Effects of treatment with liraglutide 3.0 mg in subjects with BMI < 35 and BMI ≥35 kg/m2: subgroup analysis of the SCALE Obesity and Prediabetes 56-week trial

This post-hoc analysis investigated effects of liraglutide 3.0 mg in those with BMI < 35 v ≥35 kg/m² at baseline in the SCALE Obesity and Prediabetes trial.3731 adults (mean ± SD: age 45.1 ± 12.0y; BMI 38.3 ± 6.4 kg/m²; male 21.5%; with prediabetes 61.2%) were randomized 2:1 to liraglutide 3.0 mg or placebo as adjunct to diet and exercise (D&E) for 56 weeks (W). Treatment effect across baseline BMI subgroups was evaluated by testing interaction between baseline BMI subgroup and treatment (BMI < 35: liraglutide 3.0 mg 856 patients; placebo 423; BMI ≥35: liraglutide 3.0 mg 1581; placebo 802). Baseline demographics were similar for liraglutide and placebo, and across BMI subgroups, except prediabetes prevalence (higher with BMI ≥35 kg/m²). Relative change in BW (baseline -W56) was greater with liraglutide 3.0 mg vs. placebo and consistent across subgroups (interaction p = 0.2565; ETD-5.7% [95% CI -6.5; -5.0] for BMI < 35 kg/m²; -5.2% [-5.7; -4.7] for BMI ≥35 kg/m²). Proportion of those achieving ≥5% and > 10% weight loss (WL) at W56 was consistent across BMI subgroups (interaction: p = 0.0859 & p = 0.7252; estimated OR for ≥5% WL: 5.8 [4.4;7.5] for BMI < 35 kg/m²; 4.4 [3.6;5.3] for BMI ≥35 kg/m²; for > 10% WL: 4.6 [3.3;6.4] for BMI < 35 kg/m²; 4.2 [3.3;5.5] for BMI ≥35 kg/m²). Greater improvements (liraglutide 3.0 mg vs. placebo) in both BMI subgroups were seen for SBP, FPG, and IWQoL-Lite Total score. Only IWQoL-Lite Physical Function score improved more with BMI ≥35 kg/m² (interaction p = 0.0398). AEs and SAEs were generally comparable across BMI subgroups. Effects of liraglutide 3.0 mg, as adjunct to D&E, on BW, metabolic control and safety were similar in adults with BMI < 35 and ≥35 kg/m².