Esben Thyssen Vestergaard

Ghrelin receptor agonist (TZP-101) accelerates gastric emptying in adults with diabetes and symptomatic gastroparesis

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  • N Ejskjaer, Denmark
  • Esben Thyssen Vestergaard
  • P M Hellström, Denmark
  • L C Gormsen
  • S Madsbad, Denmark
  • Sten Madsbad, Denmark
  • J L Madsen, Denmark
  • T A Jensen, Denmark
  • J C Pezzullo, Denmark
  • Jens Sandahl Christiansen, Denmark
  • L Shaughnessy, Denmark
  • G Kosutic, Denmark
  • Department of Mathematical Sciences
  • The Department of Endocrinology and Diabetes
  • Medical Research Laboratory
Abstract Background: TZP-101 is a synthetic, selective ghrelin agonist in development for gastroparesis. Aim: Assess safety and effects of TZP-101 in diabetes patients with symptomatic gastroparesis. Methods: Adults with type 1 or 2 diabetes mellitus received placebo and TZP-101 (80, 160, 320 or 600 mug/kg) infusions in a cross-over manner following a radiolabeled meal. Blood glucose levels were stabilized using a hyperinsulinemic-euglycemic clamp. Primary endpoints were gastic half emptying and latency times. Secondary measures included assessment of gastroparesis symptoms and endocrine responses. Results: Ten patients with type 1 (n=7) or 2 (n=3) diabetes, moderate to severe gastroparesis symptoms, and >/=29% retention 4 hours after a radiolabeled solid meal were enrolled. TZP-101 produced significant reductions in solid meal half-emptying (20%, p=0.043) and latency (34%, p=0.037) times vs. placebo. Reductions in overall post-meal symptom intensity (24%) and postprandial fullness (37%) following TZP-101 infusion were not statistically significant. Most adverse events were mild and self-limiting and there were no identifiable differences in numbers or types of adverse events between TZP-101 and placebo. Conclusions: This proof-of-concept study demonstrates that the ghrelin agonist TZP-101 is well-tolerated in diabetes patients with moderate to severe chronic gastroparesis and shows statistically significant improvements in gastric emptying.
Original languageEnglish
JournalAlimentary Pharmacology and Therapeutics
Pages (from-to)1179-87
Number of pages9
Publication statusPublished - 2009

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