |
Gl AEs greater (62% of intervention versus 42% of placebo) 4% with cholestasis in intervention SAEs in 11% of intervention versus 9% of placebo |
Liraglutide and semaglutide have received United States Food and Drug Administration approval for oPesity in age 12 years and above.
AE = adverse event; AST = aspartate transaminase; BMI = body mass index; %BMip95 = body mass index per cent over the 95th percentile; DE = dose escalation; ETD = estimated treatment difference; Gl = gastrointestinal; HbA 1 c = hemoglobin A1 c; HDL = high-density lipoprotein; p85 = 85th percentile; RCT = randomized controlled trial; SAE = serious adverse event; SD = standard deviation; T2D = type 2 diabetes; TG = triglyceride; zBMI = body mass index Z-score.