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news.Tranzyme Pharma, a biopharmaceutical company, has initiated dosing in a Phase II study of TZP-102, its potent and selective second generation oral ghrelin agonist, in diabetic patients with gastroparesis.
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This Phase II, randomized, double-blind, placebo-controlled study to be conducted at multiple sites in the US and Europe, will evaluate the safety and efficacy of three 28-day, once-daily, dosage regimens of TZP-102 (10, 20 and 40mg) in accelerating gastric emptying and improving symptoms of gastroparesis among 80 patients with diabetic gastroparesis.
Gastroparesis is an inability of the stomach to empty food efficiently, and comprises a prevalent and serious complication of diabetes mellitus. The characteristics of the compound allow for chronic administration in an out-patient setting, the company said.
Vipin Garg, president and CEO of Tranzyme, said: “Initiating this study of TZP-102, our second novel, internally discovered compound, is another important milestone for Tranzyme. This follows on the recent completion of two successful Phase II trials of our lead product TZP-101 for the treatment of gastroparesis in acute settings and postoperative ileus.”