Renal injury and potential species difference from PG exposure have not been reported. In advance of the first-in-human clinical study of MEDI7219 (NCT03362593), the toxicity profile of entericcoated MEDI7219 tablets containing the intended excipients, including PG, was evaluated in dogs to supplement the literature-based safety information. Toxicology studies using the complete formulated, enteric coated tablets in dogs showed signs of renal toxicity. As this finding was observed in the presence or absence of the GLP-1 peptide, it was suspected that one or more of the excipients included in the formulation was responsible for the toxicity. To further elucidate this, a series of tablets that included different combinations of the various excipients were tested in dogs. This was followed by a second study investigating the requirement of an enteric-coated tablet to induce PG-mediated nephrotoxicity. Only enteric-coated tablets containing PG induced nephrotoxicity. The combined results of these studies indicated that PG, when formulated in enteric-coated tables, was likely inducing the renal toxicity, either directly or indirectly.