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This Phase I, single-blind, placebo-controlled, single ascending dose study evaluated the safety, tolerability and pharmacokinetics of oral CVT-3619, a partial A1 adenosine receptor agonist, in 55 healthy and 23 obese volunteers. No clinically meaningful changes in heart rate or blood pressure were observed in the study.
The data showed CVT-3619 was safe and well tolerated in this study up to a single dose of the highest dose tested, 1,800mg in healthy subjects and up to 1,500mg in overweight or obese subjects, with no serious adverse events. In the same study, additional exploratory analyses of pharmacodynamic effects in healthy and obese volunteers show a dose dependent reduction in FFA.
CVT-3619, in preclinical models, has been shown to bind to the A1 adenosine receptors on fat cells, called adipocytes, leading to a reduction in the breakdown of fats, also known as lipolysis, thereby resulting in a lowering of free fatty acids (FFA).
Luiz Belardinelli, senior vice president of clinical research and pharmacology at CV Therapeutics, said: "The exciting initial data from this clinical trial are consistent with our preclinical observations that CVT-3619 causes dose-dependent reductions of circulating FFA."
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