Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis

Abstract

Objective: To investigate whether the efficacy and safety of liraglutide 3.0 mg differed between two subgroups, BMI 27 to <35 and BMI ≥ 35 kg/m², in individuals without and with type 2 diabetes (T2D).

Methods: A post-hoc analysis of two 56-week, randomized, double-blind, placebo-controlled trials (SCALE Obesity and Prediabetes; SCALE Diabetes). Subgroup differences in treatment effects of liraglutide 3.0 mg were evaluated by testing the interaction between treatment group and baseline BMI subgroup.

Results: Significantly greater weight loss (0-56 weeks) was observed with liraglutide 3.0 mg versus placebo in all patient groups while on treatment. There was no evidence that the weight-lowering effect of liraglutide 3.0 mg differed between BMI subgroups (interaction p > 0.05). Similarly, for most secondary endpoints significantly greater improvements were observed with liraglutide 3.0 mg versus placebo, with no indication treatment effects differing between subgroups. The safety profile of liraglutide 3.0 mg was broadly similar across BMI subgroups.

Conclusion: This post-hoc analysis did not indicate any differences in the treatment effects, or safety profile, of liraglutide 3.0 mg for individuals with BMI 27 to <35 or ≥35 kg/m². Liraglutide 3.0 mg can therefore be considered for individuals with a BMI of ≥35 as well as for those with a BMI of 27 to <35 kg/m².

Keywords: Efficacy; Liraglutide; Obesity; Safety.

Fig. 1

Forest plots showing the treatment effects of liraglutide 3.0 mg, by baseline BMI 27 to <35 and ≥35 kg/m². Data are 0-56 weeks for the full analysis set. Statistical analysis is analysis of covariance with last observation carried forward. P-values are based on a test of interaction between treatment effect and baseline BMI subgroup and reflect the evidence of a difference in treatment effect between BMI subgroups. ETDs refer to change from baseline to 56 weeks (liraglutide 3.0 mg – placebo). CI = Confidence interval; DBP = diastolic blood pressure; ETD = estimated treatment difference; FAS = full analysis set; FPG = fasting plasma glucose; HbA_1c = glycated hemoglobin; IWQOL-Lite = Impact of Weight of Quality of Life-Lite questionnaire; SBP = systolic blood pressure; T2D = type 2 diabetes.

Fig. 2

Achievement of categorical fasting weight-loss (loss of ≥5%, >10%, and >15% body weight at 56 weeks) by baseline BMI and diabetes status. Statistical analysis is analysis of covariance with last observation carried forward. Data are model-based estimates of ORs and proportions, based on the full analysis set. Estimated proportions are adjusted to the observed baseline distribution of the individuals included in the models in each BMI subgroup. Interaction p values are based on a test of interaction between treatment effect and baseline BMI subgroup and reflect the evidence for a difference in treatment effect between BMI subgroups. CI = Confidence interval; OR = odds ratio.