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 reports the effect of intervention in liraglutide-treated individuals categorized as early responders (ERs) who lost ≥4% body weight at week 16. This subgroup corresponded to individuals considered eligible to continue treatment after 16 weeks in a real-world clinical setting.

Methods

The 56-week SCALE Insulin trial randomized adults with overweight/obesity and T2D (BMI ≥27 kg/m2; HbA1c 6–10%) treated with basal insulin and ≤2 OADs to liraglutide 3.0 mg or placebo as adjunct to IBT. 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=198) for liraglutide 3.0 mg-treated individuals: 56y, 55% female, 222 lb, BMI 36 kg/m2. At 16 weeks, 62.1% of all randomized individuals had achieved ≥4% WL (ERs). At 56 weeks, mean WL in ERs was 8.8%, with 78.8% and 35.8% of this subset achieving WL ≥5% and >10%, respectively. Mean WL in ENRs was 1.1%; 10.4% and 1.7% of ENRs achieved ≥5% and >10% WL, respectively. Gastrointestinal adverse events were reported in 66.1% of ERs and 54.2% of ENRs. The proportion of individuals experiencing ≥1 hypoglycemic episode was 76.8% for ERs and 66.7% for ENRs.

Conclusions

Over 60% of people with overweight/obesity and insulin-treated T2D receiving liraglutide 3.0 mg as adjunct to IBT were eligible for long-term treatment according to FDA prescribing information. Of these, most continued on therapy to 56 weeks, achieving clinically relevant reductions in body weight.