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  • Ejskjaer, N. (author)

A phase 2a, randomized, double-blind 28-day study of TZP-102 a ghrelin receptor agonist for diabetic gastroparesis

  • Article/chapterEnglish2013

Publisher, publication year, extent ...

  • 2012-12-23
  • Wiley,2013
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-194865
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-194865URI
  • https://doi.org/10.1111/nmo.12064DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Background Gastroparesis causes significant morbidity and treatment options are limited. TZP-102 a novel, macrocyclic, selective, oral ghrelin receptor agonist, was evaluated in a randomized, double-blind, placebo-controlled trial in patients with diabetic gastroparesis. Methods A total of 92 outpatients were randomized to once-daily administrations of 10-mg (n=22), 20-mg (n=21), 40-mg (n=23) TZP-102 or placebo (n=26). The primary endpoint was the change from baseline in gastric half-emptying time (T1/2) utilizing 13C-breath test methodology and secondary endpoints included symptom improvement using patient-reported gastroparesis symptom scores (PAGI-SYM questionnaire) and patient and physician overall treatment evaluations (OTE). Key Results Gastric T1/2 changes were not statistically significant between TZP-102 and placebo after 28days of treatment at any dose. Clinical improvements (-1.0 to -1.4 point mean decrease in symptom severity) occurred in the Gastroparesis Cardinal Symptom Index (GCSI) component of the PAGI-SYM, which was significant vs placebo for all TZP-102 doses combined. Improvements became evident after 1week of treatment. Significantly, more patients given TZP-102 (any dose) had a 50% reduction in baseline GCSI score (28.8%vs 7.7% placebo). Safety profiles were similar across groups. All TZP-102 doses were well-tolerated with no adverse cardiac, weight, or glucose control outcomes. Conclusions & Inferences TZP-102 for 28days, at doses of 10-40mg once daily, was well-tolerated and resulted in a reduction in symptoms of gastroparesis. The lack of correlation between symptom improvement and gastric emptying change is consistent with previous studies in diabetic gastroparesis, and emphasizes the value of patient-defined outcomes in determining therapeutic benefit.

Subject headings and genre

  • Diabetes type 1
  • Diabetes type 2
  • Diabetic gastroparesis
  • Gastroparesis
  • Oral ghrelin receptor agonist

Added entries (persons, corporate bodies, meetings, titles ...)

  • Wo, J. M. (author)
  • Esfandyari, T. (author)
  • Mazen Jamal, M. (author)
  • Dimcevski, G. (author)
  • Tarnow, L. (author)
  • Malik, R. A. (author)
  • Hellström, Per M.Uppsala universitet,Gastroenterologi/hepatologi(Swepub:uu)perhe742 (author)
  • Mondou, E. (author)
  • Quinn, J. (author)
  • Rousseau, F. (author)
  • Mccallum, R. W. (author)
  • Uppsala universitetGastroenterologi/hepatologi (creator_code:org_t)

Related titles

  • In:Neurogastroenterology and Motility: Wiley25:2, s. e140-e1501350-19251365-2982

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