Evaluation of the safety of daily administration of capromorelin in cats

Abstract

Capromorelin is a ghrelin receptor agonist that is FDA approved for appetite stimulation in dogs. The objective of this study was to evaluate the safety of daily oral administration of capromorelin to cats over a range of doses and for an extended period. Two randomized, controlled studies were conducted: in Study 1, cats (n = 6 per group) received placebo or capromorelin at a dose of 9, 15, 30 or 60 mg/kg once daily for 14 days; and in Study 2, cats received capromorelin at 6 mg/kg (n = 8) or placebo (n = 4) once daily for 91 days. Cats were evaluated using clinical observations and clinical pathology test results for both studies, with the addition of postmortem examination in Study 1 and measurements of growth hormone and insulin-like growth factor 1 in Study 2. Abnormal clinical observations were limited to emesis, hypersalivation, lethargy/depression, head shaking and lip smacking, which occurred more frequently in the capromorelin-treated groups than in the placebo group. There were no clinically relevant differences in clinical pathology test results between the capromorelin and placebo groups in either study.

Capromorelin: a ghrelin receptor agonist and novel therapy for stimulation of appetite in dogs

“…Body weights of capromorelin-treated cats increased between approximately 3.9-5.4%, while the placebo group lost weight (approximately 1.1%) . Statistically significant increases in food intake and body weight were seen in a 91-day study of laboratory cats treated with 6 mg/kg capromorelin, at day 91, mean weight increases were 0.8 kg and 0.16 kg for the capromorelin and placebo-treated groups respectively (Wofford et al 2017).…”

“…Statistically significant increases in food intake and body weight were seen in a 91‐day study of laboratory cats treated with 6 mg/kg capromorelin, at day 91, mean weight increases were 0.8 kg and 0.16 kg for the capromorelin and placebo‐treated groups respectively (Wofford et al . ).…”

“…) and in a 91‐day safety study in laboratory cats, treatment with 6 mg/kg capromorelin increased GH and IGF‐1 levels as compared to placebo treatment (Wofford et al . ).…”

“…Other than some salivation and head shaking after dosing, no adverse effects were seen (Wofford et al . ).…”

“…The treatment effect overall was found to be statistically significant for fructosamine, but the mean fructosamine concentrations were higher in the placebo than in the capromorelin‐treated group at days 30 and 91, and no fructosamine value was outside of the reference range (Wofford et al . ).…”