Background: Treatment effects on eating behaviour require further characterisation in people living with overweight/obesity. This analysis of a Phase II trial (NCT04667377) of glucagon/glucagonlike peptide-1 receptor dual agonist survodutide (Bl 456906) in adults with BMI 27 kg/m2 assessed the effect of treatment on eating behaviour using an Eating Behaviour Patient-Reported Outcome (EB PRO) measure.
Methods: The trial was a randomised, double-blind, placebo-controlled, 46-week, dose-finding study of weekly subcutaneous survodutide 0.6–4.8 mg. The EB PRO (scored as Total Eating Behaviour Score [TEBS] and two domains of Desire to Eat [DtE] and Capacity to Resist [CtR]) was assessed at Screening, Baseline, Week 20 and 46.
Results: 387 participants were randomised (treated set, N=386; full analysis set [FAS], N=384; n 77 per arm). Baseline (FAS) mean (standard deviation [SD]) age was 49.1 (12.9) years, 68.2% of participants were female, and 78.4% were White. Mean (SD) bodyweight and body mass index (BMI) were 105.7 (20.4) kg and 37.1 (6.1) kg/m2, respectively; 90.1% of participants (n=346/384) had obesity (BMI 30 kg/m2). Survodutide-treated participants showed greater improvement vs placebo in both domains at all tested doses, with the largest improvement observed in participants treated with survodutide 3.6 and 4.8 mg. Post hoc Mixed-model repeated measures analysis (n=185) revealed that survodutide (3.6 mg and 4.8 mg groups pooled) vs placebo improved adjusted DtE score (-5.15 vs -2.57), CtR score (-6.38 vs -4.23), and TEBS (-11.51 vs -6.81) at Week 46. Responder analysis showed that more survodutide-treated participants than placebo recipients had a 4-point improvement in DtE (64.7% vs 38.0%) and CtR (72.5% vs 56.0%). An 8-point improvement in TEBS was reported by 67.6% of survodutide-treated participants vs 44.0% participants on placebo.
Conclusions: Survodutide had substantially greater efficacy vs placebo in improving eating behaviours on top of appropriate dietary and lifestyle counselling.