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- Title
Ghrelin Agonist (TZP-101) Gastroprokinetic Action in Diabetic Patients with Gastroparesis: A Pilot Study.
- Authors
Madsen, Jan Lysgård; Madsbad, Sten; Shaughnessy, Laura; Jensen, Thorbjørn; Pezzullo, John; Kosutic, Gordana
- Abstract
TZP-101, a ghrelin receptor agonist has, to date, been evaluated for safety and pharmacokinetic/pharmacodynamic properties in 50 healthy subjects at doses ranging from 20-600µg/kg. The aim of this pilot study was to evaluate the effects of TZP-101 on gastric emptying in patients with diabetic gastroparesis. Two subjects with diabetic gastroparesis (Table 1) received, immediately after a radio-labeled meal, a 30 minute IV infusion of TZP-101 at three dose levels (80, 320 & 600µg/kg) and placebo (4-way cross-over design). Gastric emptying was evaluated using scintigraphy and a[sup 99m]Tc-labeled egg sandwich meal (two scrambled eggs, two pieces of toasted bread; 282 kcal). Gastric emptying was measured 0, 30, 60, 120, 180 and 240 min after the meal. Percent intragastric residual content was calculated for each time point. Half-emptying and latency (first 5% emptying) times were determined by non-linear least squares regression analysis of a power-exponential gastric emptying model. Table 2 presents the reduction in half emptying and latency time, relative to placebo. Conclusion: Analyses of gastric emptying data show a statistically significant reduction in the half-emptying and latency time for TZP-101 relative to placebo, suggesting that TZP-101 is a promising agent for management of diabetic gastroparesis. Further clinical investigation is warranted.
- Subjects
GHRELIN; INSULIN agonists; PHARMACOKINETICS; PHARMACODYNAMICS; GASTROINTESTINAL diseases
- Publication
Diabetes, 2007, Vol 56, pA159
- ISSN
0012-1797
- Publication type
Article