Capromorelin promotes weight gain in cats with unintended weight loss: a randomized, masked, placebo-controlled clinical trial

Objectives The aim of the study was to evaluate the efficacy and safety of capromorelin to manage weight loss in cats with unintended weight loss, as occurs in chronic kidney disease (CKD), in a randomized, masked, placebo-controlled, multicenter clinical field study. Methods A total of 176 client-owned cats with existing CKD and unintended weight loss of 5% or more were enrolled. Cats were randomized 2:1 to receive capromorelin or a vehicle placebo orally once daily for 55 days. Changes in body weight and safety parameters were monitored throughout the study. Results Body weight increased progressively with time in the capromorelin group and decreased in the placebo group. For the effectiveness population data sample (n = 112), mean change in body weight from day 0 to day 55 was +5.18% (95% confidence interval [CI] 3.45–6.91) with capromorelin and –1.65% (95% CI –3.82 to 0.55) with placebo. The treatment effect (capromorelin minus placebo) from day 0 to day 55 was +6.81% (95% CI 4.21–9.42) with P <0.0001, representing +0.25 kg (95% CI 0.15–0.35) body weight. Hypersalivation was observed only in the capromorelin group ( P <0.0001). For all other adverse events (AEs), there was no significant difference between the treatment groups: in the capromorelin group 96/118 (81.4%) cats and in the placebo group 41/58 (70.7%) cats had at least one reported AE ( P = 0.3650). Conclusions and relevance Capromorelin was safe and effective, and provides a valuable new option to maintain or increase body weight in cats with CKD.