The SCALE Maintenance trial randomised adults with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with comorbidities who lost ≥5% of initial body weight during a 4-12-week low-calorie diet (1200-1400 kcal/day) run-in period pre-randomisation to liraglutide 3.0 mg or placebo as adjunct to diet and exercise. This SCALE Maintenance trial post-hoc analysis compares outcomes in liraglutide 3.0 mg early responders (ERs) vs. early non-responders (ENRs) who completed 56 weeks’ treatment (ERs vs. ENRs; ≥5% vs. <5% weight loss at week 16 post-randomisation).
Materials and methods:
Efficacy outcomes for liraglutide 3.0 mg ERs vs. ENRs are reported as observed means or proportions for individuals completing 56 weeks’ treatment. The safety analysis set was used for AEs.
Randomisation mean characteristics (n=212) for participants on liraglutide 3.0 mg were: 46 years, 84% female, BMI 36 kg/m2. Of those completing 56 weeks’ treatment (n=159), 108 (68%) were ERs to liraglutide 3.0 mg and 51 (32%) ENRs. 91.7% ERs maintained their run-in weight loss (or lost further weight) during 56 weeks’ treatment vs. 47.1% of ENRs. The percentage of those regaining all weight lost during the run-in period by week 56 was 0.0% for ERs vs. 3.9% for ENRs. At week 56, greater mean (9.9% vs. 0%) and categorical weight loss (≥5%: 73.1% vs. 11.8%; >10%: 47.2% vs. 0%; >15%: 20.4 vs. 0%) and similar improvements in cardiometabolic risk factors, including waist circumference and plasma glucose levels, were observed in ERs vs ENRs. AEs were reported in 92.7% of ERs vs. 91.0% of ENRs. For SAEs, proportions were 4.9% vs. 0.0% and for gastrointestinal AEs 78.9% vs. 62.7% for ERs vs. ENRs, respectively.
Among those who completed 56 weeks’ treatment, liraglutide 3.0 mg ERs achieved greater mean and categorical weight loss than liraglutide 3.0 mg ENRs, following ≥5% weight loss pre-randomisation.