Phase 2 study of TZP-102 for diabetic gastroparesis

Tranzyme Pharma announced positive results from its Phase 2 study of TZP-102 for the treatment of gastroparesis in patients with diabetes mellitus (DM). This study was a double-blind, placebo-controlled parallel group in 92 patients with either Type 1 or Type 2 DM and a confirmed diagnosis of gastroparesis, documented by the presence of both chronic symptoms and delayed gastric emptying (GE). Patients were randomly assigned to receive one of three oral daily doses of TZP-102 (10, 20 & 40 mg) or placebo, for a treatment period of 28 days. TZP-102's effects on symptom severity were evaluated by a validated patient-reported outcome (PRO) instrument, the Patient Assessment of Gastrointestinal Symptoms scale (PAGI-SYM), and the Gastroparesis Cardinal Symptom Index (GCSI) after 8, 15, and 28 days of treatment.

At the end of the treatment period, statistically significant improvements in symptom scores for Nausea, Early Satiety, Excessive Fullness, Postprandial Fullness and total GCSI were observed, with p-values of 0.029, 0.001, 0.002, 0.020 and 0.015, respectively. The average severity of symptoms during the 28-day treatment (mean of Days 8, 15 & 28) demonstrated similar statistically significant improvements. TZP-102 also improved Upper & Lower Abdominal Pain/Discomfort (p=0.025 and p=0.016). At the end of treatment, over 50% of patients on TZP-102 had normalized gastric emptying (vs. 20% on placebo).

TZP-102 is an oral ghrelin agonist with potent prokinetic properties being developed for the treatment of chronic gastrointestinal dysmotility disorders such as gastroparesis, functional dyspepsia, and refractory GERD.

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