Introduction: The SCALE Obesity and Prediabetes trial (NCT01272219) investigated the efficacy and safety of liraglutide 3.0 mg for weight management as adjunct to a 500 kcal/day deficit diet and exercise programme.
Methods: Adults with BMI ≥27 kg/m² and ≥1 comorbidity or with BMI ≥30 kg/m² were randomised 2:1 to once-daily liraglutide 3.0 mg (n=2487) or placebo (n=1244). Data are observed means for the full analysis set with LOCF at week 56, unless stated otherwise. Statistical analyses report estimated treatment differences (ETD; ANCOVA, continuous variables) or odds ratios (logistic regression, categorical). Baseline BMI subgroups were ≤29.9, 30–34.9, 35–39.9 and ≥40 kg/m².
Results: Baseline characteristics were: mean age 45 years, 79% female, mean body weight (BW) 106 kg, mean BMI 38 kg/m² and 61% with prediabetes. A total of 92% of individuals on liraglutide lost BW vs 65% on placebo. Completers on liraglutide (n=1789, 72%) lost 9.2% (9.7 kg) of their BW vs 3.5% (3.8 kg) on placebo (n=801, 64%; ETD –5.7%, p<0.0001). In total, 73% of completers on liraglutide lost ≥5% BW vs 35% on placebo. WL of >10% occurred in 41% of completers on liraglutide vs 14% on placebo vs placebo-treated individuals. Overall, WL with liraglutide was similar in those with and without prediabetes at screening (8.0% vs 7.9%, respectively, p=0.59) and across baseline BMI subgroups (interaction between BMI subgroup and treatment for relative WL (%): p=0.054 and absolute WL (kg): p=0.54). Non-completion was mainly due to GI AEs (liraglutide group) and lack of efficacy (placebo group).
Conclusion: Liraglutide 3.0 mg, as adjunct to diet and exercise, induced significant WL compared to placebo. WL with liraglutide was independent of both baseline prediabetes status and baseline BMI. Liraglutide 3.0 mg was generally well tolerated and gastrointestinal disorders were the most commonly reported AEs. No new safety signals emerged.