Background

The FDA label for liraglutide 3.0 mg defines a stopping rule for individuals achieving <4% body weight reduction after 16 weeks’ treatment. This post hoc analysis explored the effect of intervention in the subgroup of liraglutide-treated individuals categorized as early responders (ERs) who lost ≥4% body weight at week 16. This subgroup corresponded to individuals who would have been eligible to continue treatment after 16 weeks in a real-world clinical setting.

Methods

The 56-week SCALE IBT trial randomized adults with obesity (BMI ≥30 kg/m2) and without diabetes to liraglutide 3.0 mg or placebo as an adjunct to IBT (physical activity escalating to 250 min/week, 1200–1800 kcal/day hypocaloric diet and 23 behavior counselling sessions). Data are presented for ERs (≥4% weight loss [WL] at week 16) and early non-responders (ENRs: <4% WL at week 16) after 56 weeks’ treatment. Missing data were imputed using J2R-MI. Data presented for the two subsets are for descriptive purposes only. As data are not placebo-adjusted, any differences in outcomes between ERs and ENRs should be interpreted with caution.

Results

Mean characteristics at randomization (n=142) for liraglutide 3.0 mg-treated individuals: 45y, 84% female, BMI 39 kg/m2. At 16 weeks, 76.1% of all randomized individuals had achieved ≥4% WL (ERs). At 56 weeks, mean WL in ERs was 9.4%, with 72.7%, 38.6% and 22.8% of this subset achieving WL ≥5%, >10% and >15%, respectively. Mean WL in ENRs was 0.8%; 24.5%, 0% and 0% of ENRs achieved ≥5%, >10% and >15% WL, respectively. Gastrointestinal adverse events were reported in 75.0% of ERs and 58.8% of ENRs.

Conclusions

Over 75% of people with obesity receiving liraglutide 3.0 mg as an adjunct to IBT were eligible for long-term treatment according to FDA prescribing information. Of these, the majority continued on therapy to 56 weeks, achieving clinically relevant reductions in body weight.